This list of Frequently Asked Questions (FAQs) has been derived with input from experts and has been based on current user (including industry) concerns that have been sourced using a worldwide questionnaire. This list will be reviewed and updated on a regular basis, to maintain its currency. It is intended that this list will also provide a good source of information for the new user.

1. When will the revised standards be available?

The revised quality management system standards (ISO 9000, 9001 and 9004) are scheduled to be available in the final quarter of the year 2000.

The timetable is currently as follows:

Committee Draft 2, CD2 (Issue for Comments & Ballot)               1Q-1999

Draft International Standard, DIS (Issue for Ballot)                        4Q-1999

Final Draft International Standard, FDIS (Issue for Ballot)              3Q-2000

International Standard published                                                     4Q-2000

At this time, the date for publication of the auditing standard is not defined due to the planned merger of ISO 10011 with ISO 14010, 14011, and 14012.
 

2. What will happen to ISO 9002 and 9003?

The 1994 versions of ISO 9002 and 9003 (as well as ISO 9001) will become obsolete following the publication of ISO 9001:2000.  The situations addressed by those standards, however, will be incorporated into the revised ISO 9001 standard.  This will be achieved by using the applicable requirements in ISO 9001:2000 according to the organization’s activities.
 

3. Why are the standards being revised?

The main reason for the year 2000 revision to the ISO 9000 standards is to give users the opportunity to add value to their activities and to improve their performance continually by focussing 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 will take into account
previous experience with quality management system standards (1987 and 1994 revisions) and emerging insights into generic management systems. They will result in a closer alignment of the quality management system with the needs of the organization and reflect the way those organizations run their business activities.

ISO directives also specify that standards be periodically revised to ensure that those standards are current and satisfy the needs of the global community.

The major reasons for the year 2000 revisions of the standards include emphasizing the need to measure customer satisfaction, meeting the need for more user-friendly documents, assuring consistency between quality management system requirements and guidelines, and incorporating generic quality management principles into organizations.
 

4. What will happen to the other standards and documents in the current (1994) ISO 9000 family?

The current ISO 9000 family of quality standards contains over twenty standards and documents. This proliferation of standards has been a particular concern of ISO 9000 users and customers.  To respond to this concern, ISO/TC 176 has agreed that the year 2000 quality management system standards will consist of three primary standards, i.e., ISO 9000, ISO 9001 and ISO 9004.

At present, it is intended that the other standards and documents in the ISO 9000 family will either be withdrawn or replaced by technical reports (with the exception of ISO 10011 and ISO 10012). The migration of the other ISO 9000 family standards and documents, to the year 2000 ISO 9000 family of standards, will be reviewed during ISO/TC176's Plenary Meeting in San Francisco in September 1999.

To the maximum extent possible, the key points in the other standards and documents (and sector-specific needs) will be integrated into the three primary standards.
 

5. Will the revised standards be available in my national language immediately after they are published by ISO?

The active participation of experts from around the world in the preparation of the new standards, and the broad distribution of the draft standards, will facilitate the timely translation of the International Standards.

Given the global importance of the quality management system standards, many national standards bodies are already working on the translation issue. ISO itself will publish the new standards in English and French, but if national language translations of the standards are currently available from your National Standards Body, we expect that they will have the translation of the revised standards ready at the time of publication by ISO or very soon thereafter.
For further details contact your national standards body.
 

6. Will my organization have to change its quality system and, if so, when?

There is no necessity to change anything at the moment, but it would be beneficial to look at the draft standards so that you can get some idea of what system requirements will be in the year 2000.  It is not the intention that you should have to change the structure of your system; however, the revised standards will include some new requirements and you should consider addressing them in your system at an appropriate opportunity.

Transition planning guidelines will be available to assist you in identifying the new requirements and the timing of those changes.
 

7. 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 are being prepared taking into account these and other guideline documents of the existing ISO 9000 family. The revised standards are intended to be sufficiently generic so as to eliminate the need for such guidelines.  There is no current plan to revise these guideline documents, and they are scheduled to be withdrawn after publication of the Year 2000 QMS standards. This situation is, of course, under constant review (see also FAQ 004).
 

8. How will the consistent pair of standards affect a registered/ certified organization?

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.
 

9. What should I do now?

You should contact your national standards body to obtain information about the changes in progress.   Since the standards are currently in the Committee Draft (CD) stage, many changes may be incorporated before their publication as International Standards.  However, the philosophies and concepts will not change significantly during the remainder of the development process.

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.
 

10. How will my organization deal with the transition from the current to the year 2000 standards?

The current 1994 standards will remain in force until the publication of the new revisions in the latter part of the year 2000.  Upon publication of ISO 9001:2000, the previous revisions of ISO 9001, ISO 9002, and ISO 9003 will be withdrawn, but it can be expected that there will be a period of overlap during which organizations may opt to use either the old or the new revisions for certification purposes.

