Change Control Log Template - ISO 13485

ISO 13485 2016 +A11 2021

QMS.4.2.4.1 - QR - Change Control Log 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. For updates on Regulatory and Quality Assurance news visit Patient Guards blogs.

What is a Change Control Log?

• This document is a Quality Record (QR) used for identifying documents that have been changed or updated.
• The change control log template provides a method of logging any changes made to documents within the Quality Management System (QMS).
• The change control log is a summary of all change control history recorded on individual procedures, forms, templates, and records.

How does a change control log help me?

• Provides an immediate overview of changes made to controlled documents, as well as the reason for the change.
• Identify documents that are changing frequently or haven’t been changed in some time and use this information when selecting documents for review.
• Allow auditors to easily review change history of documents to demonstrate compliance and good practice.
• This template is in line with the requirements needed to demonstrate document control as per ISO 13485.
• If you are carrying out measurement and analysis on your system this log may come in useful for summarising data on areas such as archiving activities.

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.