Issue 91 – Is this activity “In or Out?” of ISO 9001
ISO 9001:2015…
Is this activity “In or Out?” of ISO 9001
I appreciate receiving emails with questions and/or comments from readers of this Newsletter… please continue to do so since it provides me with direction on where to aim the content of these publications. In my last Newsletter (ISO 9001:2015 Newsletter Issue 90) we discussed the topic of “Does every QMS document need to be controlled?”, and now in this Newsletter we will discuss “Is this activity ‘In or Out?’ of ISO 9001“.
The ISO 9001:2015 Element numbering…
Element 4 – Context of the organization
Element 5 – Leadership
Element 6 – Planning
Element 7 – Support
Element 8 – Operation
Element 9 – Performance evaluation
Element 10 – Improvement
Is this activity “In or Out?” of ISO 9001… Let me begin by saying that this question goes along with the topic from the previous Newsletter (Does every QMS document need to be controlled?)… and both of these questions seem to be the most popular inquiries I get as an Auditor. My response is typically: a) Does this activity affect the customer directly? (most people will think “product” here but this question also allows for other situations covered by the “…and services” part of ISO 9001… for example, an activity in the Delivery/Shipping area, such as how we email the Customer with shipping information); b) Is this activity used for product (or service) release?; for generating the Certificate of Analysis (COA)?; for releasing Shipping/Delivery/Order Status information?; etc… Other questions I might ask would be: i) Is it important that we document how this activity is done so that we can reduce variation and maintain consistency of the output from this process?; ii) Is it important to keep a record of this activity so that you can go back in time to investigate what happened?
Another approach to answering the above question… If you want to look at this from another perspective then perhaps you can ask: “Is this activity important to how you run your business?”… and if the answer is: “Well… yes it is”, then if it’s important to how you run your business, and your Customers are the only reason you are in business, then doesn’t it mean “It’s IN the scope of ISO 9001″? The only caveat is that your Safety Dept is also needed to run your business, and the Environmental Dept is also needed to run your business… however I would place them outside the scope of ISO 9001 since they are not directly “Quality” related. I subscribe to the big “Q” approach to Quality, which means that almost every activity an organization performs only exists because of the Customer. So if you carry on with this line of thinking and you agree that you need to perform this activity for running the business, you then have to also ask: 1) Does this activity affect the Fit/Form/Function of the “product” we ship to our Customers? 2) Does this activity affect the Fit/Form/Function of the “service” we provide to our Customers? Which brings you back to basically the first set of questions I asked at the beginning. I know I may make it sound simple, and I realize it definitely is not… but my approach is “It’s in” until you justify why “It’s out”.
Be sure to watch for our next Newsletter issue where I will be answering some of the questions that I get from Readers of my Newsletters about how to implement the requirements of ISO 9001:2015 in a specific and practical way, that will also help improve business performance…
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Until next time…
Tim Renaud
Helping Business Professionals Reduce Risk and Remove Waste!