Over at MAD Magazine Quality Digest, TÜV SÜD auditor Randall D’Amico wrote a piece entitled ISO 9001:2015 Avoiding Nonconformities During the Transition which included the nearly mandatory brainsnap that ISO 9001 requires formal risk management. Except this time, even as TC 176 is scrambling trying to assure people that “risk-based thinking” doesn’t require formal risk management, TUV is threatening anyone who disagrees with nonconformities.
Says D’Amico:
The revised standard requires organizations to adopt a risk-based approach to quality but provides few details on how to achieve this. Again, many organizations are ill-equipped to develop an effective risk management assessment process that will fulfill the requirements of the standard.
The first part of the paragraph was right … there aren’t any “details on how to achieve” risk-based thinking. The second part, though, not only contradicts the first, it is typical CB auditor “I dreamt it so it must be true“ approach to auditing. Let’s look at what the FDIS 9001:2015 actually says about risk-based thinking:
Although 6.1 specifies that the organization shall plan actions to address risks, there is no requirement for formal methods for risk management or a documented risk management process. Organizations can decide whether or not to develop a more extensive risk management methodology than is required by this International Standard, e.g. through the application of other guidance or standards.
It’s up the organization — not some moron at TÜV SÜD — to determine how to address the risk-based thinking clause. And the standard specifically contradicts the dimwitted imaginings of D’Amico.
How does this stuff get published? Could be that TÜV SÜD and Quality Digest are co-sponsoring an upcoming webinar on the subject, run by none other than D’Amico. I invite all you O-Fans out there to attend the free event, August 11, 2015, at 2 PM EST, and tell D’Amico he’s wrong. Sign up for the event is here.
Christopher Paris is the founder and VP Operations of Oxebridge. He has over 35 years’ experience implementing ISO 9001 and AS9100 systems, and helps establish certification and accreditation bodies with the ISO 17000 series. He is a vocal advocate for the development and use of standards from the point of view of actual users. He is the writer and artist of THE AUDITOR comic strip, and is currently writing the DR. CUBA pulp novel series. Visit www.drcuba.world
