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Change control management in Advisera Toolkit

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Guest user Created:   May 17, 2019 Last commented:   May 17, 2019

Change control management in Advisera Toolkit

Our team is making progress on transforming your 13485 doc packet into our company QMS, but they have said "there is no mention of change control management". Can you tell me where this is in the packet?
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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Verlene Law May 17, 2019

Answer:

Change control management is incorporated into critical procedures in ISO 13485 such as control of documentation, control of design and development changes. You can refer to 06_Procedure_for_Risk_Management as well as 00_Procedure_for_Document_and_Record_Control.
For each procedure in the toolkit, there are details for the company to incorporate their own method of change control.
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May 17, 2019

May 17, 2019

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