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Design and development

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Guest user Created:   Jan 07, 2020 Last commented:   Jan 07, 2020

Design and development

I am currently working on design and development, for which I studied Standard clause 8.3, my question is what type of documents do I need to fulfill the requirements of clause 8.3 and can I have any such formats for Planning, input, controls, outputs, and changes?

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ISO 9001 DOCUMENTATION TOOLKIT

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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Carlos Pereira da Cruz Jan 07, 2020

what type of documents do I need to fulfil the requirements of clause 8.3

Answer:

Please check this article about the mandatory documents required by ISO 9001:2015 - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/ there you can check that only records are mandatory. However, I recommend that organizations develop a procedure about the good design and development practices that need to be followed and authorities and responsibilities.
 

can I have any such formats for Planning, input, controls, outputs and changes?"

Answer:

Yes, you can have a format for each topic, or for two or more topics simultaneously.
 

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://training.advisera.com/course/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 07, 2020

Jan 07, 2020