Dorin dan Kawan-kawan di Asrama saat Mau Berangkat Wisuda ISO 9000 and ISO 14000
This section provides a concise overview of ISO's best known management system standards and their impact on the world.
In brief
The ISO 9000 and ISO 14000 families are among ISO's best known standards ever.
ISO 9001:2000 and ISO 14001: 2004 are implemented by over a million organizations in 175 countries.
ISO 9000 family
The ISO 9000 family addresses "Quality management".
This means what the organization does to fulfill:
• the customer's quality requirements, and
• applicable regulatory requirements, while aiming to
• enhance customer satisfaction, and
• achieve continual improvement of its performance in pursuit of these objectives.
ISO 14000 family
The ISO 14000 family addresses "Environmental management".
This means what the organization does to:
• minimize harmful effects on the environment caused by its activities, and to
• achieve continual improvement of its environmental performance.
Quality management principles
The following text is an integral reproduction of the content of the document "Quality Management Principles".
Introduction
This document introduces the eight quality management principles on which the quality management system standards of the ISO 9000:2000 and ISO 9000:2008 series are based. These principles can be used by senior management as a framework to guide their organizations towards improved performance. The principles are derived from the collective experience and knowledge of the international experts who participate in ISO Technical Committee ISO/TC 176, Quality management and quality assurance, which is responsible for developing and maintaining the ISO 9000 standards.
The eight quality management principles are defined in ISO 9000:2005, Quality management systems Fundamentals and vocabulary, and in ISO 9004:2000, Quality management systems Guidelines for performance improvements.
This document gives the standardized descriptions of the principles as they appear in ISO 9000:2005 and ISO 9004:2000. In addition, it provides examples of the benefits derived from their use and of actions that managers typically take in applying the principles to improve their organizations' performance.
ISO 9000 essentials
This section concisely describes the essential features of the ISO 9000 family.
The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines relating to quality management systems and related supporting standards.
ISO 9001:2008 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.
The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects.
Why an organization should implement ISO 9001:2008
Without satisfied customers, an organization is in peril! To keep customers satisfied, the organization needs to meet their requirements. The ISO 9001:2008 standard provides a tried and tested framework for taking a systematic approach to managing the organization's processes so that they consistently turn out product that satisfies customers' expectations.
How the ISO 9001:2008 model works
The requirements for a quality system have been standardized - but many organizations like to think of themselves as unique. So how does ISO 9001:2008 allow for the diversity of say, on the one hand, a "Mr. and Mrs." enterprise, and on the other, to a multinational manufacturing company with service components, or a public utility, or a government administration?
The answer is that ISO 9001:2008 lays down what requirements your quality system must meet, but does not dictate how they should be met in any particular organization. This leaves great scope and flexibility for implementation in different business sectors and business cultures, as well as in different national cultures.
Checking that it works
1. The standard requires the organization itself to audit its ISO 9001:2008-based quality system to verify that it is managing its processes effectively - or, to put it another way, to check that it is fully in control of its activities.
2. In addition, the organization may invite its clients to audit the quality system in order to give them confidence that the organization is capable of delivering products or services that will meet their requirements.
3. Lastly, the organization may engage the services of an independent quality system certification body to obtain an ISO 9001:2008 certificate of conformity. This last option has proved extremely popular in the market-place because of the perceived credibility of an independent assessment.
The organization may thus avoid multiple audits by its clients, or reduce the frequency or duration of client audits. The certificate can also serve as a business reference between the organization and potential clients, especially when supplier and client are new to each other, or far removed geographically, as in an export context.
Selection and use of the ISO 9000 family of standards
The ISO 9000 family of international quality management standards and guidelines has earned a global reputation as a basis for establishing effective and efficient quality management systems.
The need for International Standards is very important as more organizations operate in the global economy by selling or buying products and services from sources outside their domestic market.
This content has been developed by ISO technical committee ISO/TC 176, Quality management and quality assurance, which is responsible for developing and maintaining the ISO 9000 family. Supporting guideline standards and other documents are developed and updated on a continual basis to meet the needs and expectations of users and the market itself. It explains how you can use them to improve your quality management system. It provides a general perspective of the ISO 9000 family of standards. It is an overview of the standards and demonstrates how, collectively, they form a basis for continual improvement and business excellence.
ISO 9001 specifies the basic requirements for a quality management system (QMS) that an organization must fulfil to demonstrate its ability to consistently provide products (which include services) that enhance customer satisfaction and meet applicable statutory and regulatory requirements.
The standard can be used for certification/registration and contractual purposes by organizations seeking recognition of their quality management system. ISO 9001 has been organized in a user-friendly format with terms that are easily recognized by all business sectors.
You will obtain the greatest value by using the entire family of standards in an integrated manner. It is highly recommended that you use ISO 9000 to become familiar with the basic concepts and the language used before you adopt ISO 9001 to achieve a first level of performance. The practices described in ISO 9004 may then be implemented to make your quality management system more effective and efficient in achieving your business goals and objectives. The ISO 9001 and ISO 9004 standards have been written to enable you to relate them to other management systems (e.g. environmental), or to sector specific requirements (such as ISO/TS 16949 in the automotive industry) and to assist you in gaining recognition through national or regional award programmes.
This brochure provides you with :
• An overview of the ISO 9000 core standards
• A step-by-step process to implement a quality management system
• Examples of typical applications of the documents, and
• Information on the ISO 9000 family of standards.
ISO 9001:2008
Introduction and support package
In conjunction with the publication of ISO 9001:2008, Quality management systems - Requirements, ISO technical committee ISO/TC 176, Quality management and quality assurance, subcommitte SC 2, Quality systems, has published a number of guidance modules:
• Guidance on ISO 9001:2008 sub-clause 1.2 "Application"
• Guidance on the documentation requirements of ISO 9001:2008
• Guide to the Terminology used in ISO 9001 and ISO 9004
• Guidance on the concept and use of the process approach for management systems
• Guidance on 'Outsourced processes'
• Implementation guidance for ISO 9001:2008
• Frequently Asked Questions (FAQs)
Transition schedule
• ISO and IAF announce schedule for implementation of accredited certification to ISO 9001:2008
ISO publishes book+CD on integrated use of management system standards
2008-07-15
ISO has published a combined book and CD giving organizations advice on how to make integrated use of management system standards.
The integrated use of management system standards distils the experience and expertise of an ISO task force comprising 16 members drawn from business organizations representing a wide range of countries and sectors, as well as from standards bodies and academia.
“The book provides a good mixture of theory and practice and will be useful for beginners as well as for the experienced,” declares Petra Eckl of MLPC International, France, leader of the ISO task force. “It will form a bridge between the increasing number of ISO management system standards that meet specific concerns of organizations and their stakeholders, and the user organization’s own and unique management approach.”
ISO management system standards (MSS), such as ISO 9001:2000 for quality management and ISO 14001:2004 for environmental management, are among the most widely used International Standards, while new ISO MSS are gaining ground, including ISO 22000 (food safety), ISO 28000 (supply chain security) and ISO/IEC 27001 (information security).
Contrary to many other types of standard, management system standards cover multiple aspects, levels and functions of an organization and, therefore, their implementation can have a substantial impact on how an organization operates and manages its business processes. In addition, more and more organizations are applying not only one, but a range of management system standards to satisfy their own needs as well as those of external stakeholders.
The book acknowledges that there is a market need for separate management system standards addressing different aspects, issues or risks that organizations need to manage. It provides guidance on how organizations can apply the different standards in a combined way, integrated with their business processes.
Based on the practical experience of organizations that have successfully made integrated use of management system standards, the book identifies a variety of methodologies, tools and practices.
The book, which is in colour and includes numerous graphics, is structured as follows:
• a description of the main characteristics, parts and functions of the management system of an organization
• what sort of requirements are contained in a management system standard, why these are important and how an organization should apply them
• guidance on how requirements from multiple management system standards can be integrated in a combined way within the existing management system of an organization.
Each chapter includes the following distinct sections:
• Guiding questions that helps to focus the reader
• Overview summarizing the theory of the topic concerned
• Approach featuring the methodologies and tools applied
• Jim the Baker – an imaginary character whose company is used to illustrate the implementation of the methodologies and tools
• Cases in point with actual practices and examples from case studies
• Practice assists readers in applying the principles and methods provided to their own situation.
The accompanying CD (inside the back cover), contains real-life examples extracted from 15 case studies made in a wide variety of situations. Examples are included from companies in Asia, South America and the Middle East, as well as Europe and North America. Multinational companies are included as well as smaller ones, in different sectors of activity, for profit and not-for-profit, applying different sets of management system standards.
ISO Secretary-General Alan Bryden comments: “This book should prove to be a very useful complement to ISO’s continuing efforts to ensure theconsistency, coverage and effective useof its management system standards.”
The integrated use of management system standards (ISBN 978-92-67-10473-7), 146 pages + CD, A5 format, ring binder, costs 48 Swiss francs and is available from ISO national member institutes (see the complete list with contact details) and from ISO Central Secretariat through the ISO Store or by contacting the Marketing & Communication department (see right-hand column).
Quality management principles
The following text is an integral reproduction of the content of the document "Quality Management Principles".
Introduction
This document introduces the eight quality management principles on which the quality management system standards of the ISO 9000:2000 and ISO 9000:2008 series are based. These principles can be used by senior management as a framework to guide their organizations towards improved performance. The principles are derived from the collective experience and knowledge of the international experts who participate in ISO Technical Committee ISO/TC 176, Quality management and quality assurance, which is responsible for developing and maintaining the ISO 9000 standards.
The eight quality management principles are defined in ISO 9000:2005, Quality management systems Fundamentals and vocabulary, and in ISO 9004:2000, Quality management systems Guidelines for performance improvements.
This document gives the standardized descriptions of the principles as they appear in ISO 9000:2005 and ISO 9004:2000. In addition, it provides examples of the benefits derived from their use and of actions that managers typically take in applying the principles to improve their organizations' performance.
ISO 9001:2000 – What does it mean in the supply chain?
• Introduction
• What is ISO 9001:2000?
• What does “Conformity to ISO 9001:2000” mean?
• How does ISO 9001:2000 help you in selecting a supplier?
• How can you have confidence that your supplier meets ISO 9001:2000?
• Can suppliers claim that their goods or services meet ISO 9001:2000?
• What to do if things go wrong
• To summarize...
Introduction
As someone who is involved in the selection of suppliers, and possibly responsible for purchasing decisions, you may have seen or used goods and services that are promoted using reference to ISO 9001:2000, or, more simply “ISO 9000”. What does this mean? How can this help you? How can you be sure that your suppliers understand what you expect from them, and are capable of providing you with a consistent, conforming product? This information brochure provides some answers to these questions, and will inform you about how you can get the most out of using ISO 9001:2000 as a supply chain tool.
What is ISO 9001:2000?
ISO 9001:2000 is an international standard that gives requirements for an organization’s Quality Management System (“QMS”). It is part of a family of standards published by the International Organisation for Standardisation (“ISO”) often referred to collectively as the “ISO 9000 series”. For this reason, you may sometimes hear your suppliers refer to being “ISO 9000 certified”, or having an “ISO 9000-compliant QMS”. This will normally mean that they are claiming to have a QMS meeting the requirements of ISO 9001:2000, the only standard in the ISO 9000 family that can be used for the purpose of conformity assessment. It is important to understand however, that ISO is the body that develops and publishes the standard - ISO does not “certify” organizations, as will be explained later in this brochure.
The objective of ISO 9001:2000 is to provide a set of requirements that, if they are effectively implemented, will provide you with confidence that your supplier can consistently provide goods and services that:
• Meet your needs and expectations and
• Comply with applicable regulations
The requirements cover a wide range of topics, including your supplier's top management commitment to quality, its customer focus, adequacy of its resources, employee competence, process management (for production, service delivery and relevant administrative and support processes), quality planning, product design, review of incoming orders, purchasing, monitoring and measurement of its processes and products, calibration of measuring equipment, processes to resolve customer complaints, corrective/preventive actions and a requirement to drive continual improvement of the QMS. Last but not least, there is a requirement for your supplier to monitor customer perceptions about the quality of the goods and services it provides.
ISO 9001:2000 does not specify requirements for the goods or services you are purchasing. That is up to you to define, by making clear your own needs and expectations for the product. You might, for example, refer to product specifications, drawings, national or international product standards, supplier’s catalogues or other documents as appropriate.
What does “Conformity to ISO 9001:2000” mean?
This means that your supplier has established a systematic approach to quality management, and is managing its business to ensure that your needs are clearly understood, agreed and fulfilled. A statement of conformity to ISO 9001:2000:2000 should not, however, be considered as a substitute for a declaration or statement of product conformity.
How does ISO 9001:2000 help you in selecting a supplier?
ISO 9001:2000 provides some requirements for the purchasing process that include you as the customer. These requirements address the following topics:
• requirements regarding the purchasing information that should be provided so that suppliers clearly understand their customers' needs
• the ways in which supplied products can be verified as meeting the requirements of the customer
Note that whenever ISO 9001:2000 refers to “products”, this also includes intangible products like services, or software.
You have an important role to play, by specifying to your supplier what you actually want. You may need to consult with your own internal technical staff (the actual users) in this process. If you don’t do this, you might find that you receive a product that meets all your stated requirements and the applicable regulatory requirements, but which is absolutely wrong for your intended application. So, first of all, you should concentrate on specifying your needs related to the intended use of the product.
To help in this task you may consider the following:
• What is the specific product (goods or service) you are buying?
• What impact does this product have on your own business?
• What are the risks to your business if you experience problems with this product?
• How can you be sure that the product you receive will actually meet your requirements?
o What do you know about the reputation and historical performance of your supplier?
o What level of confidence do you need in your supplier’s ability to provide you with conforming product on a consistent basis?
o If you decide that conformity to ISO 9001:2000 is important, (based on your assessment of the risks associated with the goods and services you are buying) how can you be sure that your supplier does have a QMS that meets ISO 9001:2000 requirements?
o Are the goods and services you require covered by your supplier’s QMS? (You may need to ask for a copy of your supplier’s actual certificate or declaration of conformity to find this out!)
How can you have confidence that your supplier meets ISO 9001:2000?
