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ISO 13485 (Clause 5.4) - Change Request and Planned Deviation Log ISO 9001 Record and regulatory requirements

ISO 13485 (Clause 5.4) - Change Request and Planned Deviation Log ISO 9001 Record and regulatory requirements

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Description

and regulatory requirements

providing evidence of compliance or justifications for non-applicable requirements

Track Non-Conformances: Record any non-conformances found and plan corrective actions

ISO 9001 states that when measurement traceability is required or deemed essential by the organization

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ISO 13485 (Clause 5.4) - Change Request and Planned Deviation Log ISO 9001 Record and regulatory requirements

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