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Quality Management Planning Procedure - ISO 13485

Quality Management Planning Procedure - ISO 13485

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ISO 13485 2016 + A11 2021 

QMS.5.4.2 – QP – QMS Planning Procedure

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.

Why do I need to plan my Quality Management System (QMS)?

  • Planning helps ensure that the quality management system is implemented properly, objectives are met, and the system is effective.
  • Quality planning also helps ensure compliance with relevant regulatory requirements, standards, Quality Objectives, and the QMS in all stages of development, production, and marketing of products.
  • The QMS Planning Procedure Template will help you to identify the planning needs to successfully employ and oversee the QMS and comply with ISO 13485 requirements.

How should I set about planning my organisation’s QMS?

  • Quality system processes are planned to ensure that the system is appropriate for its intended purpose, and that it is effective and efficient.
  • Quality Plans must be supported by the Top Management team and must be understood by all personnel involved.
  • Appoint a Management Representative within your organisation who will be responsible for maintaining this procedure in a current state and for ensuring that accurate records are maintained.

What should be the Purpose of the QMS Plan?

  • The purpose of the QMS Planning Procedure is to identify the planning requirements needed to effectively implement and manage the QMS.
  • The purposes of the quality management system include:
    • Achieving the Quality Policy
    • Ensuring high level of customer satisfaction.
    • Complying with applicable regulatory requirements

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 qmsregs@patientguard.com.

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