Master Document List - ISO 13485

ISO 13485 - Q.M.S.4.2.4.2 – Master Document List

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.

How will a Master Document List help me/my organisation?

• Will provide you with an Instant overview of information relating to QMS documents;
  • Important information such as document title, revision number and issue date can be reviewed at ease
  • Easily check if documents are due for revision
• Demonstrates good QMS practice
  • All staff can review the list to ensure they are using the correct/most up-to-date version of any document related to the QMS
  • Essential during Internal/external audits for auditors to easily navigate and sample documents

Does maintaining a Master Document List mean I have to list every single worksheet or note my organisation uses or produces?

• Only QMS procedures, forms, templates, and records MUST be listed, as well as external standards and regulations used for compliance.
• The list may be used to keep track of work instructions/standard operating procedures and other company documents too. This is not required but may aid in demonstrating best practice.

Who is responsible for the Master Document List?

• You/your organisation will appoint an employee as the Management Representative, who will have responsibility for maintaining the Master Document List.
• The Management Representative may appoint a delegate to manage such documentation.

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 qmsregs@patientguard.com.

Quality Management Support:

If you are looking for support with your QMS then Patient Guards consultancy services could be a cost effective solution for your organisation.