ISO 9000 and ISO 14000 families are among ISO's most widely known standards ever. They are implemented by some 610 000 organizations in 160 countries. Vast majority of ISO standards are highly specific to a particular product, material, or process.
ISO 9000 and ISO 14000 families are among ISO's most widely known standards ever. They are implemented by some 610 000 organizations in 160 countries. Vast majority of ISO standards are highly specific to a particular product, material, or process.
ISO 9000 and ISO 14000 families are among ISO's most widely known standards ever. They are implemented by some 610 000 organizations in 160 countries. Vast majority of ISO standards are highly specific to a particular product, material, or process.
The ISO 9000 and ISO 14000 families are among ISO's most widely known standards ever. ISO 9000 and ISO 14000 standards are implemented by some 610 000 organizations in 160 countries. ISO 9000 has become an international reference for quality management requirements in business-to- business dealings, and ISO 14000 is well on the way to achieving as much, if not more, in enabling organizations to meet their environmental challenges. The ISO 9000 family is primarily concerned with "quality management". This means what the organization does to fulfil: - 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. The ISO 14000 family is primarily concerned with "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. The vast majority of ISO standards are highly specific to a particular product, material, or process. However, the standards that have earned the ISO 9000 and ISO 14000 families a worldwide reputation are known as "generic management system standards". "Generic" means that the same standards can be applied: - to any organization, large or small, whatever its product - including whether its "product" is actually a service, - in any sector of activity, and - whether it is a business enterprise, a public administration, or a government department. "Generic" also signifies that no matter what the organization's scope of activity, if it wants to establish a quality management system or an environmental management system, then such a system has a number of essential features for which the relevant standards of the ISO 9000 or ISO 14000 families provide the requirements. "Management system" refers to the organization's structure for managing its processes - or activities - that transform inputs of resources into a product or service which meet the organization's objectives, such as satisfying the customer's quality requirements, complying to regulations, or meeting Page 1 of 2 ISO 9000 and ISO 14000 - In brief 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/index.html?printable=true environmental objectives. Latest update September 2003
ISO | ISO name and logo | Privacy policy Page 2 of 2 ISO 9000 and ISO 14000 - In brief 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/index.html?printable=true
ISO 9000
ISO 9000 - Frequently Asked Questions (FAQs) This list of Frequently Asked Questions (FAQs) has been updated after publication of the ISO 9000:2000 family of International Standards. Input has been obtained from experts and users of the ISO 9000 standards, expressed during seminars and presentations around the world. The list will be reviewed and updated on a regular basis to maintain its accuracy, and to include new questions where appropriate. It is intended that this list will also provide a good source of information for new users of the standards. Why were the standards revised? The major reasons for the year 2000 revisions of the standards include: emphasizing the need to monitor customer satisfaction, meeting the need for more user-friendly documents, assuring consistency between quality management system requirements and guidelines, promoting the use of generic quality management principles by organizations, and enhancement of their compatibility with ISO 14001. In addition, the year 2000 revision of the ISO 9000 standards gives users the opportunity to further increase value to their activities and to improve their performance continually by focusing on the major processes within the organization. Extensive surveys have been performed on a worldwide basis to understand the needs of all users of the quality management system standards. The new revisions take into account previous experience with quality management system standards (1987 and 1994 editions) and emerging insights into generic management systems. They result in a closer alignment of quality management systems with the needs of organizations and better reflect the way organizations run their business activities. ISO's rules of procedure (the ISO/IEC Directives) also specify that standards be periodically revised to ensure that those standards are current and satisfy the needs of the global community. [FAQ 001, March 2001]
Who is responsible for revising the standards? The revision process is the responsibility of ISO Technical Committee (TC) 176 and is conducted on the basis of consensus among quality and industry experts nominated by ISO Member bodies, and representing all interested parties [FAQ 002, March 2001]
Will the year 2000 revision affect my organization's current quality system registration/certification? Page 1 of 13 FAQs 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/faqs.html?printable=true Yes. The strategy adopted by your organization to meet the requirements of ISO 9001:2000 should include an appropriate timing for upgrading your organization's registration/ certification. It is expected that the process of upgrading registration/certification will be a smooth transition that is incorporated into the applicable Registration or Certification Body's regular audit routine. The International Accreditation Forum (IAF has already established a set of guidelines for Certification Bodies/ Registrars to follow, and this includes a transition period of up to three years after the 15th of December 2000. You are advised to contact your registration/certification body to negotiate a suitable transition time frame for the assessment of your own organization. [FAQ 003, March 2001]
How much is the transition to the new standards going to cost? One of the goals of ISO/TC 176 is to produce standards that will minimize any potential costs during a smooth transition. Any additional costs may be considered as a value-added investment. The cost of implementing any necessary changes in order to meet the new requirements of ISO 9001:2000 will vary from one organization to another, depending on various factors such as the actual state of implementation of the quality management system, the size and complexity of the organization, the attitude and commitment of the top management, etc. It is expected that the benefits to all organizations will outweigh eventual costs associated with the transition. Regarding the costs of upgrading the certification, the International Accreditation Forum's (IAF) guidelines provide for the incorporation of audits to the new standard into surveillance visits for existing (1994) certifications, wherever possible. [FAQ 004, March 2001]
Where can my organization obtain copies of the revised standards? Copies of the revised standards may be purchased from National Standards Bodies. Many countries may have these available in local-language versions (see ISO Online for a listing of member body, i.e. national standards bodies, contact details) [FAQ 005, March 2001]
Where can I obtain information on the revised standards? There are a number of sources of information on the revision of ISO 9000 quality management system standards, including, of course, this web site, which carries detailed information on the revised standards and is updated on a regular basis. ISO Central Secretariat in Switzerland is also maintaining a web site at http://www.iso.org that carries general information on the revised standards. Your National Standards Body should be able to provide copies of the revised standards and registrars/certification bodies will be able to provide guidance on transitional registration arrangements (see the ISO web site for a listing of the member bodies, i.e. the national standards bodies, contact details). [FAQ 006, March 2001]
Where does my organization go if it needs clarification or interpretation of the revised standards?
