What Changed from the FDIS (Final Draft International Standard) to the "Final Released" International Standard (IS)

ISO 9001:2000 includes the following changes from the FDIS version of the standard:

0.1 General: Added "ISO 9000 and " in last sentence (before ISO 9004) as source of statements about quality management principles.

0.2 Process Approach: Replaced "fulfilling" with "meeting" in sub-clause a).

Figure 1: Revised "Customer" to "Customers" in the left and right boxes of the diagram.

1.2 Application: Replaced "fulfils" with "meets" in the last sentence.

2. Normative Reference: Revised "ISO 9000" to "ISO 9000:2000" in the last line and removed the footnote and the bottom of the page.

4.1 General Requirements: Moved the NOTE to the end of the section behind the outsourcing requirements.

4.2.1 General: Revised "quality records" to "records" in sub-clause e).

4.2.3 Control of Documents: Revised "Quality records" to "Records" in the second sentence.

4.2.4 Control of Records: The section title is no longer "Control of Quality Records". In addition, three "quality records" were changed to "records" within the paragraph.

5.2 Customer Focus: Replaced "fulfilled" with "are met".

5.5.1 Responsibility and Authority: Replaced "the responsibilities, authorities, and their interrelation" with "responsibilities and authorities".

5.6.2 Review Input: Revised "planned changes" to "changes" in sub-clause f).

6.3 Infrastructure: Replaced "for example" with "as applicable" in second sentence and added parentheses around the examples in sub-clauses b) and c).

7.1 Planning of Product Realization: Replaced "fulfill" with "meet" in sub-clause d).

7.2.1 Determination of Requirements Related to the Product: Revised "specified use or known and intended use" to "specified or intended use, where known" in sub-clause b).

7.3.2 Design and Development Inputs: Revised "These shall" to "These inputs shall" in the second sentence.

7.3.4 Design and Development Review: Replaced "conducted" in first sentence with "performed in accordance with planned arrangements (see 7.3.1)". Also replaced "fulfill" with "meet" in sub-clause a).

7.3.5 Design and Development Verification: Revised "perform" in first sentence with "performed in accordance with planned arrangements (see 7.3.1)". Also replaced "satisfied" with "met" in the same sentence.

7.3.6 Design and Development Validation: Replaced "fulfilling" with "meeting" in the first sentence. Also revised "specified or known intended use or application" in the same sentence to "specified application or intended use, where known".

7.3.7 Control of Design and Development Changes: Revised "delivered product" in the last sentence of the first paragraph to "product already delivered".

7.5.1 Control of Production and Service Provision: Added "as necessary" after sub-clause b) on the availability of work instructions.

8.2.1 Customer Satisfaction: Replaced "fulfilled" with "met" in the first sentence.

8.2.4 Monitoring and Measurement of Product: Replaced "are fulfilled" with "have been met". Also revised "until all the planned" to "until the planned".

8.4 Analysis of Data: Added "the effectiveness of" in front of the second occurrence of "quality management system" in the first sentence. Also replaced "conformance" with "conformity" in sub-clause b).

Annex A.1 (Correspondence between ISO 9001:2000 and ISO 14001:1996)

4.2.4 in 9001: Title changed to "Control of Records".

5.1 in 9001: Added reference of 4.4.1 for 14001.

Annex A.2 (Correspondence between ISO 14001:1996 and ISO 9001:2000)

4.4 in 14001: Added reference of 4.2.1 for 9001.

4.4.6 in 14001: Note that reference to 7.5.2 for 9001 is still out of sequence.

Annex B.1 (Correspondence between ISO 9001:1994 and ISO 9001:2000)

4.1.2.2 in 1994: Removed references to 5.1 and 6.3.

4.1.3 in 1994: Removed references to 5.6.2 and 5.6.3.

4.2.1 in 1994: Removed references to 4.2.1, 5.1, and 5.4.1.

4.2.3 in 1994: Removed reference to 6.2.1.

4.4.6 in 1994: Removed reference to 7.3.1.

4.4.7 in 1994: Removed reference to 7.3.1.

4.4.8 in 1994: Removed reference to 7.3.1.

4.5.1 in 1994: Removed reference to 4.2.1.

4.9 in 1994: Removed references to 7.1 and 8.2.3.

4.10.3 in 1994: Removed references to 7.4.3 and 7.5.1.

4.10.4 in 1994: Removed reference to 7.4.3.

4.14.2 in 1994: Removed reference to 8.4.

4.14.3 in 1994: Removed reference to 8.4.

4.15.6 in 1994: Removed reference to 7.5.5

4.18 in 1994: Removed reference to 6.2.1.

4.19 in 1994: Removed reference to 7.1.

4.20.2 in 1994: Added references to 8.1, 8.2.3, 8.2.4, and 8.4.

Annex B.2 (Correspondence between ISO 9001:2000 and ISO 9001:1994)

4.2.1 in 2000: Added reference to 4.2.2 and removed 4.2.1 and 4.5.1.

4.2.4 in 2000: Changed title to "Control of Records".

5.1 in 2000: Added reference to 4.1.1 and removed 4.1, 4.1.2.2, and 4.2.1.

5.4.1 in 2000: Removed reference to 4.2.1.

5.6 (title only) in 2000: Removed reference to 4.1.3.

5.6.2 in 2000: Removed reference to 4.1.3.

5.6.3 in 2000: Removed reference to 4.1.3.

6.2.1 in 2000: Removed references to 4.2.3 and 4.18.

6.3 in 2000: Removed reference to 4.1.2.2.

7.1 in 2000: Removed reference to 4.9.

7.3.1 in 2000: Removed references to 4.4.6, 4.4.7, and 4.4.8.

7.4.3 in 2000: Removed references to 4.10.3 and 4.10.4.

7.5.1 in 2000: Removed reference to 4.10.3.

7.5.5 in 2000: Removed reference to 4.15.6.

8.1 in 2000: Added references to 4.10.1 and 4.20.2; removed 4.10 and 4.17.

8.2.3 in 2000: Added reference to 4.20.2 and removed 4.9.

8.2.4 in 2000: Added reference to 4.20.2.

8.4 in 2000: Added references to 4.20.1 and 4.20.2; removed 4.14.2, 4.14.3, and 4.20.

Bibliography

[2] Added "2000" to ISO 9000 reference and removed the footnote.

[6], [7], and [8] Changed footnotes from 2 to 1 (changed title of ISO 19011).

[10] Removed footnote.

[16] Moved Principles to [17] and added footnote 3 regarding the ISO web site.

[17] Moved web site references to [19].

[16] Added new reference to IEC 60300-1 on Dependability Management, along with footnote 2 that it is to be published as a revision of ISO 9000-4.

[18] Added reference to ISO bimonthly publication along with footnote 4.