Quality - SOP - Document and Data Control

Quality - SOP - Document and Data Control

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

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Purpose of Document

The purpose of this procedure is to:

  • Define how documents and data are controlled, including assigning responsibilities for the establishment, review, approval, release, distribution, and revision of controlled documents
  • Explain how the document management system works, and
  • Create a system of unique identifiers for documents and to differentiate between different revisions of a document.

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

Scope of Document/s

This procedure applies to the establishment, review, approval, release, distribution, and revision of all controlled quality management system documentation.

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