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. 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. ISO 13485:2016 ”Medical devices – Quality management systems – Requirements for with “I” and a serial number enclosed in {} as for example {I-0001 End

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