Quality System


The Six mandatory / Required procedure activities:

1. Control of Dcuments (4.2.3.).

2. Control of Records (4.2.4.)

3. Internal Audit (8.2.2.)..

4. Control Of Nonconforming Products (8.3.).

5. Corrective Action (8.5.2.).

6. Preventive Action (8.5.3.).

 

Records required by ISO 9001.

  • Management Review Meetings – minutes (5.6.1)
  • Training records (6.2.2)
  • Product realization – evidence that requirements are fulfilled (7.1)
  • Sales activities where the customer requirements are reviewed, including enquiry & quotation, order receipt, order processing, order changes.(7.2.2)
  • Design and development – inputs, reviews, verification, validation, changes (7.3)
  • Supplier Evaluations (7.4.1)
  • re-validation of Special Processes (7.5.2) (processes where parameters are controlled e.g. temperature, rather than controlling the product)
  • Unique product ID records – (e.g. serial / batch number) if traceability is required (7.5.3)
  • Customer property – lost, damages or unsuitable for use (7.5.4)
  • Calibrations (7.6)
  • Internal Audits – findings and actions (8.2.2)
  • Product checks – throughout process and for final release, including ‘who’ (8.2.4)
  • Non-conformances (8.3)
  • Corrective actions (8.5.2)
  • Preventive actions (8.5.3)

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