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“Documented Information” in ISO 9001:2015

In the transition from ISO 9001:2008 to 9001:2015, some key definitions have shifted to Support the more holistic philosophy of the revision. In particular, references to “documentation,” the “Quality Manual,” “procedures,” and “records” have been replaced by the more nebulous “documented information.”

What does this mean? Should you get rid of your Quality Manual?

The short answer is no – you shouldn’t stop documenting your processes, and you shouldn’t toss your Quality Manual if it’s facilitating communication in your organization and helping you meet your quality goals! You should, however, feel as if the requirements can be adapted to your organization’s unique situation. The key question to ask, following clause 4.4, is: What information is necessary to support the operation of processes?

Rather than focusing on how the process itself is conducted, look at what information you need to determine whether the process outputs conform to their stated requirements. Additionally, … Read more...

The post “Documented Information” in ISO 9001:2015 appeared first on Environmental, Health, and Safety (EHS), and Quality Management Resources and News.



This post first appeared on Intelex Blog - Environmental, Health, And Safety M, please read the originial post: here

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“Documented Information” in ISO 9001:2015

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