Documentation used to satisfy ISO 9001:2008 Clause 7.3

What documentation does your firm currently use to satisfy the requirements of 7.3? I have been charged with the responsibility of implementing an ISO compliant system and then seeking certification and I need help wrapping my mind around 7.3. Any help is greatly appreciated and thank you in advance.

Re: ISO 9001:2008, 7.3 questions

What do you produce? What are your design responsibilities in production of your product? A lot of "what you need" depends on "what you do".

Re: ISO 9001:2008, 7.3 questions

We build downhole oil field equipment. Most of the time the customer gives us generalized requirements and we design our products to meet the requirements. Sometimes, we sell things off the shelf that we have marketed and sold all over the world - These items are standard products.

Re: ISO 9001:2008, 7.3 questions

Here are some typical records:

- Design project plan (e.g., timing, responsibilities)
- Design requirements (input to the design process; information on what is being designed, what functional/reliability, etc. requirements it must meet, ...)
- Product requirements (output from the design process; information on what the product should like like when manufactured; dimensions, materials, testing requirements, ...)
- Design review meeting minutes/decisions
- Design verification records (e.g., results of computer simulation/modeling or other means of verifying that the design is headed in the right direction)
- Design validation records (results of testing done to prove the product can perform as defined in the requirements document
- Design review records (decisions made about modifying the design, rationale for them)

dbuckeye said:

What documentation does your firm currently use to satisfy the requirements of 7.3? I have been charged with the responsibility of implementing an ISO compliant system and then seeking certification and I need help wrapping my mind around 7.3. Any help is greatly appreciated and thank you in advance.

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What is your question??
I can say that it is a requirement for product dsign and development ...do you have a process in place for this?
You should ensure the the phase of review, verification and validation are implmented and records are available.

Re: ISO 9001:2008, 7.3 questions

dbuckeye said:

We build downhole oil field equipment. Most of the time the customer gives us generalized requirements and we design our products to meet the requirements. Sometimes, we sell things off the shelf that we have marketed and sold all over the world - These items are standard products.

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7.3 probably does not apply to items designed by other that you sell. However, as part of 7.4 you would need to ensure that those items will perform as you advertise. You are responsible to your customers.

Re: ISO 9001:2008, 7.3 questions

We have a sole provider of stamped components and they are ISO 9001:2008 certified. We take these components and put them together to form assemblies that fit the requirements of our customers specifications. Oftentimes, our customers do not know what to order, they simply know their specific need and we design a solution - with the mix and match components - that fit the needs of the customer. To me, that falls within the parameters of clause 7.3. However, I have a question regarding clause 7.3.4. Currently, we provide the drafting department with the set of customer specifications and a drawing is generated that compiles the necessary components into an assembly. Naturally, the assembly is tested to verify correct function and the results are documented and maintained. Can we satisfy the requirements for 7.3.4 by standardizing a form that documents the discussion between sales and drafting? Do we satisfy the demands of 7.3.5 by recording the results of the function testing of the assemblies, in-process inspections, and final documented inspections? Thanks for taking the time to read my question and I appreciate your feedback.