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This all in one Quality and Procedure Manual meets ISO 13485 - 2003 as well as ISO 9001-2008 Standard requirements and is specifically designed for the Medical Devices Engineering and Manufacturing Industries. The Hardcopy Manual contains the following: Policies and Objective addressing each...

This is a 24 page Internal Audit Checklist and Guide How to Audit; it addresses each ISO 13485-2003 and ISO 9001-2008 Standard requirement in form of 328 questions including a simple to use Rating System, enabling the user to measure and provide metrics in regard to quality management system...

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