posted 22 November 2000 07:22 PM               

From: "Ware, Robert"

We received this information with our FDIS training to the new
standard, I count 21 records required.

RECORDS REQUIRED BY ISO/FDIS 9001:2000

Clause Record required
5.6.1 Management reviews
6.2.2 (e) Education, training, skills and experience
7.1 (d) Evidence that the realization processes and resulting product fulfill requirements
7.2.2 Results of the review of requirements relating to the product and actions arising from the review
7.3.2 Design and development inputs
7.3.4 Results of design and development reviews and any necessary actions
7.3.5 Results of design and development verification and any necessary actions
7.3.6 Results of design and development validation and any necessary actions
7.3.7 Results of the review of design and development changes and any necessary actions.
7.4.1 Results of supplier evaluations and actions arising from the evaluations
7.5.2 (d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement
7.5.3 The unique identification of the product, where traceability is a requirement
7.5.4 Customer property lost, damaged or otherwise found to be unsuitable for use
7.6 (a) Standards used for calibration or verification of measuring equipment where no international or national measurement standards exist
7.6 Validity of previous results when measuring equipment is found not to conform with its requirements
7.6 Results of calibration and verification of measuring equipment
8.2.2 Internal audit results
8.2.4 Evidence of product conformity with the acceptance criteria and indication of the authority responsible for the release of the product
8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
8.5.2 Results of corrective action
8.5.3 Results of preventive action

posted 23 November 2000 06:19 PM               

Take 7.1 (d) for example, where a great many records could be included under this category, as with 7.2.2, and 7.3.2, and ........