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Clause 8.3. applicability

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Guest user Created:   May 20, 2020 Last commented:   May 20, 2020

Clause 8.3. applicability

Would ISO 9001 clause 8.3 'Design and development of products and services' be applicable to a scientific research lab, which has an R&D department to design Standard Operating Procedures for use in-house to produce scientific data?

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Carlos Pereira da Cruz May 20, 2020

Clause 8.3 is not about designing Standard Operating Procedures for use in-house.

https://www.screencast.com/users/ccruz5284/folders/Default/media/e7d2dce2-14f1-43fc-a3e3-4e957565327f

Clause 8.3 is about designing a new product or service. Clause 8.3 may be the main job in your scientific research lab.

Whenever there is a go decision for a new research your lab has to:

  • Set up a project team with resources, responsibilities and authorities. Set up a project plan - (this is about clause 8.3.2)
  • Collect inputs (state of the art data and information, legislation and regulation applicable) - (this is about clause 8.3.3)
  • Following the project plan there is reviewed, final verification and validation controls are - (this is about clause 8.3.4)
  • An output comes out of a successful project plan – a prototype, specifications to manufacture or provide or use, Standard Operating Procedures to manufacture or provide or use, … - (this is about clause 8.3.5)
  • Changes - (this is about clause 8.3.6)
     

So, it is very difficult to justify that clause 8.3 is not applicable to a scientific research lab implementing a quality management system according to ISO 9001:2015

The following material will provide you more information about design and development:

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May 20, 2020

May 20, 2020

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