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!
In previous weeks, we’ve worked through clauses about identifying the organization and its context, customers and interested parties, the key processes needed to create a product or service which meets the organization’s (and its interested parties’ needs), and the objectives of each of those processes to ensure the quality management system is maintained effectively.
Now that all that planning has been completed and the organization has created methods for consistently communicating, monitoring and reporting on the objectives, there must be a plan to provide the resources needed to achieve the objectives. Specifically, the standard states “the organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system”. And it goes on to give guidance on what shall be considered:
a) the capabilities of, and constraints on, existing internal resources
b) what needs to be obtained from external providers
This section uses an economy of words to say quite a bit about a critical planning activity that is sometimes overlooked. A lack of planning can result in unplanned problems and an inability to respond to changing market conditions. An organization must understand its capabilities and constraints, and what it must rely on outside providers for, to avoid gaps in its capabilities.
Beginning with the capabilities and constraints of its existing internal resources, it is important to recognize that this will come up again later in this section as the standard does a nice job of rolling out this section just a little at a time. This first subclause makes one think of the equipment, time, money, physical capabilities (in the aggregate) of the organization. And each subclause after will give more specifics to exactly what should be considered. This presents an opportunity for those utilizing lean and Six Sigma to introduce the use of those tools into the quality management system to ensure the system, process and its tools are clearly defined.
For those of you who thought the QMS and a Continuous Improvement program are separate, independent activities, you might want to take a moment and think about the possibility of integrating them. Whatever works best for your organization is of course, your organization’s prerogative. But for companies simultaneously maintaining certification to ISO9001 and attempting to improve their processes through a separate initiative of lean and Six Sigma, this is a good opportunity to join forces and create a robust QMS with a great arsenal of tools to achieve your objectives and continually challenge them. A robust quality system captures and anchors "best practices" as standards. And lean and Six Sigma continually improve those standards through analysis to constantly rachet up better outcomes.
But even after the organization has determined its capabilities, it must also deal with any gaps in those capabilities by soliciting help from outside. This subclause, too, comes up again in more detail later. As the planning is done and external support is needed, there must be controls in the quality management system to ensure the outside processes are closely monitored.
THIS WEEK’S HOMEWORK
Take a look at your quality management system as it stands today. Have you truly adopted a process approach? (ie. are all your necessary processes clearly identified?). Have you created a quality plan identifying the objectives of each of the processes and a plan to achieve them? Use this to identify the resources needed to support each of the processes and their objectives. And identify where you will need help from the outside. Put a plan together to manage those resources as well.
As you complete this exercise, be sure to share your discoveries. Having done this activity, did you identify any hidden resource needs?
This weekly series is a DIY guide including lots of FREE STUFF like templates, examples and tutorials. 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 or VIRTUAL for IMPLEMENTATION of ANY or ALL of the 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!
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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