The ISO TC 176 develops not only standards, but supporting documents to assist organizations and individuals in understanding the contents of the standards, in terms of implementation and assessing conformance.
With the demise of the requirements for "preventive action" in the 2015 version of ISO 9001, the TC 176 SC2 decided to introduce the concept of Risk Based Thinking (RBT) in the standard. Not surprisingly, controversy ensued. Not necessarily about the concept of risk management, but HOW to make it easily understood, of pragmatic implementation and the facilitation of effective and consistent assessment by (internal and external) auditors.
Realizing that the CD and DIS have been subjected to sharp criticism around the RBT requirements, the TC 176 SC 2 has already released two documents to assist with a better understanding of the subject:
A presentation on ISO 9001 and Risk Based Thinking (here)
A paper on ISO 9001 and Risk (here)
I believe that the documents fall way short of providing practical, actionable and useful guidance for quality management system professionals to clearly understand what is needed to comply with ISO 9001:2015 in terms of RBT. Ditto for auditors.
At the risk of repeating the "process approach" fiasco since it's introduction in the 3rd Edition of ISO 9001, we might end up many diverging ideas of what RBT is. Failure to accomplish an universal comprehension of what RBT is, represents a failure of the standardization process. Standards, by design, MUST allow for effective implementation and conformity assessment practices. If Standards don't promote a COMMON UNDERSTANDING of a subject, it has failed it's mission.
So, I would like to poll Covers from all quadrants and ask if they believe that the documents developed, so far, to assist with an understanding of RBT have succeeded? Especially the paper on ISO 9001 and Risk, with the example of a road crossing. Can you extrapolate from that paper/example to your Quality System? Was the paper useful? Why did the TC cross the road?
With the demise of the requirements for "preventive action" in the 2015 version of ISO 9001, the TC 176 SC2 decided to introduce the concept of Risk Based Thinking (RBT) in the standard. Not surprisingly, controversy ensued. Not necessarily about the concept of risk management, but HOW to make it easily understood, of pragmatic implementation and the facilitation of effective and consistent assessment by (internal and external) auditors.
Realizing that the CD and DIS have been subjected to sharp criticism around the RBT requirements, the TC 176 SC 2 has already released two documents to assist with a better understanding of the subject:
A presentation on ISO 9001 and Risk Based Thinking (here)
A paper on ISO 9001 and Risk (here)
I believe that the documents fall way short of providing practical, actionable and useful guidance for quality management system professionals to clearly understand what is needed to comply with ISO 9001:2015 in terms of RBT. Ditto for auditors.
At the risk of repeating the "process approach" fiasco since it's introduction in the 3rd Edition of ISO 9001, we might end up many diverging ideas of what RBT is. Failure to accomplish an universal comprehension of what RBT is, represents a failure of the standardization process. Standards, by design, MUST allow for effective implementation and conformity assessment practices. If Standards don't promote a COMMON UNDERSTANDING of a subject, it has failed it's mission.
So, I would like to poll Covers from all quadrants and ask if they believe that the documents developed, so far, to assist with an understanding of RBT have succeeded? Especially the paper on ISO 9001 and Risk, with the example of a road crossing. Can you extrapolate from that paper/example to your Quality System? Was the paper useful? Why did the TC cross the road?
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