ISO 9001 Cl. 8.3 - Design and Development of Products and Services not applicable

Y

yamahaman1344

#1
Hello, this is my first post but a long time viewer of Elsmar. I have a question regarding whether section 8.3 is applicable to us in the following scenario. We are a contract manufacturer of electronic assemblies, customers provide the design, and we manufacturer the assembly. While maybe this seems rather cut and dry, here's where I'm hung up. I continue to see the debate while do not design products, you do design your process. While I can see benefits to these sections for process design, I'm curious as what and auditor would require in our case in our case? Can we say 8.3 in not applicable? Thanks guys, I'm curious to see what everyone's thoughts are on this.
 
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Eredhel

Quality Manager
#2
I would venture to guess most shops make their own processes for things they make, whether their own design or their customer's. If I understand you correctly you can claim the design and development section is not applicable to your organization. We make product to customer requirements, specifications, standards, and blueprints and we have always claimed exemption. And we use some very particular processes we create.
 

AMIT BALLAL

Trusted Information Resource
#3
Hello, this is my first post but a long time viewer of Elsmar. I have a question regarding whether section 8.3 is applicable to us in the following scenario. We are a contract manufacturer of electronic assemblies, customers provide the design, and we manufacturer the assembly. While maybe this seems rather cut and dry, here's where I'm hung up. I continue to see the debate while do not design products, you do design your process. While I can see benefits to these sections for process design, I'm curious as what and auditor would require in our case in our case? Can we say 8.3 in not applicable? Thanks guys, I'm curious to see what everyone's thoughts are on this.
8.3 clause which is for product design is not applicable you. What you do is called process design and there are no requirements specified in ISO9001 standard specific to process design. But, you can define your own requirements, through procedures, work instructions and follow same.



Thanks,
Amit
 
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