The starting point for any individual request for an interpretation should be with the enquirer's national standards body. ISO central secretariat and TC 176 cannot accept direct requests from individuals for interpretations of the ISO 9000 standards. Instead, ISO/TC 176 has established a Working Group for interpretation, with a formal procedure to provide answers to the questions that are forwarded by the national standard bodies.(See the ISO web site http://www.iso.org for a listing Page 2 of 13 FAQs 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/faqs.html?printable=true of the member bodies, i.e. the national standards bodies, contact details). [FAQ 007, March 2001]
Will my organization need a full reassessment for the revised standards? This is primarily an issue between your organization and your registration/certification body. It is expected that conformity to the new ISO 9001:2000 standard will be evaluated by certification bodies during regular surveillance visits, and that full reassessment will only take place once current certificates expire. [FAQ 008, March 2001]
Will my organization have to change its quality system and, if so, when? It is not the intention that you should have to change the whole structure of your system or re-write all your procedures; however, the revised standards include some new requirements and you should consider addressing them in your system at an appropriate opportunity. A joint group from the International Accreditation Forum, ISO/TC 176 and ISO/CASCO have agreed that there should be a 3 year 'transition' period during which accredited certification to the 1994 standards and ISO 9001:2000 may continue to coexist. This 'transition period' will end on 15 December 2003. By that date, all organizations wishing to retain accredited certification will have to have migrated their quality management system to being compliant with ISO 9001:2000.
ISO/TC 176/SC2 has published a Transition Planning Guide to assist organisations in their migration. [FAQ 09, March 2001]
Will my organization have to re-write all its documentation? No. If your current quality management system is successfully implemented, satisfies the needs and objectives of your organization, reflects the way your organization works, addresses all of the new requirements, no changes are required. However, if your current documented system does not address all of the new requirements, additional documentation may be necessary. The International Standard ISO 9001:2000 has clarified the need for required documentation. Only 6 documented procedures are required by the standards for administration of the system; however, other documented procedures may be required by your organization in order to manage the processes which are necessary for the effective operation of the quality management system. This will clearly vary depending on the size of the organization, the kind of activities in which it is involved and their complexity. [FAQ 010, March 2001] Are the revised standards more compatible with national quality award criteria? The quality management principles are now the basis for the revised standards, which are better aligned with the philosophy and objectives of most quality award programs. These principles are: Customer focus, Leadership, Involvement of people, Process approach, System approach to management, Continual improvement, Page 3 of 13 FAQs 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/faqs.html?printable=true Factual approach to decision making, and Mutually beneficial supplier relationships. [FAQ 011, March 2001]
Does the revised standards address financial issues? Financial issues are not addressed in the ISO 9001:2000 standard. The ISO 9004:2000 guidance standard emphasizes the financial resources needed for the implementation and improvement of a quality management system. [FAQ 012, March 2001]
What are the benefits of the revised standards? There are a number of major benefits with the revised quality management systems standards. Among them are: Applicability to all product categories, in all sectors and to all sizes of organizations Simple to use, clear in language, readily translatable, and easily understandable Significant reduction in the amount of required documentation. Connection of quality management systems to organizational processes Provision of a natural move towards improved organizational performance Greater orientation toward continual improvement and customer satisfaction Compatibility with other management systems such as ISO 14000 Provision of a consistent basis to address the needs and interests of organizations in specific sectors (e.g. medical devices, telecommunications, automotive, etc) The concept of the consistent pair - ISO 9001 covering the requirements and ISO 9004 for going beyond the requirements in order to further improve the performance of the organization. Consideration of the needs of and benefits to all interested parties. [FAQ 013, March 2001]
What are the main changes to the standards? The main changes that have been introduced in the consistent pair of quality management system standards are: A new process-oriented structure and a more logical sequence of the contents
A continual improvement process as an important step to enhance the quality management system Increased emphasis on the role of top management, which includes its commitment to the development and improvement of the quality management system, consideration of legal and regulatory requirements, and establishment of measurable objectives at relevant functions and levels. The concept of "Application" of the standard has been introduced (in clause 1.2) as a way to cope with the wide spectrum of organizations and activities. A requirement for the organization to monitor information on customer satisfaction as a measure of system performance. Significant reduction in the amount of required documentation. Terminology changes/improvements for easier interpretation. Increased compatibility with the environmental management system standard ISO 14001 Page 4 of 13 FAQs 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/faqs.html?printable=true Specific reference to quality management principles. Consideration of the benefits and needs of all interested parties. Addition of the concept of organizational self-assessment as a driver for improvement (ISO 9004:2000) [FAQ 014, March 2001]
What new requirements have been introduced into the revised ISO 9001 standard? The main new requirements include: Continual improvement Increased emphasis on the role of top management. Consideration of statutory and regulatory requirements. Establishment of measurable objectives at relevant functions and levels. Monitoring of information on customer satisfaction as a measure of system performance. Increased attention to resource availability. Determination of training effectiveness. Measurements extended to system, processes, and product. Analysis of collected data on the performance of the quality management system [FAQ 015, March 2001]
Why has the requirement for monitoring of customer satisfaction been included in ISO 9001? "Customer satisfaction" is recognized as one of the driving criteria for any organization. In order to evaluate if the product meets customer needs and expectations, it is necessary to monitor the extent of customer satisfaction. Improvements can be made by taking action to address any identified issues and concerns. [FAQ 016, March 2001]
Will the revised standards improve customer satisfaction? The quality management system described in the revised standard is based on quality management principles that include the "process approach" and "customer focus". The adoption of these principles should provide customers with a higher level of confidence that products will meet their needs and increases their satisfaction. [FAQ 017, March 2001]