There are various ways in which your supplier can claim that its QMS meets the requirements of ISO 9001:2000. These include:
• ‘Supplier’s declaration of conformity’: A declaration by your supplier itself affirming that its QMS meets ISO 9001:2000 requirements, usually supported by legally-binding signatures. This declaration can be based on your supplier’s internal audit system, or on second party or third party audits;
• Second party assessment: your supplier has been assessed directly by its customer (for example by you, or by another customer, whose reputation you respect) to check if its QMS meets ISO 9001:2000 requirements and your own requirements - sometimes used in contractual “business-to-business” transactions;
• Third party assessment: (Often referred to as certification or registration): your supplier hires an impartial third party (a certification body, or “registrar”) to conduct an assessment to verify conformity to ISO 9001:2000 requirements. This third party then issues a certificate to your supplier describing the scope of its QMS, and confirming that it conforms to ISO 9001:2000.
• Additional confidence may be derived from the fact that some certification bodies (“registrars”) are accredited by nationally or internationally recognized accreditation bodies, who verify the certification body’s independence and competence to carry out the certification process. Many accreditation bodies have multi-lateral arrangements under the umbrella of the IAF (International Accreditation Forum) to promote worldwide mutual recognitions in support of WTO (World Trade Organization) free trade principles.
Figure 1 explains this in simple schematic terms.
Figure 1 – Some ways of demonstrating conformity to ISO 9001:2000
Can suppliers claim that their goods or services meet ISO 9001:2000?
No. The reference to ISO 9001:2000 indicates that the supplier has a quality management system that meets the requirements of ISO 9001:2000. As mentioned earlier, this should provide you with confidence in your supplier’s ability to provide consistent, conforming goods or services. ISO 9001:2000 requires your supplier to monitor the levels of satisfaction of its customers (this includes you!), and to feed back this information in order to improve the effectiveness of its QMS.
What to do if things go wrong?
In the event you are not happy with specific goods or services you receive, you should first of all bring this to your supplier’s attention. You will typically do this via the normal technical and/or commercial communication channels that have been established. Your supplier is obliged to investigate your complaint, and should take appropriate actions to avoid or reduce the chances of it happening again.
If, however, you are dissatisfied with the overall performance of your supplier, (for example if they continue to provide non-conforming products, do not address your complaints, or are not taking appropriate corrective actions) then this is an indication of problems in their quality management system. Depending on the responses you receive, you should be aware that you can escalate your complaint as follows:
• If your supplier has a QMS that meets ISO 9001:2000 requirements, they are required to have nominated a person (the “management representative”) to have the responsibility and authority to ensure the system is working properly. You should find out who this is, and make a formal complaint.
• If you are still not satisfied with the response from your supplier, and if they are certified by an independent (third party) certification body (“registrar”), you should bring the matter to the certification body’s attention. You can find the certification body’s name by looking at your supplier’s certificate. The certification body will investigate the problems during their surveillance audits of your supplier’s QMS, or, in critical cases, may decide to carry out an additional specific investigation.
• If you do not receive a satisfactory response from the certification body, and if it is accredited (see Figure 1), you should complain to the relevant accreditation body. Details of any such accreditation will appear on your supplier’s ISO 9001:2000 certificate. If you have difficulty in getting this information, you can consult the list of accreditation bodies who are members of the International Accreditation Forum on the IAF website (http://www.iaf.nu).
• If you feel that you have not received a satisfactory response from the accreditation body, and if it is a member of the International Accreditation Forum (see Figure 1), you can complain to the IAF (http://www.iaf.nu).
Remember that none of the above will affect your statutory rights as a purchaser, and it may be appropriate to take legal action against your supplier instead of, or in parallel with the above channels. The way in which you do this may vary from one country to another.
To summarize…..
ISO 9001:2000 is a useful basis for organizations to be able to demonstrate that they are managing their business so as to achieve consistent (good!) quality goods and services.
There are several ways in which your suppliers can claim conformity to ISO 9001:2000, and you need to ensure that the method chosen by your supplier provides you with the necessary degree of confidence.
If you are not satisfied with the performance of your supplier, you must provide them with the appropriate feedback. Learning from complaints helps organizations to improve their future performance – that is what ISO 9001:2000 is about.
Some additional helpful information about ISO and the ISO 9000 family of standards can be obtained from www.iso.org, or by consulting your national standards body.
________________________________________
This guidance document was developed by the ISO 9000 Advisory Group, comprising representatives from ISO/TC176 (the committee responsible for writing the ISO 9000 standards), ISO/CASCO (ISO’s Conformity Assessment Committee), ISO/COPOLCO (ISO’s Committee on Consumer Policy) and IAF (The International Accreditation Forum)
ISO 9001 Auditing Practices Group
Welcome to the website of the ISO 9001 Auditing Practices Group.
The ISO 9001 Auditing Practices Group is constituted as an informal group of quality management system (QMS) experts, auditors and practitioners, drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF).
The Co-Conveners of the ISO 9001 Auditing Practices Group are Mr L Thione (CEO, SINCERT, Italy) and Mr A Ezrakhovich (General Manager, SAI Global Certification Services Pty Ltd, Australia).
This website has been established as an on-line source of papers and presentations on auditing QMSs. The ideas, examples and explanations given reflect the process-based approach that is essential for auditing the requirements of ISO 9001:2000 Quality management systems - Requirements.
The website is primarily aimed at QMS auditors, consultants and quality practitioners.
The papers and presentations that make up the content of this website are not definitive. They reflect a number of different views in QMS auditing. As such, their content may not always be consistent. It is not intended that the website's content will be used as specified requirements, an industry benchmark, or as criteria that all QMS auditors, consultants or practitioners have to follow.
The items listed under "QMS auditing topics" below have papers and presentations associated with them. Simply click on one of the links to view and download the relevant document.
Feedback from users will be used by the ISO 9001 Auditing Practices Group to determine whether additional guidance documents should be developed, or if these current ones should be revised. Comments on the papers or presentations can be sent to the following email address: charles.corrie@bsigroup.com.
A sister web page for the Accreditation Auditing Practices Group has been established to provide guidance to accreditation auditors.
QMS auditing topics
• Introduction to the ISO 9001 Auditing Practices Group
• The need for a 2-stage approach to auditing
• Measuring QMS effectiveness and improvements
• Identification of processes
• Understanding the process approach
• Determination of the “where appropriate” processes
• Auditing the “where appropriate” requirements
• Demonstrating conformity to the standard
• Linking an audit of a particular task, activity or process to the overall system
• Auditing continual improvement
• Auditing a QMS which has minimum documentation
• How to audit top management processes
• The role and value of the audit checklist
• Scope of ISO 9001:2000, Scope of Quality Management System and Defining Scope of Certification
• How to Add Value during the audit process
• Auditing competence and the effectiveness of actions taken
• Auditing Statutory and Regulatory requirements
• Auditing Quality Policy, Quality Objectives, and Management Review
• Auditing ISO 9001, Clause 7.6 Control of monitoring and measuring devices
• Making effective use of ISO 19011
• Auditing Customer Feedback processes
• Documenting a Nonconformity
• Guidance for reviewing and closing nonconformities
• Auditing Internal Communications
• Auditing Preventive Action
• Auditing Service Organizations
• Third Party Auditor Impartiality and Conflict of Interest
• Auditing the Effectiveness of the Internal Audit
• Auditing Electronic Based Management Systems
• Auditing the Management of Resources
• Auditing Customer Communications
• Auditing the Design and Development Process
• Auditor Code of Conduct and Ethics
• Guidance on Cultural Aspects of Auditing
• Output Matters!
• Auditing the Procurement and Supply Chain Processes
• Added Value Audits versus Consultancy
• Writing Audit Reports
"Zip" file of all the above documents
[TRANSLATIONS – Links to translations of the above documents]
Disclaimer
The contributions on this website have not been subject to an endorsement process by the International Organization for Standardization (ISO), ISO Technical Committee 176 or the International Accreditation Forum (IAF).
The information contained on this website is available to the public for educational and communication purposes and the ISO 9001 Auditing Practice Group does not take responsibility for any errors, omissions or other liabilities that may arise from the provision or subsequent use of such information.
Abbreviations and Definitions
On this website the following abbreviations are commonly used:
Auditee = the organization being audited
CRB = Certification/registration body
NCR = Non-conformity report
QMS = Quality management system
Further reading:
ISO and IAF have published several documents related to QMS and auditing, which are listed below. These are available from ISO or the IAF, or from your national ISO member body or IAF member body.
• [1] ISO 9000:2000, Quality management systems – Fundamentals and vocabulary
• [2] ISO 9001:2000, Quality management systems – Requirements
• [3] ISO 9004:2000, Quality management systems – Guidelines for performance improvements
•
• [4] "ISO 9000 Introduction and Support Package" guidance documents from ISO/TC 176 SC2:
• N524 – Guidance on ISO 9001:2000, Clause 1.2 'Application'
• N525 – Guidance on the Documentation requirements of ISO 9001:2000
• N526 – Guidance on the Terminology used in ISO 9001:2000 and ISO 9004:2000
• N544 – Guidance on the Concept and Use of the Process Approach
• N630 – Guidance on Outsourced Processes
•
• (These may be downloaded, for free, from the ISO or ISO/TC 176/SC 2 web sites)
•
• [5] ISO/IEC DIS 17000, Conformity assessment – General Vocabulary
• [6] ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing
• [7] ISO/IEC Guide 62, General requirements for bodies operating assessment and certification/registration of quality systems
• [8] IAF Guidance on ISO Guide 62
• (This may be downloaded, for free, from the IAF web site)
• [9] ISO/IEC CD2 17021, Conformity assessment - General requirements for bodies operating assessment and certification/registration of quality systems
• [10] ISO Handbook:2002, ISO 9001:2000 for small businesses – What to do, Advice from ISO/TC 176
Useful web sites:
http://www.iaf.nu/ International Accreditation Forum (IAF)
http://www.iso.org/ International Organization for Standardization (ISO)
http://www.tc176.org/ ISO Technical Committee no. 176, Quality Management and Quality Assurance (ISO/TC 176)
www.iso.org/tc176/sc2 ISO/TC 176, Sub-committee no.2, Quality Systems (ISO/TC 176/SC 2)
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Origins and ISO/TC 176
This section describes the origins of the ISO 9000 family and introduces the ISO technical committee responsible for these standards
ISO/TC 176
ISO standards are developed by technical committees comprising national delegations of experts from business, government and other relevant organizations. They are chosen by the ISO members – the national standards institutes participating in the technical committee concerned – and are required to present a national consensus position based on the views of stakeholders in their country.
In 1979, a new ISO technical committee was approved: ISO/TC 176, Quality management and quality assurance. Initially, 20 member countries decided to become active participants (P-members) in the work of this new committee and another 14 countries opted to follow the work as observers (O-members).
Today, 80 countries participate in ISO/TC 176, while another 21 are observers. The committee published its first standards in the early part of 1987.
Why 'ISO 9000' was the number chosen
ISO standards are usually assigned a catalogue number automatically. When the first output of ISO/TC 176 was nearing completion, ISO was already approaching a total of some 9 000 published standards. ISO realized even then that ISO/TC 176's standards would have a significant impact and so decided to give the series the next available round figure - 9000 - as a designation because round figures are more memorable.
What already existed
When ISO/TC 176 embarked on the development of generic quality management standards for worldwide application, it was able to take advantage of a substantial base of national experience, notably in the United Kingdom and in Canada.
In the United Kingdom, the BS 5750 standards were well on their way to broad acceptance and, in Canada, a series of national standards known as CSA Z299 were also widely used.
Other countries with well developed quality management practices, such as Japan, also took a keen interest in the work of the new committee. In addition, experience of military quality assurance specifications, such as the NATO AQAP series and US MIL-SPEC, enriched the sources from which ISO/TC 176 was able to draw.
ISO 14000 essentials
This section concisely describes the essential features of the ISO 14000 family.
The ISO 14000 family addresses various aspects of environmental management. The very first two standards, ISO 14001:2004 and ISO 14004:2004 deal with environmental management systems (EMS). ISO 14001:2004 provides the requirements for an EMS and ISO 14004:2004 gives general EMS guidelines.
The other standards and guidelines in the family address specific environmental aspects, including: labeling, performance evaluation, life cycle analysis, communication and auditing.
An ISO 14001:2004-based EMS
An EMS meeting the requirements of ISO 14001:2004 is a management tool enabling an organization of any size or type to:
• identify and control the environmental impact of its activities, products or services, and to
• improve its environmental performance continually, and to
• implement a systematic approach to setting environmental objectives and targets, to achieving these and to demonstrating that they have been achieved.
How it works
ISO 14001:2004 does not specify levels of environmental performance. If it specified levels of environmental performance, they would have to be specific to each business activity and this would require a specific EMS standard for each business. That is not the intention.
ISO has many other standards dealing with specific environmental issues. The intention of ISO 14001:2004 is to provide a framework for a holistic, strategic approach to the organization's environmental policy, plans and actions.
ISO 14001:2004 gives the generic requirements for an environmental management system. The underlying philosophy is that whatever the organization's activity, the requirements of an effective EMS are the same.
This has the effect of establishing a common reference for communicating about environmental management issues between organizations and their customers, regulators, the public and other stakeholders.
Because ISO 14001:2004 does not lay down levels of environmental performance, the standard can to be implemented by a wide variety of organizations, whatever their current level of environmental maturity. However, a commitment to compliance with applicable environmental legislation and regulations is required, along with a commitment to continual improvement – for which the EMS provides the framework.
The EMS standards
ISO 14004:2004 provides guidelines on the elements of an environmental management system and its implementation, and discusses principal issues involved.
ISO 14001:2004 specifies the requirements for such an environmental management system. Fulfilling these requirements demands objective evidence which can be audited to demonstrate that the environmental management system is operating effectively in conformity to the standard.
What can be achieved
ISO 14001:2004 is a tool that can be used to meet internal objectives:
• provide assurance to management that it is in control of the organizational processes and activities having an impact on the environment
• assure employees that they are working for an environmentally responsible organization.
ISO 14001:2004 can also be used to meet external objectives:
• provide assurance on environmental issues to external stakeholders – such as customers, the community and regulatory agencies
• comply with environmental regulations
• support the organization's claims and communication about its own environmental policies, plans and actions
• provides a framework for demonstrating conformity via suppliers' declarations of conformity, assessment of conformity by an external stakeholder - such as a business client - and for certification of conformity by an independent certification body.
