Our guest blog contributor this week is Dan T Nelson. Dan is a consultant, trainer, coach and author specializing in quality management as it relates to ISO 9001 and related standards.
With a new version of ISO 9001 expected in 2015, for those organizations that currently hold 9001 registration, Dan believes it’s going to be all about your approach as to how you manage the change.
A standard-based approach to ISO 9001 certification has been widely applied by organizations since release of the standard in 1987. In 2000 (and 2008), the standard explicitly admonishes against this approach (ISO 9001:2000/2008, 0.1), endorsing and demanding instead a process approach (ISO 9001:2000/2008, 0.2 and 4.1, respectively).
Because the standard-based approach is still successful in achieving ISO 9001 registration, contrary to the standard’s intent, the upcoming version of the standard (expected in 2015) will again increase the emphasis upon the requirement to apply a process approach to quality management (ISO 9001:2015 Committee Draft, 4.2.2).
So what’s the difference between the standard-based approach and the process approach?
The process approach is a management principle that has been around much longer than ISO 9001. The process approach is a way of managing processes to control and improve them. Its objective is to systemically manage quality toward improvement. A process approach results in system documentation that is unique to each organization, as no two organizations operate exactly the same.
Successful organizations employ a process approach at some level, many since Deming and the advent of Plan-Do-Check-Act (PDCA). The process approach is based upon PDCA. (ISO 9001:2000/2008, 0.2.)
Even without knowing Deming, many organizations for decades before ISO 9001 recognized the importance of process. Many successful organizations operate a process approach at some level despite confusing quality management system documentation actually belying or opposing a process approach.
The standard-based approach arose in response to the original release of ISO 9001 in 1987. This approach depends upon a standard to define management systems. It’s objective is certification to a standard like ISO 9001. Though organizations may have been applying a process approach before ISO 9001 came along, when it did came along, they defined their management systems according to the standard itself. Thus they procedurally abandoned a process approach in an effort to cheaply, easily, and quickly achieve ISO 9001 certification.
Rather than developing documentation intended to view and manage organizational processes affecting quality, a standard-based mindset views documentation as something intended to demonstrate conformity to ISO 9001 requirements. Manuals and procedures are written in response to the standard’s requirements, rather than being written to manage processing. Documentation resulting from a standard-based approach does not describe processes to make them clear; on the contrary, it confuses and obscures processes in the name of ISO 9001 certification. It results in management systems being defined by the same structure—that of the standard.
At 0.1, the standard admonishes against the standard-based approach by saying (ISO 9001:2000/2008): “It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.”
While there is more to the process approach to quality management than just process definition and documentation, the same cannot be said of the standard-based approach. The standard-based approach is little more than an exercise of writing documentation in response to the standard’s requirements.
Bob’s Machine Shop Transitions
Bob’s Machine Shop employs 30 people. Bob operates five core processes: Sales, Purchasing, Receiving, Production, and Shipping.
Bob’s Machine Shop first became certified to ISO 9001:2008 using a standard-based approach to certification. Just last year, Bob decided to adopt a process approach to quality management instead. The following diagram depicts Bob’s procedural structure before and after the transition.
Using a standard-based approach, Bill in the Receiving area has eight procedures to read and become confused by, none of which tell him how to receive the next incoming package. Following standard-based procedures, nothing really happens at all. These procedures aren’t really procedures since they don’t describe processes, thus they cannot be followed like process documentation.
Using a process approach to document processes, Bill has one procedure to read. It tells him how to receive the next incoming package. Because this one procedure is robust enough to address multiple requirements, when Bill follows it, he complies with those requirements.