Perspectives: Taken for Granted

Abstract:Every year, it seems like there's a new contender for the most popular quality strategy. And in the midst of this carousel, tried-and-true methods get lost or discarded. In this Perspectives column, Bob Kennedy describes a recent experience that led him to wonder whether the quality profession is foolishly casting aside the ISO 9000 family of …

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I want to thank you all for commenting on my article. The emphasis on auditing and auditors is striking. I have always felt that quality comes from within and should not depend on the external auditor to enforce it or find us out.
Regarding the additional documentation, I have no problem with this as indeed nobody else does either. Product/process documentation is, in my experience, never resisted. There is a general perception out there that ISO 9001 imposes a lot more documentation than the essential product/process stuff. It is for that reason that I placed emphasis on the quality manual and six core functions, which are the only additional documents required by ISO 9001.
--Bob Kennedy - Author, 04-10-2012

@ Robert - You fail to see the significance of the standard based on the experience of organizations that look for short cuts rather than it's intended purpose. ISO certification only means something if the organization is properly audited to the standard, and even then it means very little if the organization doesn't use the standard for its intended purpose: to promote and encourage continuous improvement. The standard itself is sound if organizations take it upon themselves to use it for that purpose. All you have explained is that people are not responsible for their own actions and require control and supervision by auditors who are then controlled and audited by the board. Who then controls and audits the board? It's a never-ending cycle when we step away from who is ultimately responsible for implementing standards regardless of what they are.

If you look at the CE requirements, they put sole responsibility on the manufacturer. The organization self-certifies the products and is required to produce evidence in the event a consumer or other organization requests or disputes the claims of certification. At the end, the manufacture needs to maintain evidence of self-certification, which is where the responsibility starts and ends anyway. I wonder why some insist that a third party certify a manufacturer's claim. Honesty and integrity don't go very far.
--Steve, 02-17-2012

Well said. The continued proliferation of QMS standards are marketing strategies to lure organizations to variety private and industry sponsored regulating bodies. However, when examined closely, they all rely on the core principles of the ISO 9000 Series. All the certification standards follow the format of ISO 9001. The problem, as stated in an earlier comment, lies in the failure to maintain a uniform standard for auditing. This has been a flaw in the system from the inception of the standard.

"Lean" it not truly related to product quality. It is an efficiency issue. 75 years ago, the efficiency expert was known as the "time-study person." Later, it was the manufacturing engineer. Now, it is the "Lean Expert." I have no gripe with an individual being more relevant by being both, but calling it a quality issue is in my opinion a bit of a stretch.
--Tony Adams, 02-16-2012

I think that these comments come from the high difficulty to provide evidence of QMS benefits in a tangible way. That is why a lot of managers are now reluctant to pursue ISO 9001 certification, so they start saying that ISO is not a good standard anymore. Obviously, this statement is wrong.
--Luis E Lopez, 02-15-2012

A very astute analysis of the importance of ISO standards to the attaining, maintaining, and improving of quality.
--Lonnie Miller, 02-15-2012

Referring to Rock Solid item 6, it is incorrect to believe that only
1. Document control.
2. Records control.
3. Internal audits--how to conduct these is in ISO 19011.
4. Nonconforming product.
5. Corrective action.
6. Preventive action
are the only procedures needed for certification.
Clause 4.2.1(d) of ISO 9001:2008 - "documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes" are necessary documents needed though may not be in the same procedural format for the 6 documents you mentioned, but in some form of documentation (form, SOP's, flows, diagrams, photographs, illustrations etc.) is necessary for certification audit as evidence that these other requirements have been planned and supporting records as evidence that these other requirements have been implemented.
I fully agree that ISO 9001 is Quality 101 that must not be missed out by any organization desiring to satisfy their customers'. I had worked in a company that implemented MIL-Q-9858 QMS before the advent of ISO 9001 in 1987, and later had opportunity to review competitors without the Mil-Q-9858, there is a huge difference in the understanding, alignment and commitment and compliance to quality. I am glad that ISO 9001 came along that aligns almost 100% closely to Mil-Q-9858 and gets accepted by the million organizations you mentioned, to get the whole industry upgrade their quality understanding, commitment and compliance to a very basic level by implementing ISO 9001 compliantly.
I am a quality consultant in South East Asia, and my clients having implemented a QMS based on ISO 9001 recognises and realises a significant reduction on business hassles allowing them to concentrate on their core business of producing and servicing their customers while their compliance to ISO 9001 is an understood and necessary compliance. ISO 9001 is Business 101 for organizations to satisfy their customers' to survive and continually grow their business.
--Loo Choon Chwi, 02-15-2012

ISO 9000 was doomed the minute a conflict of interest developed in the way auditors audited. If they hammered a company hard for noncompliances, they got a reputation as a hard nose, and companies would not hire them as their auditor. They would look for the easy auditor that would let them slide. Carry this forward a few years, and ISO 9000 means nothing. The International Organizations for Standardization failed to recognize the conflict of interest and failed to do anything to correct it. An auditing board should have been created ,and auditors should be members of that board. Companies apply to the board to be audited. The auditor they get should be controlled by the board, and the company should have no control over which auditor they get. Any auditor found not auditing to a certain standard should be put on probation or kicked off the board. Then we would see ISO certification mean something. Once it means something, then quality professionals and the rest of the world might reconsider. Until then, ISO 9000 is only a check in the box required to export into the EU or do business with the automotive sector, not the driver of change and quality it was meant to be. I am shocked that a published professional cannot see what the rest of us are so painfully aware of. Or maybe aware but simply choosing to put his head in the sand.
--Robert C Bills, 02-15-2012

Delivering quality-as-process and quality-as-result is our goal, correct? If we agree nothing is or can be unchanging and we are planning for alternative futures, we need thinkers, doers, leaders and usable tools. Yes, ISO 9000 is a usable tool. It is in the tool kit along with many other tools. Bob Kennedy has given us important issues to think about. As quality professionals, we support results. We support systems delivering results. If we undermine our systems, if we lose our tools, there are significant problems. If we the "quality experts" are undermining one of our tool systems, we are causing a problem. Bob's ideas had better be considered.
--Jerry Brong, 02-15-2012

This is an excellent explanation of the benefits of a QMS. I have to add that ISO 9000 is written with so much emphasis on product that it takes a great deal of extrapolation to apply the standard to a service organization. I have also seen auditors try to apply product realization questions to a service and then not understand the answer. It would help the service sector, including government services, if the ISO standards were developed to more closely align with the needs of service providers and the associated infrastructure.
--Carol, 02-15-2012

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