Business benefits of ISO 14000
This section identifies typical benefits for organizations of implementing ISO 14000 standards.
Most managers will try to avoid pollution that could cost the company a fine for infringing environmental legislation. But better managers will agree that doing only just enough to keep the company out of trouble with government inspectors is a rather weak and reactive approach to business in today's environment-conscious world.
The ISO 14000 standards are practical tools for the manager who is not satisfied with mere compliance with legislation – which may be perceived as a cost of doing business. They are for the proactive manager with the vision to understand that implementing a strategic approach can bring return on investment in environment-related measures.
The systematic ISO 14001:2004 approach requires the organization to take a hard look at all areas where its activities have an environmental impact. And it can lead to benefits like the following:
• reduced cost of waste management
• savings in consumption of energy and materials
• lower distribution costs
• improved corporate image among regulators, customers and the public
• framework for continual improvement of environmental performance.
The manager who is "too busy managing the business" to listen to good sense about environmental management could actually be costing the business, instead of achieving benefits like those above.
ISO 14001:2004 and SME's
This section explains that small and medium-sized enterprises can also benefit from ISO 14001:2004 and points to some resources.
The importance of small and medium-sized enterprises (SMEs)to economies around the world is beyond dispute. Surveys have shown that, on a global basis, more than 90 % of all businesses are SMEs.
Experience shows that SMEs can implement an effective EMS and can realize a variety of benefits from doing so. However, EMS implementation in smaller enterprises can present significant challenges. An SME Task Group at ISO has developed recommendations to change that perception, and make it easier for SMEs to benefit from implementing an EMS based on ISO 14001:2004.
Taking the first steps
This article from ISO Management Systems magazine explains clearly how an SME can implement an environmental management system so that the process is not a series of hurdles, but rather a set of practical steps towards raising environmental and business performance.
• Read more (PDF, 412 kB)
Using an EMS consultant – or going it alone
This article from ISO Management Systems magazine helps SME managers answer some essential questions. Should you hire a consultant to help with environmental management system implementation, or go it alone? What are the advantages and potential pitfalls? How can you get best value for money if you hire a consultant and what are the criteria you should use for choosing one?
• Read more (PDF, 447 kB)
ISO and the environment
The ISO 14000 family is the most visible part of ISO's work for the environment. This section gives the whole picture.
ISO has a multi-faceted approach to meeting the needs of business, industry, governments and consumers in the field of the environment.
Firstly, ISO it offers a wide-ranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 350 International Standards for the monitoring of such aspects as the quality of air, water and soil. These standards are a means of providing business and government with scientifically valid data on the environmental effects of economic activity. They may also be used as the technical basis for environmental regulations.
Secondly, ISO offers a strategic approach through the ISO 14000 family of environmental management standards developed by ISO technical committee ISO/TC 207 that can be implemented in any type of organization in either public or private sector (companies, administrations, public utilities).
Thirdly, ISO/TC TC 207 also works on documents to facilitate the fusion of business and environmental goals by encouraging the inclusion of environmental aspects in product design.
ISO/TR 14062, Environmental management - Integrating environmental aspects into product design and development, enables organizations to identify the likely effects on the environment of their future products and make effective decisions during the design and development stages to improve their environmental performance.
Fourthly, ISO/TC 207 is helping to meet the new challenge of climate change with standards such as ISO 14064:2006 and ISO 14065:2007 standards for greenhouse gas verification and accounting.
Origins and ISO/TC 207
This section describes the origins of the ISO 14000 family and introduces the ISO technical committee responsible for these standards
Sustainable development
The ISO 14000 family grew out of ISO's commitment to support the objective of sustainable development discussed at the United Nations Conference on Environment and Development, in Rio de Janeiro, in 1992.
ISO/TC 207
ISO launched the new technical committee, ISO/TC 207, Environmental management, in 1993. However, this was preceded by an intensive consultation process, carried out within the framework of the ISO/IEC Strategic Advisory Group on Environment (SAGE), set up in 1991, in which 20 countries, 11 international organizations and more than 100 environmental experts participated in defining the basic requirements of a new approach to environment-related standards.
Today, delegations of business and government experts from 75 countries participate actively within TC 207, with another 26 as observers, along with 41 international or regional organizations, including UNCTAD, UNEP, WHO and WTO. The delegations are chosen by the national standards institute concerned and they are required to bring to TC 207 a national consensus on issues being addressed by the committee. This national consensus is derived from a process of stakeholder consultation.
More ISO 14000 resources
The integrated use of management system standards
ISO has published a combined book and CD giving organizations advice on how to make integrated use of management system standards.
• Continue
ISO 14064 and 14065 for greenhouse gas accounting and verification
The ISO 14064 and ISO 14065 standards for greenhouse gas accounting and verification provide government and industry with an integrated set of tools for programmes aimed at reducing greenhouse gas emissions, as well as for emissions trading.
• Climate change
Specific applications
The tremendous impact of ISO 9001 and ISO 14001 on organizational practices and on trade has stimulated the development of other ISO standards and deliverables that adapt the generic management system to specific sectors or aspects.
Sector Standard or series of standards
Automotive
ISO/TS 16949:2002
Education
IWA 2:2007
Energy
PC 242, ISO 50001
Food safety
ISO 22000:2005
Information security
ISO/IEC 27001:2005
Health care
IWA 1:2005
Local government
IWA 4:2005
Medical devices
ISO 13485:2003
Petroleum and gas
ISO 29001:2003
Ship recycling
ISO 30000
Supply chain security
ISO 28000:2007
Certification
Certification is not a requirement of any of ISO's management system standards. This section provides a basic understanding of what certification and related terms mean.
Certification, registration and accreditation
In the context of ISO 9001:2000 (and ISO 9001:2008) or ISO 14001:2004, “certification” refers to the issuing of written assurance (the certificate) by an independent external body that it has audited a management system and verified that it conforms to the requirements specified in the standard.
“Registration” means that the auditing body then records the certification in its client register. So, the organization’s management system has been both certified and registered.
Therefore, in the ISO 9001:2000 (and ISO 9001:2008) or ISO 14001:2004 context, the difference between the two terms is not significant and both are acceptable for general use. “Certification” is the term most widely used worldwide, although registration is often preferred in North America, and the two are used interchangeably.
On the contrary, using “accreditation” as an interchangeable alternative for certification or registration is a mistake, because it means something different.
In the ISO 9001:2000 (and ISO 9001:2008) or ISO 14001:2004 context, accreditation refers to the formal recognition by a specialized body – an accreditation body – that a certification body is competent to carry out ISO 9001:2000 (and ISO 9001:2008) or ISO 14001:2004 certification in specified business sectors.
In simple terms, accreditation is like certification of the certification body. Certificates issued by accredited certification bodies may be perceived on the market as having increased credibility.
• See ISO/IEC 17000:2004, Conformity assessment - Vocabulary and general principles
ISO does not carry out certification
ISO is responsible for developing, maintaining and publishing the ISO 9000 and ISO 14000 families of standards but ISO does not itself audit or assess the management systems of organizations to verify that they have been implemented in conformity with the requirements of the standards.
ISO does not issue ISO 9001:2000 (or ISO 9001:2008) or ISO 14001:2004 certificates.
The auditing and certification of management systems is carried out independently of ISO by more than 750 certification bodies active around the world. ISO has no authority to control their activities. The ISO 9001:2000 (and ISO 9001:2008) and ISO 14001:2004 certificates issued by certification bodies are issued under their own responsibility and not under ISO's name.
ISO itself does not carry out assessments or audits to check that its standards are being implemented by users in conformity with the requirements of the standards. Conformity assessment – as this process is known – is a matter between suppliers and their customers in the private sector, and of regulatory bodies when ISO standards have been incorporated into public legislation.
In addition, there exist many testing laboratories and certification bodies which offer independent (also known as "third party") conformity assessment services to provide confirmation that products (including hardware, software and processed materials), services or systems measure up to ISO standards.
Such organizations may perform these services under a mandate to a regulatory authority, or as a commercial activity, the aim of which is to create confidence between suppliers and their clients.
In some countries, the national standards institutes that make up ISO's membership carry out conformity assessment, either on behalf of their respective governments, or as a business operation. ISO itself has no authority to control conformity assessment activities, whether these are business activities by its members, or by other organizations.
However, ISO's Committee on conformity assessment, ISO/CASCO, develops standards and guidelines covering various aspects of conformity assessment activities and the organizations that perform them. The voluntary criteria contained in these standards and guides represent an international consensus on good practice. Their use contributes to the consistency of conformity assessment worldwide and so facilitates trade across borders.
Choosing a certification body
When choosing a certification body to carry out ISO 9001:2000 (or ISO 9001:2008) or ISO 14001:2004 certification, these are the aspects the organization needs to take into account.
• The first point is that an organization can implement ISO 9001:2000 (or ISO 9001:2008) or ISO 14001:2004 without seeking certification. The best reason for wanting to implement the standards is to improve the efficiency and effectiveness of company operations. Certification of the management system is not an ISO 9001:2000 (or ISO 9001:2008) or ISO 14001:2004 requirement.
• Deciding to have an independent audit of the system to confirm that it conforms to ISO 9001:2000 (or ISO 9001:2008) or ISO 14001:2004 is a decision to be taken on business grounds: for example
o if it is a contractual or regulatory requirement
o if it is a market requirement or to meet customer preferences
o if it falls within the context of a risk management programme
o or if the organization thinks it will motivate staff by setting a clear goal for the development of its management system.
• Criteria to consider include:
• evaluate several certification bodies
• bear in mind that the cheapest might prove to be the most costly if its auditing is below standard, or if its certificate is not recognized by the organization's customers
• establish whether the certification body has auditors with experience in the organization's sector of activity
• establish whether the certification body implements, or is migrating to ISO/IEC 17021:2006, Conformity assessment – Requirements for bodies providing audit and certification of management systems
• Another point to clarify is whether or not the certification body has been accredited and, if so, by whom. Accreditation, in simple terms, means that a certification body has been officially approved as competent to carry out certification in specified business sectors by a national accreditation body.
In most countries, accreditation is a choice, not an obligation and the fact that a certification body is not accredited does not, by itself, mean that it is not a reputable organization. For example, a certification body operating nationally in a highly specific sector might enjoy such a good reputation that it does not feel there is any advantage for it to go to the expense of being accredited. That said, many certification bodies choose to seek accreditation, even when it is not compulsory, in order to be able to demonstrate an independent confirmation of their competence.
The list of accreditation bodies with their contact information and links to their Web sites can be found on the Internet site of the International Accreditation Forum (www.iaf.nu), under "Members" > "Accreditation members". In general, accreditation bodies' Web sites contain an up-to-date list of certification bodies that they have accredited which can be used for selecting a certification body.
The ISO sectoral portfolio
ISO develops International Standards for all industry sectors (with the exception of electrotechnology, covered by IEC, and telecommunications, covered by ITU), as well as for a variety of cross-sector, horizontal themes (such as metrology and generic management systems).
Given the level of specialization that characterizes ISO’s technical work regarding both the structure of ISO’s technical bodies and ISO’s deliverables, it is often not easy for the non-expert (and sometimes for the expert as well) to identify the scope and extent of ISO activities in a given field and from a general perspective.
Most ISO standards are highly specific and require specialized knowledge to develop. Therefore, the technical committees that develop these standards are also specialized in a specific area of technology or business activity. Despite this, the aggregated work of several technical or subcommittees can often provide a complete offering for a broad sector of activitiy.
The ISO sectoral portfolio is an information tool that provides aggregated information on the ISO work covering selected areas of activities. It includes summaries and hyperlinks to the relevant ISO technical committee Web sites and highlights some of the most important relevant ISO standards and related bibliographical information.
ISO plans to expand significantly the ISO sectoral portfolio over time. However, to a certain extent, it will always be "work in progress". We are therefore most grateful to all ISO Online users who would like to share their views, feedback and suggestions that will help us to modify, expand and improve this section.
Why does the work matter?
ISO has developed a three-pronged approach to meeting the needs of business, industry, governments and consumers in the field of the environment. Firstly, it offers a wide-ranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 560 International Standards (out of a total of over 17 000) for the monitoring of such aspects as the quality of air, water and soil. These standards are a means of providing business and government with scientifically valid data on the environmental effects of economic acitivity. They also serve in a number of countries as the technical basis for environmental regulations.
Secondly, and more recently, ISO is leading a strategic approach by developing environmental management system standards that can be implemented in any type of organization in either public or private sector (companies, administrations, public utilities). To spearhead this strategic approach, ISO established a new technical committee, ISO/TC 207, Environmental management, in 1993. This followed ISO's successful pioneering experience in management system standardization with the ISO 9000 series for quality management.
In addition to standards on environmental management systems and supporting tools, TC 207 works on documents to facilitate the fusion of business and environmental goals by encouraging the inclusion of environmental aspects in product design - which represents the third axis of ISO's environmental approach. An example is a technical report which promotes the convergence of environment-friendly products with company profits.
The management of environmental aspects and impacts has established itself as a cornerstone of effective organizational practice alongside the management of quality, security, and health and safety issues. Ongoing concern about environmental issues and sustainable development has significantly affected global practices in recent years as organizations strive to be responsive to government regulations, shareholder concerns and interested parties’ expectations all at the same time. The work products of ISO/TC 207 – the basic standard for environmental management, ISO 14001, standards for environmental auditing and performance evaluation, product labelling and declarations, lifecycle assessment, greenhouse gas emission reporting, and others – provide effective management tools for organizations to better manage and communicate about their environmental aspects and to work towards improving their environmental performance and contributing to sustainable development. When used properly, these tools can provide significant advantages and benefits to users in both the private and public sectors.
ISO/TC 207 is not alone in developing standards for the protection of our environment. Three other ISO technical committees deal with the quality of three important elements of our planet:
• ISO/TC 146 Air quality
• ISO/TC 147 Water quality
• ISO/TC 190 Soil quality
Another related technical committee is ISO/TC 224 Service activities relating to drinking water supply systems and wastewater systems - Quality criteria of the service and performance indicators.
The ISO Oil and Gas activities derive from very active and driven groups of professionals, striving to accomplish a solution to the oil and natural gas industries need for global equipment and material standards. It is in the economic interest of all stakeholders to produce timely, clearly written, internationally acceptable standards for use by suppliers, purchasers and regulators.
