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.
 
Elsmar Forum Sponsor

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

Hunkered Down for the Duration
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
 
Thread starter Similar threads Forum Replies Date
M ISO 9001:2015 and AS6081:2012 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Implementation ISO 9001: 2015 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
J ISO 9001:2015, ISO 14001 & OHSAS18000 (IMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
L How to understand the clause 6 Planning of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T ISO 9001:2015 - Small Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M ISO 9001:2015 case study sample ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Sample of Nonconformity report for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Case study help as per ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
F Logistics and IT clauses in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
V Quality Objectives - ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
Gun46 ISO 9001 : 2015 Lead Auditor Exam General Auditing Discussions 16
Q ISO 9001:2015 man days for surveillance audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D ISO 9001:2015 4.3 Determining the Scope of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I ISO 9001:2015 Section 9.3.2 C1 "customer satisfaction and feedback from relevant interested parties" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
I ISO-9001:2015 and "Relevant Parties" Management Review Meetings and related Processes 2
I Master Document Access - ISO 9001:2015 clause 7.5.3 Document Control Systems, Procedures, Forms and Templates 5
qualprod Why new clause (7.1.6) in ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
M ISO 9001:2015 8.2.1 Contingency Plan required for small Business? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Help with Drawing Review - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
V ISO 9001:2015 7.2 Competence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 35
B ISO 9001:2015 Transition: Much Easier Than You Think! Misc. Quality Assurance and Business Systems Related Topics 0
A Process Documentation for ISO 9001:2015 Internal Auditing 2
C Migrate ISO 9001:2015 Certificate Registrars and Notified Bodies 4
J ISO 9001:2015 Small Operation Management Review General Auditing Discussions 6
E Three basic questions about ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO 9001:2015 Monitoring and measuring resources. Application a service industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
W ISO 9001:2015 Management Review Input Template wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
N ISO 9001:2015 Customer Complaints Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
O Performance Measurement ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Does ISO 9001-2015 have a requirement for manufacturing equipment to be numbered? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
V ISO 9001: 2015 Production drawing Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
KCalaba21 ISO 9001:2015 6.2.2 E - "e) how the results will be evaluated." ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S ISO 9001:2015 & ISO 14001 Re-Certification Audit Preparation ISO 14001:2015 Specific Discussions 8
S ISO 9001:2015 & ISO 14001:2015 - I need a format for Design & Development planning ISO 14001:2015 Specific Discussions 2
N ISO 9001:2015 - 5.3 - The roles and responsibilities matrix rears it's head ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J ISO 9001:2015 Excel Gap Analysis wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D ISO 9001:2015 Internal Audit Training Advice Internal Auditing 10
M IATF 16949:2016 clause 8.4.2.3 - We don't have ISO 9001:2015 certificate IATF 16949 - Automotive Quality Systems Standard 26
GreatNate Document Control info - What is required on a controlled form/document for ISO 9001: 2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
E ISO 9001:2015 - Record requirements for out of calibration tool ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
GreatNate ISO 9001:2015 Lead Auditor Course? (who to take with) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
S ISO 9001:2015 Clause 9.3.2 - MR (Management Review) - Adequacy of resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S ISO 9001:2015 Clause 8.7 Control of Nonconforming Outputs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
qualprod ISO 9001:2015 8.2.3.2 and 8.5.5 - Guidance for Reviews ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8

Similar threads

Top Bottom