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What is ISO 13485 Process Clause Matrix about?

This document is an ISO 13485:2003 process/clause matrix that maps the requirements of the ISO 13485 quality management standard to various processes. It shows which processes each clause applies to, including management, production planning, purchasing, customer service, field service, and monitoring and measurement of quality assurance and research and development. The matrix covers all clauses and processes to demonstrate the integration of quality management system requirements.

Author

saiavi

Language

EN