Annex B
Source Document: ISO/TC 176/SC 2/N 525R Guidance on the Documentation Requirements of ISO 9001:2000
Records required by ISO 9001:2000
Clause
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Record required
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5.6.1
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Management reviews
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6.2.2 (e)
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Education, training, skills and experience
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7.1 (d)
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Evidence that the realization processes and resulting product fulfil requirements
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7.2.2
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Results of the review of requirements related to the product and actions arising from the review
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7.3.2
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Design and development inputs relating to product requirements
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7.3.4
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Results of design and development reviews and any necessary actions
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7.3.5
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Results of design and development verification and any necessary actions
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7.3.6
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Results of design and development validation and any necessary actions
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7.3.7
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Results of the review of design and development changes and any necessary actions
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7.4.1
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Results of supplier evaluations and any necessary actions arising from the evaluations
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7.5.2 (d)
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As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement
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7.5.3
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The unique identification of the product, where traceability is a requirement
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7.5.4
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Customer property that is lost, damaged or otherwise found to be unsuitable for use
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7.6 (a)
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Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist
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7.6
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Validity of the previous measuring results when the measuring equipment is found not to conform to requirements
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7.6
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Results of calibration and verification of measuring equipment
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8.2.2
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Internal audit results and follow-up actions
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8.2.4
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Indication of the person(s) authorizing release of product.
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8.3
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Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
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8.5.2
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Results of corrective action
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8.5.3
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Results of preventive action
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