ISO has issued guidelines for those changing from ISO 9001:2000 to ISO 9001:2008. Whilst there are no major differences between the two standards, the new guide is worth reading. Here are the key points in the document.
ISO 9001:2008 Documentation Requirements. You must have these documents as a minimum.
- A quality Policy
- Quality Objectives
- Quality Manual
- Document Control Procedure
- Record Control Procedure
- Corrective Action Procedure
- Preventive Action Procedure
- Internal Audit Procedure
- Control of non conforming products
The organization must then decide what other documents it needs to demonstrate conformity to the requirements of ISO 9001:2008
ISO 9001:2008 also requires records that show that the organization is indeed achieving what it set out to achieve.
- Management reviews
- Education, training, skills and experience
- Evidence that the realization processes and resulting product fulfil requirements
- Results of supplier evaluations and any necessary actions arising from the evaluations
- The unique identification of the product, where traceability is a requirement
- Customer property that is lost, damaged or otherwise found to be unsuitable for use
- Results of calibration and verification of measuring equipment
- Internal audit results and follow-up actions
- Indication of the person(s) authorizing release of product.
- Nature of the product non-conformities
- Results of corrective action
- Results of preventive action
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