Do you need FMEA and PPAP in your ISO9001-2008 Quality System?

Do some of your company’s products find their way into the world of automobile manufacturing? Are your customers, or your customers’ customers, pressuring you to provide documentation related to the automotive standard ISO/TS16949, including PPAP and FMEA and other statistical requirements?

If you already have an ISO9001-2008 quality management system, don’t let anyone tell you that a Production Part Approval Process or Failure Mode and Effects Analysis are necessary as part of ISO9001. There are no requirements in ISO9001-2008 for these processes.

Although these are not ISO9001 requirements, you may have a customer-driven requirement that’s equally important to you. You are, of course, free to integrate these and any other processes, important to your organization, into your ISO9001-2008 quality management system.

Talk to your customer. If your company is a low enough tier to avoid having to fully implement ISO/TS16949, you may be able to satisfy your customer requirements by implementing certain portions of the TS standard.

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One Response to “Do you need FMEA and PPAP in your ISO9001-2008 Quality System?”

  1. Useful information.Am consultant in ISO CB, this information really benefit

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