Processes – Understanding A Key Concept And Harnessing Its Potential.
There is perhaps no concept more central or core to what ISO 9001 is all about than the idea of processes. The idea that an organization ought to be able to understand itself in terms of what it’s moving parts are and how they interact.
At the time the process approach was introduced (with the publication of ISO 9001:2000) it represented a radical shift in how an organization approached ISO 9001 certification. The prior two revisions of ISO 9001 preached an “elemental” approach top heavy with mandatory procedures and other documentation that felt superfluous in some cases. This had the unintended consequence of making a lot of organizations feel like their ISO 9001 system was an adjunct to their everyday business, rather than something that was blended with the everyday business. This was not what the framers had in mind.
Consequently, the 2000 revision of ISO 9001 tossed away the detailed, top heavy approach of procedures and began to promote the idea that an organization could decide for itself what it was and how it was built. This concept has endured and now appears in section 4.4 of ISO 9001:2015. The key phrase from this clause reads as follows: “The organization shall determine the processes needed for the quality management system.” Clause 4.4 continues with an equally important statement: “(The organization shall) determine the sequence and interaction of these processes.”
Therein lies both a challenge and an opportunity! The organization is permitted to either keep things simple in defining their quality management system, or to push themselves to whatever level of complexity makes the most sense (or adds the most value.)
Many organizations opt to define themselves in a very narrow fashion (which of course makes sense in a smaller organization.) Common process names associated with such systems are Sales/Order Entry, Purchasing, Manufacturing, and Support. As you might imagine, “Support” is intended to be a compressive designation, encompassing areas such as internal audit, management review, corrective action, training, and so forth. “Manufacturing” is intended to have similar collective qualities in this content.
As the organization gets larger and the nature of its activities get more complex, it’s natural (and probably beneficial) for the list of processes to get a bit longer. An organization may have a whole team dedicated to product inspection, and so could potentially choose to allocate “Inspection” as one of their defined processes. Similar decisions could be made for things like “Warranty Processing”, “Shipping”, or “Customer Support.”
Whatever approach you opt to take, it’s important to remember a few key ideas:
- Your processes should be reflective of who you truly are. If you have a unique business model that includes a process like “motor disassembly”, don’t be afraid to designate it accordingly. Having process designations that truly reflect who you are makes the quality management system your own and increases the “buy-in” you’re going to get from management and employees.
- Remember that all aspects of your quality management system revolve around your processes. Internal audits, training actions, KPI/goals, continual improvement efforts, etc. are all supposed to be structured around your processes.
- Your certification body will conduct its audits against your processes as well and will expect you to have a clear understanding of what they are, and how they interact.
- Remember that a process is not a single step, rather it is a series of steps intended to transform inputs into outputs. In addition, no process exists in a vacuum. It is intended and expected that your processes will interact with each other in an effective manner.
- While Procedures are no longer required, they are still important to your processes. They align your unique operating environment. Good procedures and work instructions provide a way to communicate and apply consistent standards and practices within your organization.
In defining a quality management system, the wise person takes careful consideration of what the processes are and how they interact with each other. Doing so can make your system much more value added to you, and can improve your certification experience dramatically.