It’s Time to Delete ISO 9001’s Clause on Quality Objectives

As we undergo a revision to ISO 9001, this is the perfect time to fix one of the few mistakes that had popped up back in the 2000 version. That edition is widely seen as the best version of ISO 9001, but it had two or three mistakes in it that were, unfortunately, never corrected in subsequent editions.

One of those was the inclusion of a clause on “Quality Objectives.” From the 2000 edition:

Top management shall ensure that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.

This, itself, came from earlier language in the original 1987 standard, which referenced “objectives for quality” in the clause on the Quality Policy:

The supplier’s management shall define and document its policy and objectives for, and commitment to, quality.

Since then, the idea of “quality objectives” has been an embedded part of every ISO 9001-style quality management system (QMS). And, not to put too fine a point on it, has been wholly wrong.

History Lesson

To understand this, we have to go back to the evolution of quality systems. In its earliest days, the quality profession began, more or less, as a function involved in the inspection or testing of products. “QC” (quality control) emerged and set up an army of inspectors near the shipping door to stop bad product from getting shipped. This approach was largely adopted by the original MIL-Q-9858 standard, which then acted as the donor DNA for the eventual ISO 9001:1987 standard. But by 1987, the idea of QC inspectors having sole authority for quality was already debunked. Deming, Juran, Ishikawa and the rest had already been pushing for an evolution beyond this backwards approach for decades. These became more modern “quality management” and “quality assurance” approaches.

It took ISO  yet another decade to finally get on board, and in 2000, it introduced the (already aging) “process approach” to ISO 9001. This was the approach folks like Deming had been arguing must be adopted to replace the somewhat backwards idea of inspecting products to find defects after they’ve already been made. And here is where the authors of that standard made a rare mistake, one that still infects the standard to this day.

QC vs QA

Under a process-based QMS, the quality management system itself is a set of processes. The performance and effectiveness of each process, when taken collectively, then provide evidence of the performance and effectiveness of the entire QMS. Quality objectives, however, undo this arrangement and ask the company ot measure itself outside of the context of a QMS.

In this illustration, we see the traditional QC approach to quality objectives. The company merely exists, and the objectives are measured without any link to processes. This is because this method was established long before the process approach was invented.

So, the company would measure things like “first pass yield” or “scrap rate” but absent any context. So if the scrap rate was high, it was not immediately evident as to why, or as to what department in the company might be having problems, thus causing the high scrap rate. Was the sales department taking orders wrong? Was purchasing buying poor raw materials? Was the machine shop equipment causing defects due to a lack of maintenance?

A global “quality objective” that is not tied to the process approach provides no insight. It’s a meaningless metric on its own.

Consider the QMS like the human body. The body is comprised of organs, just as the QMS is composed of processes. If you go to the doctor and feel sick, he will eventually investigate to find out which organ might be causing the problem, and then treat that. The doctor cannot do anything to fix “the entire human body” at once and must understand where the problem is.

Under a process-based QMS, the objectives are set within the processes, and referred to in clause 4.4 of ISO 9001:2015 as “performance indicators.” We commonly refer to them as key performance indicators, or “KPIs.”

Now the objectives are no longer abstract, but tied to each process. When a process does not meet its objectives, we know immediately and at the same time where any problems are arising. If the purchasing folks are buying bad raw materials, we will know that long before defective product ever reaches final inspection. Corrections can be made beforehand, saving time, money, and resources.

Now we can also measure the overall performance and effectiveness of the QMS. We do this by reviewing the overall performance of the processes against their applicable KPIs. Here is what an ineffective QMS would look like, based on whether processes are meeting KPIs (green), almost meeting them (yellow), or failing to meet them (red):

And, then, this is what an effective QMS looks like:

By solely measuring some random, “global” objectives that are not tied to processes, we have deviated from the process approach and created two competing systems to measure performance.

How to Fix It

Back to ISO 9001. As I said, the earlier editions of ISO 9001 (1987 and 19914) discussed quality objectives because those standards were based on the 1950s standard, MIL-Q-9858. When the authors of the 2000 edition added the process approach, they should have removed the clause on quality objectives, recognizing they had set up two competing systems of measurement. They did not, and this was one of the few mistakes the team made at the time.

Since then, consultants have been unwilling to admit this obvious error and have instead created complicated, high-minded explanations to justify this after the fact. (In filmmaking, we’d call this “retroactive continuity” or “retconning“). They insist that (a) quality objectives and KPIs are entirely different, upon some imagined hierarchical order and (b) that the two can sit side-by-side unmolested.

They are wrong. 

In a process-based quality management system, the KPIs for each process are the quality objectives. There is no need for some higher, detached, ethereal — and thus meaningless — objectives.  If you have a global “scrap rate” objective and it fails, eventually you have to go back and find out which process is causing that failure anyway. You’ve wasted everyone’s time and made reporting on the QMS effectiveness murky and overcomplicated.

What ISO 9001:2026 should do, therefore, is embrace the process approach once and for all. This means deleting clause 6.2 entirely as it is made redundant by the process approach clause in 4.4.

Next, in 4.4, the authors should more clearly require “process quality objectives” and then indicate, in a note, that this may also be referred to as “key performance indicators,” so everyone knows what we are talking about.

Later, in clause 9, the authors must then return to the concept and insist that the quality management system be measured by analysis of the individual performance of each process per 4.4. This helps fix the standard’s current broken PDCA loop, which I talked about in this video. (Under the current standard, the authors promptly forget the process approach by the very next clause.)

ISO 9001’s authors need to decide whether ISO 9001 is going to require a process approach or not. Right now, we have a hybrid system that is partly based on the more contemporary process approach, but which still has elements of 1930s-style sweatshop manufacturing. It doesn’t work.

Alternatively, if they want to go all-in on random, detached “quality objectives,” they need to remove the process approach entirely. That would be disastrous, but they need to make a choice.