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Design of processes - applicability

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Guest user Created:   Jan 22, 2019 Last commented:   Jan 22, 2019

Design of processes - applicability

"I followed your webinar and I appreciate your work, was excellent!
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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Carlos Pereira da Cruz Jan 22, 2019
I have one doubt about the exclusion of clause 8.3 Design and development.
In my opinion, nobody can exclude this clause because design and development mean not only design of the product but also the design of the process and the processes are particular for each organization and has to be completed by each organization!”

Answer:
Thank you for your kind words, glad you appreciated!
During the webinar, because time is short, I develop this figure:https://www.screencast.com/t/6oWcA7Qr
During offline training, I develop this one because I have more time: https://www.screencast.com/t/EtxdizG50Jv

The green company is a real case that I audited some years ago. They had no own brand, they did not design the products, but they were picked by customers because they were very good at developing finishing processes that made products stand out as different.

Back to your question, imagine that you buy a plastics injection machine, you receive a mold from the client , you buy the raw-materials and start to manufacture plastic parts for the client. There is no real process design or product design. Most of the time organizations truly do not design processes and auditors do not expect them to do it. So, in your shoes I would think openly: do this organization stands out for anything they do differently with their processes? If yes, clause 8.3 is applicable. If not, you can consider clause 8.3 not applicable and justify it.

The following material will provide you with more information about applicable clauses:
- ISO 9001 – What clauses can be excluded in ISO 9001:2015? - https://advisera.com/9001academy/blog/2015/07/07/what-clauses-can-be-excluded-in-iso-90012015/2015/
- free online training ISO 9001:2015 Foundations Course – https://training.advisera.com/course/iso-9001-foundations-course/
- book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
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Jan 22, 2019

Jan 22, 2019

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