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Transition Matrix for ISO 9001:2015

Colin

Quite Involved in Discussions
#31
Unless it is specifically stated by a customer, FMEA would not be mandatory, but it is an example of using risk management techniques, more likely to be found in the likes of automotive and aerospace companies.

Given the fact that you are a small company, you probably consider and manage risk with every order, you might have to make it more visible to others how you do that e.g. when reviewing enquiries and orders, when selecting where to buy from and which subcontractors to use.

Remember, it refers to 'risk based thinking', not a full blown risk management process. Please keep us informed on how you get on, it helps to get feedback so we know how CB's are interpreting this.
 
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Colin

Quite Involved in Discussions
#32
This helped me tremendously. As Claes said, it was very similar to my own list but with much more detail. I have just finished updating my Procedures Manual and creating a matrix to assist the auditor in finding objective evidence that my company has made this transition. Your document was an invaluable tool in this process.:thanx:
Thanks very much for the feedback, it is good to hear that it has been a practical benefit, not just a paper one
 
C

cdunnagan

#34
Hi,
We are currently transitioning to AS9100 Rev D, my question is: how is everyone going from the procedure requirement to the process flow approach? my Idea was to take the 7 clauses and flowchart those adding risk? Any ideas...
 
Q

QAMTY

#36
4 Quality

look on the web this article (this is a part of the information).

Hope this helps

Prove It
How to demonstrate risk-based thinking for auditors
By John J. Guzik
Most organizations implement risk-based thinking without realizing it. When a decision is made that affects a business, there’s a formal or informal assessment of risk versus opportunity. The emphasis on risk-based thinking in ISO 9001:2015’s requirements supports the notion that a proactive decision-making mentality is crucial for the continual improvement of a quality management system (QMS) and an entire organization.
etc.....
 

howste

Thaumaturge
Super Moderator
#37
4 Quality

look on the web this article (this is a part of the information).

Hope this helps

Prove It
How to demonstrate risk-based thinking for auditors
By John J. Guzik
Most organizations implement risk-based thinking without realizing it. When a decision is made that affects a business, there’s a formal or informal assessment of risk versus opportunity. The emphasis on risk-based thinking in ISO 9001:2015’s requirements supports the notion that a proactive decision-making mentality is crucial for the continual improvement of a quality management system (QMS) and an entire organization.
etc.....
Direct link to this ASQ article here.
 
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