Analysis of data of ISO 13485
Analysis of data of ISO 13485
Clause 8.4
The organization shall establish documented procedures to determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate if improvement of the effectiveness of the quality management system can be made.
This shall include data generated as a result of monitoring and measurement and from other relevant sources.
The analysis of data shall provide information relating to
a) feedback (see 8.2.1),
b) conformity to product requirements (see 7.2.1),
c) characteristics and trends of processes and products including opportunities for preventive action, and
d) suppliers.
Records of the results of the analysis of data shall be maintained (see 4.2.4).
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