For organizations currently registered/certified to ISO 9001, ISO 9002, or ISO 9003 these and other transition arrangements will be addressed in the transition planning guidance.

11. My organization is applying for ISO 9000 certification/registration in 1999/2000.  What should I do?

Continue with your plans to implement your system and to apply for certification.  Consult your certification/registration body who will keep you up-to-date with the progress of the revisions of the quality management system standards.

We strongly recommend that you read the draft standards, particularly ISO 9004 in conjunction with ISO 9001, and ensure that your management system effectively adds value to your organization's activities.

12. What needs to be done to ensure that auditors will be ready to work to the revised standards once they are published?

Auditors, whether external or internal, will have to be trained not only on the structure, content and terminology of the revised standards, but also on the underlying quality management principles. This training can be initiated using the draft standards as a basis, to ensure that the auditors are ready in time.  The revised standards will require that auditors be 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. Expertise in the concepts and philosophy of the ISO 9004:2000 standard is essential.
 

13. Will I be able to certify/register my organization to ISO 9004:2000?

Since ISO 9004:2000 will be a guideline specification, it is not intended to be used for third party certification purposes.  A key element in the new ISO 9004 will be the possibility for self-evaluation, but third party QMS certifications/registrations will be to ISO 9001:2000, which will consolidate the current ISO 9001, 9002, and 9003 standards.
 

14. Which standard will my organization be registered/certified to?

As the currently existing ISO 9001/ISO 9002/ISO 9003 standards will be replaced by the revised ISO 9001 standard, the choice is clear and simple.  All organizations will be registered/certified to ISO 9001:2000 and the scope of registration/certification will need to clearly reflect the organization's activities.
 

15. Will my organization need a full re-assessment once the revised standards are available?

This is primarily an issue between your organization and your registration/certification body.  Certification bodies worldwide are preparing guidance on this issue in conjunction with the accreditation bodies.   ISO/TC 176 is working with the IAF (International Accreditation Forum) and ISO-CASCO in order to provide relevant information this issue, in a timely manner.
 

16. What will happen to my organization if it is currently registered/certified to ISO 9002:1994?

If design activities are required to demonstrate your organization's capability to meet customer requirements for products and/or services covered by the 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 requirements for products and/or services covered by the quality management system
certification or if your product (including service) is provided on the basis of established design, you will still be registered to ISO 9001:2000, but by using a reduced scope your lack of design activities can be accounted for.
 

17. Can organizations remain certified/registered to the 1994 version of ISO 9001, 9002 and 9003?

Certifications/registrations to ISO 9001, ISO 9002, and ISO 9003 will remain valid for a period of time after the revised ISO 9001:2000 is adopted as a national standard by countries around the world.

It is expected that there will be a transition period before quality management systems will have to conform to the year 2000 edition. The duration of such a transition period will be established in consultation with the International Accreditation Forum (IAF) and other concerned parties.   Consideration will also be given to the contractual obligations of the organization and the registration/certification bodies.

18. My organization is thinking about developing a Quality Management System to ISO 9001, ISO 9002, or ISO 9003.  Should we wait until the revised standards are published?

No, you should not delay the introduction of the quality management system in your organization.  Like those who are currently in the process of being registered/certified, anything you do now to lay the foundation of a quality management system within your organization will be beneficial.
If and when you decide to proceed with certification, you will be registered/certified to one of the current standards should you be ready in time or to the revised ISO 9001:2000 standard
once it becomes available. You should, of course, take every opportunity to acquaint yourself with the drafts of the revised standards (with emphasis on ISO 9004:2000) as they evolve and keep in close contact with your chosen certification body, who will assist you during the transition.

19. 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 will replace the existing ISO 10011 and ISO 14010/14011/14012 documents. The planned publication date for this new standard is in the second quarter of 2001.
 

20. 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 9000 standards 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.

21. How will certificates to the revised ISO 9001:2000 identify the scope of the quality management system?

It has always been necessary to clearly define the scope of registration/ certification.  The merging of ISO 9001, 9002, and 9003 into a single requirements standard (ISO 9001:2000) will require more emphasis for the scope to define the products, services and processes covered by certification/registration.  This need is already being considered and discussed with certification/accreditation bodies, who will provide guidance at an appropriate time.
 

22. What are the main changes to the standards?

The main changes that have been introduced in the consistent pair of quality management system standards at the Committee Draft stage 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
· The measurement of customer satisfaction to provide key information for improvement

· Increased attention to resources such as communication and work environment.

