Our ref XXXX
Secretariat of ISO/TC 176/SC 2 Date: DecSeptember 1999
To the Members of ISO/TC 176/SC 2 - Quality Management and Quality Assurance/Quality
Systems
Transition Planning Guidance for ISO/DIS 9001:2000
4.0 FREQUENTLY ASKED QUESTIONS
Whilst While this Transition Planning Guidance provides guidance on a number of issues facing the various users during the transition period, it is considered that a concise list of questions and answers will also provide additional help.
This list of Frequently Asked Questions (FAQs) given below has been updated after publication of the Draft International Standards for the Year 2000 ISO 9000 family, and is structured in a more logical sequence. 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.
It is expected that the FAQs will be updated on a more regular basis than this Transition Planning Guidance. For the latest version of the FAQs, reference should be made to the open access web site at http://www.bsi.org.uk/iso-tc176-sc2.
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 editions) and
emerging insights into generic management systems. They will 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 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 monitor customer satisfaction, meeting the need for more user-friendly documents, assuring consistency between quality management system requirements and guidelines, and promoting the use of generic quality management principles by organizations.
[FAQ 001, November 1999; formerly FAQ 003]
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, November1999; formerly FAQ 042]
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 fourth quarter of the year 2000.
The timetable is currently as follows:
Draft International Standard, DIS (Issue for Ballot) Q4 1999
Final Draft International Standard, FDIS (Issue for Ballot) Q3 2000
International Standard published Q4 2000
At this time, the date for publication of the joint Quality Management System and Environmental Management System auditing standard (ISO 19011) is planned for the third quarter of 2001 and will merge the current ISO 10011 Parts 1,2 and 3 with ISO 14010, 14011, and 14012. It is expected that this new auditing standard will be available as a Draft International Standard at the time the new ISO 9000, 9001 and 9004 are published as International Standards.
[FAQ 003, November 1999; formerly FAQ 001]
Will the year 2000 revision affect my organization's current quality system registration/certification?
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 new standards are published. You are advised to contact your registration/certification body to negotiate a suitable transition time frame for your own organization.
[FAQ 004, November1999; formerly FAQ 053]
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, IAF guidelines provide for the incorporation of audits to the new standard into surveillance visits for existing (1994) certifications, wherever possible.
[FAQ 005, November1999; formerly FAQ 038]
Where can my organization obtain copies of the drafts of the revised standards?
Copies of the Draft International Standards may be purchased from National Standards Bodies. Many countries will have these available in local-language versions.
[FAQ 006, November1999; formerly FAQ 037]
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 revision program and is 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.
[FAQ 007, November1999; formerly FAQ 036]
Where does my organization go if it needs clarification or interpretation of the revised standards?
The new Standards are still in draft form. It is not appropriate to clarify or try to interpret requirements until these have been agreed and the final text approved by ISO member bodies.
Once the new standards are published, 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 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.
[FAQ 008, November1999; formerly FAQ 040]
Will my organization need a full reassessment once the revised standards are available?
This is primarily an issue between your organization and your registration/certification body. ISO/TC 176 is working with the IAF (International Accreditation Forum) and ISO-CASCO (Committee for Conformity Assessment) in order to provide relevant information in a timely manner. ISO CASCO is responsible for the standards to which the Certification/Registration Bodies work (ISO/IEC Guide 61 and ISO/IEC Guide 62), and the Accreditation Bodies are responsible for monitoring and approving the performance of Certification Bodies within their geographical area. 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 009, November 1999; formerly FAQ 015]
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.
[FAQ 010, November 1999; formerly FAQ 005]
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 whole structure of your system or re-write all your procedures; 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 are available to assist you in identifying the new requirements and the timing of those changes.[FAQ 011, November 1999; formerly FAQ 006]
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, and already 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 Draft International Standard ISO 9001:2000 has clarified the need for required documentation. Only 6 documented procedures are required by the standard 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 012, November1999; formerly FAQ 030]
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 focus,
leadership,
involvement of people,
process approach,
system approach to management,
continual improvement,
factual approach to decision making, and
mutually beneficial supplier relationships.
Further Information on the quality management principles can be obtained from the website at http://www.bsi.org.uk/iso-tc176-sc2.
[FAQ 013, November1999; formerly FAQ 041]
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 emphasize the financial resources needed for the implementation and improvement of a quality management system.