Internationally developed consensus-based standards ensure sustainability to the oil and gas industry by providing a means to:
- carry out buisness efficiently and cost effectively;
- enhance technical integrity, thereby assuring no harm to people, assets or the environment; and
- transfer knowledge and share best practice
• ISO’s engagement
ISO, as the principal developer of international standards, makes a major contribution to the building construction industry. Its standards for this sector incorporate the technical advice provided by the hundreds of experts participating in the related technical committees. In addition, they also respect the international agreements drafted on environmental protection, such as the Kyoto Protocol to the United Nations Framework Convention on Climate Change.
Building construction should also be associated with the term "sustainable construction". The construction industry has such a great impact on our planet’s natural resources, that the environmental issues touched by the increasing building activities as the world’s population continues to grow cannot be ignored.
From the planning phase, through the laying of foundations, to the end product, ISO has published standards for all these stages of development.
Not only are there technical benefits from implementing ISO standards, there are also social and economic benefits to be gained. The Council for Research and Innovation in Building and Construction (CIB) estimates that for every dollar spent on construction, three dollars are generated in other sectors.
• ISO's engagement
Standards FAQs
What can I do if I'm looking for a standard, but I'm not sure if it's an ISO standard or not?
Consult the World Standards Services Network, accessible via the ISO Online home page. It contains links to international, regional and national standardization bodies, including international and regional organizations which develop standards in their specialized subject area, in addition to their principal activity.
Where can I find links to other international, regional or national standardization bodies, or information about their standards?
Consult the World Standards Services Network, accessible via the ISO Online home page. It contains links to international, regional and national standardization bodies, including international and regional organizations which develop standards in their specialized subject area, in addition to their principal activity.
How can I find out which standards are equivalent to ISO standards?
ISO itself does not have data on equivalent standards (such as national or regional standards). However, a number of ISO members are able to provide this information. Therefore, please contact the ISO member in your country.
Can I access ISO standards on ISO Online or some other electronic database?
Not yet, but it is in the pipeline. At present, you can find out what standards exist in ISO's portfolio by accessing the ISO Catalogue. For the moment, there is no electronic access to the content of ISO standards. However, we are working towards provision of that service.
Are any ISO standards available electronically?
Some ISO standards are available as electronic products. Contact the ISO member in your country or our sales department using the online contact form.
Where can I obtain technical assistance on standards?
Contact the ISO member in your country. A list of members can be accessed on this site. The ISO Central Secretariat does not provide technical assistance, but the online enquiry service may be able to help you save time by directing you to appropriate sources of information.
Can I order ISO standards and publications via ISO Online?
Your first contact should be the ISO member for your country. However, if you have a problem, you can order through our sales department.
Can I reproduce material from ISO standards?
All ISO publications, including ISO standards, are protected by copyright. See the ISO copyright guide page for further information.
I've heard the word `standard', but how would I know an ISO standard if I saw one?
An ISO standard can be anything from a four-page document to one several hundred pages' long. It is usually also available in electronic form. It carries the ISO logo and the designation International Standard. In most cases, the paper version is published in A4 format - which is itself one of the ISO standard paper sizes. The standardization of paper sizes is a typical example of ISO's work: agreement on a sufficient number of variations of a product to meet most current applications allows economies of scale with cost benefits to both producers and consumers.
What can I expect to find in an ISO standard?
An ISO standard is a documented agreement containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics to ensure that materials, products, processes and services are fit for their purpose. It is a living agreement that can have a profound influence on things that deserve to be taken seriously - such as the safety, reliability and efficiency of machinery and tools, means of transport, toys, medical devices, and so on.
Could you give me a few practical examples of ISO standards?
Take a look at the graphical symbols on the dashboard of your car or at the pictorial symbol on a package marked with handling instructions such as "This way up". Various ISO technical committees have developed or adopted hundreds of carefully researched signs and symbols that convey clear-cut messages which cross language bounderies.
On the inside cover of nearly every book, there is something called an ISBN number. ISBN stands for International Standard Book Number. Publishers and booksellers are very familiar with ISBN numbers, since they are the keyway that books are ordered and bought. Try buying a book on the Internet, and you will soon learn the value of the ISBN number - there is a unique number for the book you want! And, it is based on an ISO standard.
Almost everything you need and use for work and home comes from somewhere else. Whether departure and destination points are as close as A to B, or as far apart as Antwerp and Bangkok, freight containers ensure a smooth passage for your goods and materials. From truck to train, from boat to plane, there are more than five million freight containers transiting across the globe. This has become possible principally through international standardization.
Yet another example: the chair that you're probably sitting on, or the desk your computer is perched on, are held together by bolts and screws. Humble bolts and screws also hold together our children's bicycles - and also the aircraft we trust our lives to during business trips or holiday travel. The diversity of screw threads used to represent big problems for industry, particularly in maintenance, as lost or damaged nuts and bolts could not easily be replaced. A global solution is supplied in the ISO standards for metric screw threads.
Also, the credit card you may have used to buy your computer can be used worldwide because all its basic features are based on ISO standards. We are so familiar with many objects, like credit or telephone cards, that we tend to assume they just "fell out of the sky". In fact, the ease with which we can use them can be traced back to an ISO standard.
Further examples are given in the ISO Café and Widely used standards sections.
Technology moves on - what about ISO standards?
ISO standards represent, by an international consensus among experts in the technology concerned, the state of the art. To ensure that ISO standards retain this lead, they are reviewed at least every five years after their publication. The technical experts then decide whether the standard is still valid, or whether it should be withdrawn or updated. In some fields, the pace of development is such that when an ISO standard is published, the experts who developed it are already thinking about the next version!
Does ISO have standards for everything?
Not quite! Scroll through the list of our technical committees on this site to get an idea of the huge range of technologies, industries and business sectors for which ISO develops standards.
ISO's work programme ranges from standards for traditional activities, such as agriculture and construction, through mechanical engineering to the newest information and communications technology (ICT) developments, such as the digital coding of audio-visual signals for multimedia applications. We collaborate on ICT with our partners, IEC (International Electrotechnical Commission) and ITU (International Telecommunication Union), which are specialized in the domains indicated by their names.
What are ISO's `new deliverables'?
ISO standards are developed according to strict rules to ensure that they are transparent and fair. The reverse side of the coin is that it can take time to develop consensus among the interested parties, and for the resulting agreement to go through the public review process in the ISO member countries. For some users of standards, particularly those working in fast-changing technology sectors, it may be more important to agree and publish a technical specification quickly, before going through the various checks and balances needed to win the status of a full International Standard. Therefore, to meet such needs, ISO has developed a new range of "deliverables", or different categories of specifications, allowing publication at an intermediate stage of development before full consensus.
What other products does ISO offer?
In addition to International Standards and the "new deliverables" (see previous question), ISO develops guideline documents, manuals for developing countries, standards compendia and handbooks and a whole range of standards-related publications. Listings of these can be found in the ISO Catalogue. We also publish two magazines: the monthly ISO Focus which presents an overview of ISO's activities, and the bimonthly ISO Management Systems.
How does ISO decide what standards to develop?
Working through the ISO community, it is the people who need the standards that decide. What happens is that the need for a standard is felt by an industry or business sector, which communicates the requirement to one of ISO's national members. The latter then proposes the new work item to ISO as a whole. If accepted, the work item is assigned to an existing technical committee. Proposals may also be made to set up technical committees to cover new scopes of technological activity. In order to use resources most efficiently, ISO only launches the development of new standards for which there is clearly a market requirement.
Who actually develops ISO standards?
ISO standards are developed by technical committees comprising experts on loan from the industrial, technical and business sectors which have asked for the standards, and which subsequently put them to use. These experts may be joined by others with relevant knowledge, such as representatives of government agencies, testing laboratories, consumer associations, environmentalists, and so on. It is estimated that, every year, some 30 000 such experts participate in the development of ISO standards. The experts participate as national delegations, chosen by the ISO member for the country concerned to represent not just the views of the organizations in which the experts work, but a full national consensus on the issues involved.
How are ISO standards developed?
The national delegations of experts of a technical committee meet to discuss, debate and argue until they reach consensus on a draft agreement. This is then circulated to ISO's membership as a whole for comment and balloting. Many members have public review procedures for making draft standards known and available to interested parties and to the general public. The ISO members then take account of any feedback they receive in formulating their position on the draft standard. Finally, if the voting is in favour, the document is published as an International Standard. Every working day of the year, some 15 ISO meetings are taking place somewhere in the world. In between meetings, the experts continue the standards' development work by correspondence. Increasingly, their contacts are made by electronic means and some ISO technical bodies have already gone over entirely to electronic working, which speeds up the development of standards and reduces travel costs.
What should I do if I want to take part in the development of a standard?
The business sectors most interested in implementing the eventual standards are the ones who provide experts to develop the standards. Your own interest may be such that you would like to provide input, or even participate in the work. In fact, there are channels and opportunities for you to have a say in the development of future ISO standards through the ISO members for your country.
Who chooses the experts that participate in the standards' developing committees?
The national delegations that make up ISO technical committees are chosen by the national standards institute of that country, which is an ISO members. According to ISO rules, the standards institute is expected to take account of the views of the range of parties interested in the standard under development and to present a consolidated, national consensus position to the technical committee's work.
Why aren't ISO standards free?
ISO standards cost money to develop, publish and distribute. Someone has to pay. The current system whereby users are requested to pay for the standards they use, not only sustains the development process but also, very importantly, ensures that the balance of independent vs. government, private vs. public interests can be maintained.
Are ISO standards mandatory?
ISO standards are voluntary. ISO is a non-governmental organization and it has no power to enforce the implementation of the standards it develops. A number of ISO standards - mainly those concerned with health, safety or the environment - have been adopted in some countries as part of their regulatory framework, or are referred to in legislation for which they serve as the technical basis. However, such adoptions are sovereign decisions by the regulatory authorities or governments of the countries concerned. ISO itself does not regulate or legislate. Although voluntary, ISO standards may become a market requirement, as has happened in the case of ISO 9000 quality management systems, or ISO freight container dimensions.
ISO 9000 adalah kumpulan standar untuk sistem manajemen mutu (SMM). ISO 9000 yang dirumuskan oleh TC 176 ISO, yaitu organisasi internasional di bidang standarisasi.
• adanya satu set prosedur yang mencakup semua proses penting dalam bisnis;
• adanya pengawasan dalam proses pembuatan untuk memastikan bahwa sistem menghasilkan produk-produk berkualitas;
• tersimpannya data dan arsip penting dengan baik;
• adanya pemeriksaan barang-barang yang telah diproduksi untuk mencari unit-unit yang rusak, dengan disertai tindakan perbaikan yang benar apabila dibutuhkan;
• secara teratur meninjau keefektifan tiap-tiap proses dan sistem kualitas itu sendiri.
Sebuah perusahaan atau organisasi yang telah diaudit dan disertifikasi sebagai perusahaan yang memenuhi syarat-syarat dalam ISO 9001 berhak mencantumkan label "ISO 9001 Certified" atau "ISO 9001 Registered".
Sertifikasi terhadap salah satu ISO 9000 standar tidak menjamin kualitas dari barang dan jasa yang dihasilkan. Sertifikasi hanya menyatakan bahwa bisnis proses yang berkualitas dan konsisten dilaksanakan di perusahaan atau organisasi tersebut.
Walaupan standar-standar ini pada mulanya untuk pabrik-pabrik, saat ini mereka telah diaplikasikan ke berbagai perusahaan dan organisasi, termasuk perguruan tinggi dan universitas.
[sunting] Kumpulan Standar dalam ISO 9000
ISO 9000 mencakup standar-standar di bawah ini:
• ISO 9000:2005 - Quality Management Systems - Fundamentals and Vocabulary: mencakup dasar-dasar sistem manajemen kualitas dan daftar bahasa dan istilah dalam kumpulan ISO 9000.
• ISO 9001:2000 - Quality Management Systems - Requirements: ditujukan untuk digunakan di organisasi manapun yang merancang, membangun, memproduksi, memasang dan/atau melayani produk apapun atau memberikan bentuk jasa apapun. Standar ini memberikan daftar persyaratan yang harus dipenuhi oleh sebuah organisasi apabila mereka hendak memperoleh kepuasan pelanggan sebagai hasil dari barang dan jasa yang secara konsisten memenuhi permintaan pelanggan tersebut. Implementasi standar ini adalah satu-satunya yang bisa diberikan sertifikasi oleh pihak ketiga.
• ISO 9004:2000 - Quality Management Systems - Guidelines for Performance Improvements: mencakup perihal perbaikan sistem yang terus-menerus. Bagian ini memberikan masukan tentang apa yang bisa dilakukan untuk mengembangkan sistem yang telah terbentuk lama. Standar ini tidaklah ditujukan sebagai panduan untuk implementasi, hanya memberikan masukan saja.
Masih banyak lagi standar yang termasuk dalam kumpulan ISO 9000, dimana banyak juga diantaranya yang tidak menyebutkan nomor "ISO 900x" seperti di atas. Beberapa standar dalam area ISO 10000 masih dianggap sebagai bagian dari kumpulan ISO 9000. Sebagai contoh ISO 10007:1995 yang mendiskusikan Manajemn Konfigurasi dimana di kebanyakan organisasi adalah salah satu elemen dari suatu sistem manajemen.
ISO mencatat "Perhatian terhadap sertifikasi sering kali menutupi fakta bahwa terdapat banyak sekali bagian dalam kumpulan standar ISO 9000 ... Suatu organisasi akan meraup keuntungan penuh ketika standar-standar baru diintegrasikan dengan standar-standar yang lain sehingga seluruh bagian ISO 9000 dapat diimplementasikan".
Sebagai catatan, ISO 9001, ISO 9002 dan ISO 9003 telah diintegrasikan menjadi ISO 9001. Kebanyakan, sebuah organisasi yang mengumumkan bahwa dirinya "ISO 9000 Registered" biasanya merujuk pada ISO 9001.
Di Posting Oleh : Dorin Mutoif, Poltekkes Depkes Yogyakarya, Jurusan Kesehatan Lingkungan
Occupational Health and Safety, University of Indonesia
Munggu, petanahan, Kebumen, Jawa Tengah, Indonesia
In brief
The ISO 9000 and ISO 14000 families are among ISO's best known standards ever.
