Quality - SOP - Record Control

Quality - SOP - Record Control

$350.00 AUD

The process outlined in this document will ensure that your company complies with the relevant clauses of ISO 13485 (4.2.4/5), 21 CFR (820.40/180/186), and EU MDR/IVDR.

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Purpose of Document

The purpose of this procedure is to provide a uniform and consistent method for the identification, collection, indexing, access, filing, storage, maintenance, and eventual disposition of records generated by the quality management system of Company. These requirements ensure that Company is compliant with ISO 13485 (4.2.4/5), 21 CFR (820.40/180/186) and EU MDR/IVDR for record control.

Scope of Document/s

This procedure applies to the records generated by Company’s quality management system to show that its activities are completed in accordance with the relevant policies and procedures. It describes how to generate compliant records, the types of records maintained, where they are stored, and the responsibilities assigned thereof.

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