US TAG176 Press Release - 12 August 1999


Fully vaccinated are you?
US TAG176 Press Release

Subject: FYI: US TAG176 Press Release
Date: Thu, 12 Aug 1999 11:49:18 -0600
From: ISO Standards Discussion

From: Dennis Arter
Subject: FYI: US TAG176 Press Release

* A special Thank-you to Dennis Arter for sharing this information.

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US TAG to TC 176 on Quality Management and Quality Assurance
Jack West, Chairman

NEWS RELEASE For Immediate Release August 9, 1999 In accordance with the schedule established by Technical Committee (TC) 176 of the International Organization for Standardization (ISO), all ISO member bodies had until August 1, 1999, to submit their ballots and comments on the second committee drafts (CD 2) of ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000. In the United States, the American National Standards Institute (ANSI), the US national standards body, is the ISO member body with the authority and responsibility to accumulate comments from the US community and to vote. ANSI has established the US Technical Advisory Group (TAG) to TC 176, a segment of the US Standards Group for Quality, Environment, Dependability and Statistics (QEDS), under the administration of the American Society for Quality (ASQ), to develop the US position for this purpose. Following numerous meetings and discussions with US TAG members and other interested parties, the US met the ISO deadline for CD 2 balloting by submitting their vote and comments on these documents. Below is a summary of the positions taken by the US in their submission to ISO.

ISO CD 2 9000:2000

"The US position on ISO 9000:2000 is to disapprove the CD 2 document and four critical issues were identified. For each of these issues, a remedy is offered which would allow the US Delegation to ISO/TC 176 to change the US vote from 'Disapprove' to 'Approve' if the remedy or something deemed equivalent by the US Delegation were adopted," said Jack West, Chairman of the US TAG to TC 176.


Structure of the Document. The order in which the terms are listed is not designed for easy access and use by the user.

Remedy: Include an alphabetical listing of definitions.


Clause 3.3, Figure 1. The figure is complicated and hard to understand, even with the explanatory text.

Remedy: Delete Figure 1 and references to it in Clause 3.3. ISSUE 3.

Clause 4.1.11, Definition of 'quality'. It is confusing to users of the standard to have two definitions of quality. The practical definition is not correct. The technical definition as stated does not make clear the relationship between the 'nature of an object' and 'needs and expectations' even when Note 3 is taken into account. Also, the use of a new term 'object' in the definition of quality is not necessary. The definition of 'quality' in the context of the ISO 9000 family of standards is only used to refer to a product, i.e., result of a process, or to a process. The definition proposed by the US avoids use of the term 'object' and substitutes in its place 'product or process'.

Remedy: Provide a single definition of 'quality' in ISO 9000. The US has proposed a single definition of 'quality': "Extent to which the complete set of realized characteristics of a product or a process satisfies needs and expectations."


Consistency of definitions in ISO 9000 with usage in ISO 9001 and ISO 9004. Many of the definitions in this CD still do not appear to be consistent with the usage of terms in the two management system standards.

Remedy: This must be corrected prior to release of ISO 9000. If this cannot be corrected in time to issue ISO 9000 concurrently with ISO 9001 and ISO 9004, the most significant terms should be identified, correctly defined and included in ISO 9001:2000.

ISO CD 2 9001:2000

The US position on ISO 9001:2000 is to approve the CD 2 document with the following critical comments: "The US believes that satisfactory resolution of the following critical observations is needed to retain our support," stated West. "Each issue offered a remedy which would remove the US concerns."


The CD 2 is not as clear as the 1994 edition on which procedures must be documented. We consider it vital to have clarity to promote user-friendliness.


1. Follow the 1994 edition practice of identifying "documented procedures" (While this may not be elegant, it is very clear to the user exactly which procedures must be written).

2. As an alternate, use the notation "see 5.6.6" and revise that clause to make it clear that procedures so referenced must be documented/written. Or, provide a statement that "Where the phrase 'documented procedures' is used in this standard, these procedures must be written."

3. Move first paragraph of clause 4 to clause 5.1 and delete the rest of clause 4.


Several clauses have been added in the name of compatibility with ISO 14001. The two standards are compatible without these additions. Compatibility does not require adding inappropriate clauses to ISO 9001.


1. Delete clause 5.3 on Legal Requirements. In any case this clause is largely redundant with 7.2.1.c and 7.3.2.b.

2. Delete clause 5.6.4 on Internal Communications. In any case, this clause is redundant with other clauses (e.g., 6.3).

3. Delete clause 6.2.2, paragraph 2, bullets e-I on Employee Awareness. These items are redundant to the requirements of 5.4 and 6.2.2a through d.


Clause 6.5, paragraph 2, bullets a-d. The factors may be national issues and not applicable across countries and cultures, therefore they should not be prescribed. Also, these factors are subjective in nature and difficult to audit.


Change these requirements to a Note. "Note x, this may include:

a) health and safety conditions;
b) work methods;
c) work ethics;
d) ambient working conditions".


Clause 8.5.1. is largely redundant with the content of 8.4. The procedure required is unnecessarily prescriptive.