ISO 9001:2000 and ISO 14001: 2004 are implemented by over a million organizations in 175 countries.
ISO 9000 family
The ISO 9000 family addresses "Quality management".
This means what the organization does to fulfill:
• the customer's quality requirements, and
• applicable regulatory requirements, while aiming to
• enhance customer satisfaction, and
• achieve continual improvement of its performance in pursuit of these objectives.
ISO 14000 family
The ISO 14000 family addresses "Environmental management".
This means what the organization does to:
• minimize harmful effects on the environment caused by its activities, and to
• achieve continual improvement of its environmental performance.
Quality management principles
The following text is an integral reproduction of the content of the document "Quality Management Principles".
Introduction
This document introduces the eight quality management principles on which the quality management system standards of the ISO 9000:2000 and ISO 9000:2008 series are based. These principles can be used by senior management as a framework to guide their organizations towards improved performance. The principles are derived from the collective experience and knowledge of the international experts who participate in ISO Technical Committee ISO/TC 176, Quality management and quality assurance, which is responsible for developing and maintaining the ISO 9000 standards.
The eight quality management principles are defined in ISO 9000:2005, Quality management systems Fundamentals and vocabulary, and in ISO 9004:2000, Quality management systems Guidelines for performance improvements.
This document gives the standardized descriptions of the principles as they appear in ISO 9000:2005 and ISO 9004:2000. In addition, it provides examples of the benefits derived from their use and of actions that managers typically take in applying the principles to improve their organizations' performance.
ISO 9000 essentials
This section concisely describes the essential features of the ISO 9000 family.
The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines relating to quality management systems and related supporting standards.
ISO 9001:2008 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.
The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects.
Why an organization should implement ISO 9001:2008
Without satisfied customers, an organization is in peril! To keep customers satisfied, the organization needs to meet their requirements. The ISO 9001:2008 standard provides a tried and tested framework for taking a systematic approach to managing the organization's processes so that they consistently turn out product that satisfies customers' expectations.
How the ISO 9001:2008 model works
The requirements for a quality system have been standardized - but many organizations like to think of themselves as unique. So how does ISO 9001:2008 allow for the diversity of say, on the one hand, a "Mr. and Mrs." enterprise, and on the other, to a multinational manufacturing company with service components, or a public utility, or a government administration?
The answer is that ISO 9001:2008 lays down what requirements your quality system must meet, but does not dictate how they should be met in any particular organization. This leaves great scope and flexibility for implementation in different business sectors and business cultures, as well as in different national cultures.
Checking that it works
1. The standard requires the organization itself to audit its ISO 9001:2008-based quality system to verify that it is managing its processes effectively - or, to put it another way, to check that it is fully in control of its activities.
2. In addition, the organization may invite its clients to audit the quality system in order to give them confidence that the organization is capable of delivering products or services that will meet their requirements.
3. Lastly, the organization may engage the services of an independent quality system certification body to obtain an ISO 9001:2008 certificate of conformity. This last option has proved extremely popular in the market-place because of the perceived credibility of an independent assessment.
The organization may thus avoid multiple audits by its clients, or reduce the frequency or duration of client audits. The certificate can also serve as a business reference between the organization and potential clients, especially when supplier and client are new to each other, or far removed geographically, as in an export context.
Selection and use of the ISO 9000 family of standards
The ISO 9000 family of international quality management standards and guidelines has earned a global reputation as a basis for establishing effective and efficient quality management systems.
The need for International Standards is very important as more organizations operate in the global economy by selling or buying products and services from sources outside their domestic market.
This content has been developed by ISO technical committee ISO/TC 176, Quality management and quality assurance, which is responsible for developing and maintaining the ISO 9000 family. Supporting guideline standards and other documents are developed and updated on a continual basis to meet the needs and expectations of users and the market itself. It explains how you can use them to improve your quality management system. It provides a general perspective of the ISO 9000 family of standards. It is an overview of the standards and demonstrates how, collectively, they form a basis for continual improvement and business excellence.
ISO 9001 specifies the basic requirements for a quality management system (QMS) that an organization must fulfil to demonstrate its ability to consistently provide products (which include services) that enhance customer satisfaction and meet applicable statutory and regulatory requirements.
The standard can be used for certification/registration and contractual purposes by organizations seeking recognition of their quality management system. ISO 9001 has been organized in a user-friendly format with terms that are easily recognized by all business sectors.
You will obtain the greatest value by using the entire family of standards in an integrated manner. It is highly recommended that you use ISO 9000 to become familiar with the basic concepts and the language used before you adopt ISO 9001 to achieve a first level of performance. The practices described in ISO 9004 may then be implemented to make your quality management system more effective and efficient in achieving your business goals and objectives. The ISO 9001 and ISO 9004 standards have been written to enable you to relate them to other management systems (e.g. environmental), or to sector specific requirements (such as ISO/TS 16949 in the automotive industry) and to assist you in gaining recognition through national or regional award programmes.
This brochure provides you with :
• An overview of the ISO 9000 core standards
• A step-by-step process to implement a quality management system
• Examples of typical applications of the documents, and
• Information on the ISO 9000 family of standards.
ISO 9001:2008
Introduction and support package
In conjunction with the publication of ISO 9001:2008, Quality management systems - Requirements, ISO technical committee ISO/TC 176, Quality management and quality assurance, subcommitte SC 2, Quality systems, has published a number of guidance modules:
• Guidance on ISO 9001:2008 sub-clause 1.2 "Application"
• Guidance on the documentation requirements of ISO 9001:2008
• Guide to the Terminology used in ISO 9001 and ISO 9004
• Guidance on the concept and use of the process approach for management systems
• Guidance on 'Outsourced processes'
• Implementation guidance for ISO 9001:2008
• Frequently Asked Questions (FAQs)
Transition schedule
• ISO and IAF announce schedule for implementation of accredited certification to ISO 9001:2008
ISO publishes book+CD on integrated use of management system standards
2008-07-15
ISO has published a combined book and CD giving organizations advice on how to make integrated use of management system standards.
The integrated use of management system standards distils the experience and expertise of an ISO task force comprising 16 members drawn from business organizations representing a wide range of countries and sectors, as well as from standards bodies and academia.
“The book provides a good mixture of theory and practice and will be useful for beginners as well as for the experienced,” declares Petra Eckl of MLPC International, France, leader of the ISO task force. “It will form a bridge between the increasing number of ISO management system standards that meet specific concerns of organizations and their stakeholders, and the user organization’s own and unique management approach.”
ISO management system standards (MSS), such as ISO 9001:2000 for quality management and ISO 14001:2004 for environmental management, are among the most widely used International Standards, while new ISO MSS are gaining ground, including ISO 22000 (food safety), ISO 28000 (supply chain security) and ISO/IEC 27001 (information security).
Contrary to many other types of standard, management system standards cover multiple aspects, levels and functions of an organization and, therefore, their implementation can have a substantial impact on how an organization operates and manages its business processes. In addition, more and more organizations are applying not only one, but a range of management system standards to satisfy their own needs as well as those of external stakeholders.
The book acknowledges that there is a market need for separate management system standards addressing different aspects, issues or risks that organizations need to manage. It provides guidance on how organizations can apply the different standards in a combined way, integrated with their business processes.
Based on the practical experience of organizations that have successfully made integrated use of management system standards, the book identifies a variety of methodologies, tools and practices.
The book, which is in colour and includes numerous graphics, is structured as follows:
• a description of the main characteristics, parts and functions of the management system of an organization
• what sort of requirements are contained in a management system standard, why these are important and how an organization should apply them
• guidance on how requirements from multiple management system standards can be integrated in a combined way within the existing management system of an organization.
Each chapter includes the following distinct sections:
• Guiding questions that helps to focus the reader
• Overview summarizing the theory of the topic concerned
• Approach featuring the methodologies and tools applied
• Jim the Baker – an imaginary character whose company is used to illustrate the implementation of the methodologies and tools
• Cases in point with actual practices and examples from case studies
• Practice assists readers in applying the principles and methods provided to their own situation.
The accompanying CD (inside the back cover), contains real-life examples extracted from 15 case studies made in a wide variety of situations. Examples are included from companies in Asia, South America and the Middle East, as well as Europe and North America. Multinational companies are included as well as smaller ones, in different sectors of activity, for profit and not-for-profit, applying different sets of management system standards.
ISO Secretary-General Alan Bryden comments: “This book should prove to be a very useful complement to ISO’s continuing efforts to ensure theconsistency, coverage and effective useof its management system standards.”
The integrated use of management system standards (ISBN 978-92-67-10473-7), 146 pages + CD, A5 format, ring binder, costs 48 Swiss francs and is available from ISO national member institutes (see the complete list with contact details) and from ISO Central Secretariat through the ISO Store or by contacting the Marketing & Communication department (see right-hand column).
Quality management principles
The following text is an integral reproduction of the content of the document "Quality Management Principles".
Introduction
This document introduces the eight quality management principles on which the quality management system standards of the ISO 9000:2000 and ISO 9000:2008 series are based. These principles can be used by senior management as a framework to guide their organizations towards improved performance. The principles are derived from the collective experience and knowledge of the international experts who participate in ISO Technical Committee ISO/TC 176, Quality management and quality assurance, which is responsible for developing and maintaining the ISO 9000 standards.
The eight quality management principles are defined in ISO 9000:2005, Quality management systems Fundamentals and vocabulary, and in ISO 9004:2000, Quality management systems Guidelines for performance improvements.
This document gives the standardized descriptions of the principles as they appear in ISO 9000:2005 and ISO 9004:2000. In addition, it provides examples of the benefits derived from their use and of actions that managers typically take in applying the principles to improve their organizations' performance.
ISO 9001:2000 – What does it mean in the supply chain?
• Introduction
• What is ISO 9001:2000?
• What does “Conformity to ISO 9001:2000” mean?
• How does ISO 9001:2000 help you in selecting a supplier?
• How can you have confidence that your supplier meets ISO 9001:2000?
• Can suppliers claim that their goods or services meet ISO 9001:2000?
• What to do if things go wrong
• To summarize...
Introduction
As someone who is involved in the selection of suppliers, and possibly responsible for purchasing decisions, you may have seen or used goods and services that are promoted using reference to ISO 9001:2000, or, more simply “ISO 9000”. What does this mean? How can this help you? How can you be sure that your suppliers understand what you expect from them, and are capable of providing you with a consistent, conforming product? This information brochure provides some answers to these questions, and will inform you about how you can get the most out of using ISO 9001:2000 as a supply chain tool.
What is ISO 9001:2000?
ISO 9001:2000 is an international standard that gives requirements for an organization’s Quality Management System (“QMS”). It is part of a family of standards published by the International Organisation for Standardisation (“ISO”) often referred to collectively as the “ISO 9000 series”. For this reason, you may sometimes hear your suppliers refer to being “ISO 9000 certified”, or having an “ISO 9000-compliant QMS”. This will normally mean that they are claiming to have a QMS meeting the requirements of ISO 9001:2000, the only standard in the ISO 9000 family that can be used for the purpose of conformity assessment. It is important to understand however, that ISO is the body that develops and publishes the standard - ISO does not “certify” organizations, as will be explained later in this brochure.
The objective of ISO 9001:2000 is to provide a set of requirements that, if they are effectively implemented, will provide you with confidence that your supplier can consistently provide goods and services that:
• Meet your needs and expectations and
• Comply with applicable regulations
The requirements cover a wide range of topics, including your supplier's top management commitment to quality, its customer focus, adequacy of its resources, employee competence, process management (for production, service delivery and relevant administrative and support processes), quality planning, product design, review of incoming orders, purchasing, monitoring and measurement of its processes and products, calibration of measuring equipment, processes to resolve customer complaints, corrective/preventive actions and a requirement to drive continual improvement of the QMS. Last but not least, there is a requirement for your supplier to monitor customer perceptions about the quality of the goods and services it provides.
ISO 9001:2000 does not specify requirements for the goods or services you are purchasing. That is up to you to define, by making clear your own needs and expectations for the product. You might, for example, refer to product specifications, drawings, national or international product standards, supplier’s catalogues or other documents as appropriate.
What does “Conformity to ISO 9001:2000” mean?
This means that your supplier has established a systematic approach to quality management, and is managing its business to ensure that your needs are clearly understood, agreed and fulfilled. A statement of conformity to ISO 9001:2000:2000 should not, however, be considered as a substitute for a declaration or statement of product conformity.
How does ISO 9001:2000 help you in selecting a supplier?
ISO 9001:2000 provides some requirements for the purchasing process that include you as the customer. These requirements address the following topics:
• requirements regarding the purchasing information that should be provided so that suppliers clearly understand their customers' needs
• the ways in which supplied products can be verified as meeting the requirements of the customer
Note that whenever ISO 9001:2000 refers to “products”, this also includes intangible products like services, or software.
You have an important role to play, by specifying to your supplier what you actually want. You may need to consult with your own internal technical staff (the actual users) in this process. If you don’t do this, you might find that you receive a product that meets all your stated requirements and the applicable regulatory requirements, but which is absolutely wrong for your intended application. So, first of all, you should concentrate on specifying your needs related to the intended use of the product.
To help in this task you may consider the following:
• What is the specific product (goods or service) you are buying?
• What impact does this product have on your own business?
• What are the risks to your business if you experience problems with this product?
• How can you be sure that the product you receive will actually meet your requirements?
o What do you know about the reputation and historical performance of your supplier?
o What level of confidence do you need in your supplier’s ability to provide you with conforming product on a consistent basis?
o If you decide that conformity to ISO 9001:2000 is important, (based on your assessment of the risks associated with the goods and services you are buying) how can you be sure that your supplier does have a QMS that meets ISO 9001:2000 requirements?
o Are the goods and services you require covered by your supplier’s QMS? (You may need to ask for a copy of your supplier’s actual certificate or declaration of conformity to find this out!)
How can you have confidence that your supplier meets ISO 9001:2000?
