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Quality Manual Template - ISO 13485

Quality Manual Template - ISO 13485

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QMS.4.2.2 - QM - Quality Manual 

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 we need a Quality Manual?

  • A quality manual provides you with an introduction to your company’s scope, applicable standards, and regulations you are showing conformance to, the structure of the QMS, a list of procedures, your organisational chart and a central index library for internal and external documents, records, and forms
  • The quality manual comes in useful for external and internal auditors to gain an overview and insight into your system
  • It can also be a good starting point for your Management Review Meetings to ensure your system/ scope is up to date
  • This template meets the above requirements and is compliant with EN ISO 13485:2016

What should be included in the Quality Manual?

  • The scope of the quality management system
  • Details and justifications for any exclusions or non-applicable clauses that don’t apply to your business scope
  • A table of documented procedures in place for the quality management system, or reference to the master document list
  • A description of the interaction between the processes of the quality management system
  • The quality manual should also outline the structure of the documentation used in the quality management system

Which clause within the ISO 13485 standard will this template help our company comply to?

  • The Quality Manual will assist you in compliance with clause 4.2.2 which states; your company should have a quality manual in place to include all the details outlined above.

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

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.

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