Is the IAF drinking in the last chance saloon?

Marc

Hunkered Down for the Duration
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#51
You know - This all just sounds like increasing international regulation to me. I'm not against regulation, quite the opposite. Just pointing out what this discussion looks like to me.
 
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gramaley

#52
Thanks for the splash of cold water. Yes it does seem that way. I work under regulated QMS based on ISO 13485 and it is overkill for a lot of low risk medical products that are just as easily screened from the market by unhappy customers, without posing a public health risk in the interim.

ISO 9001 serves a purpose, but product quality can be achieved without it. Where the dependency on numerous employees and process interact to make a quality product, a QMS can come in handy. In fact, even none-9001 companies have some kind of system to manage quality. Each manufacturer is its own stakeholder in quality, so do we need others? - maybe sometimes.
 

Sidney Vianna

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#53
You know - This all just sounds like increasing international regulation to me. I'm not against regulation, quite the opposite. Just pointing out what this discussion looks like to me.
It might look like that, Marc, but in my opinion, accredited certification is like fair taxation: the theory behind and the motives supporting it are noble and value-added. The problem is not with the theory, but the actual implementation and credibility of the process.

Few people would try to make a case against standardization and conformity assessment programs as a way to promote fair trade and consumer protection. The devil, as they say, are in the details. The lack of competence, trivialization of the processes, fraud, scams, loopholes, etc...
 

Paul Simpson

Trusted Information Resource
#54
... The IAF is a continuous improvement based group and they certainly add value to certification.
Unfortunately there aremany covers who might dispute this claim. Mainly those involved in certification. :D
The area of competency of auditors is a tremendous challenge since product scopes and their relationship to the QMS is hard to tackle. The beauty of ISO 13485 is that a QMS auditor can hunt through the mandated risk management file and shape their audit to particular product specific risks. This may be where ISO 9001 needs to go.
Agreed. Competence is a huge issue. Having another raft of documents for accreditation auditors to pore over instead of getting out and seeing with their own eyes is not the answer IMHO - and I'm not referring to 13485 specifically. 9001 does have a risk based approach to it - starting with customer requirements. The trouble is many auditors think a management system is the document - not the practices that deliver customer value.

From talking with the head of ISO 9001, they see this a natural evolution, but ISO 9001 does not have an equivalent ISO risk management standard, such as ISO 14971, at least not one I know would be universally accepted as a component of the next ISO 9001 scheme.
Again I have no experience of ISO14971. I cannot comment on the value of your suggestion - Perhaps you can provide some more details ... in another thread?
 

Sidney Vianna

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#55
This thread is over 10 years old and the problem still persists, but now, at a much larger scale. The IAF is derelict; pure and simple. The people supposed to ensure effective oversight of the management systems conformity assessment sector are either incapable and/or unwilling to revert the commoditization of system certification. Why, one could ask. Simple, my dear Watson, by commoditizing "ISO certification", short term gains are possible....

In one of the previous posts in this thread, Howste said that AB's/CB's have a policy of no child left behind...that means: no company left uncertified.

Just as a reminder: business and society at large don't need certificates; they need assurance of reliable supply chains. When certificates are not delivering on that expectation, the accredited certification process is defective. But, and once again, the IAF has longly demonstrated it's inability to change the situation.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#56
ISO 9001 serves a purpose, but product quality can be achieved without it.
I can not count the times that I have pointed out that there are millions of companies in the world, only a small fraction of which are registered to ISO 9001, and my bet is few have even heard of ISO 9001. I am far from convinced that ISO 9001 "assures" anything, including reliable supply chains (much less product quality).
 
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