Checklist of Mandatory Documentation Required by Iso 13485 2016
Checklist of Mandatory Documentation Required by Iso 13485 2016
Checklist of Mandatory Documentation Required by Iso 13485 2016
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FUSION CONSULTANT REGULATORY AFFAIRS
CHECKLIST FOR ISO 1485: 2016
Procedure for preventive actions 8.5.3
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FUSION CONSULTANT REGULATORY AFFAIRS
CHECKLIST FOR ISO 1485: 2016
Identity of personnel performing any inspection or testing of 8.2.6
Record of nonconformity
implantable 8.3.1
Records of the product acceptance by concession and the identity 8.3.2
Records
of the of actions relating to the issuance of advisory notices 8.3.3
Records of rework 8.3.4
Records of the results of data analyses 8.4
Records of corrective actions 8.5.2
Records of preventive actions 8.5.3
These are the documents and records that are required to be maintained for the ISO 13485
Quality Management System, but you should also maintain any other records that you
have identified as necessary to ensure your management system can function, be maintained,
and improve over time.
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