Featured Product
This Week in Quality Digest Live
Standards Features
Bill Marler
New FDA rule proposes that farms conduct water assessments rather than previously required tests
Mike Richman
A standard, a framework, and a guess at the future of quality
Steven Severt
Looking at intent, realities, and possibilities
Roxanne Oclarino
ISO and IEC are taking an ecosystem approach to accelerate AI adoption
Dawn Bailey
A legacy of forward thinking kept medical center on its award-winning path

More Features

Standards News
Providing high-quality semiconductors in challenging times
Applications close Monday, January 10, 2022
Control System Integrators Association’s certification program demonstrates dedication to continuous improvement
Newly independent LRQA business brings together expertise in certification, cybersecurity, inspection, and training
World standards leaders issued a call to action to the heads of state
KinAiry system features 2.3-m reference bar custom-tailored to precision requirements of the ISO interim field test
First trial module of learning tool focuses on ISO 9001 and is available now
Both quality professionals and their business leaders agree that openness and communication is essential to moving forward
July 8, 2021, at 12:01 p.m Pacific standard time, 12 p.m GST, and 10 a.m Beijing time

More News

Dan Nelson

Standards

Three Ways ISO 9001:2015 Will Encourage a Process Approach

New draft provides more specific requirements

Published: Sunday, December 8, 2013 - 13:01

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.

Standard-based QMSs are designed to pass audits, not to manage quality. Because a process approach is required, standard-based systems shouldn’t even succeed in passing audits. But they do. That’s why the 2015 standard will again increase the emphasis on the requirement to apply a process approach.

ISO 9001:2015: again with the process approach

While the upcoming standard may provide more ways to promote a process beyond the existing introductory remarks and requirements found in ISO 9001:2008, here are three:

1. A general general requirement
Notice the general requirements of CD 4.4.2 very closely resemble the existing requirements of ISO 9001:2008 subclause 4.1. However, CD 4.2.2 makes at least two important contributions to clarifying the requirement to apply a process approach.

First, look at the very first sentence beneath 4.2.2: “The organization shall apply a process approach to its quality management system.” That seems pretty clear now that a process approach is indeed required. What may be less clear is that the existing requirements of ISO 9001:2008 effectively require a process approach already.

2. A specific general requirement
The CD includes a little more detail about the processes needed for a QMS, specifically at 4.2.2 b): [The organization shall] “determine the inputs required and the outputs expected from each process.” Notice that a standard-based QMS fails to address processes actually needed for the QMS (again, the same processes needed to output product), and this is clear by examining process inputs and outputs. Outputs from one core process constitute inputs to other core processes. QMS procedures should describe these processes, from input to output, also describing the controlled conditions under which these processes operate (conditions that happen to satisfy ISO 9001 requirements).

Following QMS procedures based upon the standard—either the clause-by-clause, standard-based approach or the six-procedure-only, standard-based approach—product is not output. For example, if in response to the standard’s requirement to identify product, an organization created a “product identification” procedure, that procedure implies a QMS process called “product identification.” The inputs to this process might be construed as being “unidentified product,” while the outputs might be identified as being “identified product.”

The same for, say, customer property requirements. Viewed as a process, inputs to the “customer property” process is product intended to be used somehow by the company. The output would be product that was somehow processed or used by the organization.

How do these QMS “processes” fit into the chain of core processes responsible for outputting product? They don’t. If they did, they would have been recognized as processes before ISO 9001 came along, like the rest of the core processes.

Operating upon the inputs and outputs defined by standard-based procedures, product is not output by the organization. These simply are not processes, let alone processes needed for a QMS. Following procedures responding to the standard, nothing happens. The defined system doesn’t work. As defined, the system is not effective. Neither is it therefore compliant with ISO 9001, but apparently that is not clear enough yet. So the standard continues to clarify.

To be sure, when establishing and documenting a QMS using a process approach, the resulting documentation describes actual core processing. Following procedures that describe how processes operate and interact, product is output. A process-based QMS is effective (or at least assessable for effectiveness.)

3. A requirement for top management
5.1.1 c) of the CD makes top management responsible for making sure QMSs are integrated into business processes. That is, systems defined according to the standard and then bolted onto processing are not acceptable, so top management is responsible for ensuring QMSs are integrated into business processes. A QMS should reside within, or be built into, the very processes that really output product.

Management has always been responsible for managing processing to output quality product. So the standard is not hanging any extra responsibility on management here. The system simply needs to be defined to reflect management’s planned arrangements for processing—as opposed to management’s planned arrangements to pass an audit.

If ISO 9001:2015 is effectively implemented by auditors, the standard-based approach will not only fail to help management manage, it will also fail to pass ISO 9001 audits.

It’s never too soon to adopt the process approach. A QMS defined by a process approach today will not change significantly in structure due to future changes in the standard's structure. A system designed to output quality product doesn't rely on a standard for its definition in the first place, so the structure of that system (like the documentation describing it) will not need to change when 2015 comes out. Process-based systems meeting 2008 will simply need enhancements to be robust enough to meet new requirements of 2015 and any future revision of ISO 9001.

Discuss

About The Author

Dan Nelson’s picture

Dan Nelson

T. D. (“Dan”) Nelson is a quality management consultant and trainer specializing in the process approach of ISO 9001 and related sector schemes. Nelson has 20 years of experience with ISO 9000 and years of experience as an IRCA QMS lead or principal auditor. He has also trained lead auditors in accredited course. Nelson also holds an MA in Business Administration from the University of Iowa. He is the author of The Process Approach of  ISO 9001 (Create Space, 2014, updated for ISO 9001:2015).

Comments

Very confusing article

You lost me several times. I'll read it again to see if it becomes clearer.

Sorry for the confusion

I'm sorry you are confused by the article. If re-reading it failed to clarify, please feel free to contact me.