ISO 9001:2015 - Right method to address clause 6.1?

qualprod

Trusted Information Resource
#1
Hi guys
During last weeks I have talked with some colleagues in respect to 6.1 addressing.
Some say I see the context and interested parties and in both I identify R and O, then go to processes and top management, and that is all.
Others say In the planning of the QMS, I consider context and IP and as a whole picture , I identify R and O.
I ask you, what method do you follow?
The standard in 6.1 apparently could be interpreted to apply both methods.
Thanks for your responses.
Pd Finally maybe we could have same results but not sure.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Risk is "the effect of uncertainty" but we need some structure so it makes sense to start with (context) 4.1 and 4.2. Issues can be thought of as factors that can enable risk.

4.1 Issue: geopolitical uncertainty
4.2 Interested parties: suppliers, customers
6.1 Risk: single-source overseas supplier may not be able to provide a given critical raw material, resulting in missed shipments
6.1 Opportunity: a new potential supplier has opened in a different location
6.1.1 Risk: The new supplier may not be reliable or supply adequately.
6.1.2 Action: Run the new supplier through the qualification process to retain as contingency vendor.

These are not usually done in management review (MR), but an output of MR could be a decision to qualify the second supplier if the above items are presented as part of inputs.

Does this help?
 
Last edited:

Golfman25

Trusted Information Resource
#3
Risk is "the effect of uncertainty" but we need some structure so it makes sense to start with (context) 4.1 and 4.2. Issues can be thought of as factors that can enable risk.

4.1 Issue: geopolitical uncertainty
4.2 Interested parties: suppliers, customers
6.1 Risk: single-source overseas supplier may not be able to provide a given critical raw material, resulting in missed shipments
6.1 Opportunity: a new potential supplier has opened in a different location
6.1 Risk: The new supplier may not be reliable or supply adequately.
6.2 Action: Run the new supplier through the qualification process to retain as contingency vendor.

These are not usually done in management review (MR), but an output of MR could be a decision to qualify the second supplier if the above items are presented as part of inputs.

Does this help?
Why isn't this just plain old common sense? Are we really adding value by writing it out?
 

Marc

Fully vaccinated are you?
Staff member
Admin
#5
Why isn't this just plain old common sense? Are we really adding value by writing it out?
Much of ISO 9001 is "common sense" business practices. That is why in the many companies I worked with over the years, other than internal audits almost every one was more teaching them to understand the standard than anything else. I can not begin to say how many times it came down to discussing a requirement and pointing out "You already do that <point out where in their business system>. You're already compliant with the requirement."

That is not to say there are not successful businesses which in some areas do NOT have "just plain old common sense", and/or do not do some things one might consider "common sense". Sometimes this is because in context of their business (it) isn't critical, in their opinion, and sometimes (it) isn't practical.

In Jen's example, for example, many businesses do not have alternate suppliers, at least not for every raw material/component/assembly, and some have none at all. A second aspect to consider is the actual business, their product(s) and/or service(s). A small "mom and pop" making pastries marketed locally will have quite different issues to consider than, for example, McDonalds need for beef and buns.

What one person in a specific business considers "common sense" isn't always transferable to another type/size of business.

When ever I see the words "common sense", this comes to mind: Is Common Sense Learned, Taught, Inherent or An Outcome Of Life Experience?
 
#6
Why isn't this just plain old common sense? Are we really adding value by writing it out?
I'm not sure how big your organization is, but I know of one, only 6 people, (doing graphic design solutions for customers), and I can assure you that a) the owner didn't have time to keep telling people what was expected, b) writing it down prevented them from lowered design standards that had been established as successful and c) the owner didn't have to keep checking his employees' work.

Unless you've got some pretty special people (I mean super human), writing it down is going to be necessary at some time. If you don't, I'd guarantee your people spend a lot of time doing all kinds of non-value added activities. I see it every day.

"The problem with common sense is you discover it's not so common"...
 

Joeem

Involved In Discussions
#7
I'm not sure how big your organization is, but I know of one, only 6 people, (doing graphic design solutions for customers), and I can assure you that a) the owner didn't have time to keep telling people what was expected, b) writing it down prevented them from lowered design standards that had been established as successful and c) the owner didn't have to keep checking his employees' work.

Unless you've got some pretty special people (I mean super human), writing it down is going to be necessary at some time. If you don't, I'd guarantee your people spend a lot of time doing all kinds of non-value added activities. I see it every day.

"The problem with common sense is you discover it's not so common"...
I couldn't explain that better. Good for you.[emoji3]

Sent from my Pixel 2 using Tapatalk
 
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