This is a 52 week discussion of ISO9001:2015. We challenge you to follow us each week, and review your QMS from top to bottom with us as we discuss a specific clause of the ISO9001:2015 standard in detail and look for ways to trim the fat from our quality management systems. By year end 2021, you can have your QMS revitalized! (As an added bonus, I’m now a member of TAG/TC176, the committee responsible for review and revision of ISO9001, which is in discussions for a possible revision in 2023. I’ll keep you posted on what I learn!)
(It is strongly recommended that you purchase a copy of the ISO9001:2015 Revision for reference). And, be sure to do your homework!
4.2 Understanding the needs and expectations of interested parties
Welcome to Week 5 of our discussion. This “clause 4” stuff is really exciting to me.
As discussed last week, this particular section is where some of the most valuable content of the standard comes from. And yet, it really doesn’t get that much attention or consideration. All organizations should take a moment of self-evaluation to really think long and hard about who we are and why we’re developing a quality (or business) management system in the first place.
I like the language a lot. In 4.2, the organization must ask itself who has the potential to impact their ability to “consistently provide products and services that meet customer and applicable statutory and regulatory requirements”. This is critical to know in order to make an effective strategic plan.
Does your QMS (quality management system) include this critical area? Have you identified your interested parties? Who has the ability to impact your ability to meet your customers’ expectations? Your suppliers? Your landlord or property manager? The local/state/federal government? How about your neighbors? For example, if you are a manufacturer located in an industrial park, do you share parking space or traffic patterns? Could these logistics challenges impact your ability to service your customer? Are there interested parties you must collaborate with in order to run your business effectively? Do you know all of these requirements? How do you monitor them?
Understanding who the interested parties are, and what their requirements are, is a paramount consideration when developing a QMS. Next week, we’ll pair this information with the processes needed to fulfill the product or service requirements of those interested parties, and that will form the “scope” of the QMS.
LAST WEEK’S HOMEWORK
Did you identify your organization’s purpose and strategic direction? Did you also begin to list your external and internal issues? There was a free SWOT analysis template. Are you using it? If so, you’re ready to take the next step in defining who you are- what you do – and how you do it. If not, click the form below to get yours today.
THIS WEEK’S HOMEWORK
Take a moment to identify the “interested parties” for your organization. In other words, who has the ability to impact your ability to meet your customers’ and applicable statutory and regulatory requirements”? After you’ve identified “who” may impact this, ask yourself “how” they may impact you. This becomes the infrastructure for next week’s identification of the scope of the entire QMS. Keep in mind while you’re doing this that you will want to create a way to review and monitor this over time and take measures to mitigate any undesirable risk or impact to your QMS. Get your creative juices flowing and then look for those internal and external “interested parties” and jot them down. You can even add it to your SWOT Analysis to keep your thoughts organized. Because next week, we’re going to consider the processes needed to satisfy the needs of these internal and external customers/parties.
THIS WEEK! Get help with this week's homework with a FREE PREVIEW of ISO9001 in Plain English! This 22 minute video is packed with tips and information on how to identify your context, external and internal issues and interested parties and their expectations.
AND AS AN ADDED BONUS, get a FREE DOWNLOAD of a simple SWOT Analysis Template to get you started. Click the form below.
Learn more about a great resource to accompany this series in this short video. Get 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.
DON'T MISS OUT! Get a FREE PREVIEW of ISO9001 in Plain English about this week's section 4.2 with a bonus preview of 4.3!
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.
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.
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