Three Ways ISO 9001:2015 Will Encourage a Process Approach

Three Ways ISO 9001:2015 Will Encourage a Process Approach

Based on a reading of the ISO 9001:2015 Committee Draft (CD), the 2015 standard will further clarify and emphasize the requirement to apply a process approach. Although the requirement has been resident in the standard since 2000, this fundamental requirement has been overlooked often enough to warrant further clarification and emphasis in the upcoming standard.

ISO 9001:2015 will further promote the process approach beyond the existing requirements of ISO 9001:2008 in at least three clear ways. First, how does ISO 9001:2008 promote a process approach?

ISO 9001:2008 already demands a process approach

Arguably, there are several provisions within the standard that, if interpreted properly, demand a process approach. Here, only a few are considered:

First, in the introduction of ISO 9001:2008 subclause 0.1—General, the standard explains to the reader that ISO 9001 is not intended to compel uniformity of quality management system (QMS) structure and documentation. This express statement of non-intent appears to be included to clarify that QMSs created in response to ISO 9001 requirements—and thus structured and documented according to the clauses of ISO 9001—are not acceptable QMSs. The standard never intended for QMSs to be designed in answer to ISO 9001 requirements.

Instead of being suited to ISO 9001, a QMS is supposed to be suited to the unique operations of an organization. A process approach demands that an organization's real, operational, core processes are developed in accordance with the "plan" phase of the plan-do-check-act cycle (PDCA). These are the processes needed for a QMS. QMSs are not, and were never supposed to be, composed of processes deriving from ISO 9001. (ISO 9001 does not describe or prescribe organizational processes, though it does recognize some common organizational functions, e.g., purchasing.)

Second, also in the introduction, this at subclause 0.2—Process approach, the standard explains to the reader that the process approach is based on the PDCA cycle, mentioning W. Edwards Deming by name. The idea of the process approach is, basically, to plan processes, perform them according to plan, assess performance, and improve the processes. Of course, when QMSs are structured and documented according to the requirements of ISO 9001, the processes defined as QMS processes do not match the processes of the organization. This disconnect is the cause of many headaches with ISO 9001. It's the difference between applying a standard-based approach (to ISO 9001 certification) and applying a process approach (to quality management).

Finally, in ISO 9001:2008 subclause 4.1—General requirements, contain requirements seemingly adequate to verify whether a process approach has been applied. After all, ISO 9001 is a standard intended merely to assess QMSs, not a standard for QMS design (as was previously addressed). The actual requirements of ISO 9001 don't tell us how to apply a process approach (that was done in the introduction); they provide an auditor with criteria to determine if a process approach has been applied by the organization to establish and document its QMS.

One important word is common in all of the subclauses beneath ISO 9001:2008 subclause 4.1 (a-f): process. It's all about process. 4.1 a) requires organizations to determine the processes needed for its QMS. To make this determination, management should look to its own organization, at the process operating today. Management should view those processes as processes and define them accordingly. The plan for how to carry out these processes is documented in a procedure. QMS procedures are supposed to reflect real organizational processes; they should not reflect the requirements of ISO 9001.

Establish a QMS using PDCA, not ISO

When QMS procedures pertaining to core processes are defined according to the standard, these are called standard-based procedures. They are not process-based procedures, as described above. Using ISO parlance, a procedure describes how a process is carried out. So if you have a procedure, you have a process that the procedure describes. QMS procedures describe QMS processes, i.e., processes needed for the QMS.

When procedures are written in response to ISO 9001 requirements, instead of being written to describe processing, the procedures suggest that QMS processes are different from core organizational processes. Notice that a system uniformly responding to ISO 9001 requirements does not describe how processing happens. It merely describes how processes comply with individual ISO 9001 requirements.

Following standard-based documentation, personnel would never output product at all, let alone quality product. The fact that quality product is being output suggests that a system designed to output quality product is in place. However, this system is the very system that is not defined using standard-based documentation.

Standard-based documentation was never designed to be a foundation for process transparency, consistency, and improvement. Process-based documentation is designed to do just that, again, per the plan phase of PDCA. QMSs raised using a process approach are designed to output quality product. Such systems are in place in any successful organization. QMSs should be documented to suit these very systems, being built into the very processes needed for these systems.



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