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SOP Document and Record Control

Use this SOP Document and Record Control template to establish standardized procedures for creating, reviewing, approving, labeling, and archiving quality management system documents and records throughout your medical device organization. This template is essential for ensuring regulatory compliance, document traceability, and secure retention, and should be filled out when implementing or updating document control processes, especially prior to audits or regulatory submissions. Proper use of this template helps you maintain up-to-date, accessible, and auditable documentation as required by ISO 13485, FDA 21 CFR Part 820, and EU MDR/IVDR.
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SOP Document and Record Control

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1. Purpose

This document provides the procedures for control of documents and control of records. This procedure describes the process for labeling, creation, drafting, review, approving, and archiving of documents and records.

2. Scope

This SOP is applicable to all documents and records created by the manufacturer.

Documents shall be:

  • reviewed and approved prior to issuance;
  • when updates are needed, reviewed, updated as necessary and re-approved;
  • identified with a current revision status;
  • changes to document are identified;
  • relevant versions of documents are available at points of use;
  • remain legible and readily identifiable;
  • when coming from an external origin, are properly identified and controlled;
  • prevented from deterioration or loss;
  • prevented from unintended use of obsolete documentation through suitable identification.

Records shall be:

  • maintained to provide evidence of conformity to requirements and effectiveness of the quality management system;
  • controlled through identification, storage, security and integrity, retrieval, retention time and disposition procedures;
  • have confidential health information protected in accordance to relevant regulatory requirements;
  • remain legible, identifiable, and retrievable;
  • have any changes identifiable;
  • retain records for at least the lifetime of the medical device or as specified by regulatory requirements but not less than two years from medical device release by the organization.

3. References

  • ISO 13485:2016 - Medical devices - Quality management systems - Requirements for regulatory purposes
  • Quality Manual
  • SOP Design Control

4. Document and Record Labeling

4.1 Naming Schema

Documents and records are named according to this schema:

FUNCTIONAL_GROUP-DOC_TYPE-NUMBER.REV-NAME

FUNCTIONAL_GROUP refers to the department or functional group to which the document or record belongs. Functional groups and their associated abbreviations to be used in the document or record name are found in the table below. FUNCTIONAL_GROUP should be written with two capital letters identified in the abbreviation column.

DOC_TYPE refers to the type of document and should be identified by three (3) capital letters from the abbreviation column in the table below.

NUMBER refers to the document number. This is a version 4 Universally Unique Identifier (UUID) that contains 32 hexadecimal characters (128 bits), divided into five groups separated by hyphens in this format: xxxxxxxx-xxxx-xxxx-xxxx-xxxxxxxxxxxx. You may also see this written as 8-4-4-4-12.

REV refers to the document revision number. This is a two (2) digit number that increases with each newly approved document with changes. All documents start at REV 01 and increase by one (1) with each new revision. The document number and rev are separated by a period.

FUNCTIONAL_GROUP-DOC_TYPE-xxxxxxxx-xxxx-xxxx-xxxx-xxxxxxxxxxxx.01-NAME

NAME refers to the name of the document. The NAME should be descriptive as to what the document or record is to provide context for its content.

An example of a Software specifications document created while using the above naming schema can be seen here:

SW-TCD-a3aaf6cb-d2bf-441c-9f53-c0783f371ec4.01-Software Specifications

4.2 Retention Periods

Quality management system (QMS) documents and records shall be stored for at least 10 years after their archival date.

Technical Documentation, DHF, DHR, and QMS documents shall be stored for at least 10 years after the lifecycle of the respective device has ended.

4.4 Review Periods

QMS documents are to be reviewed at least once every two years to ensure they remain up to date.

The quality manual must be reviewed at least once annually.

All other processes and associated documents can be reviewed every three years or as necessary once they have been reviewed before without any findings.

Review periods can be adjusted by the person responsible for quality management should findings from management review, audits, corrective and preventative actions, or other inputs deem it necessary.

A document tracking system will be maintained to record QMS document details, including version history, approval timestamps, and assigned custodians. This system ensures full traceability of document revisions and supports regulatory audits.

5. Process Steps

5.1 Document and Record Control

5.1.1 Management Inside the Electronic QMS

All documents are saved and maintained in the electronic QMS (eQMS). The eQMS manages the draft, approval, and archival of documents and records.

Documents will be drafted within the eQMS and sent for approvals using the eQMS approval pathway. Documents are only considered live once they have achieved the prescribed number of approvals and have been released into the eQMS. Revision histories should be updated for each new document revision, saved within the eQMS, and be readily available for review.

For a document that is considered live, once a new version of that document is released, the previous live version will be archived. Document status will be identified using "unapproved draft", "live", and "archived" tags within the software.

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