Record Retention Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 aligned Record Retention Procedure provides guidelines for the retention of all confidential, electronic, quality and archived records and supportive documentation per applicable standards and regulations.

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Supplied as one editable Microsoft Word document in a digital download.

Quality-record storage, retention and retrieval

The procedure gives departments a method for identifying, protecting and retrieving active quality records. For archived material it covers boxing, numbering and dating cartons, logging their contents, using on-site or off-site storage, and recording retrieval and authorized destruction. A retention schedule identifies the period for each class of record, while audit checks verify control of the archive. The result is an implementable path from record creation to eventual disposition.

Standards and frameworks addressed: ISO 13485:2016; FDA QMSR.

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.

Use this retention schedule with the Document Control Procedure for approved document versions and the separately sold Good Documentation Practices Procedure for how personnel make and correct entries. Record retention and document control are included in the Document Control Procedure Bundle.

Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.

Practical guide

Read Medical Device Document Control: From Approval to Record Retention for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

This document is also included in ISO 13485 Document Control Procedure Bundle. Explore the bundle for the related documents.