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Quality Policy Template - ISO 13485

Quality Policy Template - ISO 13485

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ISO 13485 2016 +A11 2021 

QMS.5.3.0 – Quality Policy 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.

What is a Quality Policy?

  • A Quality Policy is a document within the Quality Management System (QMS) that should state your organisation's:
    • Purpose and strategic direction
    • Framework for Quality Objectives
    • Commitment to any applicable statutory and regulatory requirements
  • The Quality Policy Template will aid top management in developing this policy to express these directives.

How does the Quality Policy fit into the QMS?

  • The Quality Policy forms part of your evidence demonstrating your compliance with clause 5 of ISO 13485, along with other documents such as:
    • The Management Responsibilities Procedure
    • The Quality Objectives
    • The Management Review Meeting Procedure
  • The Quality Policy template aids top management in ensuring the Quality Policy is applicable to the organisation, supports the objectives and the scope of the QMS.

How will having a Quality Policy help me/my organisation?

  • The Quality Policy serves a pivotal role within your organisation’s QMS, and contributes to business’s commitment to quality.
  • It states the prime purpose of your QMS, providing overall direction for quality related decision and actions your team make within its scope.
  • The Quality Policy should act as primary motivator for continuous improvement within your QMS and organisation.
  • The Quality Policy should be approved by Top Management and accessible to everyone within the organisation. It can also be shared to any interested third parties or displayed on your company’s website to demonstrate your investment in quality.

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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