What is a process? Any activity or operation, which receives inputs and converts them to outputs, can be considered as a process. Almost all activities and operations involved in making a product or providing a service are processes. For organizations to function, they have to define and manage numerous inter- linked processes. Often the output from one process will directly form the input into the next process. The systematic identification and management of the various processes employed within an organization, and particularly the interactions between such processes, may be referred to as the process approach to management. The revised quality management system standards are based on just such a process approach, in line with the guiding quality management principles. Page 5 of 13 FAQs 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/faqs.html?printable=true [FAQ 018, March 2001]
What is meant by "continual improvement"? "Continual improvement" requires an organization to focus on continually increasing the effectiveness and/or efficiency of its processes, to fulfill its policies and objectives. Continual improvement (where "continual" highlights that an improvement process requires progressive consolidation steps) responds to the growing needs and expectations of customers and ensures a dynamic evolution of the quality management system. [FAQ 019, March 2001]
How will the implementation of the new standards help my organization to improve its efficiency? ISO 9001:2000 aims at guaranteeing the effectiveness (but not necessary the efficiency) of the organization. For improved organizational efficiency, however, the best results can be obtained by using the new ISO 9004:2000 in addition to ISO 9001:2000. The guiding quality management principles are intended to assist an organization in continual improvement, which should lead to efficiency throughout the organization. [FAQ 020, March 2001] How will the revised standards improve the perception of ISO 9001 certification/registration? By demonstrating to organizations that the process of certification based on the new ISO 9001 standard adds value to their own business goals, a market-wide improvement in the perception of ISO 9001 certification should be developed. The rationale behind the revision process places great emphasis on making quality management systems closer to the processes of the organization and on continual improvement. As a result, the revised standards (ISO 9001:2000 and ISO 9004:2000) are directed to the achievement of business results, including satisfaction of customers and others. There is confidence that management of the organization will be able to adopt the quality management system standards not only for certification purposes, but also as a profitable investment. [FAQ 021, March 2001]
What will happen to the guideline documents (e.g., ISO 9000-3, ISO 9004- 2) in the ISO 9000 family? The revised ISO 9001 and ISO 9004 quality management system standards have been prepared taking into account these and other guideline documents of the former ISO 9000 family. The revised standards are intended to be sufficiently generic so as to eliminate the need for specific guidance on their application.. It is intended that the responsibility for some of the guideline standards (such as ISO 9000-3 and 9000-4) will be transferred to other ISO/IEC Technical Committees. It is proposed that standards such as ISO 9004-2 and ISO 9004-3 be withdrawn and other documents (e.g. ISO 10013) may become technical reports at their next revisions. ISO 10012 will remain as an international standard. This situation is currently under review by ISO/TC 176. [FAQ 022, March 2001]
What will happen to ISO 10012-1 and ISO 10012-2? Current plans are to maintain these measurement systems standards as part of the year 2000 ISO 9000 family. A work item has been approved for the merger of 10012-1 and 10012-2 into one Page 6 of 13 FAQs 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/faqs.html?printable=true standard. The new ISO 10012 standard is targetted for publication in early 2002. [FAQ 023, March 2001]
What happened to ISO 8402 and ISO 9000-1? The terms and vocabulary previously found in the ISO 8402 standard are addressed in the ISO 9000:2000 (Quality Management Systems: Fundamentals and Vocabulary) standard. The quality management concepts in ISO 9000-1 have been integrated into the ISO 9000:2000 standard. [FAQ 024, March 2001]
Which standard will my organization be registered/certified to? All organizations will be registered/certified to ISO 9001:2000. The scope of registration/certification will need to reflect clearly the activities covered by the organization's Quality Management System, and any exclusion to non-applicable requirements of the standard (through 1.2 "Application") documented and justified in the quality manual. (See also the ISO/TC 176/SC2 Introduction and Support Package: Guidance on ISO 9001:2000 Clause 1.2 Application.) [FAQ 025, March 2001]
What happened to the 1994 versions of ISO 9001, 9002 & 9003? The year 2000 publications have superseded corresponding 1994 versions of the standards. However, noting the IAF-ISO/CASCO-ISO/TC 176 agreement that accredited certification to the 1994 editions should remain possible for up to 3 years after the publication (i.e. until 15 December 2003) of the revised standards, copies of the 1994 editions will still be available on request from ISO and the national standards bodies during that period. [FAQ 026, March 2001]
My organization is currently registered/certified to ISO 9003. What do we need to do? There are significant differences between the ISO 9003 standard and the revised ISO 9001:2000 standard, notably in the product realization activities. You should perform a gap analysis based on the standard to determine what areas in your organization's quality management system already comply with the revised requirements. Where your current system does not address the applicable ISO 9001:2000 requirements, development and implementation of processes to ensure compliance will need to be made. [FAQ 027, March 2001]
What will happen to my organization if it is currently registered/certified to ISO 9002:1994? The organization is not obliged to include within the scope of its certification all the products that it provides. (Note that the ISO 9000:2000 definition of "Product" includes services!). However, for those products that are included in the certification scope, all applicable requirements of ISO 9001:2000 will need to be addressed. The standard allows for the exclusion of some requirements (via clause 1.2 Application), but only if it can be shown that these requirements are not applicable to the organization. Exclusions are limited to Section 7 ("Product Realization"), and requirements may only be excluded if it can be shown that they do not affect the organization's ability to provide product which meets customer and applicable statutory/regulatory requirements. If design activities are required to demonstrate your organization's capability to meet customer or statutory/regulatory requirements for products covered by the Page 7 of 13 FAQs 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/faqs.html?printable=true quality management system certification, then these design activities must be included in the scope of your registration/certification to the ISO 9001:2000 standard. If design activities are not required to demonstrate your organization's capability to meet customer and applicable statutory /regulatory requirements, or if your product is provided on the basis of established design, you will still be registered to ISO 9001:2000. In this case, you will need to justify the exclusion of the design and development requirements in your quality manual. (See also the ISO/TC 176/SC2 Introduction and Support Package: Guidance on ISO 9001:2000 Clause 1.2 Application.) [FAQ 028, March 2001]
Can organizations remain certified/registered to the 1994 version of ISO 9001, 9002 and 9003? Although organizations are encouraged to make the transition to ISO 9001:2000 certification as soon as possible, according to the IAF/ISO-CASCO/ISO-TC 176 Communiqu on transition policy, organizations may choose to continue or even seek new certification/registration to the 1994 versions of ISO 9001, ISO 9002, and ISO 9003. Any accredited certificates issued or renewed will, however, only remain valid for a maximum of three years after the publication of ISO 9001:2000 (i.e. until 15 December 2003). [FAQ 029, March 2001]