There are various ways in which your supplier can claim that its QMS meets the requirements of ISO 9001:2000. These include:
• ‘Supplier’s declaration of conformity’: A declaration by your supplier itself affirming that its QMS meets ISO 9001:2000 requirements, usually supported by legally-binding signatures. This declaration can be based on your supplier’s internal audit system, or on second party or third party audits;
• Second party assessment: your supplier has been assessed directly by its customer (for example by you, or by another customer, whose reputation you respect) to check if its QMS meets ISO 9001:2000 requirements and your own requirements - sometimes used in contractual “business-to-business” transactions;
• Third party assessment: (Often referred to as certification or registration): your supplier hires an impartial third party (a certification body, or “registrar”) to conduct an assessment to verify conformity to ISO 9001:2000 requirements. This third party then issues a certificate to your supplier describing the scope of its QMS, and confirming that it conforms to ISO 9001:2000.
• Additional confidence may be derived from the fact that some certification bodies (“registrars”) are accredited by nationally or internationally recognized accreditation bodies, who verify the certification body’s independence and competence to carry out the certification process. Many accreditation bodies have multi-lateral arrangements under the umbrella of the IAF (International Accreditation Forum) to promote worldwide mutual recognitions in support of WTO (World Trade Organization) free trade principles.
Figure 1 explains this in simple schematic terms.
Figure 1 – Some ways of demonstrating conformity to ISO 9001:2000
Can suppliers claim that their goods or services meet ISO 9001:2000?
No. The reference to ISO 9001:2000 indicates that the supplier has a quality management system that meets the requirements of ISO 9001:2000. As mentioned earlier, this should provide you with confidence in your supplier’s ability to provide consistent, conforming goods or services. ISO 9001:2000 requires your supplier to monitor the levels of satisfaction of its customers (this includes you!), and to feed back this information in order to improve the effectiveness of its QMS.
What to do if things go wrong?
In the event you are not happy with specific goods or services you receive, you should first of all bring this to your supplier’s attention. You will typically do this via the normal technical and/or commercial communication channels that have been established. Your supplier is obliged to investigate your complaint, and should take appropriate actions to avoid or reduce the chances of it happening again.
If, however, you are dissatisfied with the overall performance of your supplier, (for example if they continue to provide non-conforming products, do not address your complaints, or are not taking appropriate corrective actions) then this is an indication of problems in their quality management system. Depending on the responses you receive, you should be aware that you can escalate your complaint as follows:
• If your supplier has a QMS that meets ISO 9001:2000 requirements, they are required to have nominated a person (the “management representative”) to have the responsibility and authority to ensure the system is working properly. You should find out who this is, and make a formal complaint.
• If you are still not satisfied with the response from your supplier, and if they are certified by an independent (third party) certification body (“registrar”), you should bring the matter to the certification body’s attention. You can find the certification body’s name by looking at your supplier’s certificate. The certification body will investigate the problems during their surveillance audits of your supplier’s QMS, or, in critical cases, may decide to carry out an additional specific investigation.
• If you do not receive a satisfactory response from the certification body, and if it is accredited (see Figure 1), you should complain to the relevant accreditation body. Details of any such accreditation will appear on your supplier’s ISO 9001:2000 certificate. If you have difficulty in getting this information, you can consult the list of accreditation bodies who are members of the International Accreditation Forum on the IAF website (http://www.iaf.nu).
• If you feel that you have not received a satisfactory response from the accreditation body, and if it is a member of the International Accreditation Forum (see Figure 1), you can complain to the IAF (http://www.iaf.nu).
Remember that none of the above will affect your statutory rights as a purchaser, and it may be appropriate to take legal action against your supplier instead of, or in parallel with the above channels. The way in which you do this may vary from one country to another.
To summarize…..
ISO 9001:2000 is a useful basis for organizations to be able to demonstrate that they are managing their business so as to achieve consistent (good!) quality goods and services.
There are several ways in which your suppliers can claim conformity to ISO 9001:2000, and you need to ensure that the method chosen by your supplier provides you with the necessary degree of confidence.
If you are not satisfied with the performance of your supplier, you must provide them with the appropriate feedback. Learning from complaints helps organizations to improve their future performance – that is what ISO 9001:2000 is about.
Some additional helpful information about ISO and the ISO 9000 family of standards can be obtained from www.iso.org, or by consulting your national standards body.
________________________________________
This guidance document was developed by the ISO 9000 Advisory Group, comprising representatives from ISO/TC176 (the committee responsible for writing the ISO 9000 standards), ISO/CASCO (ISO’s Conformity Assessment Committee), ISO/COPOLCO (ISO’s Committee on Consumer Policy) and IAF (The International Accreditation Forum)
ISO 9001 Auditing Practices Group
Welcome to the website of the ISO 9001 Auditing Practices Group.
The ISO 9001 Auditing Practices Group is constituted as an informal group of quality management system (QMS) experts, auditors and practitioners, drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF).
The Co-Conveners of the ISO 9001 Auditing Practices Group are Mr L Thione (CEO, SINCERT, Italy) and Mr A Ezrakhovich (General Manager, SAI Global Certification Services Pty Ltd, Australia).
This website has been established as an on-line source of papers and presentations on auditing QMSs. The ideas, examples and explanations given reflect the process-based approach that is essential for auditing the requirements of ISO 9001:2000 Quality management systems - Requirements.
The website is primarily aimed at QMS auditors, consultants and quality practitioners.
The papers and presentations that make up the content of this website are not definitive. They reflect a number of different views in QMS auditing. As such, their content may not always be consistent. It is not intended that the website's content will be used as specified requirements, an industry benchmark, or as criteria that all QMS auditors, consultants or practitioners have to follow.
The items listed under "QMS auditing topics" below have papers and presentations associated with them. Simply click on one of the links to view and download the relevant document.
Feedback from users will be used by the ISO 9001 Auditing Practices Group to determine whether additional guidance documents should be developed, or if these current ones should be revised. Comments on the papers or presentations can be sent to the following email address: charles.corrie@bsigroup.com.
A sister web page for the Accreditation Auditing Practices Group has been established to provide guidance to accreditation auditors.
QMS auditing topics
• Introduction to the ISO 9001 Auditing Practices Group
• The need for a 2-stage approach to auditing
• Measuring QMS effectiveness and improvements
• Identification of processes
• Understanding the process approach
• Determination of the “where appropriate” processes
• Auditing the “where appropriate” requirements
• Demonstrating conformity to the standard
• Linking an audit of a particular task, activity or process to the overall system
• Auditing continual improvement
• Auditing a QMS which has minimum documentation
• How to audit top management processes
• The role and value of the audit checklist
• Scope of ISO 9001:2000, Scope of Quality Management System and Defining Scope of Certification
• How to Add Value during the audit process
• Auditing competence and the effectiveness of actions taken
• Auditing Statutory and Regulatory requirements
• Auditing Quality Policy, Quality Objectives, and Management Review
• Auditing ISO 9001, Clause 7.6 Control of monitoring and measuring devices
• Making effective use of ISO 19011
• Auditing Customer Feedback processes
• Documenting a Nonconformity
• Guidance for reviewing and closing nonconformities
• Auditing Internal Communications
• Auditing Preventive Action
• Auditing Service Organizations
• Third Party Auditor Impartiality and Conflict of Interest
• Auditing the Effectiveness of the Internal Audit
• Auditing Electronic Based Management Systems
• Auditing the Management of Resources
• Auditing Customer Communications
• Auditing the Design and Development Process
• Auditor Code of Conduct and Ethics
• Guidance on Cultural Aspects of Auditing
• Output Matters!
• Auditing the Procurement and Supply Chain Processes
• Added Value Audits versus Consultancy
• Writing Audit Reports
"Zip" file of all the above documents
[TRANSLATIONS – Links to translations of the above documents]
Disclaimer
The contributions on this website have not been subject to an endorsement process by the International Organization for Standardization (ISO), ISO Technical Committee 176 or the International Accreditation Forum (IAF).
The information contained on this website is available to the public for educational and communication purposes and the ISO 9001 Auditing Practice Group does not take responsibility for any errors, omissions or other liabilities that may arise from the provision or subsequent use of such information.
Abbreviations and Definitions
On this website the following abbreviations are commonly used:
Auditee = the organization being audited
CRB = Certification/registration body
NCR = Non-conformity report
QMS = Quality management system
Further reading:
ISO and IAF have published several documents related to QMS and auditing, which are listed below. These are available from ISO or the IAF, or from your national ISO member body or IAF member body.
• [1] ISO 9000:2000, Quality management systems – Fundamentals and vocabulary
• [2] ISO 9001:2000, Quality management systems – Requirements
• [3] ISO 9004:2000, Quality management systems – Guidelines for performance improvements
•
• [4] "ISO 9000 Introduction and Support Package" guidance documents from ISO/TC 176 SC2:
• N524 – Guidance on ISO 9001:2000, Clause 1.2 'Application'
• N525 – Guidance on the Documentation requirements of ISO 9001:2000
• N526 – Guidance on the Terminology used in ISO 9001:2000 and ISO 9004:2000
• N544 – Guidance on the Concept and Use of the Process Approach
• N630 – Guidance on Outsourced Processes
•
• (These may be downloaded, for free, from the ISO or ISO/TC 176/SC 2 web sites)
•
• [5] ISO/IEC DIS 17000, Conformity assessment – General Vocabulary
• [6] ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing
• [7] ISO/IEC Guide 62, General requirements for bodies operating assessment and certification/registration of quality systems
• [8] IAF Guidance on ISO Guide 62
• (This may be downloaded, for free, from the IAF web site)
• [9] ISO/IEC CD2 17021, Conformity assessment - General requirements for bodies operating assessment and certification/registration of quality systems
• [10] ISO Handbook:2002, ISO 9001:2000 for small businesses – What to do, Advice from ISO/TC 176
Useful web sites:
http://www.iaf.nu/ International Accreditation Forum (IAF)
http://www.iso.org/ International Organization for Standardization (ISO)
http://www.tc176.org/ ISO Technical Committee no. 176, Quality Management and Quality Assurance (ISO/TC 176)
www.iso.org/tc176/sc2 ISO/TC 176, Sub-committee no.2, Quality Systems (ISO/TC 176/SC 2)
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Document Revision Status Information
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Therefore and unless otherwise specified, no part of these ISO / IAF publications may be reproduced or utilized (including reproduction in whole or in part to another Internet site), in any form or by any means, electronic or mechanical, including photocopying, microfilm, scanning, etc., without permission in writing from the publishers.
Requests should be addressed to:
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Origins and ISO/TC 176
This section describes the origins of the ISO 9000 family and introduces the ISO technical committee responsible for these standards
ISO/TC 176
ISO standards are developed by technical committees comprising national delegations of experts from business, government and other relevant organizations. They are chosen by the ISO members – the national standards institutes participating in the technical committee concerned – and are required to present a national consensus position based on the views of stakeholders in their country.
In 1979, a new ISO technical committee was approved: ISO/TC 176, Quality management and quality assurance. Initially, 20 member countries decided to become active participants (P-members) in the work of this new committee and another 14 countries opted to follow the work as observers (O-members).
Today, 80 countries participate in ISO/TC 176, while another 21 are observers. The committee published its first standards in the early part of 1987.
Why 'ISO 9000' was the number chosen
ISO standards are usually assigned a catalogue number automatically. When the first output of ISO/TC 176 was nearing completion, ISO was already approaching a total of some 9 000 published standards. ISO realized even then that ISO/TC 176's standards would have a significant impact and so decided to give the series the next available round figure - 9000 - as a designation because round figures are more memorable.
What already existed
When ISO/TC 176 embarked on the development of generic quality management standards for worldwide application, it was able to take advantage of a substantial base of national experience, notably in the United Kingdom and in Canada.
In the United Kingdom, the BS 5750 standards were well on their way to broad acceptance and, in Canada, a series of national standards known as CSA Z299 were also widely used.
Other countries with well developed quality management practices, such as Japan, also took a keen interest in the work of the new committee. In addition, experience of military quality assurance specifications, such as the NATO AQAP series and US MIL-SPEC, enriched the sources from which ISO/TC 176 was able to draw.
ISO 14000 essentials
This section concisely describes the essential features of the ISO 14000 family.
The ISO 14000 family addresses various aspects of environmental management. The very first two standards, ISO 14001:2004 and ISO 14004:2004 deal with environmental management systems (EMS). ISO 14001:2004 provides the requirements for an EMS and ISO 14004:2004 gives general EMS guidelines.
The other standards and guidelines in the family address specific environmental aspects, including: labeling, performance evaluation, life cycle analysis, communication and auditing.
An ISO 14001:2004-based EMS
An EMS meeting the requirements of ISO 14001:2004 is a management tool enabling an organization of any size or type to:
• identify and control the environmental impact of its activities, products or services, and to
• improve its environmental performance continually, and to
• implement a systematic approach to setting environmental objectives and targets, to achieving these and to demonstrating that they have been achieved.
How it works
ISO 14001:2004 does not specify levels of environmental performance. If it specified levels of environmental performance, they would have to be specific to each business activity and this would require a specific EMS standard for each business. That is not the intention.
ISO has many other standards dealing with specific environmental issues. The intention of ISO 14001:2004 is to provide a framework for a holistic, strategic approach to the organization's environmental policy, plans and actions.
ISO 14001:2004 gives the generic requirements for an environmental management system. The underlying philosophy is that whatever the organization's activity, the requirements of an effective EMS are the same.
This has the effect of establishing a common reference for communicating about environmental management issues between organizations and their customers, regulators, the public and other stakeholders.
Because ISO 14001:2004 does not lay down levels of environmental performance, the standard can to be implemented by a wide variety of organizations, whatever their current level of environmental maturity. However, a commitment to compliance with applicable environmental legislation and regulations is required, along with a commitment to continual improvement – for which the EMS provides the framework.
The EMS standards
ISO 14004:2004 provides guidelines on the elements of an environmental management system and its implementation, and discusses principal issues involved.
ISO 14001:2004 specifies the requirements for such an environmental management system. Fulfilling these requirements demands objective evidence which can be audited to demonstrate that the environmental management system is operating effectively in conformity to the standard.
What can be achieved
ISO 14001:2004 is a tool that can be used to meet internal objectives:
• provide assurance to management that it is in control of the organizational processes and activities having an impact on the environment
• assure employees that they are working for an environmentally responsible organization.
ISO 14001:2004 can also be used to meet external objectives:
• provide assurance on environmental issues to external stakeholders – such as customers, the community and regulatory agencies
• comply with environmental regulations
• support the organization's claims and communication about its own environmental policies, plans and actions
• provides a framework for demonstrating conformity via suppliers' declarations of conformity, assessment of conformity by an external stakeholder - such as a business client - and for certification of conformity by an independent certification body.
