The 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.
What is apparently less clear, is that the requirements demanding a process approach already reside in ISO 9001:2008. Notice the balance of the requirements beneath 4.2.2 closely resemble those of ISO 9001:2008, 4.1.
From the CD’s introduction, 0.3, Significant changes: “c) Process approach
ISO 9001:2008 promoted the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system. This proposed revision to the standard makes this more explicit by including clause 4.4.2 Process approach – specifying requirements considered essential to the adoption of a process approach.”
Here, the CD is saying that the requirement to apply a process approach is being made more explicit. In other words, the process approach is already required of ISO 9001:2008, the upcoming standard will make it more clear.
Why?
Because organizations failing to apply a process approach still succeed in achieving ISO 9001 registration, contrary to the intent and requirements of the standard. Enough organizations are doing this, and enough certifying bodies are accepting it, to warrant this needed clarification and emphasis to apply a process approach to management in order to achieve ISO 9001 certification.
EFFECTIVENESS PRECEDES CONFORMITY
4.2.2 of the CD adds a few clarifying requirements, among them 4.2.2 b [The organization shall] “determine the inputs required and the outputs expected from each process.” (It seems more clear to say, “determine the inputs required OF and the outputs expected from each process,” but oh well, it should be clear enough.]
This will help (or force) auditors to evaluate QMS effectiveness. Is the defined QMS effective? In other words, as the QMS has been established, does it work? Following established QMS documentation, is quality product output?
Systems defined according to the standard, using either a clause-by-clause or 6-procedure-only standard-based approach, do not describe QMS processing. Of course QMS processing occurs, resulting in release of quality product, but that very system of processes needed for the QMS is ignored by the established QMS, as defined. The QMS as defined doesn’t match the system in operation—the one outputting product. The QMS as defined describes something other than that system. As defined, the QMS describes how conformity to individual requirements is accomplished, it doesn’t describe how processing itself is accomplished.
Documented according to ISO 9001 requirements, procedures do not describe organization’s core processes, the ones that should have been recognized as the ones needed for the QMS in the first place. Looking to the standard to identify QMS processes, focused upon conformity to ISO 9001, the very processes really needed for QMSs were often overlooked in favor of (false) “processes” “needed” for ISO 9001 certification.
These “processes” are defined according to ISO 9001 requirements, then bolted on to processes. So core processes are lost among procedures dedicated to ISO 9001 requirements. Important process events and drivers escape description by documentation responding to requirements. ‘Process’ is lost among requirements.
On the other hand, process-based documentation describes a process first, in such a way that the controlled conditions of processing can be seen to satisfy ISO 9001 requirements. Using a process approach, the value of a procedure is primarily in its ability to help manage a process. It provides a foundation for process stability, transparency, consistency, and improvement. Representing management’s plan for processing, pursuant to the plan phase of the Plan Do Check Act cycle (PDCA), a good procedure gives the CDA phases of PDCA something to work on.
A standard-based approach renders a QMS merely as an audit solution, designed simply to address ISO 9001 requirements. Applying PDCA to pseudo-processes defined by a standard-based approach is senseless. PDCA works when it is applied to real processes.
HOW DO YOU REALLY DO IT?
Recognizing this, the CD is reasonably requiring organizations to consider what the inputs and outputs of their (real) QMS processes really are. Understanding that defined QMS processes based upon ISO 9001 clauses or subclauses are actually misdefined processes, the standard is requiring management to really (or, effectively) determine which processes impact product quality in their organization.
In a system that outputs quality product, the processes needed for that system operate upon inputs and produce outputs that are eventually intended for the customer who is paying for quality product. Each of these processes should be viewed and managed as a process, and documented accordingly. The for each process, the plan for processing is captured in a procedure that describes the process from input to output, describing the activities and controlled conditions under which these activities are performed to assure quality product results.
The inputs and outputs of processes defined by a standard-based set of ‘procedures’ do not work together to output product. Inputs and outputs of processes defined by process-based procedures DO work together to output product. As defined, process-based systems can be said to be effective when the dots are connected between the inputs and outputs to arrive at an understanding of how the system works to output quality product. These processes can be viewed as links on a chain, interacting where the output from one process is used as an input to another. In this sense, inputs and outputs reconcile as part of the system description.
As defined, standard-based systems provide no connection between dots. Inputs and outputs of the defined processes have nothing to do with each other, such process could not work together as a system to output product. As defined, these systems do not convey an understanding of how core processes operate together to ship product.
While those operating standard-based QMSs can claim that operations are conducted in accordance with QMS procedures, they cannot claim that operations are conducted according to QMS procedures, as those operating process-based QMSs can. The standard admonishes against the former, while endorsing and requiring the latter. The process approach is the future of quality management.
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