[This series of articles tries to emphasize the benefits of ISO 9001, and how to yield results from each major clause of the standard.]
Clause 9.0 is called “Performance Evaluation” and assumes you have completed providing your products and/or services. With that in mind, the standard now wants you to start gathering data so you can determine if your QMS is on track, or if you’re running the ship aground.
The clause is divided into three sub-clauses, so let’s take them one at a time.
The first sub-clause is divided further, with 9.1.1 being “Monitoring, Measurement, Analysis and Evaluation.” This prompts you to determine what you will monitor and measure. This is another poorly worded clause that actually violates ISO’s own rules on how to write standards. Standards are supposed to define what to do (not how), and here we see the authors offloading the “what” part back on the readers!
Whereas I complained about this in other clauses, the authors catch a break for 9.1, however. This is because in the next two sub-clauses they will tell you “what” to measure anyway, so they don’t entirely shrug their job on you. So 9.1.1 is weak, but you can ignore it because they are about to layer in more detail.
The authors commit another sin here. Where 9.1.1 says to “retain documented information” (meaning records) of this, ISO procedures would say that this requirement only applies to the requirements in 9.1.1 itself. If we read on, we find that 9.1.2 and 9.1.3 don’t require any records. Some folks have claimed — wrongly, I argue — that the requirement for records “flows down” to 9.1.2 and 9.1.3. If so, then ISO has lost all control over how to write standards, as one sub-clause should not contain requirements for another sub-clause. But, whatever… you can interpret this as such, and know that the rest of the clause will require records, even if the actual words don’t appear.
9.1.2 then says one of the things you need to measure is customer satisfaction. So, do that.
9.1.3 then goes further, and lists some other things you need to be measuring, too. The wording here is poor — it doesn’t literally say to measure these things, but instead says “the results of analysis shall be used to evaluate” them — but that means you have to collect data first. So, do these, too.
The next major sub-clause defines all the requirements for your internal audit program/process. I have to use both words here, since the standard flips back and forth throughout, not sure whether auditing should be a program or process. They are dumb.
This article series isn’t intended on going into detailed implementation advice, so I’ll summarize as such: you have to do internal audits, they have to be done impartially, you have to audit the full set of ISO 9001 requirements (meaning clauses), and you have to keep records of the entire thing.
Finally, the last sub-clause assumes you’ve done all of this, and it’s time to present it to management. The “management review” clause has been around since ISO 9001 was invented, and hasn’t changed all that much. 9.3.1 says to do the reviews, and schedule them. 9.3.2 provides a list of agenda items, which must be reviewed. 9.3.3 then defines what needs to come out as a result of this review.
While this is usually done as a “meeting,” the standard doesn’t require that, as such. It can be done in a variety of ways, but (again) that’s out of scope for this article. Just do it!
When implemented properly, Clause 9 should result in the following tangible benefits for your company:
- You will have a well-defined set of data that you can collect, from all sorts of sources, for the purposes of analyzing y our company and its processes as a whole.
- If these are well-defined, then gathering that data should be easier. The right people will know what data to collect, how to collate it, and how to crunch the numbers.
- All of this will get presented to senior management, who will review the data and make crucial decisions to steer the company ship.
- A good management review will have huge benefits, including improved communication within the company, clearly defined objectives, and goals, and will keep the senior management team engaged in actually directing the company.
- From the management review, you should also generate critically important opportunities for improvement, which can have dramatic results on the company’s overall improvement. Maybe this will result in huge problems being put before management for resolution, which could save the company itself; or maybe it will just be trends in problems that management can take action on, in order to improve a single product, or make a process more efficient. Maybe, still, it will just be an opportunity to let top management know where resources (staff, equipment, etc.) are needed.
The benefits of a solid management review, backed up by meaningful data, can’t be overstated.
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.