13485 quality manual example

 

 

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A Medical Device Quality Manual is a Document required by ISO 13485 2016 · The purpose of the Quality Manual is to help you navigate your Quality A quality manual is not just a requirement in ISO 13485; it helps companies manage their QMS and describe all the important elements in one place. ISO 13485:2016 ”Medical devices – Quality management systems – Requirements for with “I” and a serial number enclosed in {} as for example {I-0001 End The quality manual outlines the policies, procedures and requirements of the Quality. Management System. your quality system, such as for example:.Quality Manual, Policy and Objectives. ISO 13485:2016 Section, Document Section. 4.1.1, 1. 4.1.2, 4.

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