What does my organization need to do if it is currently registered/certified to ISO 9002:1994 or ISO 9003:1994? Since publication of ISO 9001:2000, ISO 9002 and ISO 9003 are superseded. You will need to evaluate which specific requirements of ISO 9001:2000 are applicable to the nature of your business and the extent to which your present QMS meets those requirements. Provisions have been made to exclude non-applicable requirements within Section 7 of the standard through clause 1.2 Application. If, for example, the nature of your products does not require you to perform design activities or if your product is provided on the basis of established design, you will need to discuss and justify the exclusion of these requirements with your certification/registration body. (See also the ISO/TC 176/SC2 Introduction and Support Package: Guidance on ISO 9001:2000 Clause 1.2 Application.) [FAQ 030, March 2001]
Will I be able to certify/register my organization to ISO 9004:2000? No. As ISO 9004:2000 is a guidance standard, it is not intended to be used for third party certification purposes. A key element in the new ISO 9004 is the ability to perform self-evaluation. Third party QMS certifications/registrations are performed to ISO 9001:2000, which has consolidated the previous ISO 9001, 9002, and 9003 standards. [FAQ 031, March 2001]
How do certificates to the revised ISO 9001:2000 identify the scope of the quality management system? It has always been necessary to define clearly the scope of registration/certification. The merging of ISO 9001, 9002, and 9003 into a single requirements standard (ISO 9001:2000) requires more emphasis for the scope to define the products, services and processes covered by certification/registration. [FAQ 032, March 2001]
How will the consistent pair of standards affect a registered/certified organization? Page 8 of 13 FAQs 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/faqs.html?printable=true The idea of a "consistent pair" of standards is the very core of the revision process. The aligned structure of ISO 9001:2000 and ISO 9004:2000 will encourage organizations not only to look at their activities from a process standpoint, but also to look beyond certification to a system which will be truly beneficial in improving operational performance. [FAQ 033, March 2001]
What should I do now? You should contact your National Standards Body to obtain information. (See the ISO web site http://www.iso.org for a listing of the member bodies, i.e. the national standards bodies, contact details). You should be careful with the information that you receive from sources other than your National Standards Body, professional associations, or ISO member organizations. It is recommended that your organization familiarize your personnel with the quality management principles, analyze the changes in the revised standards, and consider how those changes may affect your activities and related processes. [FAQ 034, March 2001]
How should my organization deal with the transition to the year 2000 standards? Consultation on 'transition' arrangements between ISO TC 176, ISO CASCO, and the International Accreditation Forum (IAF) in September 1999 resulted in the following agreements: Accredited certificates to ISO 9001: 2000 shall not be granted until its publication as an International Standard. Certification/registration body assessments to the latest draft of the revised standard may begin prior to publication of ISO 9001: 2000 as an International Standard. Certificates issued to the 1994 editions of ISO 9001, ISO 9002, or ISO 9003 shall have a maximum validity of three years from the date of publication of ISO 9001: 2000. ISO 9001: 2000 will require auditors and other relevant certification body personnel to demonstrate new competencies. Certification bodies will need to take particular care in defining the scope of certificates issued to ISO 9001: 2000 and the permissible exclusions to the requirements of the standard. [FAQ 035, March 2001]
My organization is applying now for ISO 9001 certification/registration. What should I do? Continue with your plans to implement your system and to apply for certification. We strongly recommend that you read the new standards, particularly ISO 9004 in conjunction with ISO 9001, and ensure that your quality management system effectively adds value to your organization's activities. [FAQ 036, March 2001]
How does ISO 9001:2000 relate to the needs of specific business sectors? The text of ISO 9001:2000 is more generic than the 1994 version in order to be applicable to different types of product and to organizations of different sizes. Due to this generic nature it may be that some industrial or commercial sectors will identify additional requirements to attend to their specific needs. Page 9 of 13 FAQs 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/faqs.html?printable=true To assure consistency between the ISO 9001 requirements and sector requirements, a pilot study has been conducted using the development of an automotive industry document as the test vehicle. The pilot project has successfully achieved the publication of an ISO technical specification (ISO/TS 16949). The full results of the pilot scheme, and the working methods employed, will be reviewed in due course. [FAQ 037, March 2001]
How will interested parties benefit by the organization adopting the new ISO 9004? If the system is appropriately implemented, utilizing the eight Quality Management Principles, all the interested parties will benefit from ISO 9004. Customers and users will benefit by receiving the products (see ISO 9000:2000) that are: Conforming to the requirements Dependable and reliable Available when needed Maintainable People in the organization will benefit by: Better working conditions Increased job satisfaction Improved health and safety Improved morale Improved stability of employment Owners and investors will benefit by: Increased return on investment Improved operational results Increased market share Increased profits Suppliers and partners will benefit by: Stability Growth Partnership and mutual understanding Society will benefit by: Fulfillment of legal and regulatory requirements Improved health and safety Reduced environmental impact Increased security [FAQ 038, March 2001]
How will a small organization be able to adapt the requirements of the standard? What flexibility will be allowed? The requirements of the revised ISO 9001 are applicable to small, medium, and Page 10 of 13 FAQs 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/faqs.html?printable=true large organizations alike. ISO 9001:2000 provides some flexibility, through clause 1.2 Application, on the exclusion of certain requirements for specific processes (i.e. those covered by clause 7, such as design activities) that may not be performed by the organization. However, the individual organization will still need to be able demonstrate its capability to meet customer and applicable statutory or regulatory requirements for its products, and will need to consider this when determining the complexity of its quality management system. [FAQ 039, March 2001] What will happen to the ISO Handbook: ISO 9000 for Small Businesses? The small business handbook was published by ISO in 1996 and was intended to provide guidance from ISO/TC 176 for the 1994 versions of ISO 9001, ISO 9002, and ISO 9003. ISO 9001:2000 applies a more generic approach, devoid of the hardware and manufacturing bias of the current standard, and is designed to be much more user-friendly for smaller organizations. ISO/ TC 176/SC2 will be revising the Small Business Guide during 2001. [FAQ 040, March 2001]
Whats the relationship between the revised ISO 9001 and ISO 14001? The revised ISO 9001 has been developed to enhance compatibility with ISO 14001 Environmental management systems, particularly with regard to terminology and content. There is close collaboration between the technical experts of ISO/TC 176 and ISO/TC 207 (the Technical Committee responsible for the ISO 14000 series of standards). A recent review of ISO 14001 and ISO 14004 by ISO/TC 207/SC 1 has led to the initiation of a revision of those standards. This will provide the opportunity for further enhancement of the compatibility between the ISO 9000 and ISO 14000 standards. [FAQ 041, March 2001]
