ISO 13485 audit checklist about general of measurement, analysis and improvement
ISO 13485 audit checklist about general of measurement, analysis and improvement
Clause 8.1
1. How do you plan and implement measurement, analysis and improvement processes needed
a) to demonstrate conformity of the product?
b) to ensure conformity of the quality management system?
c) to (continually improve) maintain the effectiveness of the quality management system?
2. How do you determine what monitoring measurement, and analysis methods to use, including statistical techniques?
3. How do you determine the extent of their use?
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