This is a 52 week discussion of ISO9001:2015. Each week, we discuss a specific clause of the ISO9001:2015 standard in detail and look for ways to trim the fat. (As a member of TAG/TC176, the committee responsible for review and revision of ISO9001, (possible revision in 2023), I’ll keep you posted on what I learn all year!)
(It is strongly recommended that you purchase a copy of ISO9001:2015 for reference). And, be sure to do your homework!
7.1.4 Environment
In Week 15, we hit quickly on “People as a resource”, due to the structure of ISO9001:2015, (and we discussed how weird the layout is in this section). In Week 16, the standard is a little more straightforward as we discuss “infrastructure”. Infrastructure is clarified to describe things like buildings, equipment, information systems, etc. And this makes our discussion much easier. (We still haven’t had the opportunity to really discuss people as a resource, because the standard doesn’t dive into the real “people” issues (like 7.1.6 Organizational knowledge, 7.2 Competence, 7.3 Awareness and 7.4 Communication) until later.
Here in Week 17, we come to a very interesting crossroads.
7.1.4 begins easily enough with “The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of its goods and services”. [Check – no problem].
However, the “NOTE” adds, not clarification in my opinion, but a perfectly fashioned rabbit hole when it says environment can include “physical, social, psychological, environmental and other factors (such as temperature, humidity, ergonomics, and cleanliness).” Temperature, humidity, ergonomics, and cleanliness? Ok. Most organizations are pretty successful with this. And it isn’t a common source of written nonconformances. But, I’ve participated in audits where the auditor has chosen to debate some of these areas and even has demanded that these parameters be identified on paper and monitored to ensure they are maintained. Either way, not an insurmountable task. I mean, that can pave a nice path toward lean with 5S for those companies interested in a variety of tools to improve processes and quality.
But, back up just a second to….whoa….social and psychological?! How does an auditor audit that? What does that audit checklist look like?
I’ve known auditors who would do the logical thing and simply address this area in an anecdotal way. S/he may interview a few folks and ask questions about training, communication, etc to assure compliance with the broader intent of the clause. But I also know other auditors who could exploit the language and (incorrectly) demand social and psychological surveys or who knows what as objective evidence in these areas. This could create real difficulty in an audit situation. With the often limited understanding of so much of the language between both the auditors and the “auditees”, dropping these words into the standard without more clarity wasn’t the best idea. Any standard which is written should also provide enough detail to clearly understand compliance v noncompliance for each of the requirements. In my opinion, this section falls far short of that. But, thankfully, we can always fall back on the notion that notes are just that. Just notes. Not requirements.
In the meantime, it is obviously critical that a suitable environment be maintained by an organization to achieve conformity of its products and services.
THIS WEEK’S HOMEWORK
Take a moment to think about this area of your quality management system. Does your current system address each of these areas? Are changes required to address each one? What changes will you make? What will your discussion be with your auditor when compliance to this clause comes along in your audit cycle? Is your top management engaged in creating and maintaining a suitable “social” and “psychological” environment? How so? Can your organization demonstrate this? How? (Remember, this doesn’t necessarily mean documentation, but how would you demonstrate this?)
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But, if you’re ready for more - if you’re ready to TRANSFORM your organization, we can team up LIVE or VIRTUAL for IMPLEMENTATION of ANY or ALL ISO9001 Clauses. We’ll lead your team and build a fully compliant foundation for your quality system so you and your team can understand the requirements and have the confidence to continue forward on your ISO9001 journey toward BETTER QUALITY. World Class Quality, ISO9001 certification, lower costs and higher yields are just the beginning of the benefits of a robust quality system. Connect with us today and LET'S GET STARTED!
And if you’re in the US in the state of Michigan, I’m offering a great summer SPECIAL with no travel reimbursement for projects completed between US Memorial Day and US Labor Day anywhere in the lower peninsula of Michigan!
And the options don't stop there.
Watch this 3-minute video about another great resource to accompany this series. Get the self-directed, on demand, online learning series ISO9001 in Plain English, today and you'll get:
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For a deeper dive into the process side of your quality system, get Tribal Knowledge - The Practical Use of ISO, Lean and Six Sigma Together, a simple guide to UNITE ISO9001, lean and Six Sigma to create a robust quality system with better results. Read what ASQ American Society for Quality – Quality Progress Magazine had to say about it.
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