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Product Realisation Planning Template - ISO 9001

Product Realisation Planning Template - ISO 9001

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ISO 9001:2015 - QMS.8.2.2 - QP - Product Realisation Planning

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 Product Realisation Planning?

  • Product realisation is the collection of processes involved in a product's life cycle, all the way from conception to completion.
  • Product Realisation Planning is the process that defines controls such as:
    • the quality objectives and regulations
    • the necessary processes, documents and resources
    • the required checks and criteria for product acceptance
    • one or more processes for risk management
    • the records needed.

Why do I need to carry out Product Realisation Planning?

  • The requirements of the ISO 9001 standard stipulate that the organisation shall determine the above controls.
  • When your team has agreed-upon documentation and specifications to work from, analysing the work completed becomes much more effective.
  • Without a product realisation plan in place, establishing a model for the outcomes that produce your ideal product will be difficult.
  • With a product realisation plan in place your organisation can ensure that each step taken will be taken towards the attainment of your desired outcome.

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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