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ISO 9001:2015 checklist

ISO 9001:2015 checklist

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ISO 9001:2015 - Checklist

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 the ISO 9001 checklist? Why do I need it in my Quality Management System (QMS)?

  • This is not a required part of the documentation for ISO 9001, however it is a very useful tool to allow you to check that you have the required evidence in place against the clauses of the standard, and able to monitor and see that you have all the necessary documents in place to show compliance. 

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

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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