Control of Documents

Control of Documents

[ISO 13485 Cl 4.2.4] 

Control of Document Process

Organizations implementing ISO 13485 or 21 CFR 820 must maintain a large number of critical documents. Control of documents must be established over all internal documents and those of external origin, covering their preparation, issuance, adequacy, approval, re-approval, revision, retrieval, availability, legibility, archival, storage, and destruction. The specific documents that require control can differ based on the risk class of the medical device produced. Common documents subject to ISO 13485 document control include:


  • Quality Policy, Manual, and Objectives
  • Quality Procedures, including validation procedures
  • Medical Device Files
  • Work Instructions / SOP
  • Forms and templates
  • Specifications, Quality Plans/Control plans
  • Drawings etc.

Document Review and Approval

Documents require review and approval from different individuals prior to their release into the Quality Management System. The process of reviewing and approving new documents is important for maintaining control over documentation.

Once incorporated into the QMS, any modifications to a released document require a review and approval process. Companies must follow change control procedures for the review and approval of documents as mentioned earlier. As per ISO 13485 (4.2.4), changes to documents must be reviewed and approved by the initial approving authority or another authorized person in consultation with a management representative.

Document Legibility

Documents should indicate their revision, which can be a letter, number, or a combination thereof, to easily identify the version in use. A revision history, typically found at the document’s end, summarizes the changes made in each new version.

The documents must be legible and identifiable, requiring clear formatting for readability with a title and identification number. Although not explicitly mandated by ISO 13485, assigning document numbers is a widely adopted practice to aid in document identification.

Safe Preservation of Documents

Organizations must establish a system to protect documents against loss or damage. Electronic systems require backup procedures, and paper-based systems need safeguards such as fireproof storage to prevent loss or damage.

Documents that are no longer in use should be marked as obsolete and removed from active use. For reference purposes, at least one copy of these obsolete documents should be preserved, with retention periods determined by the medical device’s lifespan and regulatory obligations.

The duration for retaining documents should be established according to the document control procedure and the applicable regulatory requirements. Electronic systems may preserve documents for an indefinite period, whereas paper-based systems must comply with regulatory standards and incorporate a safety margin in their retention timeline.

Important Forms / Templates

  1. Master List of Internal/External Documents
  2. Master List of SOP and Work Instruction
  3. Document Revision Request
  4. Document Approval Record
  5. Master List of Formats
  6. Document Issue Register
  7. Obsolete Document Register

Frequently Asked Questions

What are the contents of a Document Header portion?

The header of the document should contain the:

    • Logo
    • Company Name
    • Document code
    • Document Number
    • No/Issue date
    • Page number

What are the contents of the body of a procedure?

The body of the procedure  generally includes the following:

    • Purpose – The purpose describes the reason for implementing the QSP in 1 or 2 sentences.
    • Scope – Scope defines the applicability of the QSP & also specifies the department to which the QSP will be applicable.
    • Responsibility – Responsibility states the person directly responsible for the implementation & compliance of the QSP.
    • Procedure – Stepwise instructions for carrying out a particular process will be described. Short & precise instructions will be used in simple language.
    • Reference documents – List the references which have formed the basis for the procedure.
    • Templates – List the templates/formats associated with the QSP & required to document various activities of the quality management system.
    • Revision history – A revision history format is provided at the end of every QSP to record any changes made to a QSP.


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