Are there any guidelines covering joint implementation of ISO 9001 and ISO 14001? It is expected that the revisions of the two standards will be compatible in terminology and content. It is not expected that an ISO guideline will be prepared on this subject at the present time. If the need for such a document arises, ISO will consider the request as a new project. For the quality and environmental auditing guidance standards (ISO 10011 and ISO 14010/14011/14012), the two responsible ISO technical committees (TC 176 and TC 207) are preparing a single common auditing standard (ISO 19011), scheduled for publication in the third quarter of 2002. [FAQ 042, March 2001]
Will there be a common guideline standard for auditing QMS and EMS according to ISO 9001 and 14001? Yes. A specific agreement between the two ISO Technical Committees (TC 176 and TC 207) has set up a joint working group to prepare a single standard on auditing activities, both for quality management and environmental management systems. This new standard (ISO 19011) will replace the existing ISO 10011 and ISO 14010/14011/14012 documents. The planned publication date for this standard is the third quarter 2002. [FAQ 043, March 2001]
My organization provides services. How are the new standards applicable to us? Page 11 of 13 FAQs 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/faqs.html?printable=true The standards are applicable to all types of organizations. The language in the revised standards is simpler, more user-friendly, and with less manufacturing bias. The new standards are equally appropriate to all sectors, including service providers. (Note: the definition of the term 'product' in ISO 9000:2000 also includes services. ISO 9001:2000 and ISO 9004:2000 have been written to reflect this definition.) [FAQ 044, March 2001]
I am a qualified quality management practitioner (consultant, auditor, or trainer). What do I need to do? As a minimum, you should familiarize yourself not only with the requirements of the new ISO 9001:2000, but also with the content and philosophies of ISO 9000:2000, ISO 9004:2000 and the quality management principles. You must clearly understand your clients activities and processes and appropriately interpret the requirements of the standards to add value to their operations. [FAQ 045, March 2001]
My organization is a regulatory body. What do we need to do? You should review the regulations currently in effect and ensure that any references to the quality management system standards are appropriate. You should then examine the revised standards and determine if the changes are relevant to the regulations that you have issued and make recommendations to the legislative body. [FAQ 046, March 2001]
What needs to be done to ensure that auditors are ready to work to the revised standards? Auditors, whether external or internal, will have to demonstrate their competence not only on the structure, content and terminology of the revised standards, but also on the underlying quality management principles. The revised standards require that auditors are able to understand the organization's activities and processes and appropriately audit against the requirements of the standard in relation to the organization's objectives. According to the IAF/ ISO-CASCO/ ISO TC 176 Transition Policy, auditors must demonstrate competency in: The requirements of the ISO 9001:2000. The concepts and terminology of the ISO 9000:2000. The eight Quality Management Principles A general understanding of the performance improvement guidelines of ISO 9004:2000 Familiarity with the latest draft of the auditing guidance standard (ISO 19011). [FAQ 047, March 2001]
Where can I find a competent speaker to make a presentation on the revised standards? ISO cannot provide speakers for individual organizations, but has a register of experts, with language skills, who would be willing to make presentations to industry groups, regional conferences, etc. based on the remuneration of expenses only. You should contact the Secretary of ISO/TC 176/SC2 (charles_corrie@bsi- global.com) for further information. [FAQ 048, March 2001]
Page 12 of 13 FAQs 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/iso9000/faqs.html?printable=true
The Magical Demystifying Tour of ISO 9000 and ISO 14000
The Magical Demystifying Tour of ISO 9000 and ISO 14000 To give you a handle on the ISO 9000 and ISO 14000 phenomena, we invite you on a grand tour. At the first stop, we shall tell you how they fit into "the big picture" of ISO's work.
We shall be visiting "generic management system standards". If that phrase has sounded rather indigestible in the past, our clear explanation will enable you to take it at a single bite in future.
During the voyage, we'll clear up some misunderstandings about what ISO does and does not do in relation to ISO 9000 and ISO 14000.
You'll know in future what is meant when you hear terms like "certification", "registration", "accreditation". We'll point you in the right direction for information on how to publicize your ISO 9001 or ISO 14001 certification. After this, our guided tour will branch into two parties: one visiting ISO 9000 and the other ISO 14000. There, we shall get into more detail - but not too much - on what the respective standards are all about, why you might want to use them, how they work and what benefits you may achieve if your business implements them.
You can go directly to one of the stops on the tour (above), or join us for each visit in sequence. The first stop is...In the beginning ISO | ISO name and logo | Privacy policy Page 1 of 1 ISO 9000 / ISO 14000 - The basics 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/general/basics_1.html?printable=true
The Magical Demystifying Tour of ISO 9000 and ISO 14000
In the beginning ISO has been developing voluntary technical standards over almost all sectors of business, industry and technology since 1947. So, if the first you heard of us was in connection with ISO 9000 or ISO 14000, then you are probably asking yourself, "How come I have never heard of ISO before?" The answer is that if you are asking yourself the question, then you are probably not an engineer, because if you were, you would almost certainly have come into contact with at least some of ISO's technical standards. With the exception of ISO 9000 and ISO 14000, the vast majority of ISO standards are highly specific. They are documented agreements 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. If that sounds like engineering talk, you're absolutely right! It also explains why ISO standards were, before ISO 9000 and ISO 14000, principally of concern to engineers and other technical specialists concerned by the precise scope addressed in the standard. To take just one example, ISO standards for such seemingly humble items as bolts, nuts, screws, pins and rivets literally help stop much in the world around us from falling apart - but you're not likely to come across references to them in the business and economic press, nor see companies proudly advertising that they implement them.
Then, in 1987, came ISO 9000, followed nearly 10 years later by ISO 14000, which have brought ISO to the attention of a much wider business community. These are very different from the majority of ISO's highly specific standards. We'll introduce you to them on the next stop of the Magical Demystifying Tour: Generic management system standards. ISO | ISO name and logo | Privacy policy Page 1 of 1 In the beginning 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/general/basics_2.html?printable=true
The Magical Demystifying Tour of ISO 9000 and ISO 14000
Generic management system standards The vast majority of ISO standards are highly specific to a particular product, material, or process. However, both ISO 9000 and ISO 14000 are known as generic management system standards.
