The requirement that processes are identified, defined, understood and measured is (supposedly) a fundamental requirement of ISO 9001. But is it ever really examined?

In this article we look at the intent of ISO 9001 and contrast that with how things tend to work in reality, with intention and reality often being two quite different things

Processes – what’s the big deal?

It’s a reasonable question. Why exactly do we need to build and manage our system from a process perspective when there are clearly other ways of doing things? What’s the big deal?

Well, let’s look at the merits and weaknesses of the traditional procedure-based systems. First the merits. Procedure-based systems can set clear standards of operation and execution, they can promote consistency through the use of system documentation, and they can be audited. Procedures do have a value and, typically, focus on the execution of tasks in the correct way (i.e. they have a clear conformance focus). All good so far, now for the main weakness. It is well nigh impossible to establish the efficiency of a system from a procedural perspective. Conformance yes, efficiency no – and efficiency is important

Basically, if we do not understand our end-to-end workflows we have no basis for establishing whether things are as efficient (quick, cost effective etc) as they could be. Our system could well be afflicted with all manner of bottlenecks, delays, duplication and misunderstandings and our procedural scrutiny will simply not pick them up. This is because weaknesses of this type tend to occur at interface points – in the gaps between procedures – that is, in those places we aren’t looking

That, in a nut-shell is why we need to understand and manage our processes

How does ISO 9001 examine the “process approach”?

In summary, not very well. The intent is laid out in clause 4.1, however take a look at this discussion thread on the IRCA Forum relating to the examination of Clause 4.1 (General Requirements). Note how some contributors have taken the view that clause 4.1 is effectively met by default provided that conformance across all other clauses is strong. Let’s think about that for a moment, is that quite right? There is no doubt that a “General Requirement” is difficult to audit by definition, in so much that an audit criteria should enable clear and objective evidence based assessment, and “general” standards are at odds with that principle. But let’s take a closer look at the “general requirements” of clause 4.1. There is one word that pops up time and time again, and that word is “processes”. Processes need to be identified (a), their sequence and interactions need to be determined (b), criteria and methods for control need to be applied (c), resources need to be allocated to them (d), they need to be monitored and measured (e), and planned with a focus on continual improvement (f). The other clauses of ISO 9001 simply don’t pick up on all of these points
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