· Terminology changes/improvements, for easier interpretation.

· Increased compatibility with the environmental management system standard.

· Specific reference to quality management principles

· Addition of the concept of organizational self-assessment as a driver for improvement (ISO 9004).
 

23. Will the revised standards address financial issues?

Financial issues are not addressed in the ISO 9001:2000 standard, which is a requirements standard.

The ISO 9004:2000 guidance standard will give more emphasis on financial resources needed for the implementation and improvement of the quality management system.
 

24. What new requirements have been introduced into the revised ISO 9001 standard?

The text of ISO 9001:2000 is not yet in its final version. However, on the basis of the Committee Draft documents, a large percentage of the 1994 revision requirements will be included in the ISO 9001:2000 standard.  The new/more clearly defined requirements include:

· Measurement of customer satisfaction

· Continual improvement

· Increased attention to resource availability

· Measurements extended to system, processes, and product (including service)

· Analysis of collected data on the performance of the quality management system

Continual improvement is the process focussed on continually increasing the effectiveness and/or efficiency of the organization 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 the customers and ensures a dynamic evolution of the quality management system.
 

25. Why has the measurement 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 and/or service meet customer needs and expectations, it is necessary to measure the extent of customer satisfaction and/or dissatisfaction.
 

26. What are the benefits of the revised standards?

There are a number of major benefits with the revised quality management systems standards.

The benefits are:

· Applicability to all product and/or service sectors and to all sizes of organizations

· Simple to use, clear in language, readily translatable, and easily understandable

· Connection of quality management systems to organizational processes

· Provision of a natural stepping stone 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.
 

27. What is a process?

Any activity or operation, which receives inputs and converts them to outputs, can be considered as a process. Almost all product and/or service activities and operations 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.

28. 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 the product (including service) meets their needs and increases their satisfaction.
 

29. Will my organization have to re-write all its documentation?

No.  If the quality management system is successfully implemented, satisfies the needs and objectives of the organization, and reflects the way the organization works, there should be no need for complete re-writing.  It is likely, however, that some adjustments will have to be made to address new specific requirements such as measurement of customer satisfaction and/or dissatisfaction and to update the cross reference of the quality system documentation to ISO 9001:2000
 

30. How will ISO 9001:2000 relate to the needs of specific business sectors?

The text of ISO 9001:2000 will be more generic than the 1994 version to be applicable to different types of product (including services) 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.

To assure consistency between the ISO 9000 requirements and sector requirements, a pilot study is being 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. The full results of the pilot scheme, and the working methods employed, will be reviewed in due course. Other industry sectors (e.g. aerospace, telecommunications) have already indicated their wish to develop similar documents.
 

31. What will happen to the ISO guide for small business?

The "Guide for Small Businesses" was published by ISO in 1996 and was intended to provide guidance from ISO/TC176 for the existing 1994 versions of ISO 9001, ISO 9002, and ISO 9003.   ISO 9001:2000 will apply 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 will be reviewing the need to update the Small Business Guide, against the usability of the revised ISO 9000 standards, in due course.
 

32. 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 will be applicable to small, medium, and large organisations alike. The Committee Drafts of the standard already provide some guidance on
reducing the scope of the standard for specific processes  (such as design activities) that are not performed by the organization.  It will, however, be up to the individual organization, in consensus with the certification body, to determine the complexity of the system needed to demonstrate its capability to meet customer requirements for its products and/or services.
 

33. What’s the relationship between the revised ISO 9001 and ISO 14001?

The revised ISO 9001 is being developed to have enhanced compatibility with ISO 14001, particularly with regard to terminology and content. There is close collaboration between the technical experts of ISO/TC176 and TC207.

A recent review of ISO 14001 and ISO 14004 by ISO/TC 207/SC1 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.

34. Are their 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, have agreed to prepare a single common audit standard.
 

35. 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 systems, including, of course, this web site, which carries detailed information on the revision program, updated on a regular basis.  ISO Central Secretariat in Switzerland also maintains a web site at http://www.iso.ch that carries general information on the revision program.
Your national standards body should be able to provide copies of the latest draft revisions and registrars/certification bodies will be able to provide guidance on transitional registration arrangements in due course.
 

36. Where can my organization obtain copies of the drafts of the revised standards?

Copies of the drafts of the revised standards can be obtained from national standards bodies.  There may be a nominal fee for copies of these documents.
 

37. How much is the transition to the new standards going to cost?

The cost will vary from one organization to another, depending on elements such as the actual state of implementation of the quality management system, the size of the organization, and the attitude of the management. It is expected that the benefits to all organizations will outweigh eventual costs associated with the transition.
 

