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Non-conformance Report Template - ISO 9001

Non-conformance Report Template - ISO 9001

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ISO 9001:2015 - QMS.10.2.1 - QR - Non-Conformance Report

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.

What is a Non-Conformance Report? Why do I need it in my Quality Management System (QMS)?

  • Non-Conformances are where something is happening within the Quality Management System that is either not in line with the organisations policies, procedures, work instructions etc. Non-conformances need to be raised to allow the monitoring of the Quality Management System. 
  • The Non-Conformance Report is a detailed report on what the non-conformance is and what part of the quality management system is affected, this is used to escalate or allow the correct people in the organisation to evaluate the non-conformity as part of risk management to see how the organisation is affected by the Non-conformity. The report details if an investigation is required and if the outcome of that investigation leads to a Corrective and Preventative Action being required. 

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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