Changes in the Standards from the FDIS Versions

The key changes from the FDIS to the IS versions of the ISO 9000:2000 family of standards are described below. Links to more complete lists of the changes are at the end of each section.

ISO 9000:2000

Three terms were removed from the ISO 9000 definitions: audit scope, auditor qualifications, and qualified auditor. A definition for competence was added to the Standard. These changes caused nine terms in section 3.9 to be renumbered, as well as, the references to them in other definitions.

The text of some definitions were slightly modified: infrastructure, dependability, preventive action, corrective action, correction, rework, repair, scrap, audit, criteria, audit evidence, audit findings, audit conclusion, auditor, audit team, metrological confirmation, measuring equipment, and metrological function. Numerous definitions had NOTEs revised for improved explanations or because of the changed reference numbers.

If your organization prepared a draft glossary document based on ISO/FDIS 9000:2000, you should verify your definitions are still appropriate by checking the modified terms in the published Standard.

ISO 9001:2000

 

The word “fulfil” and its variations were replaced by “meet” and its variations throughout the standard. Interestingly, ISO 9004 also made the same changes, but ISO 9000 went the other direction and changed from “meet” to “fulfil”.

 

The title of clause 4.2.4 was changed from “Control of Quality Records” to just “Control of Records”. This change makes sense because clause 4.2.3 is merely “Control of Documents. All references to “quality records” were changed to “records” within the Standard.

 

Clause 7.2.1, Determination of Requirements Related to the Product, revised “specified use or known and intended use” to more clearly say “specified or intended use, where known”. Similarly, clause 7.3.5, Design and Development Validation, changed “specified or known intended use or application” to “specified application or intended use, where known”.

 

Clause 7.3.4 (Review) and 7.3.5 (Verification) both added “performed in accordance with planned arrangements (see 7.3.1)”. This phrase was already in clause 7.3.5 (Validation).

 

Although it should have been clear in clause 7.5.1 (due to “as applicable”) that work instructions are not a requirement, the Standard now has “as necessary” at the end of sub-clause b) about the availability of work instructions.

 

Four cross-references in Annex B.1 (1994 to 2000) were added and twenty-two cross-references were dropped. Annex B.2 (2000 to 1994) had eight cross-reference added and twenty-six cross-references dropped. If you included cross-references in your draft ISO 9001:2000 quality manual, you may need to revise them to reflect the published cross-references.                                         

ISO 9004:2000

 

Most of the changes in ISO 9004 were slight wording differences, but in a few cases the modifications resulted in quite different meanings. For example, the phrase “transparent manner” was replaced by “visible manner” in clause 4.3 on the use of the quality management principles.

 

The clause numbers in ISO 9004 are still different from ISO 9001 in parts of clauses 7.5 and 8.2. For example, ISO 9004 does not include guidance for Process Validation (7.5.2) and uses that reference number for its guidance on Identification and Traceability, which is actually clause 7.5.3 in ISO 9001. As a result, the guidance clause numbers are offset for the remainder of that section.

 

If you were wondering about the plans for ISO 9000-4 (Dependability Management), a reference to IEC 60300-1 was added to the bibliography and this new entry is described as the replacement for ISO 9000-4.