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Frequently Asked Questions (FAQ's)  

This list of Frequently Asked Questions (FAQ's) 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:

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?

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.ch 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.ch  for a listing 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 organizations 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:

 [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:

[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:

[FAQ 014, March 2001]
 
What new requirements have been introduced into the revised ISO 9001 standard?

The main new requirements include:

[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.
[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 standard. The new ISO 10012 standard is targeted 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 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 Communiqué 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?

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.ch  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: 

[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.
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:

People in the organization will benefit by:

Owners and investors will benefit by:

Suppliers and partners will benefit by:

Society will benefit by:

[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 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]
 
What’s 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?

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 client’s 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:

 [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]

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