38. My organization has comments on the draft standards.  How can we participate in the revision process?

The ISO member body  (usually the National Standards Body) for your country is responsible for receiving and collating individual comments. These organizations should be contacted for specific instructions for submission of comments.
 

39. Where does my organization go if it needs clarification or interpretation of the revised standards?

The committee drafts of the new standards have been released to facilitate the future introduction of the standards.  It is not appropriate to clarify or try to interpret requirements until these have been agreed and the final text approved by ISO/TC 176.

Once the new standards are published, the starting point for any individual request for an interpretation should be with the submitter'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 Project Management Group (PMG) Task Group with a formal procedure to examine and validate interpretations of its standards that are forwarded by national standards bodies.
 

40. Will the revised standards be more compatible with national quality award criteria?

The quality management principles are now the basis for the revised standards, which will be better aligned with the philosophy and objectives of most quality award
programs.  These principles are:

• customer-focused organizations, • leadership, • involvement of people, • process approach, • system approach to management, • continual improvement, • factual approach to decision making, and • mutually beneficial supplier relationships.
 

41. 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 experts from member bodies around the world. These experts meet at regular intervals (and communicate frequently by electronic means between meetings) for these revisions.

42. 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 standard.
 

43. How will the implementation of the new standards help my organization to improve its efficiency?

ISO 9001:2000 aims at guaranteeing the effectiveness (and not 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 efficiencies throughout the organization.

44. My organization is currently registered/certified to ISO 9003.  What do we need to do?

There are significant differences between the current ISO 9003 standard and the revised ISO 9001:2000 standard.  You should perform a gap analysis based on the draft standards 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 must be made.
 

45. I am a qualified quality management practitioner (consultant, auditor, or trainer).  What do I need to do?

As a minimum, you should familiarize yourself with the content and philosophies of the revised standards, especially ISO 9000:2000, ISO 9004:2000 and the quality management principles.  You must clearly understand your client’s activities and processes and appropriately interpret the requirements of the standards to add value to their operations.
 

46. 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.
 

47. My organization provides services.  How are the new standards applicable to us?

The standards are applicable to all types of organizations.  The language in the revised standards is equally appropriate to all sectors, including service providers.

48. What will happen to ISO 8402 and ISO 9000-1?

The terms and vocabulary currently found in the ISO 8402 standard are being addressed in the ISO 9000:2000 standard.  Once this process is complete, the ISO 8402 standard will be withdrawn.The quality management concepts in ISO 9000-1 will be integrated into the ISO 9000:2000 standard.  The topic of  "Selection and Use" of the appropriate standard in ISO 9000-1:1994 will be addressed in a separately published brochure.
 

49. Is there any way I can participate in the validation of the new standards?

Yes. A validation process is currently being undertaken by National Standards Bodies, under the overall coordination of ISO/TC 176.  If you are interested, but have not yet been invited to participate, you should contact your National Standards Body for further details.
There are several potential benefits. Your organization will have an opportunity to initiate the implementation/transition process at an early stage and have a direct input into determining if the standards, as written, are usable and user-friendly for all kinds of organization.
 

50. 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 and/or services 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:

· fulfilment of legal and regulatory requirements

· improved health and safety

· reduced enviromental impact

· increased security
 

51. What will happen to the 1994 versions of ISO 9001, 9002 & 9003?

The year 2000 publication of the ISO 9000 standards will supercede corresponding 1994 versions.

ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 will be become obsolete, merged as a single standard and published as ISO 9001:2000.
 

52. Will the year 2000 revision affect my organizations current quality system registration  / certification?

Yes.  The transition strategy adopted by your organization to meet the requirements of ISO 9001:2000 should include an appropriate timing for upgrading the registration / certification.

It is envisaged that the process of upgrading registration / certification would be a smooth transition process that is incorporated into the applicable Registration or Certification Bodies regular audit routine.

You are advised to contact your Registration / Certification Body to negotiate a suitable transition time frame.
 

53. What does my organization need to do if it is currently registered/certified to ISO 9002:1994 or ISO 9003:1994?

Once ISO 9001:2000 is published, ISO 9002 and ISO 9003 will become obsolete.

You will be able to assess the requirements of ISO 9001:2000 with a view of applying the standard by reducing its scope as it applies to the specifics of your business.

Prior to the publication of ISO 9001:2000 an organization is able to select ISO 9002:1994 or ISO 9003:1994 to avoid the inclusion of design in the scope of their certification.  Once ISO 9002 and ISO 9003 have been made obsolete, an organization that performs design activities, cannot exclude design from their scope of registration/certification to ISO 9001:2000.

If you do not perform design activities or if your product (including service) is provided on the basis of established design, you will need to discuss the reduced scope of requirements with your Certification / Registration Body.