Tag Archives: T. Dan Nelson

#40 – WILL THE REAL USERS OF ISO 9001 PLEASE STAND UP? – T. DAN NELSON

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T. Dan Nelson - Screen Shot 2013-09-06 at 8.16.28 PMIn America, the law is written in English.  Lawyers speak English. Yet they require training for how to properly understand and apply the law.

ISO 9001 is no different in this regard.  The standard assumes proper training to understand ISO 9001 requirements, good enough training to assure a consistent understanding of the requirements’ intent.

The challenge is that professionals in the ISO 9000 business don’t seem to consistently understand or appreciate the fundamental importance of the process approach and its implications for QMS implementation and assessment.  So even between two ISO 9000 professionals discussing ISO 9001-certified QMSs, unknown to both, they might be talking about completely different things.  One might be talking about systems of ill-conceived documents, while the other might be talking about an actual systems of processes outputting product. (Only the latter is really talking about QMS) Continue reading →

#38 – WHY IS PDCA SO PAINFUL? – T. DAN NELSON

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T. Dan Nelson - Screen Shot 2013-09-06 at 8.16.28 PMThe short answer: the standard has been widely misinterpreted and misapplied. A lack of understanding how to approach quality management vis-à-vis ISO 9001 has stymied proper use of the standard. As a result, many ISO 9001-certified organizations (I dare say most) have adopted a poor approach to quality management in the name of ISO 9001 certification. No wonder they don’t like it.

What tool produces good results when it is used contrary to its manufacturer’s instructions? Misusing a tool often produces undesirable results. Before discarding a tool as being useless, it might be worth the effort to ensure that it is being used properly. After all, misusing a tool can also be costly in many ways. Continue reading →

#37 – A CURVE ‘BACK’ TO THE PROCESS APPROACH – T. DAN NELSON

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MEET BOB’S MACHINET. Dan Nelson - Screen Shot 2013-09-06 at 8.16.28 PM
Bob’s Machine was operating successfully before ISO 9001 came along.  Bob was introduced to ISO 9001 when it appeared among his largest customer’s supplier requirements.  Although the requirements of ISO 9001 were unclear, the requirement to become ISO 9001 certified needed no clarification.

Bob’s objective became to ‘get certified.’  Unknown to Bob, what the standard requires is a demonstrably effective quality management system (QMS).  To ‘get certified,’ Bob needed to sensibly document the system of processes currently operating to output product.  To Bob, those processes were (in order of appearance): Sales, Purchasing, Receiving, Production, and Shipping. Continue reading →

#36 – BALDRIGE AND ISO 9000: UNIQUE BREEDS – T. DAN NELSON

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T. Dan Nelson - Screen Shot 2013-09-06 at 8.16.28 PMBaldrige and ISO 90001?  They can’t be twins.  They’re different animals.

When ISO 9000 was first released as an international standard in 1987, it was not without an American competitor: the national Malcolm Baldrige Award.  Though ostensibly not intended to compete with ISO 9001, Baldrige did compete with ISO 9001.  Baldrige has been hindering an understanding of ISO 9001 and how to apply it since the nearly simultaneous release of these two quality initiatives in the late 80s.  Born nearly at the same time, it seems quality professionals often treat them as twins. Continue reading →

#35 – YES VIRGINIA, A PROCESS APPROACH REALLY IS REQUIRED – T. DAN NELSON

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T. Dan Nelson - Screen Shot 2013-09-06 at 8.16.28 PMThe question as to whether a process approach is required of ISO 9001 will be laid to rest, should the language of ISO 9001:2015 Committee Draft (CD) prevail.  Specifically, the first sentence of sub-clause 4.2.2, headed ;Process approach’: “The organization shall apply a process approach to its quality management system.”  That’s pretty clear. Continue reading →