The Cove Business Standards Discussion Forums More Free Files Forum Discussion Thread Post Attachments Listing Cove Discussion Forums Main Page
UL - Underwriters Laboratories - Health Sciences
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > National and International Business System Standards > ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

How the addition of "Risk" will affect ISO 9001:2015 - Page 6


Elsmar XML RSS Feed
Elsmar Cove Forum RSS Feed

Monitor the Elsmar Forum
Sponsor Links




Courtesy Quick Links


Links that Cove visitors will find useful in your quest for knowledge:

International Standards Bodies - World Wide Standards Bodies

ASQ - American Society for Quality

International Standards Organization - ISO Standards and Information

Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC


NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags (Not all threads are Tagged)
iso 31000 - risk management, iso 9001 - quality management systems, iso 9001:2015, risk based thinking (rbt), risk management and analysis
Reply
 
Thread Tools Search this Thread Rating: Thread Rating: 2 votes, 5.00 average. Display Modes
  Post Number #41  
Old 15th September 2014, 10:19 AM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,717
Re: How the addition of "Risk" will affect ISO 9001:2015

Quote:
In Reply to Parent Post by Colin View Post

Sidney, I share many of your concerns with regard to RBT but I also wonder whether we may be being overly worried about the subject.
Good point, Colin. RBT might get the same treatment that the "process approach" got. I.e., either be totally ignored, or cheapened with a high level flow chart as the only evidence that an organization has a process approach based QMS (which, by the way, it becomes explicitly mandatory with the 2015 revision).
So, I can envision a lip-service type organization doing one risk-based exercise, such as a FMECA for a single product design and development and milking that single example for the next 6 years in order to "pass audits".

Tom's comment is also very emblematic of many organizations approach. Instead of deciding for themselves how to comply with the standard, defer it to "what the auditor wants to see" and follow that path. That tends to work very well..........until there is a change of auditors and the new one wants to see something different. That is the risk of tailoring your system to the auditor du jour, instead of using the standard to develop a coherent system that supports the business.
Thanks to Sidney Vianna for your informative Post and/or Attachment!

Sponsored Links
  Post Number #42  
Old 15th September 2014, 10:47 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,227
Re: How the addition of "Risk" will affect ISO 9001:2015

With so much told about the RBT approach, the system must get renamed to Enterprise Management System (EMS) ... Has a clash with the ISO14k or Organization Management System (OMS) rather than tagging the word Quality, and like always the Quality function being made responsible to do all the RBT.
RBT is more of a cultural thinking. Perhaps I can say the Europeans are more analytical and good at RBT than say the Asian. How much will the Top management align with the good RBT management system. Somewhere, this will get countered with the thought "Lets cross the bridge when we come to it".
I see a risk, I not see a risk ... Who wins.
Sponsored Links

  Post Number #43  
Old 15th September 2014, 11:38 AM
Colin's Avatar
Colin

 
 
Total Posts: 1,495
Re: How the addition of "Risk" will affect ISO 9001:2015

Sidney, I most definitely agree with the comment about the process approach, in fact I ran a discussion on the DIS with one of the UK's largest CB's just last week and we used the same analogy.

We also came to the conclusion that probably the biggest challenge with the changed standard will be with CB's and their interpretations of what is really required - I am not confident.
Thanks to Colin for your informative Post and/or Attachment!
  Post Number #44  
Old 22nd September 2014, 03:32 PM
Marc's Avatar
Marc

 
 
Total Posts: 25,731
Re: How the addition of "Risk" will affect ISO 9001:2015

I assume everyone has seen this...
.
Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: docx ISO9001_2015_and_Risk.docx (39.4 KB, 932 views)
Thank You to Marc for your informative Post and/or Attachment!
  Post Number #45  
Old 23rd September 2014, 04:37 PM
wny4ever

 
 
Total Posts: 19
Re: How the addition of "Risk" will affect ISO 9001:2015

I read that one risk management ?guru? defines ?risk? as ?uncertainty that matters?. Sounds good to me.

Maybe the question is better put as "How will the addition of RBT affect those certified to ISO 9001:2008 and needing to transition to ISO 9001:2015?

I believe that the concept of risk has always been implicit in ISO 9001. The DIS makes it more explicit and incorporates it in requirements for the establishment, implementation, maintenance and continual improvement of the QMS. It makes preventive action part of strategic planning.

One of my major questions is how a 3rd party auditor will audit for RBT.

Isn't the entire QMS is essentially a ?preventive tool?, using the ?Plan-Do-Check-Act? (PDCA) methodology?
Thank You to wny4ever for your informative Post and/or Attachment!
  Post Number #46  
Old 10th October 2014, 11:09 AM
John Broomfield's Avatar
John Broomfield

 
 
Total Posts: 2,460
Yin Yang Re: How the addition of "Risk" will affect ISO 9001:2015

wny4ever,

Unfortunately, ISO Guide 83 (now the mandatory management systems' standards' language) has moved away from prevention to engage us all in the wonders of more intentional risk management.

Risk management instead of prevention may help stop some willful blindness but at what cost? Imagine our suppliers intentionally shipping bad product because their risk assessment (and implicitly, "ISO") said it was okay!

Risk management without the principle of prevention smacks of compromise and moral relativity instead of living by the principles of preventing nonconformity to fulfill customer requirements.

John
  Post Number #47  
Old 10th October 2014, 12:24 PM
Johnnymo62

 
 
Total Posts: 21
Re: How the addition of "Risk" will affect ISO 9001:2015

Draft Standard says:

0.5 Risk is the effect of uncertainty on an expected result...
3.09 Risk: effect of uncertainty on an expected result.

0.5 ... and ISO 31000 provides guidelines on formal risk management which can be appropriate in certain organizational contexts.
  Post Number #48  
Old 10th October 2014, 12:34 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 8,717
Re: How the addition of "Risk" will affect ISO 9001:2015

Quote:
In Reply to Parent Post by John Broomfield View Post

Unfortunately, ISO Guide 83 (now the mandatory management systems' standards' language) has moved away from prevention to engage us all in the wonders of more intentional risk management.
John, as previously mentioned, ISO Guide 83 does not exist anymore.
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > National and International Business System Standards > ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Easy Way of "Implementing" Risk in ISO 9001 2015 QAMTY ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7 3rd April 2017 01:50 AM
Including the Word "Risk" into the Quality Policy (ISO 9001:2015)? QAMTY ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4 15th February 2017 04:26 PM
What can be considered a "Post Delivery Activity" (ISO 9001:2015 Clause 8.5) kcoryell1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5 4th February 2017 09:54 AM
"Partial Design" Designation and Applicable ISO 9001:2015 Exemptions MichelleMcR ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11 10th January 2017 10:41 AM
ISO 9001:2015 4.4.1 - Providing Evidence of QMS Processes "Shalls" ogghall ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9 3rd October 2016 02:02 AM



The time now is 10:02 PM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


 
 


NOTE: This forum uses "Cookies"