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Product Identification & Traceability Template - ISO 9001

Product Identification & Traceability Template - ISO 9001

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ISO 9001:2015 - QMS.8.5.2 - QP - Product Identification & Traceability

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 are the requirements of ISO 9001 relating to Product Identification & Traceability?

  • The standard requires that your organisation documents procedures for identification of outputs and that you identify your product by suitable means throughout the product realisation process when this is a requirement.
  • Your organisation must also document procedures for traceability, defining the extent of traceability in accordance with applicable regulatory requirements.

How will the template help me meet the requirements of the standard?

  • The template will help your organisation create a procedure for establishing and maintaining product identification and traceability controls throughout product realisation (i.e., receiving inspection, handling, production, storage, product returns etc).
  • The template covers:
    • a process for received materials,
    • manufacturing activities,
    • Batch History,
    • Ensuring the finished product is traceable to customer and to the Batch History Records,
    • Contract Manufacturers requirements where applicable.

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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