Control of Records Procedure - ISO 13485

ISO 13485 2016 + A11 2021

Q.M.S.4.2.5 – Control of Records Procedure

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.

Why do I need a Control of Records Procedure?

• Maintaining control of certain documents is important for demonstrating compliance with requirements within ISO 13485. 
• Without effective control of these records, you may struggle to show internal/ external auditors and competent authorities that you are preforming due diligence. 

What will controlling my organisation’s records require me to do?

• Records that are stored internally within the quality management system must be controlled correctly as these are used as evidence to prove conformity to ISO 13485
• All documents and records should be stored securely with a defined archive process, the retention period for record keeping should align with the lifetime of the medical device or as specified by applicable regulatory requirements
• Standard practice is to appoint a document owner and approver for all QMS procedures, forms, templates, and records
• All changes made within such documents shall be easily recognisable
• Controlled documents must be stored in a way in which they are easily identifiable, retrievable to approved members of the organisation and protected.
• This template aids users in setting up a procedure that meets these requirements along with others necessary for demonstrating compliance.

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.