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ISO 13485 Standard:2016 –  4.2.5 Control of records

ISO 13485 Standard:2016 – 4.2.5 Control of records

Itay Abuhav June 10, 2018 0

Directly related to document control, I will now discuss record control requirements. The ISO 13485 Standard requires a definition of what records are included in the quality management system and how they are controlled.

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