Specification Format Procedure | ISO 13485 | FDA QMSR

The Specification Format Procedure gives teams a common structure for controlled specifications and work documents. It covers general headers, numbering and revision presentation, then specific formats for procedures, test methods, labeling, instructions for use and drawings.

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

Controlled specification structure and formatting

Document authors are given conventions for headers, document numbers, revision history and change references. The source addresses the format of operating and manufacturing procedures, inspection methods, forms, lists, labels, instructions for use and drawings. By making the identifiers and approval information consistent, it helps reviewers tell which version is effective and lets Document Control connect a revised document to its engineering-change record.

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.

Apply these formats within the Document Control Procedure for issuance and revision tracking and the Engineering Change Notice Procedure for approved changes. All three 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.