Remedy: Revise the 2nd sentence of this clause to read "The organization shall use the quality policy, objectives, internal audit results, analysis of data, corrective and preventive action and management review to facilitate continual improvement."

ISO CD 2 9004:2000

"As with ISO CD 2 9001:2000, the US position on ISO 9004:2000 is to approve the CD 2 document with the several critical observations offered as comments," said West. ISSUE 1.

ISO 9004 should provide better guidance to be more complete, describing a higher performance QMS.

Remedy: Take care to assure that the full range of concepts included in national quality award criteria are included. These should:

1. Describe the concepts that encourage the organization to continue the quality journey.

2. Lay a foundation to make Quality Award transition the next natural step, being careful not to duplicate or replace Quality Award or become an auditable standard.


Content seems needlessly long and excessively verbose.

Remedy: Increase effort to shorten the existing wording, while assuring that all subject matter is covered.


Assurance is needed that contents of other ISO 9000 standards ( 9004-1, 9004-2, etc.) are appropriately covered.

Remedy: Continue review of the ISO 9004 standards family. Good work so far, but more is needed.


Inclusion of self assessment process in Annex.

Remedy: Inclusion is worthwhile, and should remain. Also consider self assessment document as a Technical Specification.


Should the subject of society responsibility remain in the standard?

Remedy: Retain. Subject seems appropriate.


Consistency of language usage.

Remedy: Care should be taken that ISO 9004 language is consistent with referenced or other published standards


Inclusion of Process Model diagram.

Remedy: Retain diagram in ISO 9004, as in ISO 9001. Titles and content should be consistent between the two standards.

Specified Issues

In addition to other comments, ISO/TC 176 had asked member bodies to examine the second committee drafts of ISO 9001:2000 and ISO 9004:2000 and make specific comments on the following issues:

1. Can the drafts be accurately translated into their national languages?

2. Are the drafts compatible with the ISO 14000 series of environmental management systems standards?

3. Which method of numbering the clauses of ISO 9001 and ISO 9004 is preferred: to number the main paragraphs 0-8 or 0-4?

US Position on Translations:

"The US believes the CD 2 drafts of ISO 9001:2000 and ISO 9004:2000 are generally translatable into American English without difficulty," noted West. "However, the US TAG identified the several terms that may not be easy to translate accurately." These terms are:

'Realization' (5.5.2, 7) - is generally not used with the meaning intended in the CDs. It is stilted English at best.

'Monitoring' (7.6, 8.2.2, 8.2.3) - has potential consequences

'Aspects' (5.3) - In Colima, the drafting groups were advised to not use such terms as 'quality' without appropriate modifiers. Using the term 'quality aspects' has the same difficulty; it can have multiple meanings and create great confusion

'Potential consequences' (6.2.2I) - replace with 'potential effects'

The terms 'verification, validation' are confusing to many in any case when used in regard to the design function. They may be even more confusing when used outside design clause. Clause 7.5.5 provides for if there is no verification, then validate the 'processes'. This causes confusion at least in American English.

US Position on Compatibility with 14000 Series

The US points out that ISO 9001 is a minimum generic QMS while ISO 14001 is a comprehensive EMS. West observed, "given this difference in scope, the US believes that ISO 9001 and ISO 14001 are and have been highly compatible, even with the current 1994 edition of ISO 9001. The US believes that some of the changes introduced with CD 2 in the name of enhanced compatibility actually cause the addition of unneeded requirements in ISO 9001." Therefore, the US recommends deleting clause 5.3 Legal, 5.6.4 Internal Communications and 6.2.2 Paragraph 2 Employee Awareness which were not in CD 1. "These additions go beyond the scope of ISO 9001," said West.

The US points out that ISO 9004 provides guidance on a comprehensive QMS while ISO 14004 provides guidance for application of ISO 14001. Given these scope differences, the US believes that it is not appropriate to compare the compatibility of ISO 9004 and ISO 14004.

The number '14004' was picked to mimic ISO 9004 and this causes confusion for the users. The US recommends that TC 176 petition TC 207 to renumber ISO 14004 when it is next revised. US Position on Clause Numbering for ISO 9001 and ISO 9004. The US favors option A, retaining the "0 - 8" numbering system used in the CD 2 drafts.

"The US notes that retaining a numbering system similar to that used in the 1994 edition may add to confusion on the part of the users since a similar clause number may now cover totally different material," said West.


In addition to the primary comments cited above, the US submitted a number of substantive and editorial comments on the CD 2 documents which are not critical in nature. While these are not summarized in this news release, they have been submitted to ISO/TC 176 for their consideration in developing the next stage of the revision process. "The Draft International Standard is still scheduled for release in the fourth quarter of 1999," confirmed West.

For information on how to join the US TAG and how you can contribute to the revision process, call Patricia Kopp at (800) 248-1946 or e-mail her at [email protected]. Additional information can be obtained from the US TAG website at

Robin Gildersleeve
ASQ Standards Group Communications Coordinator
(703) 680-1436
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