ISO9001:2015 52-Wk Challenge (Week 5)

This is a 52 week discussion of the proposed 2015 revision of ISO9001. We challenge you to follow us each week, and review your QMS from top to bottom with us. By year end 2015, you can have your QMS upgraded and ready for the 2015 revision!

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.  Sure, the 2008 revision made us stop and clearly identify any “exclusions” we wanted to take, but to what end?  For whose benefit?  Mostly, for the benefit of a third party to provide rules for compliance.  But in many cases, the organization itself could be shortchanged, because there isn’t traditionally a period 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 new 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?  As suggested in a comment in our discussion last week, perhaps Management Review (upcoming in Clause 9 Performance Evaluation) will be a good place.  Also, as we approach the new “Risk Based Thinking” language in the 2015 revision, these areas will be critical to know in order to effectively evaluate which may create the most significant opportunities for risk, and what we should do about 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?  If so, you’re ready to take the next step in defining who you are- what you do – and how you do it.

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.  Because next week, we’re going to consider the processes needed to satisfy the needs of these internal and external customers/parties.

Stay involved and engaged – SUBSCRIBE!