Documented information mandatory in 9001:2015

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DOCUMENTED INFORMATION AS REQUIRED BY ISO 9001:2015 While the New standard does not explicitly mentions the need for a procedure or a record -However you can still trace some of the requirements for Procedures and Records as identified in ISO 9001:2015. One should be careful though that this is not the FULL and EXHAUSTIVE list of documented information but may be considered as the bare minimum Clause of ISO 9001:2015 4.3, 4.4.2, 5.2.2, 6.2.1 7.1.5.1 7.1.5.2 7.1.6 7.2 7.5, 7.5.1, 8.1, 8.2.4 7.5.3, 7.5.3.1, 7.5.3.2, 8.5.6 8.2.3.2 8.3.2, 8.3.3, 8.3.4, 8.3.5, 8.3.6 8.5.1, 8.5.2, 8.5.3 8.6 8.7.2 9.1.1 9.2.2 9.3.3 10.2.2

Procedure or records( DOCUMENTED INFORMATION ) Part of Quality Manual and Annexure Records of In process and final Quality check List of Monitoring and measuring instruments Work Instructions Competency criteria and records of evidence of meeting the criteria List of documents and records with retention time Procedure for Document control , with special attention to External origin documents List of documents and records with retention time Procedure for Design and Development with associated records Procedure for Identification and Traceability List of documents and records with revision and issue details Non conformity and action taken reports Monitoring MAP ( what needs to be monitored and when and how ) Internal Audit program and Records Management review records Records for Non conformities and Corrective action

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