“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 In particular, references to “documentation,” the “Quality Manual,” “procedures,” and “records” have been replaced by the more nebulous “documented information.”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, you could explore new media or new formats to do it, including video, slide presentations, audio recordings and benchmarks.

Although this may be initially confusing, this will ultimately help organizations leverage two important things: 1) the value of tacit knowledge (information obtained through learning-by-doing and mentorship) and 2) new innovations in capturing process information, like Virtual Reality (VR) simulators and Augmented Reality (AR) training material.

Nicole Radziwill is the Quality Practice Lead at Intelex Tecnologies Inc. You can follow her on LinkedIn by clicking HERE.

Learn more about ISO 9001:2015 in Intelex’s free Insight Report, Starting Your Certification to ISO 9001:2015 – The Basics You Need to Know. Download your copy today.

 

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About Nicole Radziwill

Nicole Radziwill is a quality manager and data scientist with more than 20 years leadership experience in software, telecommunications, research infrastructure, and higher education. Prior to joining Intelex, she was an associate professor of data science and production systems at James Madison University, Assistant Director for End to End Operations at the National Radio Astronomy Observatory (NRAO), managed software product development for the Green Bank Observatory (GBO), and managed client engagements for Nortel Networks and Clarify (CRM). She is an ASQ-certified manager of operational excellence (CMQ/OE), an ASQ-certified Six Sigma Black Belt (CSSBB), and contributed to the development of ISO 26000—“Guidance on Social Responsibility.”

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