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!
Last week’s discussion focused on creating, communicating and understanding the organization’s mission and commitment to quality. Your homework was to consider how well, in fact, everyone understands the quality policy. In other words, the quality policy is meant to communicate that quality is “everyone’s job”. Thankfully, the standard follows the quality policy clause immediately with the “organizational roles, responsibilities and authorities” clause. Because when something is “everyone’s job”, it often results in everyone assuming that “someone did it”, when in fact, no one really has.
There is a subtle, but impactful phrase at the beginning of this clause. It’s clear that the organization must assign authorities and responsibilities. And organizations (and people) love to have titles and ranking on org charts, so this is rarely missed. But, the more difficult part lies with the requirement that those responsibilities must also be “communicated and understood within the organization”. Everyone in the organization must understand who has responsibility to:
a) Ensure that the QMS meets the standard – one might assume that is a major function of the internal audit process, so it would be logical to assign responsibility for internal audits and their outputs to someone or a team of someones, which brings us to:
b) Ensure that the process are “delivering their intended outputs”. Once the organization’s context, processes and quality policy are created, responsibility must be assigned to ensure that the key processes are delivering on their intent. Woo hoo! One step closer to getting greater benefit from ISO9001 compliance = actual improved product/service!
c) Reporting performance and responding to the metrics of the QMS “especially for reporting to top management”. This does more to ensure real engagement and ownership of the QMS by top management. Someone must be identified to report, but also to respond appropriately to the data reported. And they must also watch out for improvement opportunities.
d) Ensuring the promotion of customer focus throughout the organization. Personally, I’d like to see this one moved to position “a)”, but I nitpick…
e) Ensuring the integrity of the QMS is maintained through changes and transition of the business. This is one of the most overlooked, and yet critical areas of maintaining an effective QMS. This item has been moved from “planning” to actually making it an assigned responsibility. But I still get the feeling it will continue to be buried. In my experience, CBs/auditors aren’t tough enough on this point. I’ve worked with many organizations who have seen real decline in their QMS as a result of changes to the business without consideration for the QMS. But, I’ve rarely worked with anyone who has actually received a nonconformance or finding on this point. Perhaps moving this to an assigned person will result in more interaction and exploration of this point and exactly how changes are managed, and more visibility and understanding of the importance it deserves.
The structure of this small clause has two big takeaways that have the potential to have a very positive impact and two major benefits:
Clause 5 Leadership and everything in it sets the table for an effective management system intended to operate a business and provide tools for achieving its performance goals.
THIS WEEK’S HOMEWORK
How does your organization assign these responsibilities? Is it a job description? An org chart? A responsibilities matrix? A combination of all of the above? Update your current system to meet the requirements, ensuring each of the items (a through e) is specifically assigned. But, as always, keep it simple. Consider whether there is a way to use the processes you identified in 4 Context of the Organization and perhaps assign responsibilities for each process? What other methods might you use to ensure that the people who are assigned responsibility and authority know they are responsible, and that everyone in the organization also understands who does what, how it is reported, by whom and to whom, and how actions are taken. And then finally, do a little sanity check. Ask around using the list above. (Perhaps even do a mini-audit?). Does everyone know who’s responsible? If not, be sure to fix that.
This series is a DIY guide including lots of FREE STUFF. So, SUBSCRIBE today and we’ll keep it coming to your inbox weekly.
But, if you’re ready for more - if you’re ready to TRANSFORM your organization, we can team up LIVE for 100% VIRTUAL IMPLEMENTATION of ISO9001 Clauses 1-6 (there are only 10 clauses total!). 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!
Here are some other VIRTUAL LIVE options, Connect with us today and we'll create an exciting and engaging experience for your team on:
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:
Each video is about 15 minutes and targets a specific element of ISO9001, (with over 6 hours of total content!). We translate all the gobbledegoop into Plain English you can understand and leverage the requirements to get maximum VALUE from your quality efforts.
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.
We look forward to taking this YEAR LONG journey with you. SUBSCRIBE today and the series will come to you weekly to get you off to a great start and your quality system reinvigorated.
And join me on my journey to always keep improving!
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