Plenty of companies got the idea that ISO 9001 certification was about proving conformity to requirements. We can tell by all of the QMS documentation designed to do just that. Sure, ISO 9001 certification certainly does involve demonstrating conformity to requirements. There are an infinite number of ways organizations could choose to define QMSs meeting ISO 9001 requirements.
ONE SHORT OF INFINITY
To define a QMS, there are infinity minus one ways, actually. The one way of demonstrating conformity to requirements that isn’t acceptable per ISO 9001: documenting the system according to the requirements of ISO 9001 (or, using a standard-based approach).
The standard assumes an existing quality management system (QMS) will provide a basis for the standard to be applied. Quality management is supposed to precede application of ISO 9001; quality management was not supposed to arrive with ISO 9001. How an organizations chose to manage quality was agreed (although maybe only tacitly) before ISO 9001 came along.
The foundation of a QMS is provided by the very (business) processes that are already in operation to output quality product. A QMS is built into (or, to use terms expected of the 2015 standard, “integrated” into) those very business processes at the core of any organization’s operations.
Defining a QMS using those business processes as its foundation is using a process approach to define the system. It’s the right way to do it, and there are many right ways to get it done that way. On the other hand, the one way the standard says not to do it is by structuring QMSs and documenting according to the requirements of the standard. Defining quality management according to the criteria against quality management will be assessed is basically cheating.
PASS THE EXAM BY UNDERSTANDING IT!
ISO 9001 assessment is like an open-book test. Think of it like a final exam following a semester of biology. The idea of the test isn’t to provide a semester of biology lessons, nor is a semester of learning expected to be imparted by taking the test. The test is to assess what was learned and perhaps even the ability to apply it. A student doesn’t learn biology from taking tests any more than management learns quality from getting ISO 9001 certified.
This standard-based approach is actually a form of very cheeky cheating and the standard itself says it is unacceptable. Of course you shouldn’t be able to pass the test simply by writing procedures pandering to ISO 9001 clauses and sub-clauses, or limiting description of the system to the six procedures explicitly required of the standard.
SYSTEM INTEGRATION
Some companies mix procedures like ‘Product Identification’ and ‘Customer Property’ in with real procedures describing processing like ‘Shipping’ and ‘Production’, thus regarding their system as compliant AND addressing ISO 9001 requirements. This simply shows systems that are only partly confused in definition by the requirements of ISO 9001 (being partly based on the standard and partly based on processes), while also demonstrating that processes needed for the QMS have not been effectively determined. (It also suggests a failure to properly understand and apply requirements of ISO 9001.)
‘Product Identification’ and ‘Customer Property’ are non-processes. Procedures describing these non-processes aren’t really procedures in the first place. They didn’t describe real processes, all they really did was proclaim how processing meets individual requirements. Since non-processes are determined to be needed for the QMS–with procedures dedicated to them as evidence–processes needed for the system have not been (effectively) determined.
These non-processes, based on standard requirements, express QMS requirements that have not been integrated properly into the QMS. These provisions lie outside of the processes that really are needed by a QMS. By the 2015 standard (5.1.1), the above may provide evidence of nonconformity due to these (pseudo) QMS processes not being ‘integrated’ into business processes (in addition to 2008’s requirement to ‘determine’ processes needed to output quality product).
Is it any wonder that nobody likes the documentation based on ISO 9001? It’s confusing, counterproductive, and more costly than it needs to be. To whom is it helpful or valuable?
The standard will continue to clarify and emphasize the requirement to apply a process approach until it is clear to auditors that they should not be passing standard-based systems. At that time, the market for pre-written procedures and manuals will dry up and we can proceed with the quality revolution unfettered with senseless documentation.
Bio:
T. D. (“Dan”) Nelson is a quality management consultant, author, and trainer specializing in the process approach, ISO 9001, and related sector schemes. Dan has roughly 20 years of experience with ISO 9000 and over 15 years’ experience with the process approach. Dan holds an MA in Business Administration from the University of Iowa. Dan can be reached at:
dan@tdnelson.com
319.210.2642