[FAQ 014, November 1999; formerly FAQ 023]
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 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 015, November1999; formerly FAQ 027]
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 "permissible exclusions" to the standard has been introduced as a way to cope with the wide spectrum of organizations and activities.
A requirement for the organization to monitor information on customer satisfaction and/or dissatisfaction 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.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).
[FAQ 016, November 1999; formerly FAQ 022]
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 Draft International Standard 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:
Continual improvement
Increased emphasis on the role of top management.
Consideration of legal and regulatory requirements.
Establishment of measurable objectives at relevant functions and levels.
Monitoring of information of customer satisfaction and/or dissatisfaction 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 017, November 1999; formerly FAQ 024]
Why has the requirement for monitoring of customer satisfaction and dissatisfaction 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 and/or dissatisfaction. Improvements can be made by taking action to address any identified issues and concerns.
[FAQ 018, November1999; formerly FAQ 026]
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 meets their needs and increases their satisfaction.
[FAQ 019, November1999; formerly FAQ 029]
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.
[FAQ 020, November1999; formerly FAQ 028]
What is meant by "continual improvement"?
Continual improvement is the process focused 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.
[FAQ 021, November1999; formerly FAQ 025]
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 necessarily 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.
[FAQ 022, November1999; formerly FAQ 044]
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.
[FAQ 023, November 1999; formerly FAQ 020]
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 seven 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 four primary standards, i.e., ISO 9000, ISO 9001, ISO 9004 and ISO 19011.
At present, it is intended that the other standards and documents in the ISO 9000 family will either be withdrawn, transferred to other Technical Committees, or replaced by technical reports, technical specifications or brochures (with the exception of ISO 10012, "Quality Assurance for Measuring Equipment", which will remain as an international standard). The migration of the other ISO 9000 family standards and documents to the year 2000 ISO 9000 family of standards has been reviewed during ISO/TC176's Plenary Meeting in San Francisco in September 1999, and the recommendations will be balloted among member bodies during the second quarter of 2000.
To the maximum extent possible, the key points in the other standards and documents (and sector-specific needs) will be integrated into the four primary standards.
[FAQ 024, November 1999; formerly FAQ 004]
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. 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, 9004-3, 9004-4 and 10005 be withdrawn and other documents (ISO 10006, 10007, 10013, 10014, 10015 and 10017) 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 (see also FAQ 024).
[FAQ 025, November 1999; formerly FAQ 007]
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.
[FAQ 026, November1999; formerly FAQ 043]
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 (Quality Management Systems: Fundamentals and Vocabulary) 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.
[FAQ 027, November1999; formerly FAQ 049]
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. The scope of registration/certification will need to reflect clearly the activities covered by the organization's Quality Management System, and any exclusions to non-applicable requirements of the standard ("permissible exclusions") documented and justified in the quality manual
[FAQ 028, November 1999; formerly FAQ 014]
What will happen to the 1994 versions of ISO 9001, 9002 & 9003?
The year 2000 publications will supersede corresponding 1994 versions of the standards. However, noting the IAF/ISO-CASCO/ISO TC176 agreement that accredited certification to the 1994 editions should remain possible for up to 3 years after the publication 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, and possibly for even longer.
[FAQ 029, November 1999; formerly FAQ 052]
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, notably in the product realization activities. 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.
[FAQ 030, November1999; formerly FAQ 045]
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 must be addressed. The standard allows for the "exclusion" of some requirements, 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 legal/regulatory requirements.
If design activities are required to demonstrate your organization's capability to meet customer or legal/regulatory requirements for products 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 and applicable legal/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
[FAQ 031, November 1999; formerly FAQ 016]
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-TC176 Communique 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 certificates issued or renewed will, however, only remain valid for a maximum of three years after the publication of ISO 9001:2000.
[FAQ 032, November 1999; formerly FAQ 017]
How soon can my organization seek certification to ISO 9001:2000?
The policy defined by IAF, ISO-CASCO and ISO TC176 is very clear; Accredited certificates to ISO 9001: 2000 may only be granted after its publication as an International Standard. Certification Bodies/Registrars may, however, begin to assess conformity to the new standard using the DIS and FDIS versions, during normal surveillance audits to the current standards. Provided there are no significant changes from the FDIS to the International Standard, this should mean that new certificates can be issued immediately after publication of ISO 9001:2000.
[FAQ 033, November 1999]
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 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 as defined in the subsection addressing "permissible exclusions".