Generic means that the same standards can be applied to any organization, large or small, whatever its product - including whether its "product" is actually a service - in any sector of activity, and whether it is a business enterprise, a public administration, or a government department. Management system refers to what the organization does to manage its processes, or activities in order that the products or services that it produces meet the objectives it has set itself, such as the following: satisfying the customer's quality requirements, complying to regulations, or meeting environmental objectives. In a very small organization, there is probably no "system", as such, just "our way of doing things", and "our way" is probably not written down, but all in the head of the manager or owner head. The larger the organization, and the more people involved, the more the likelihood that there are some written procedures, instructions, forms or records. These help ensure that everyone is not just "doing his or her own thing", and that the organization goes about its business in an orderly and structured way, so that time, money and other resources are utilized efficiently. To be really efficient and effective, the organization can manage its way of doing things by systemizing it. This ensures that nothing important is left out and that everyone is clear about who is responsible for doing what, when, how, why and where. Management system standards provide the organization with a model to follow in setting up and operating the management system. This model incorporates the features on which experts in the field have reached a consensus as representing the international state of the art. A management system which follows the model - or "conforms to the standard" - is built on a firm foundation of state-of-the-art practices. Large organizations, or ones with complicated processes, could not function well without management systems - although they may have been called by some other name. Companies in such fields as aerospace, automobiles, defence, or health care devices have been operating management systems for years. The ISO 9000 and ISO 14000 families of management system standards now make these successful practices available for all organizations when it comes to meeting their objectives concerning quality and the environment. Page 1 of 2 Generic management system standards 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/general/basics_3.html?printable=true
It's now the moment on our Magical Demystifying Tour for a guided visit to ISO 9000 and ISO 14000 in plain language. ISO | ISO name and logo | Privacy policy Page 2 of 2 Generic management system standards 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/general/basics_3.html?printable=true
The Magical Demystifying Tour of ISO 9000 and ISO 14000
ISO 9000 and ISO 14000 in plain language This section tells you briefly what ISO 9000 and ISO 14000 are and what they are not. Both "ISO 9000" and "ISO 14000" are actually families of standards which are referred to under these generic titles for convenience. Both families consist of standards and guidelines relating to management systems, and related supporting standards on terminology and specific tools, such as auditing (the process of checking that the management system conforms to the standard). ISO 9000 is primarily concerned with "quality management". In the everyday context, like "beauty", everyone may have his or her idea of what "quality" is. But, in the ISO 9000 context, the standardized definition of quality refers to all those features of a product (or service) which are required by the customer. "Quality management" means what the organization does to ensure that its products or services satisfy the customer's quality requirements and comply with any regulations applicable to those products or services. ISO 14000 is primarily concerned with "environmental management". In plain language, this means what the organization does to minimize harmful effects on the environment caused by its activities. In addition, both ISO 9000 and ISO 14000 require organizations that implement them to improve their performance continually in, respectively, quality and environmental management. Both ISO 9000 and ISO 14000 concern the way an organization goes about its work, and not directly the result of this work. In other words, they both concern processes, and not products - at least, not directly. Nevertheless, the way in which the organization manages its processes is obviously going to affect its final product. In the case of ISO 9000, the efficient and effective management of processes is, for example, going to affect whether or not everything has been done to ensure that the product satisfies the customer's quality requirements.
In the case of ISO 14000, the efficient and effective management of processes is going to affect whether or not everything has been done to ensure a product will have the least harmful impact on the environment, at any stage in its life cycle, either by pollution, or by depleting natural resources. However, neither ISO 9000 nor ISO 14000 are product standards. The management system standards in these families state requirements for what the organization must do to manage processes influencing quality (ISO 9000) or the processes influencing the impact of the organization's activities on the environment (ISO 14000). Page 1 of 2 ISO 9000 and ISO 14000 in plain language 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/general/basics_4.html?printable=true In both cases, the philosophy is that management system requirements are generic. No matter what the organization is or does, if it wants to establish a quality management system or an environmental management system, then such a system has a number of essential features which are spelled out in the relevant ISO 9000 or ISO 14000 standards.
No tour of ISO 9000 or ISO 14000 would be complete without a stop off for an explanation of "certification", "registration" and "accreditation". ISO | ISO name and logo | Privacy policy Page 2 of 2 ISO 9000 and ISO 14000 in plain language 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/general/basics_4.html?printable=true
The Magical Demystifying Tour of ISO 9000 and ISO 14000
Certification, registration and accreditation Three words that will certainly crop up on your road to ISO 9000 or ISO 14000 are "certification", "registration" and "accreditation". Just what exactly do they mean? Let's first take the first two. According to the standardized definitions*, they are not quite the same thing. In the context of ISO 9000 or ISO 14000, "certification" refers to the issuing of written assurance (the certificate) by an independent, external body that has audited an organization's 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. The organization's management system has therefore been both certified and registered. For practical purposes, in the ISO 9000 and ISO 14000 contexts, the difference between the two terms is not significant and both are acceptable for general use. "Certification" seems to be the term most widely used worldwide, although registration (from which "registrar" as an alternative to registration/certification body) is often preferred in North America, and the two are also 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 9000 or ISO 14000 context, accreditation refers to the formal recognition by a specialized body - an accreditation body - that a certification body is competent to carry out ISO 9000 or ISO 14000 certification in specified business sectors. In simple terms, accreditation is like certification of the certification body. Certificates issued by accredited certification bodies - and known as "accredited certificates" - may be perceived on the market as having increased credibility. Therefore, it is okay to state that your organization has been "certified" or "registered" (if, indeed, it has!), but inaccurate to state that it has been "accredited" (unless your organization is a certification/registration body).
* See ISO/IEC Guide 2, Standardization and related activities - Vocabulary and ISO/IEC DIS 17000, Vocabulary for conformity assessment, currently in the draft International Standard stage of development, which will replace some of the terminology defined in Guide 2.
Now that you know what certification isdid you know that certification is not compulsory? ISO | ISO name and logo | Privacy policy Page 1 of 1 Certification, registration and accreditation 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/general/basics_5.html?printable=true
The Magical Demystifying Tour of ISO 9000 and ISO 14000
Certification is not compulsory You can implement ISO 9000 or ISO 14000 without seeking to have your management system audited and certified as conforming to the standards by an independent, external certification body. What?!? That's right! We are so used to hearing about ISO 9000 and ISO 14000 certification that it's easy to assume you can't have the standard with certification - but it's a fact, you can implement and benefit from an ISO 9000 or ISO 14000 system without having it certified. Like all ISO standards, ISO 9000 and ISO 14000 are voluntary standards. Your organization can implement them solely for the internal benefits they bring in increased effectiveness and efficiency of your operations, without incurring the investment required in a certification programme. Deciding to have an independent audit of your system to confirm that it conforms to the standard is a decision to be taken on business grounds - if for example: - it is a contractual, regulatory, or market requirement, - it meets customer preferences, - it is part of a of a risk management programme, or if you think - it will motivate your staff by setting a clear goal for the development of the management system.
