I have a client that is seeking ISO 9K registration to meet pending customer requirements

Q: Can a product line that is only in its prototype phase receive certification? Would the emphasis then be on Planning, Design and Engineering activities associated with that product prototype?

Please respond directly ...

Thanks

I have a client that is seeking ISO 9K registration to meet pending customer requirements

Q: Can a product line that is only in its prototype phase receive certification? Would the emphasis then be on Planning, Design and Engineering activities associated with that product prototype?

Please respond directly to ........

Thanks

Welcome Dave,

The answer is Yes - provided you have the necessary procedures for design and development that incorporates necessary ISO 9001 requirements, practicing it and the necessary records for this stage (Clause 7.3) for audit purpose. If you fulfill these requirements, then design and development will be included in your scope of certification.

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I agree that the answer is yes.

I'm not sure you would have to treat the prototype line as a design and development project, though.

I think if you could demonstrate, through records, that you had determined the processes necessary for the prototype line, along with the resources necessary, monitoring, measurement, objectives, records and all those other things associated with process planning;
and,
if you could demonstrate, through records, that you were executing your plan;
and,
if you could demonstrate, through records, that you were checking the results;
then,
you would be able to show a PDCA cycle in operation and meet the requirements of the standard also.

Treating a new line/process as a design and development effort is TS 16949 thinking, but it's not the only way to skin this cat, IMO.

I don't think you should spend time writing a procedure to demonstrate that your work on the line meets the requirements of subclause 7.3.

Anyway, that's how I would handle it.

Is this a production line that is still being developed and producing only prototypes? Or is it a mature production line that produces prototypes? I think you are asking if a production line that is still under development and not producing finished product yet, can be included in the scope of an ISO 9001 cert.

Is this a production line that is still being developed and producing only prototypes? Or is it a mature production line that produces prototypes? I think you are asking if a production line that is still under development and not producing finished product yet, can be included in the scope of an ISO 9001 cert.


Good question.

I work for a design and development organization and we recently went through ISO 9001 certification and we included our new product development ( We development prototypes and then turn them over to a manufacturing partner) in our certification. My advice would be to ensure that all activities that are covered in 7.3 of ISO 9001:2000 are adhered to.

Best Regards,
al40