ISO 9001 clause that covers Production Line Re-Validation

[thebestroe]

I stand corrected. We are 9001:2008. Do you know of any conflicts that would arise referencing ISO 9013:2002 in our work instructions to validate our HI def plasma processes. Specifically it would be the deviation and angle chart for themal cut parts.

[Sidney Vianna]

In Reply to Parent Post by thebestroe

Do you know of any conflicts that would arise referencing ISO 9013:2002 in our work instructions to validate our HI def plasma processes.

ISO 9001 is a (quality) management system standard and does not conflict with any product or process related standards.

[Big Jim]

In Reply to Parent Post by Mikishots

AS9100C clearly identifies this requirement under clause 7.5.1.1 (usually referred to as first article inspection) Unfortunately, this is not detailed under ISO9001-2008 (one of the improvements that the ISO group can make for the next revision).

You would need to refer to Clause 8.2.4, which requires the organization to monitor and measure the characteristics of the parts coming off that line to make sure that the product requirements are still being met. The resulting records are to show proof that the part is still what the customer requires, and that you have a record of who signed-off saying that everything was good to go for a production run.

To ask if it's "required" is really a moot point, in my opinion - it would be a massive and unnecessary risk to NOT revalidate that moved line prior to resuming production. I couldn't imagine any organization that would entertain an idea like that (but maybe I'm just naive).

Loosely speaking the requirements in 7.5.1 (Control of Production) and 8.2.4 (Monitoring and Measurement of Product) are the closest topics in ISO 9001:2008, but there is nothing to keep you from requiring additional things to ensure that you are getting what you want. That would fall under 7.4.2 (Purchasing Information). There is nothing to keep you from requiring either PPAP or First Article just because they are only ISO 9001:2008. Don't expect such extras to be free though.