If your organization has decided it to go for certification, how does it go about choosing a certification body? ISO | ISO name and logo | Privacy policy Page 1 of 1 Certification is not compulsory 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/general/basics_6.html?printable=true
The Magical Demystifying Tour of ISO 9000 and ISO 14000
Choosing a certification body When choosing a certification body to carry out ISO 9001 or ISO 14001 certification, these are the aspects the organization needs to take into account. The first point out that an organization can implement ISO 9001 or ISO 14001 without seeking certification. The best reason for wanting to implement the standards is to improve the efficiency and effectiveness of company operations. Certification of your management system is not an ISO 9001 or ISO 14001 requirement.
Deciding to have an independent audit of your system to confirm that it conforms to ISO 9001 or ISO 14001 is a decision to be taken on business grounds: for example - if it is a contractual or regulatory requirement - if it is a market requirement or to meet customer preferences - if it falls within the context of a risk management programme - or if you think it will motivate your staff by setting a clear goal for the development of your 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 your customers - establish whether the certification body has auditors with experience in your business sector - following the publication of the ISO 9000:2000 series, establish whether the certification body has integrated the evolution in the focus of the standards from conformity to performance. 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. If you were under the mistaken impression that if you implemented ISO Page 1 of 2 Choosing a certification body 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/general/basics_7.html?printable=true
9000 or ISO 14000, you were obliged to seek certification, then you may also be surprised to learn that ISO does not carry out ISO 9001 or ISO 14001 certification. ISO | ISO name and logo | Privacy policy Page 2 of 2 Choosing a certification body 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/general/basics_7.html?printable=true
The Magical Demystifying Tour of ISO 9000 and ISO 14000
ISO does not carry out ISO 9001:2000 or ISO 14001 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 14001 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 9000 and ISO 14000 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 what constitutes good practice. Their use contributes to the consistency and coherence of conformity assessment worldwide and so facilitates trade across borders.
Now you're clear that ISO does not carry out ISO 9001:2000 or ISO 14001 certification, then you shouldn't be surprised to learn that ISO's logo is not for use in connection with certification. ISO | ISO name and logo | Privacy policy Page 1 of 1 ISO does not carry out ISO 9001 or ISO 14001 certification 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/general/basics_8.html?printable=true
The Magical Demystifying Tour of ISO 9000 and ISO 14000
ISO's logo is not for use Upon certification, many organizations turn to ISO to request use of "the ISO 9000 logo". No such ISO logo exists. There is only the ISO logo itself, which is a registered trademark. Unless authorized by ISO, use of its logo is prohibited. ISO will not allow its logo to be used in connection with the certification of management systems, even when these certifications attest conformity to ISO 9001 or ISO 14001. Examples of unacceptable use of the ISO logo would include use on products, on Web sites, in marketing materials, advertisements and company letterheads. Allowing the ISO logo to be used would give the false impression that ISO carries out certification activities, or has approved or authorized the organization using its logo. These activities are not business functions of ISO. ISO is not an auditor, assessor, registrar, or certifier of management systems, products, services, materials or personnel, nor does it endorse any such activities performed by other parties. ISO develops International Standards but does not operate any schemes for assessing conformity with them. ISO 9001 and ISO 14001 certificates are issued independently of ISO by more than 750 certification bodies worldwide, although the organization does develop voluntary standards and guidelines to encourage good practice by these certification bodies. ISO has no "ISO 9000 logo". In addition, you may not use ISO's logo, which is copyrighted. ISO will take whatever actions it considers necessary to prevent the misuse of its logo.
So if using ISO's logo is out of the question, what guidelines should you observe when publicizing your certification? ISO | ISO name and logo | Privacy policy Page 1 of 1 ISO's logo is not for use 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/general/basics_9.html?printable=true
The Magical Demystifying Tour of ISO 9000 and ISO 14000
Publicizing your certification If your business or organization has invested time, energy and money to obtain an ISO 9001 or ISO 14001 certificate, you understandably wish to publicize your achievement. To help you to do so, ISO has published guidelines: Publicizing your ISO 9001 or ISO 14001 certification. The guidelines will help you to apply good practice in publicizing, communicating and promoting your certification to stakeholders such as staff, customers, business partners and the general public. These guidelines will prove useful in preparing promotional and communication materials such as press releases, advertisements, marketing brochures, videos, staff announcements, logos, slogans and catch lines for diverse media ranging from print and broadcasting, and Internet, to product labels, signs, banners, vehicle fleets and so on. Among misleading practices that ISO wants to put an end to are the following: Misuse of the ISO logo, which is a registered trademark.
Giving the false impression, through expressions such as "ISO certification", that it is ISO which has issued a certificate. ISO's core business function is developing standards. Certification to ISO standards is carried out independently of ISO. ISO does not issue certificates relating to ISO 9001, ISO 14001, or any other of the thousands of International Standards it has developed.
Failing to specify whether a certification is to ISO 9001:2000 or to a 1994 version of ISO 9001, ISO 9002 or ISO 9003. This failure invites confusion between the new and improved 2000 version and the older standards which it has replaced.
Giving the false impression that ISO 9001 is a product quality label, or that ISO 14001 is a label signifying a "green" or "environmentally friendly" product. This is not so. They are not product standards. The requirements of a product standard are specific to the product concerned - a child's car seat, for example, has different specifications to an office chair and standards for these two products will have correspondingly different requirements. ISO 9001 and ISO 14001 are what are known as "generic management system standards". "Generic" means that the standards' requirements can be applied to any organization, regardless of the product it makes (or whether the "product" is actually a service activity). "Management system" refers to what the organization does to manage its processes (the activities it undertakes to realize a product or a service). When an organization has a management system certified to ISO 9001 or ISO 14001 standard, this means that an independent auditor has checked that the processes influencing quality (ISO 9001), or the processes influencing the impact of Page 1 of 2 Publicizing your certification 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/general/basics_91.html?printable=true the organization's activities on the environment (ISO 14001), conform to the relevant standard's requirements. The objective is to give the organization's management and its customers confidence that the organization is in control of the way it does things. While this confidence logically extends to the things it makes, neither ISO 9001 nor ISO 14001 contains requirements for specific products. Therefore, certifications to these standards should not be presented as product guarantees.
