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Quality performing manufacturing

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Jantani1275, Apr 18, 2017.

  1. Jantani1275

    Jantani1275 New Member

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    It has been my understanding that according to regulations that for cGMPs that quality must operate completely independent of manufacturing. Where is this stated in the QSR?
     
  2. yodon

    yodon Member

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    To do so would be a bit too prescriptive for a regulatory body / standards organization to be defining an organizational structure. Both 13485 and 21 CFR 820 have statements requiring top management to ensure independence of individuals doing work that affect quality (emphasis added in both cases).

    21 CFR 820.20(b)(1): (1) Responsibility and authority. Each manufacturer shall establish the appropriate responsibility, authority, and interrelation of all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.

    13485:2003 5.5.1: Top management shall establish the interrelation of all personnel who manage, perform, and verify work affecting quality, and shall ensure the independence and authority necessary to perform these tasks. <-- Note: also the same in :2016

    So HOW the company establishes the independence is up to the company.
     
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