Clause 8.3. applicability

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

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:

• The ISO 9001 Design Process Explained - https://advisera.com/9001academy/blog/2013/11/05/iso-9001-design-process-explained/
• Procedure for Design and Development - https://advisera.com/9001academy/documentation/procedure-design-development/
• Free online training ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
• Book – (where I use the process approach this way) - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/