Business benefits of ISO 14000
This section identifies typical benefits for organizations of implementing ISO 14000 standards.
Most managers will try to avoid pollution that could cost the company a fine for infringing environmental legislation. But better managers will agree that doing only just enough to keep the company out of trouble with government inspectors is a rather weak and reactive approach to business in today's environment-conscious world.
The ISO 14000 standards are practical tools for the manager who is not satisfied with mere compliance with legislation – which may be perceived as a cost of doing business. They are for the proactive manager with the vision to understand that implementing a strategic approach can bring return on investment in environment-related measures.
The systematic ISO 14001:2004 approach requires the organization to take a hard look at all areas where its activities have an environmental impact. And it can lead to benefits like the following:
• reduced cost of waste management
• savings in consumption of energy and materials
• lower distribution costs
• improved corporate image among regulators, customers and the public
• framework for continual improvement of environmental performance.
The manager who is "too busy managing the business" to listen to good sense about environmental management could actually be costing the business, instead of achieving benefits like those above.
ISO 14001:2004 and SME's
This section explains that small and medium-sized enterprises can also benefit from ISO 14001:2004 and points to some resources.
The importance of small and medium-sized enterprises (SMEs)to economies around the world is beyond dispute. Surveys have shown that, on a global basis, more than 90 % of all businesses are SMEs.
Experience shows that SMEs can implement an effective EMS and can realize a variety of benefits from doing so. However, EMS implementation in smaller enterprises can present significant challenges. An SME Task Group at ISO has developed recommendations to change that perception, and make it easier for SMEs to benefit from implementing an EMS based on ISO 14001:2004.
Taking the first steps
This article from ISO Management Systems magazine explains clearly how an SME can implement an environmental management system so that the process is not a series of hurdles, but rather a set of practical steps towards raising environmental and business performance.
• Read more (PDF, 412 kB)
Using an EMS consultant – or going it alone
This article from ISO Management Systems magazine helps SME managers answer some essential questions. Should you hire a consultant to help with environmental management system implementation, or go it alone? What are the advantages and potential pitfalls? How can you get best value for money if you hire a consultant and what are the criteria you should use for choosing one?
• Read more (PDF, 447 kB)
ISO and the environment
The ISO 14000 family is the most visible part of ISO's work for the environment. This section gives the whole picture.
ISO has a multi-faceted approach to meeting the needs of business, industry, governments and consumers in the field of the environment.
Firstly, ISO it offers a wide-ranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 350 International Standards for the monitoring of such aspects as the quality of air, water and soil. These standards are a means of providing business and government with scientifically valid data on the environmental effects of economic activity. They may also be used as the technical basis for environmental regulations.
Secondly, ISO offers a strategic approach through the ISO 14000 family of environmental management standards developed by ISO technical committee ISO/TC 207 that can be implemented in any type of organization in either public or private sector (companies, administrations, public utilities).
Thirdly, ISO/TC TC 207 also works on documents to facilitate the fusion of business and environmental goals by encouraging the inclusion of environmental aspects in product design.
ISO/TR 14062, Environmental management - Integrating environmental aspects into product design and development, enables organizations to identify the likely effects on the environment of their future products and make effective decisions during the design and development stages to improve their environmental performance.
Fourthly, ISO/TC 207 is helping to meet the new challenge of climate change with standards such as ISO 14064:2006 and ISO 14065:2007 standards for greenhouse gas verification and accounting.
Origins and ISO/TC 207
This section describes the origins of the ISO 14000 family and introduces the ISO technical committee responsible for these standards
Sustainable development
The ISO 14000 family grew out of ISO's commitment to support the objective of sustainable development discussed at the United Nations Conference on Environment and Development, in Rio de Janeiro, in 1992.
ISO/TC 207
ISO launched the new technical committee, ISO/TC 207, Environmental management, in 1993. However, this was preceded by an intensive consultation process, carried out within the framework of the ISO/IEC Strategic Advisory Group on Environment (SAGE), set up in 1991, in which 20 countries, 11 international organizations and more than 100 environmental experts participated in defining the basic requirements of a new approach to environment-related standards.
Today, delegations of business and government experts from 75 countries participate actively within TC 207, with another 26 as observers, along with 41 international or regional organizations, including UNCTAD, UNEP, WHO and WTO. The delegations are chosen by the national standards institute concerned and they are required to bring to TC 207 a national consensus on issues being addressed by the committee. This national consensus is derived from a process of stakeholder consultation.
More ISO 14000 resources
The integrated use of management system standards
ISO has published a combined book and CD giving organizations advice on how to make integrated use of management system standards.
• Continue
ISO 14064 and 14065 for greenhouse gas accounting and verification
The ISO 14064 and ISO 14065 standards for greenhouse gas accounting and verification provide government and industry with an integrated set of tools for programmes aimed at reducing greenhouse gas emissions, as well as for emissions trading.
• Climate change
Specific applications
The tremendous impact of ISO 9001 and ISO 14001 on organizational practices and on trade has stimulated the development of other ISO standards and deliverables that adapt the generic management system to specific sectors or aspects.
Sector Standard or series of standards
Automotive
ISO/TS 16949:2002
Education
IWA 2:2007
Energy
PC 242, ISO 50001
Food safety
ISO 22000:2005
Information security
ISO/IEC 27001:2005
Health care
IWA 1:2005
Local government
IWA 4:2005
Medical devices
ISO 13485:2003
Petroleum and gas
ISO 29001:2003
Ship recycling
ISO 30000
Supply chain security
ISO 28000:2007
Certification
Certification is not a requirement of any of ISO's management system standards. This section provides a basic understanding of what certification and related terms mean.
Certification, registration and accreditation
In the context of ISO 9001:2000 (and ISO 9001:2008) or ISO 14001:2004, “certification” refers to the issuing of written assurance (the certificate) by an independent external body that it has audited a management system and verified that it conforms to the requirements specified in the standard.
“Registration” means that the auditing body then records the certification in its client register. So, the organization’s management system has been both certified and registered.
Therefore, in the ISO 9001:2000 (and ISO 9001:2008) or ISO 14001:2004 context, the difference between the two terms is not significant and both are acceptable for general use. “Certification” is the term most widely used worldwide, although registration is often preferred in North America, and the two are used interchangeably.
On the contrary, using “accreditation” as an interchangeable alternative for certification or registration is a mistake, because it means something different.
In the ISO 9001:2000 (and ISO 9001:2008) or ISO 14001:2004 context, accreditation refers to the formal recognition by a specialized body – an accreditation body – that a certification body is competent to carry out ISO 9001:2000 (and ISO 9001:2008) or ISO 14001:2004 certification in specified business sectors.
In simple terms, accreditation is like certification of the certification body. Certificates issued by accredited certification bodies may be perceived on the market as having increased credibility.
• See ISO/IEC 17000:2004, Conformity assessment - Vocabulary and general principles
ISO does not carry out certification
ISO is responsible for developing, maintaining and publishing the ISO 9000 and ISO 14000 families of standards but ISO does not itself audit or assess the management systems of organizations to verify that they have been implemented in conformity with the requirements of the standards.
ISO does not issue ISO 9001:2000 (or ISO 9001:2008) or ISO 14001:2004 certificates.
The auditing and certification of management systems is carried out independently of ISO by more than 750 certification bodies active around the world. ISO has no authority to control their activities. The ISO 9001:2000 (and ISO 9001:2008) and ISO 14001:2004 certificates issued by certification bodies are issued under their own responsibility and not under ISO's name.
ISO itself does not carry out assessments or audits to check that its standards are being implemented by users in conformity with the requirements of the standards. Conformity assessment – as this process is known – is a matter between suppliers and their customers in the private sector, and of regulatory bodies when ISO standards have been incorporated into public legislation.
In addition, there exist many testing laboratories and certification bodies which offer independent (also known as "third party") conformity assessment services to provide confirmation that products (including hardware, software and processed materials), services or systems measure up to ISO standards.
Such organizations may perform these services under a mandate to a regulatory authority, or as a commercial activity, the aim of which is to create confidence between suppliers and their clients.
In some countries, the national standards institutes that make up ISO's membership carry out conformity assessment, either on behalf of their respective governments, or as a business operation. ISO itself has no authority to control conformity assessment activities, whether these are business activities by its members, or by other organizations.
However, ISO's Committee on conformity assessment, ISO/CASCO, develops standards and guidelines covering various aspects of conformity assessment activities and the organizations that perform them. The voluntary criteria contained in these standards and guides represent an international consensus on good practice. Their use contributes to the consistency of conformity assessment worldwide and so facilitates trade across borders.
Choosing a certification body
When choosing a certification body to carry out ISO 9001:2000 (or ISO 9001:2008) or ISO 14001:2004 certification, these are the aspects the organization needs to take into account.
• The first point is that an organization can implement ISO 9001:2000 (or ISO 9001:2008) or ISO 14001:2004 without seeking certification. The best reason for wanting to implement the standards is to improve the efficiency and effectiveness of company operations. Certification of the management system is not an ISO 9001:2000 (or ISO 9001:2008) or ISO 14001:2004 requirement.
• Deciding to have an independent audit of the system to confirm that it conforms to ISO 9001:2000 (or ISO 9001:2008) or ISO 14001:2004 is a decision to be taken on business grounds: for example
o if it is a contractual or regulatory requirement
o if it is a market requirement or to meet customer preferences
o if it falls within the context of a risk management programme
o or if the organization thinks it will motivate staff by setting a clear goal for the development of its management system.
• Criteria to consider include:
• evaluate several certification bodies
• bear in mind that the cheapest might prove to be the most costly if its auditing is below standard, or if its certificate is not recognized by the organization's customers
• establish whether the certification body has auditors with experience in the organization's sector of activity
• establish whether the certification body implements, or is migrating to ISO/IEC 17021:2006, Conformity assessment – Requirements for bodies providing audit and certification of management systems
• Another point to clarify is whether or not the certification body has been accredited and, if so, by whom. Accreditation, in simple terms, means that a certification body has been officially approved as competent to carry out certification in specified business sectors by a national accreditation body.
In most countries, accreditation is a choice, not an obligation and the fact that a certification body is not accredited does not, by itself, mean that it is not a reputable organization. For example, a certification body operating nationally in a highly specific sector might enjoy such a good reputation that it does not feel there is any advantage for it to go to the expense of being accredited. That said, many certification bodies choose to seek accreditation, even when it is not compulsory, in order to be able to demonstrate an independent confirmation of their competence.
The list of accreditation bodies with their contact information and links to their Web sites can be found on the Internet site of the International Accreditation Forum (www.iaf.nu), under "Members" > "Accreditation members". In general, accreditation bodies' Web sites contain an up-to-date list of certification bodies that they have accredited which can be used for selecting a certification body.
The ISO sectoral portfolio
ISO develops International Standards for all industry sectors (with the exception of electrotechnology, covered by IEC, and telecommunications, covered by ITU), as well as for a variety of cross-sector, horizontal themes (such as metrology and generic management systems).
Given the level of specialization that characterizes ISO’s technical work regarding both the structure of ISO’s technical bodies and ISO’s deliverables, it is often not easy for the non-expert (and sometimes for the expert as well) to identify the scope and extent of ISO activities in a given field and from a general perspective.
Most ISO standards are highly specific and require specialized knowledge to develop. Therefore, the technical committees that develop these standards are also specialized in a specific area of technology or business activity. Despite this, the aggregated work of several technical or subcommittees can often provide a complete offering for a broad sector of activitiy.
The ISO sectoral portfolio is an information tool that provides aggregated information on the ISO work covering selected areas of activities. It includes summaries and hyperlinks to the relevant ISO technical committee Web sites and highlights some of the most important relevant ISO standards and related bibliographical information.
ISO plans to expand significantly the ISO sectoral portfolio over time. However, to a certain extent, it will always be "work in progress". We are therefore most grateful to all ISO Online users who would like to share their views, feedback and suggestions that will help us to modify, expand and improve this section.
Why does the work matter?
ISO has developed a three-pronged approach to meeting the needs of business, industry, governments and consumers in the field of the environment. Firstly, it offers a wide-ranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 560 International Standards (out of a total of over 17 000) for the monitoring of such aspects as the quality of air, water and soil. These standards are a means of providing business and government with scientifically valid data on the environmental effects of economic acitivity. They also serve in a number of countries as the technical basis for environmental regulations.
Secondly, and more recently, ISO is leading a strategic approach by developing environmental management system standards that can be implemented in any type of organization in either public or private sector (companies, administrations, public utilities). To spearhead this strategic approach, ISO established a new technical committee, ISO/TC 207, Environmental management, in 1993. This followed ISO's successful pioneering experience in management system standardization with the ISO 9000 series for quality management.
In addition to standards on environmental management systems and supporting tools, TC 207 works on documents to facilitate the fusion of business and environmental goals by encouraging the inclusion of environmental aspects in product design - which represents the third axis of ISO's environmental approach. An example is a technical report which promotes the convergence of environment-friendly products with company profits.
The management of environmental aspects and impacts has established itself as a cornerstone of effective organizational practice alongside the management of quality, security, and health and safety issues. Ongoing concern about environmental issues and sustainable development has significantly affected global practices in recent years as organizations strive to be responsive to government regulations, shareholder concerns and interested parties’ expectations all at the same time. The work products of ISO/TC 207 – the basic standard for environmental management, ISO 14001, standards for environmental auditing and performance evaluation, product labelling and declarations, lifecycle assessment, greenhouse gas emission reporting, and others – provide effective management tools for organizations to better manage and communicate about their environmental aspects and to work towards improving their environmental performance and contributing to sustainable development. When used properly, these tools can provide significant advantages and benefits to users in both the private and public sectors.
ISO/TC 207 is not alone in developing standards for the protection of our environment. Three other ISO technical committees deal with the quality of three important elements of our planet:
• ISO/TC 146 Air quality
• ISO/TC 147 Water quality
• ISO/TC 190 Soil quality
Another related technical committee is ISO/TC 224 Service activities relating to drinking water supply systems and wastewater systems - Quality criteria of the service and performance indicators.
The ISO Oil and Gas activities derive from very active and driven groups of professionals, striving to accomplish a solution to the oil and natural gas industries need for global equipment and material standards. It is in the economic interest of all stakeholders to produce timely, clearly written, internationally acceptable standards for use by suppliers, purchasers and regulators.
