[This series of articles tries to emphasize the benefits of ISO 9001, and how to yield results from each major clause of the standard.]
Clauses 4, 5, 6 and 7 of ISO 9001:2015 dealt with higher-level planning and structure of the QMS, and assume that you are using the standard to devise it as well as structure key elements of your company. Clause 8 gets down into more of the day-to-day, nuts and bolts of operation of the QMS, now that it’s been planned and launched.
This section is the largest of the entire standard, so we need to delve into each sub-clause separately. The first is 8.1, called “Operational Planning and Control.”
I’ve written at length about how this clause is confusing to many, and often overlaps with clause 8.5.1, which we will discuss later. Suffice it to say, you may want to carefully read both clauses (8.1 and 8.5.1) and decide when and where to apply their lengthy bulleted lists of requirements. The thinking is that the list of 8.1 should happen at a higher level, with the list in 8.5.1 applying only after a given job is taken and underway, but I think this view is limiting. You’ll likely have to bite both of them at the same time.
Limiting our discussion to 8.1 for the purposes of this article, however, we see the list is prescribing some ideas on what you should be thinking about when developing the “operational” processes. In Clause 4.4, the standard asked you to develop your overall QMS processes; ISO is assuming, here, that you will have to take a second swing at this, but at the operational level. Many companies find that’s not necessary, and they’ve already considered and developed operational processes as part of 4.4. If that’s true for you, don’t worry, that’s great. If not, then 8.1 gives you a list of things to consider for the processes involving day-to-day activities.
There’s some leftover language from ancient ur-texts that predated ISO 9001, hinting at the use of “quality plans.” These had fallen out of favor in the 2000s and 2010s, but I do see a resurgence as companies see a need to tailor their QMS to suit specific customers. Quality plans are not a requirement here, but they do help satisfy this clause.
If we look ahead to the remaining sub-clauses in section 8, we get an idea of what “operational processes” are of interest to ISO 9001 here. They are asking you to consider any processes related to the intake of customer orders (covered later under 8.2.), the design of product (8.3.), purchasing (8.4.), production or service provision (8.5), inspection and testing (8.6) and nonconformity control (8.7.) That should help focus your thinking. So you can use the list in 8.1 to go back and review your process breakdown from 4.4, and check to see if you have properly defined processes related to the requirements of these clauses, and have put in the necessary controls for them.
When implemented properly, Clause 8.1 should result in the following tangible benefits for your company:
- The activities related to intake of customer orders, the design of product, purchasing, production or service provision, inspection and testing and nonconformity control will all be well thought out before you take on work. This will reduce surprises and nonconformities.
- You will have suitable means of measuring these “operational processes” in real time, so that if the processes start to deviate, you will know before a nonconformity is encountered.
- You may develop customer-specific or product-specific “quality plans” which help tailor the QMS for those cases.
Click here for the full series of articles on The Benefits of ISO 9001:2015.
About Christopher Paris
Christopher Paris is the founder and VP Operations of Oxebridge. He has over 30 years' experience implementing ISO 9001 and AS9100 systems, and is a vocal advocate for the development and use of standards from the point of view of actual users. He is the author of Surviving ISO 9001 and Surviving AS9100. He reviews wines for the irreverent wine blog, Winepisser.