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Records required by ISO 9001
ISO 9001 requires records to be kept on certain activities.
This is part of proving that you ‘do what you say’. These records are also important for making fact-based decisions on issues in your company.
Here are the activities for which records must be kept:
- Management Review Meetings – minutes (5.6.1)
- 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)
- Internal Audits – findings and actions (8.2.2)
- Product checks – throughout process and for final release, including ‘who’ (8.2.4)
- Corrective actions (8.5.2)
- Preventive actions (8.5.3)
A detailed list is available from iso.org in Annex B of this page.