General measurement, analysis and improvement of ISO 13485
General measurement, analysis and improvement of ISO 13485
Clause 8.1
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed
a) to demonstrate conformity of the product,
b) to ensure conformity of the quality management system, and
c) to maintain the effectiveness of the quality management system.
This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
NOTE National or regional regulations might require documented procedures for implementation and control of the application of statistical techniques.
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