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How the addition of "Risk" will affect ISO 9001:2015 - Page 2


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Related Topic Tags
iso 31000 - risk management, iso 9001 - quality management systems, iso 9001:2015, risk based thinking (rbt), risk management and analysis
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  Post Number #9  
Old 15th August 2013, 07:42 PM
JaneB's Avatar
JaneB

 
 
Total Posts: 3,518
Re: How the addition of "Risk" will affect ISO 9001:2015

Quote:
In Reply to Parent Post by Randy View Post

Risk will probably be similar to this definition except related to quality:

"combination of the likelihood of an occurrence of a hazardous event or
exposure(s) and the severity of injury or ill health (3.8) that can be
caused by the event or exposure(s)"
Would that it were, Randy, would that it were.

And no, it doesn't reference the 31000 one either. For some reason - which utterly escapes me - they've come up with the definition of it being the 'effect of uncertainty' which is in the CD itself. Which has no fewer than 4 Notes to it. At least they kinda got somewhere near what you say but only right at the end in Note 4.

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  Post Number #10  
Old 15th August 2013, 07:49 PM
kgott

 
 
Total Posts: 1,027
Re: How the addition of "Risk" will affect ISO 9001:2015

Quote:
In Reply to Parent Post by Boingo-boingo View Post

The definition of risk is in the ISO 9001 CD.

Perhaps the definition of risk can be simplified as:

'what are the chances'
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  Post Number #11  
Old 16th August 2013, 12:50 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,171
Re: How the addition of "Risk" will affect ISO 9001:2015

Prospects and consequences
opportunities and threats
success and failure
.
..
...
The later words of these and many more such all together forms the risks.
A planned effort quantifies and leads us to develop mitigation means.
Managing risks therefore is planned quality assurance for
Greater prospects.
More opportunities.
Sure shot success.
  Post Number #12  
Old 16th August 2013, 03:46 AM
TPMB4

 
 
Total Posts: 377
Re: How the addition of "Risk" will affect ISO 9001:2015

I'm sure I read somewhere the phrase "opportunities and risks". If I'm right that means they view risks as related to the chances of a negative event. the opportunities is not just a positive but it can come from the negative event. I guess I mean you look at the risks (possibilities of a negative) and take actions to mitigate them which improves your system and is the opportunity for improvement (that term I've heard a lot since a recent audit).

I wonder what sort of change it really is to an organization's QMS. If you plan for new processes part of it is looking at the risks to quality (take the PFMEA and DFMEA used widely in automotive sector and probably others too). Also it makes good business sense to look at all business risks during any strategic review of your business. I'm sure if this isn't being done the company is lucky to still be around. I've worked for companies who didn't look at that and I got the nice redundancy package as a result (new kitchen and a walk into new job with better prospects thank you very much. Hehehe! ).
Thanks to TPMB4 for your informative Post and/or Attachment!
  Post Number #13  
Old 18th August 2013, 09:44 AM
CarolinaQ

 
 
Total Posts: 5
Re: How the addition of "Risk" will affect ISO 9001:2015

Marc, thanks for sharing this info on the future inclusion of risk. I work within an engineering group in my company. For the last year or so there has been a stronger focus on risk during the design process. Maybe we will be ahead of the game when the revision comes out 😊. We can use this information to help us work on the continuing improvement of our QMS. But, I do hope we get clear definition of terms.
  Post Number #14  
Old 22nd September 2013, 11:46 AM
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drgnrider

 
 
Total Posts: 167
Let Me Help You Re: How the addition of "Risk" will affect ISO 9001:2015

Quote:
In Reply to Parent Post by Marc View Post

ISO 31000 isn't in the ISO 9001 Draft. I don't have the ISO 9000 Draft to know whether it's in there or not.
Guess I am way too far out of the loop(s), where/how does one gain access to all these draft, SL, etc. documents? Hearing about 'pieces' of them here on the Cove, while helpful, but getting a chance to review the entire thing gives me a chance to have more of an idea of what I am in for.
  Post Number #15  
Old 11th September 2014, 11:41 AM
Ken11

 
 
Total Posts: 23
Re: How the addition of "Risk" will affect ISO 9001:2015

As the quality mgr. for an ISO 17025 Accredited Calibration & Testing lab, some of our customers are asking about calibration uncertainty as "risk". I have not seem anyone mention this in these threads. Anyone have any thoughts? These questions are coming from our clients that are beginning to understand uncertainty.
Thanks to Ken11 for your informative Post and/or Attachment!
  Post Number #16  
Old 11th September 2014, 01:39 PM
dgriffith

 
 
Total Posts: 227
Re: How the addition of "Risk" will affect ISO 9001:2015

Quote:
In Reply to Parent Post by Ken11 View Post

As the quality mgr. for an ISO 17025 Accredited Calibration & Testing lab, some of our customers are asking about calibration uncertainty as "risk". I have not seem anyone mention this in these threads. Anyone have any thoughts? These questions are coming from our clients that are beginning to understand uncertainty.
Ken, in your case the risk is not the uncertainty, but it is related. The risk is in the decision to declare the UUT measurement as good, when it may not be.
The probability of false accept is the parameter customers will want to know-- the likelihood that a decision for pass/in tolerance is incorrect.

This is not addressed in ISO 17025, but is in ANSI Z540.3.
Thanks to dgriffith for your informative Post and/or Attachment!
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