You may already be interested in benefitting from the implementation of both quality and environmental management systems and therefore wondering about the compatibility of ISO 9000 and ISO 14000 families. ISO | ISO name and logo | Privacy policy Page 2 of 2 Publicizing your certification 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/general/basics_91.html?printable=true
The Magical Demystifying Tour of ISO 9000 and ISO 14000
Compatibility of ISO 9000 and ISO 14000 families ISO has no plans to merge the ISO 9000 and ISO 14000 families and is nevertheless sensitive to the needs of users who wish to implement both quality and environmental management systems. Therefore, the ISO technical committees ISO/TC 176 (responsible for ISO 9000) and ISO/TC 207 (responsible for ISO 14000) have an ongoing collaboration to achieve a high degree of compatibility between the two families of standards to facilitate their implementation by user, either as side-by-side systems, or as integrated management systems. This collaboration addresses such issues as common terminology and structure of the standards and its biggest achievement so far is the development of a joint auditing standard for quality and environmental management systems. ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing, replaces six older standards in the ISO 9000 and ISO 14000 families. Its use will give organizations a more integrated and balanced view of their operations, making it an outstanding tool for continuous improvement towards business excellence. It is also aimed to help user organizations optimize their management systems, facilitate the integration of quality and environmental management, and, in allowing single audits of both systems, save money and decrease disruption of work units being audited. Both the ISO 9000 and ISO 14000 families of International Standards emphasize the importance of audits as a management tool for monitoring and verifying the effective implementation of an organization's policy for quality and/or environmental management. Audits are also an essential part of activities such as external certification/registration and of supply chain evaluation and surveillance. ISO 19011 provides a uniform approach for the auditing of environmental and quality management systems. As many organizations implement both EMS and QMS - either as separate systems, or as an integrated management system - they want to harmonize and, where possible, combine the auditing of these systems.
Parting of the ways And now, our Magical Demystifying Tour splits into two parties, one headed for specific ISO 9000 destinations and the other for ISO 14000! You are, of course, welcome to stay on board for both visits in sequence. Otherwise, click here, according to your immediate interests, for ISO 9000 for busy managers, or here for ISO and the environment ISO | ISO name and logo | Privacy policy Page 1 of 1 Compatibility of ISO 9000 and ISO 14000 families 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/general/basics_92.html?printable=true
Specific to ISO 9000
ISO 9000 for busy managers Welcome to the ISO 9000-specific portion of our Magical Demystifying Tour! What is ISO 9000? The ISO 9000 family of standards represents an international consensus on good management practices with the aim of ensuring that the organization can time and time again deliver the product or services that: - Meet 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. These good practices have been distilled into a set of standardized requirements for a quality management system, regardless of what your organization does, its size, or whether it's in the private, or public sector. Why should my organization implement ISO 9000? The existence of an organization without customers, or with dissatisfied customers, is in peril! To keep customers - and to keep them satisfied - your product (which may, in fact, be a service) needs to meet their requirements. ISO 9000 provides a tried and tested framework for taking a systematic approach to managing your business processes (your organization's activities) so that they consistently turn out product conforming to the customer's expectations. And that means consistently happy customers! How does the ISO 9000 model work? The requirements for a quality system have been standardized - but most of us like to think our business is unique. So how does ISO 9000 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 9000 lays down what requirements your quality system must meet, but does not dictate how they should be met in your organization - which leaves great scope and flexibility for implementation in different business sectors and business cultures...as well as different national cultures. What if my organization implements ISO 9000? The organization should itself audit its ISO 9000-based quality system to verify that it is managing its processes effectively - or, to put it another way, to Page 1 of 2 ISO 9000 for busy managers 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/basics9000/basics9000_1.html?printa... check that it is fully in control of its activities. 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. Lastly, the organization may engage the services of an independent quality system certification body to obtain an ISO 9000 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.
If you're interested in knowing how it all came about, travel to the next Tour stop, Where ISO 9000 came from and who is behind it ISO | ISO name and logo | Privacy policy Page 2 of 2 ISO 9000 for busy managers 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/basics9000/basics9000_1.html?printa...
Specific to ISO 9000
Where ISO 9000 came from and who is behind it Who? In the ISO system, ISO standards are developed by 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, the number of countries participating in ISO/TC 176 is 69, with another 18 as observers. The new committee set to work and, in 1986, had completed its first standards. Published in the early part of 1987, these standards were known as the ISO 9000 series. Why 'ISO 9000'? At the end of 2002, ISO had 13 544 standards in its portfolio. ISO standards are usually assigned a catalogue number automatically. When the first output of ISO/TC 176 was nearing completetion, ISO was already approaching an total of some 9 000 published standards. It was realized even then that TC 176's standards would have a significant impact and so it was decided to give the series the next available round figure - 9000 - as a designation because round figures are more memorable. What? 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 TC 176 was able to draw. How? At this point, you may be wondering how you can help shape the ISO 9000 standards. In the ISO system, 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, Page 1 of 2 Where ISO 9000 came from and who is behind it 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/basics9000/basics9000_2.html?printa... or even participate in the work. In fact, there are channels and opportunities for you have a say in the future development of ISO 9000. Contact the ISO member for your country for details.
Now that you know the background, how do you get the best out of the ISO 9000 family? ISO | ISO name and logo | Privacy policy Page 2 of 2 Where ISO 9000 came from and who is behind it 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/basics9000/basics9000_2.html?printa...
Specific to ISO 9000
Get the best of out of the ISO 9000 family The emphasis on certification tends to overshadow the fact that there is an entire family of ISO 9000 standards. This family comprises standards providing requirements, guidance, terminology and vocabularly for quality management systems, and supporting standards addressing specific issues, such as auditing.
The ISO 9000 family is presented in the free brochure, ISO 9000 - Selection and use. This is the second edition of this brochure which has been updated to take into account the publication of the ISO 9000:2000 series. It presents the main features of the revised standards, such as the merging of the familiar ISO 9001, ISO 9002 and ISO 9003 into the new ISO 9001:2000, which is now the unique certification standard in the ISO 9000 family. However, the principal aim of the brochure is to emphasize that organizations stand to obtain the greatest value when the standards in the new core series are used in an integrated manner, both with each other and with the other standards making up the ISO 9000 family as a whole. The brochure includes: A list of the ISO 9000 quality management system standards and guidelines Examples of typical applications of the documents A step-by-step process to implement a quality management system A brief view of the future evolution of the ISO 9000 family.
With the knowledge you've already gained from the Magical Demystifying Tour, you're probably starting to realize the tremendous potential of ISO 9000, including for the small businesses that make up the vast majority of the world's enterprises! ISO | ISO name and logo | Privacy policy Page 1 of 1 Get the best of out of the ISO 9000 family 04-03-2004 http://www.iso.ch/iso/en/iso9000-14000/basics/basics9000/basics9000_3.html?printa...