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Measurement and Analysis Procedure - ISO 13485

Measurement and Analysis Procedure - ISO 13485

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ISO 13485:2016 +A11 2021

QMS.8.4.0 - QP - Measurement and Analysis 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 can then be modified to suit your company branding/marketing requirements.

How will the Measurement and Analysis Procedure template help my organisation?

  • The Measurement and Analysis Procedure will aid your organisation in documenting the manner in which information on products and processes are gathered, analysed, and actions taken.
  • Your organisation will then use this data to decide what actions to take.
  • The measurement and analysis you will undertake is instrumental in maintaining the effectiveness of the QMS and monitoring of Quality Objectives.

What does ISO 13485 say about measurement and analysis?

  • The standard requires that your organisation detail a procedure that establishes the nature of the data that you will collect and analyse.
  • In analysing this data, your organisation should be able use the results to evaluate and demonstrate the suitability and effectiveness of your quality management system.
  • The procedure must include an explanation and justification of your chosen methods, including the statistical techniques used.

If you would like further information on our wide range of templates or have any suggestions for improvements 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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