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.
[FAQ 034, November1999; formerly FAQ 054]
Will I be able to certify/register my organization to ISO 9004:2000?
Since ISO 9004:2000 will be a guidance document, it is not intended to be used for third party certification purposes. A key element in the new ISO 9004 will be the ability to perform 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.
[FAQ 035, November 1999; formerly FAQ 013]
How will 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) 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.
[FAQ 036, November 1999; formerly FAQ 021]
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 is published. 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.
[FAQ 037, November 1999; formerly FAQ 018]
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.
[FAQ 038, November 1999; formerly FAQ 008]
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 Draft International Standard (DIS) stage, some changes may still 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.
[FAQ 039, November 1999; formerly FAQ 009]
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. However, transition planning guidance developed in consultation among ISO TC176, ISO CASCO, and the International Accreditation Forum (IAF) has resulted in the following agreements:
Accredited certificates to ISO 9001: 2000 shall not be granted until its publication as an International Standard.
Certification 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.
Further details of the Transition Planning Guidance are available on the website at: http://www.bsi.org.uk/iso-tc176-sc2
[FAQ 040, November 1999; formerly FAQ 010]
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 new draft standards, particularly ISO 9004 in conjunction with ISO 9001, and ensure that your management system effectively adds value to your organization's activities.
[FAQ 041, November 1999; formerly FAQ 011]
How will 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.
To assure consistency between the ISO 9000 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 (TS 16949). The full results of the pilot scheme, and the working methods employed, will be reviewed in due course.
[FAQ 042, November 1999; formerly FAQ 031]
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 043, November1999; formerly FAQ 051]
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 organizations alike. The Draft International Standards already provide some guidance on excluding certain requirements for specific processes (such as design activities) that are not performed by the organization. Provisions have been made to exclude non-applicable requirements as defined in the subsection addressing "permissible exclusions". It will, however, be up to the individual organization to determine the complexity of the system needed to demonstrate its capability to meet customer and applicable legal/regulatory requirements for its products.
[FAQ 044, November1999; formerly FAQ 033]
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 is currently reviewing the need to update the Small Business Guide, and a decision is expected by the middle of the year 2000.
[FAQ 045, November1999; formerly FAQ 032]
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, the Technical Committee responsible for the ISO 14000 series of standards.
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.
[FAQ 046, November1999; formerly FAQ 034]
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 2001.
[FAQ 047, November1999; formerly FAQ 035]
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 new standard is the third quarter of 2001.
[FAQ 048, November 1999; formerly FAQ 019]
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 simpler, more user-friendly, and with less manufacturing bias. The new standards will be equally appropriate to all sectors, including service providers.
[FAQ 049, November1999; formerly FAQ 048]
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 all their individual national comments. These organizations should be contacted for specific instructions for submission of comments.
[FAQ 050, November1999; formerly FAQ 039]
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 client’s activities and processes and appropriately interpret the requirements of the standards to add value to their operations.
[FAQ 051, November1999; formerly FAQ 046]
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 052, November1999; formerly FAQ 047]
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.
[FAQ 053, November1999; formerly FAQ 050]
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 demonstrate their competence 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. According to the IAF/ISO-CASCO/ISO TC176 Transition Policy, auditors must demonstrate competency in:
The requirements of the latest draft of ISO 9001: 2000.
The concepts and terminology of the latest draft of 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 054, November 1999; formerly FAQ 012]
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.org.uk) for further information.
[FAQ 055, November1999]
5.0 AUTHENTICITY OF INFORMATION REGARDING ISO 9001:2000
It is of utmost importance to ensure the most uniform application of the standard possible, given the inevitable variations caused by linguistic differences.
The first contact for information regarding the requirements of ISO 9001:2000 should be limited to National Standards Bodies. It is however, anticipated that organizations that have already established a working relationship with Certification Bodies, may feel more comfortable discussing ISO 9001:2000 requirements with them.
Other recommended sources of information are:
ISO maintains a Web Site www.iso.ch that carries general information regarding the ISO 9001:2000 and ISO 9004:2000 revision program.
ISO/TC176 maintains a Web Site www.tc176.org which includes general information on the structure and work programme of ISO/TC176 including links to related password-protected and public websites
The ISO/TC176/SC 2 Web Site (www.bsi.org.uk/iso-tc176-sc2) carries detailed information on the ISO 9001/9004 revision program, updated on a regular basis.