New Requirements Coming in ISO 9001:2000

In addition to being restructured into a process model format, the draft ISO 9001:2000 standard introduces some new requirements (at new clause numbers):

5. Management Responsibility:
– More emphasis on top management commitment
– An expanded focus on customer satisfaction
– Extension of measurable objectives to lower levels
– More staff awareness of customer requirements
– New requirement on internal communications
– Expanded process description in quality manual
– Specific inputs and outputs for Management Review

6. Resource Management
– Clarification on “timely” provision of resources
– Addition of competency and awareness of roles
– New clause on facilities and supporting services
– Coverage of human/physical factors for work environment

7. Product Realization
– Documentation of planning of realization processes
– Inclusion of requirements not specified, but needed
– New requirement on customer communications
– Clarification of design and development inputs
– More on follow-up actions from design reviews
– More on effect of design change on parts/product
– New requirement for process validation

8. Measurement, Analysis, and Improvement
– Adds measurement and monitoring for improvement
– New requirement on customer satisfaction
– Adds measurement and monitoring of processes
– Adds analysis of data to support improvement
– New requirement for continual improvement