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

Clause 8.3 - Design and development interpretation and implementation

I need some more clarification in the clause 8.3 design & development of products & services . How to interpret this section and how can we decide the following clauses are implemented in the organization, which design development planning, D&D inputs, D&D controls, D&D verification, validation & D&D outputs.

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Carlos Pereira da Cruz Jan 20, 2020

Imagine design & development as a project.

You receive inputs explicitly mentioned by the client, you gather other inputs either regulated or implicit. You plan a D&D project with several activities. Between some of those activities you have D&D revisions to check if things go according to inputs. At the end you compare the output with the project inputs with a verification activity. If everything is OK you send a sample or the product to the customer to be tested in use, to validate D&D.

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/

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Jan 20, 2020

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