Document Control Procedure | ISO 13485 | FDA QSR Compliant
$149.00
$149.00
per item
ISO 13485 Document Control ProcedureThe Document Control Procedure governs the process for editing, issuance, tracking, obsoleting, archiving and modification for all controlled documents within the organization.
Document Control Procedure OverviewThe Document Control Procedure governs all aspects of documentation management needed to address GMP and ISO 13485:2016 requirements for controlled documents. The procedure defines departmental responsibilities and the process of creating and maintaining documents through the Engineering Change Notices (ECN) process.
The Document Control Procedure addresses specification number assignment, provides instruction on issuance, storage of electronic and CAD files, obsoleting and archiving files, and much more. Document Control Procedure ComplianceThe Document Control Procedure is both FDA QSR and ISO 13485:2016 compliant.
To learn more about our ISO 13485 Document Control Procedure please contact us at [email protected]
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