Internationally developed consensus-based standards ensure sustainability to the oil and gas industry by providing a means to:
- carry out buisness efficiently and cost effectively;
- enhance technical integrity, thereby assuring no harm to people, assets or the environment; and
- transfer knowledge and share best practice
• ISO’s engagement
ISO, as the principal developer of international standards, makes a major contribution to the building construction industry. Its standards for this sector incorporate the technical advice provided by the hundreds of experts participating in the related technical committees. In addition, they also respect the international agreements drafted on environmental protection, such as the Kyoto Protocol to the United Nations Framework Convention on Climate Change.
Building construction should also be associated with the term "sustainable construction". The construction industry has such a great impact on our planet’s natural resources, that the environmental issues touched by the increasing building activities as the world’s population continues to grow cannot be ignored.
From the planning phase, through the laying of foundations, to the end product, ISO has published standards for all these stages of development.
Not only are there technical benefits from implementing ISO standards, there are also social and economic benefits to be gained. The Council for Research and Innovation in Building and Construction (CIB) estimates that for every dollar spent on construction, three dollars are generated in other sectors.
• ISO's engagement
Standards FAQs
What can I do if I'm looking for a standard, but I'm not sure if it's an ISO standard or not?
Consult the World Standards Services Network, accessible via the ISO Online home page. It contains links to international, regional and national standardization bodies, including international and regional organizations which develop standards in their specialized subject area, in addition to their principal activity.
Where can I find links to other international, regional or national standardization bodies, or information about their standards?
Consult the World Standards Services Network, accessible via the ISO Online home page. It contains links to international, regional and national standardization bodies, including international and regional organizations which develop standards in their specialized subject area, in addition to their principal activity.
How can I find out which standards are equivalent to ISO standards?
ISO itself does not have data on equivalent standards (such as national or regional standards). However, a number of ISO members are able to provide this information. Therefore, please contact the ISO member in your country.
Can I access ISO standards on ISO Online or some other electronic database?
Not yet, but it is in the pipeline. At present, you can find out what standards exist in ISO's portfolio by accessing the ISO Catalogue. For the moment, there is no electronic access to the content of ISO standards. However, we are working towards provision of that service.
Are any ISO standards available electronically?
Some ISO standards are available as electronic products. Contact the ISO member in your country or our sales department using the online contact form.
Where can I obtain technical assistance on standards?
Contact the ISO member in your country. A list of members can be accessed on this site. The ISO Central Secretariat does not provide technical assistance, but the online enquiry service may be able to help you save time by directing you to appropriate sources of information.
Can I order ISO standards and publications via ISO Online?
Your first contact should be the ISO member for your country. However, if you have a problem, you can order through our sales department.
Can I reproduce material from ISO standards?
All ISO publications, including ISO standards, are protected by copyright. See the ISO copyright guide page for further information.
I've heard the word `standard', but how would I know an ISO standard if I saw one?
An ISO standard can be anything from a four-page document to one several hundred pages' long. It is usually also available in electronic form. It carries the ISO logo and the designation International Standard. In most cases, the paper version is published in A4 format - which is itself one of the ISO standard paper sizes. The standardization of paper sizes is a typical example of ISO's work: agreement on a sufficient number of variations of a product to meet most current applications allows economies of scale with cost benefits to both producers and consumers.
What can I expect to find in an ISO standard?
An ISO standard is a documented agreement containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics to ensure that materials, products, processes and services are fit for their purpose. It is a living agreement that can have a profound influence on things that deserve to be taken seriously - such as the safety, reliability and efficiency of machinery and tools, means of transport, toys, medical devices, and so on.
Could you give me a few practical examples of ISO standards?
Take a look at the graphical symbols on the dashboard of your car or at the pictorial symbol on a package marked with handling instructions such as "This way up". Various ISO technical committees have developed or adopted hundreds of carefully researched signs and symbols that convey clear-cut messages which cross language bounderies.
On the inside cover of nearly every book, there is something called an ISBN number. ISBN stands for International Standard Book Number. Publishers and booksellers are very familiar with ISBN numbers, since they are the keyway that books are ordered and bought. Try buying a book on the Internet, and you will soon learn the value of the ISBN number - there is a unique number for the book you want! And, it is based on an ISO standard.
Almost everything you need and use for work and home comes from somewhere else. Whether departure and destination points are as close as A to B, or as far apart as Antwerp and Bangkok, freight containers ensure a smooth passage for your goods and materials. From truck to train, from boat to plane, there are more than five million freight containers transiting across the globe. This has become possible principally through international standardization.
Yet another example: the chair that you're probably sitting on, or the desk your computer is perched on, are held together by bolts and screws. Humble bolts and screws also hold together our children's bicycles - and also the aircraft we trust our lives to during business trips or holiday travel. The diversity of screw threads used to represent big problems for industry, particularly in maintenance, as lost or damaged nuts and bolts could not easily be replaced. A global solution is supplied in the ISO standards for metric screw threads.
Also, the credit card you may have used to buy your computer can be used worldwide because all its basic features are based on ISO standards. We are so familiar with many objects, like credit or telephone cards, that we tend to assume they just "fell out of the sky". In fact, the ease with which we can use them can be traced back to an ISO standard.
Further examples are given in the ISO Café and Widely used standards sections.
Technology moves on - what about ISO standards?
ISO standards represent, by an international consensus among experts in the technology concerned, the state of the art. To ensure that ISO standards retain this lead, they are reviewed at least every five years after their publication. The technical experts then decide whether the standard is still valid, or whether it should be withdrawn or updated. In some fields, the pace of development is such that when an ISO standard is published, the experts who developed it are already thinking about the next version!
Does ISO have standards for everything?
Not quite! Scroll through the list of our technical committees on this site to get an idea of the huge range of technologies, industries and business sectors for which ISO develops standards.
ISO's work programme ranges from standards for traditional activities, such as agriculture and construction, through mechanical engineering to the newest information and communications technology (ICT) developments, such as the digital coding of audio-visual signals for multimedia applications. We collaborate on ICT with our partners, IEC (International Electrotechnical Commission) and ITU (International Telecommunication Union), which are specialized in the domains indicated by their names.
What are ISO's `new deliverables'?
ISO standards are developed according to strict rules to ensure that they are transparent and fair. The reverse side of the coin is that it can take time to develop consensus among the interested parties, and for the resulting agreement to go through the public review process in the ISO member countries. For some users of standards, particularly those working in fast-changing technology sectors, it may be more important to agree and publish a technical specification quickly, before going through the various checks and balances needed to win the status of a full International Standard. Therefore, to meet such needs, ISO has developed a new range of "deliverables", or different categories of specifications, allowing publication at an intermediate stage of development before full consensus.
What other products does ISO offer?
In addition to International Standards and the "new deliverables" (see previous question), ISO develops guideline documents, manuals for developing countries, standards compendia and handbooks and a whole range of standards-related publications. Listings of these can be found in the ISO Catalogue. We also publish two magazines: the monthly ISO Focus which presents an overview of ISO's activities, and the bimonthly ISO Management Systems.
How does ISO decide what standards to develop?
Working through the ISO community, it is the people who need the standards that decide. What happens is that the need for a standard is felt by an industry or business sector, which communicates the requirement to one of ISO's national members. The latter then proposes the new work item to ISO as a whole. If accepted, the work item is assigned to an existing technical committee. Proposals may also be made to set up technical committees to cover new scopes of technological activity. In order to use resources most efficiently, ISO only launches the development of new standards for which there is clearly a market requirement.
Who actually develops ISO standards?
ISO standards are developed by technical committees comprising experts on loan from the industrial, technical and business sectors which have asked for the standards, and which subsequently put them to use. These experts may be joined by others with relevant knowledge, such as representatives of government agencies, testing laboratories, consumer associations, environmentalists, and so on. It is estimated that, every year, some 30 000 such experts participate in the development of ISO standards. The experts participate as national delegations, chosen by the ISO member for the country concerned to represent not just the views of the organizations in which the experts work, but a full national consensus on the issues involved.
How are ISO standards developed?
The national delegations of experts of a technical committee meet to discuss, debate and argue until they reach consensus on a draft agreement. This is then circulated to ISO's membership as a whole for comment and balloting. Many members have public review procedures for making draft standards known and available to interested parties and to the general public. The ISO members then take account of any feedback they receive in formulating their position on the draft standard. Finally, if the voting is in favour, the document is published as an International Standard. Every working day of the year, some 15 ISO meetings are taking place somewhere in the world. In between meetings, the experts continue the standards' development work by correspondence. Increasingly, their contacts are made by electronic means and some ISO technical bodies have already gone over entirely to electronic working, which speeds up the development of standards and reduces travel costs.
What should I do if I want to take part in the development of a standard?
The business sectors most interested in implementing the eventual standards are the ones who provide experts to develop the standards. Your own interest may be such that you would like to provide input, or even participate in the work. In fact, there are channels and opportunities for you to have a say in the development of future ISO standards through the ISO members for your country.
Who chooses the experts that participate in the standards' developing committees?
The national delegations that make up ISO technical committees are chosen by the national standards institute of that country, which is an ISO members. According to ISO rules, the standards institute is expected to take account of the views of the range of parties interested in the standard under development and to present a consolidated, national consensus position to the technical committee's work.
Why aren't ISO standards free?
ISO standards cost money to develop, publish and distribute. Someone has to pay. The current system whereby users are requested to pay for the standards they use, not only sustains the development process but also, very importantly, ensures that the balance of independent vs. government, private vs. public interests can be maintained.
Are ISO standards mandatory?
ISO standards are voluntary. ISO is a non-governmental organization and it has no power to enforce the implementation of the standards it develops. A number of ISO standards - mainly those concerned with health, safety or the environment - have been adopted in some countries as part of their regulatory framework, or are referred to in legislation for which they serve as the technical basis. However, such adoptions are sovereign decisions by the regulatory authorities or governments of the countries concerned. ISO itself does not regulate or legislate. Although voluntary, ISO standards may become a market requirement, as has happened in the case of ISO 9000 quality management systems, or ISO freight container dimensions.
ISO 9000 adalah kumpulan standar untuk sistem manajemen mutu (SMM). ISO 9000 yang dirumuskan oleh TC 176 ISO, yaitu organisasi internasional di bidang standarisasi.
• adanya satu set prosedur yang mencakup semua proses penting dalam bisnis;
• adanya pengawasan dalam proses pembuatan untuk memastikan bahwa sistem menghasilkan produk-produk berkualitas;
• tersimpannya data dan arsip penting dengan baik;
• adanya pemeriksaan barang-barang yang telah diproduksi untuk mencari unit-unit yang rusak, dengan disertai tindakan perbaikan yang benar apabila dibutuhkan;
• secara teratur meninjau keefektifan tiap-tiap proses dan sistem kualitas itu sendiri.
Sebuah perusahaan atau organisasi yang telah diaudit dan disertifikasi sebagai perusahaan yang memenuhi syarat-syarat dalam ISO 9001 berhak mencantumkan label "ISO 9001 Certified" atau "ISO 9001 Registered".
Sertifikasi terhadap salah satu ISO 9000 standar tidak menjamin kualitas dari barang dan jasa yang dihasilkan. Sertifikasi hanya menyatakan bahwa bisnis proses yang berkualitas dan konsisten dilaksanakan di perusahaan atau organisasi tersebut.
Walaupan standar-standar ini pada mulanya untuk pabrik-pabrik, saat ini mereka telah diaplikasikan ke berbagai perusahaan dan organisasi, termasuk perguruan tinggi dan universitas.
[sunting] Kumpulan Standar dalam ISO 9000
ISO 9000 mencakup standar-standar di bawah ini:
• ISO 9000:2005 - Quality Management Systems - Fundamentals and Vocabulary: mencakup dasar-dasar sistem manajemen kualitas dan daftar bahasa dan istilah dalam kumpulan ISO 9000.
• ISO 9001:2000 - Quality Management Systems - Requirements: ditujukan untuk digunakan di organisasi manapun yang merancang, membangun, memproduksi, memasang dan/atau melayani produk apapun atau memberikan bentuk jasa apapun. Standar ini memberikan daftar persyaratan yang harus dipenuhi oleh sebuah organisasi apabila mereka hendak memperoleh kepuasan pelanggan sebagai hasil dari barang dan jasa yang secara konsisten memenuhi permintaan pelanggan tersebut. Implementasi standar ini adalah satu-satunya yang bisa diberikan sertifikasi oleh pihak ketiga.
• ISO 9004:2000 - Quality Management Systems - Guidelines for Performance Improvements: mencakup perihal perbaikan sistem yang terus-menerus. Bagian ini memberikan masukan tentang apa yang bisa dilakukan untuk mengembangkan sistem yang telah terbentuk lama. Standar ini tidaklah ditujukan sebagai panduan untuk implementasi, hanya memberikan masukan saja.
Masih banyak lagi standar yang termasuk dalam kumpulan ISO 9000, dimana banyak juga diantaranya yang tidak menyebutkan nomor "ISO 900x" seperti di atas. Beberapa standar dalam area ISO 10000 masih dianggap sebagai bagian dari kumpulan ISO 9000. Sebagai contoh ISO 10007:1995 yang mendiskusikan Manajemn Konfigurasi dimana di kebanyakan organisasi adalah salah satu elemen dari suatu sistem manajemen.
ISO mencatat "Perhatian terhadap sertifikasi sering kali menutupi fakta bahwa terdapat banyak sekali bagian dalam kumpulan standar ISO 9000 ... Suatu organisasi akan meraup keuntungan penuh ketika standar-standar baru diintegrasikan dengan standar-standar yang lain sehingga seluruh bagian ISO 9000 dapat diimplementasikan".
Sebagai catatan, ISO 9001, ISO 9002 dan ISO 9003 telah diintegrasikan menjadi ISO 9001. Kebanyakan, sebuah organisasi yang mengumumkan bahwa dirinya "ISO 9000 Registered" biasanya merujuk pada ISO 9001.
Di Posting Oleh : Dorin Mutoif, Poltekkes Depkes Yogyakarya, Jurusan Kesehatan Lingkungan
Occupational Health and Safety, University of Indonesia
Munggu, petanahan, Kebumen, Jawa Tengah, Indonesia
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