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Document Control Procedure - ISO 13485

Document Control Procedure - ISO 13485

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ISO 13485 2016 + A11 2021

QMS.4.2.4 - QP - Document Control Procedure Template

Our Medical Device Quality Assurance and Regulatory Affairs document templates have been created by fully qualified and experienced professionals at Patient Guard, a Quality Assurance and Regulatory Affairs Service provider. The templates have been specially written to ensure that they meet the basic requirements needed for each clause/section of the standard or regulation the templates relate to. We have carefully curated the templates to ensure they are easy to follow and adapt to make them specifically modified to your business needs. All the templates are fully editable Microsoft word documents allowing you to have complete control over the templates which, then be modified to suit your company branding/marketing requirements.

What is a Document Control Procedure?

  • Defines the document generation and change control process (through which an individual or organisation ensures that changes to a product or system are introduced in a controlled and coordinated manner) for documents within a certain scope, including but not limited to;
    • The control of major changes within an organisation
    • Documents required for regulatory purposes/compliance
    • Documents of external origin required for QMS purposes
  • Determines the responsibility for each activity within the scope of Document Control.
  • Includes processes for the control of major changes within an organisation.

How will a Document Control Procedure benefit me/my organisation?

  • Review and retention of documents;
    • Ease of navigation when reviewing documents annually or during management review meetings
    • Increased organisation and standardisation throughout business documentation
  • Identification and control;
    • Identifying and locating documents in advance of and during external/internal audits
    • Setting controlled access to approved users
  • Prevention and deterioration or loss of documents;
    • Archived folders to reference previous versions of documents
    • Establishes effective backup systems to prevent catastrophic loss of documents

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at

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