ISO 9001: Quality Management as a process

#1
Our company just underwent our first ISO certification. Our phase 1 and 2 initially went well, and the auditor left last week with assurances that there were no NCRs, only OFIs. Now he's calling us to say that he overlooked a major NCR, that quality is not a process. We defined our key processes as:

1. Production
2. Business Development
3. Purchasing and receiving
4. Quality Management

The auditor told us that Quality is not a process as there is no input and output. Our argument for it was that quality can be measured by NCRs issued per year, and percentage of FAIs rejected by our customers, which we used as KPIs.

We are a small 7 person shop, and hired a consulting company to guide us through the process towards certification. I'm feeling a little bit burned, as our certification is now uncertain, and we're waiting for the final word from our registrar.

I'm new to ISO and don't claim to be an expert, i'm just curious what you all think about this conclusion.
 
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PaulJSmith

(Former) Quality Jerk
#2
I'd be curious as to why the auditor is questioning Quality Management, yet not also questioning Business Development. Under the stated criteria, I don't see much difference.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#3
I don;t understand 2 things: Why would the auditor call this a major NC and why is your certification uncertain? Simply drop Quality Management as a "key process".

That doesn't stop you from measuring NCRs issued per year, and percentage of FAIs rejected by our customers or anything else you wanna measure.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#4
and hired a consulting company to guide us through the process towards certification.
I would bet the consultant was involved with the CB selection. Why can’t s/he assist you with this grave error by the CB? Or maybe s/he can, for an extra fee. Dreaming of a NC after the fact when, if had a minor semblance of validity should have been uncovered during a stage 1 audit is outrageous. Especially a MAJOR. You might be the “victim” of a scam.
 

geoffairey

Involved In Discussions
#5
I'd be curious as to why the auditor is questioning Quality Management, yet not also questioning Business Development. Under the stated criteria, I don't see much difference.
Dependent on the Business, Business Development could be the Sales Process, very different to Quality Management. But this depends if this is Quality (e.g. 9001) or quality control (conformance of the product with the spec)
 

John Broomfield

Leader
Super Moderator
#6
Managing quality could be considered a process. But it is huge; just about all the work done by everyone in the company is for quality.

In your system where are the following processes addressed:

A. Controlling documented information
B. Maintaining facilities and equipment
C. Auditing for conformity and effectiveness
D. Managing continual improvement

It could be that A, C and D are QM processes and B in part of Production.

Or, perhaps your consultant gave inspection, testing and resolving service and product nonconformities a fancy QM title.
 

Randy

Super Moderator
#7
Just from the get-go and trying to restrain myself, you need to contact the CB and file the largest and nastiest complaint you can, and contact the CB's accreditation body if less than satisfied with the response.........Absolutely restrict that clod of an auditor from ever crossing your threshold again and quite honestly if that "Unprofessional professional" holds a 3rd party certification (like Exemplar Global or IRCA" file a complaint against him. He has violated the absolute for honesty.....ABSOLUTE!

He gave you, he promised you that there were no NC's and magically remembered a MAJOR? No way in %ell is this right, correct, or professional. Nobody "forgets" a MAJOR and definitely nobody says there are no NC's and then tosses in a MAJOR after an audit closes.....That's one of that largest cases of hor&&it I've heard in a long time and I've been doing this over 20 years.

NO! NO! NO! NO!
 
#9
Our company just underwent our first ISO certification. Our phase 1 and 2 initially went well, and the auditor left last week with assurances that there were no NCRs, only OFIs. Now he's calling us to say that he overlooked a major NCR, that quality is not a process. We defined our key processes as:

1. Production
2. Business Development
3. Purchasing and receiving
4. Quality Management

The auditor told us that Quality is not a process as there is no input and output. Our argument for it was that quality can be measured by NCRs issued per year, and percentage of FAIs rejected by our customers, which we used as KPIs.

We are a small 7 person shop, and hired a consulting company to guide us through the process towards certification. I'm feeling a little bit burned, as our certification is now uncertain, and we're waiting for the final word from our registrar.

I'm new to ISO and don't claim to be an expert, i'm just curious what you all think about this conclusion.
Really? This is what CB auditors are doing these days? Arguing over what something is named? Not only would I complain, but I’d withhold payment until there’s a do-over of the stage 2.
 

Paul Simpson

Trusted Information Resource
#10
Our company just underwent our first ISO certification. Our phase 1 and 2 initially went well, and the auditor left last week with assurances that there were no NCRs, only OFIs. Now he's calling us to say that he overlooked a major NCR, that quality is not a process. We defined our key processes as:

1. Production
2. Business Development
3. Purchasing and receiving
4. Quality Management

The auditor told us that Quality is not a process as there is no input and output. Our argument for it was that quality can be measured by NCRs issued per year, and the percentage of FAIs rejected by our customers, which we used as KPIs.

We are a small 7 person shop, and hired a consulting company to guide us through the process towards certification. I'm feeling a little bit burned, as our certification is now uncertain, and we're waiting for the final word from our registrar.

I'm new to ISO and don't claim to be an expert, i'm just curious what you all think about this conclusion.
Firstly, I'd agree with the auditor that 'Quality Management' is not a process in its own right. Quality management is a part of the other 3 key processes you have listed as well as many of the support processes you operate.

I don't, however, understand why they have categorized this NC as 'Major'. At worst it is a misunderstanding and a Minor NC.

There are other questions about the assessment process including how the 'Major' was not identified during the Stage 2 audit and discussed during the audit. My policy is that only items discussed at a closing meeting can be part of the report. If, as part of the certification decision, the CB decides the assessment has not been carried out correctly and a Major NC potentially exists they should be carrying out additional assessment work at their cost.

As others have proposed, I suggest you discuss this with your consultant and raise an appeal with your CB. If you need any help, please let me know.
 
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