ISO 13485 audit checklist about analysis of data
ISO 13485 audit checklist about analysis of data
Clause 8.4
1. What data is collected and analyzed to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of its effectiveness can be made?
2. Can you show me documented procedures that describe this activity?
3. What information does this analysis provide relating to:
• (customer satisfaction) feedback? (5.6)
• conformity to product requirements? (See 5.6)
• characteristics and trends of processes and products? (See 5.6)
• suppliers? (See 7.4.1)
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