Requirement Differences from ISO 9001:1994

The key differences for the first five of the ISO 9001:1994 clauses are shown below (with the corresponding ISO 9001:2000 clause numbers identified).

 

4.1 Management Responsibility

  • Emphasis on top management commitment (5.1)

  • Policy on requirements and improvement (5.3.b)

  • Measurable objectives at relevant levels (5.4.1)

  • Awareness of customer requirements (5.1.a; 5.5.2.c)

  • Resources for improvement and satisfaction (6.1.a)

  • Requirement for internal communication (5.5.3)

  • More duties for management representative (5.5.2)

  • Specific topics for management reviews (5.6.2)

4.2 Quality System

  • Measurement and analysis of processes (4.1.e)

  • Continual improvement of effectiveness (4.1.f)

  • Identification and control of outsourcing (4.1)

  • Fewer specific procedures are required (4.2.1)

  • (see 4.2.3, 4.2.3, 8.2.2, 8.3, 8.5.2, and 8.5.3)

  • Quality manual with process interaction (4.2.2)

  • Expanded planning for quality system (5.4.3)

4.3 Contract Review

  • Now in Customer-Related Processes (7.2)

  • No requirement for documented procedure

  • Delivery and post-delivery requirements (7.2.1.a)

  • Unstated, but necessary requirements (7.2.1.b)

  • Statutory and regulatory requirements (7.2.1.c)

  • Records kept of actions from reviews (7.2.2)

  • Requirement for customer communication (7.2.3)

4.4 Design Control

  • Renamed as Design and Development (7.3)

  • No requirement for documented procedure

  • Functional and performance requirements (7.3.2.a)

  • Applicable statutory and regulatory inputs (7.3.2.b)

  • Outputs to purchasing, production, service (7.3.3.b)

  • Actions noted from Reviews and Changes (7.3.4; 7.3.7)

  • Actions from Verification and Validation (7.3.5; 7.3.6)

  • Impact on constituent parts; shipped product (7.3.7)

4.5 Document and Data Control

  • Renamed as Control of Documents (4.2.3)

  • Document reviews and updates as necessary (4.2.3.b)

  • Changes to documents must be identified (4.2.3.c)

  • Legible and readily identifiable documents (4.2.3.e)

  • Distribution control for external documents (4.2.3.f)

If you have any questions about the differences, send a note to: Larry@WhittingtonAssociates.com.