Granted, customers may want to see the details of the actual “documented process,” which is fine. Hundreds of clients have embraced this approach and never has this been an issue with any registrar. Why not draw a picture of this on one or two pieces of paper? Why use paper? In my practice I do this all the time.
QUALITY MANUAL ISO 13485 ISO
This begs the question: should we not document our processes? For those of us that practice more that just ISO compliance, the answer is: of course we should. However, it only applies the word “documented” to procedures. We can all agree that the intent of ISO 9001 is to serve as a process management platform. Nor does it suggest that it should even be in text format.Īnother possible source of confusion and diverging opinions is the use of the terms “procedure” and “processes”. It does not even say that it should be a singe document.
QUALITY MANUAL ISO 13485 MANUAL
It must describe/show the interaction of the quality management system processesĪt no point does ISO 9001 stipulate how long the quality manual should be.It must define or reference the “documented procedures” that make up your quality management system, and.It must explain any excluded elements/clauses,.
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QUALITY MANUAL ISO 13485 PROFESSIONAL
Nevertheless, the use of a very small quality manual is still a hotly contested topic, even among my professional colleagues. I developed the Lean QMS ® Map (a 2-page graphical version of a quality manual) in 1999 and have registered countless companies to ISO 9001, TS 16949, TL 9000, AS9100, and ISO 13485 with it. It is hard to believe that so many years after the release of ISO 9001:2000 there are still a lot of “old school” perspectives and misconceptions about the role, form, and function of the “quality manual” (ISO 9001:2008 sub-clause 4.2.2).
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Occupational Health & Safety Management Systems (OHS).Case Study – ISO 9001 & TL 9000 Certification – RAD Data Communication.Case Study – ISO 9001, ISO 14001 & Lean – RoMan Manufacturing.Case Study – ISO 14001 & OHSAS 18001 Certification – Hologic.Case Study – ISO 14001 Certification – Johnson Matthey.Case Study – ISO 9001 Certification – Scripps Laboratories.
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