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8 Measurement, Analysis & Improvement (ISO 13485:2016) (8.2…

- - - - Through the use of quality policy, quality objectives, audit results, post-market surveillance, analysis of data, corrective actions, preventive actions & management review
- - - - Maintain records of acceptance by concession & identity of person authorizing concession
    - - Taking action to preclude its original intended use or application
      - Authorizing its use, release or acceptance under concession
      - Taking action to eliminate the detected nonconformity
  - - - Maintain records of actions taken
    - - Procedures to be capable of being put into effect at any time
      - Maintain records of actions relating to issuing of advisory notices
  - - - A determination of the need for investigation
      - Notification of any external party responsible for the nonconformity
  - - - Procedures to undergo the same review & approval as original procedure