[This series of articles tries to emphasize the benefits of ISO 9001, and how to yield results from each major clause of the standard.]

As a change of pace, and in recognition that many companies are honestly seeking benefits from ISO 9001, it’s worthwhile to analyze each of the major clauses of ISO 9001:2015 to see how such benefits can be extracted from each. For now, I’ll put aside my criticism of the standard, and emphasize the positive aspects.

The “requirements” portion of ISO 9001 begins with clause 4.0 (the prior clauses are introductory, and do not contain requirements.) This clause is called “Context of the Organization,” and has created a lot of confusion for readers. I won’t go into line-by-line details on how to implement this clause (you’ll have to read my book Surviving ISO 9001 for that), but will summarize briefly what’s required here.

Clauses 4.1 and 4.2

The first two sub-clauses of this section (4.1 and 4.2) are to be taken collectively, and not necessarily in sequence. I find it’s easier to start with 4.2, for example. To comply with these, you need to first “determine” stakeholders (“interested parties”), and then their requirements and issues of concern. While the word “document” is not used here, listing these stakeholders and their concerns in a document or record is highly advised.

The point here is that by examining who is impacted by your QMS, as well as who has impact on it, is a critical first step in designing your QMS. This is why these requirements appear first. Yes, your customer is your primary “interested party,” but so might be your suppliers, your employees, regulatory bodies, etc.  If you don’t consider your suppliers and their needs, you may get surprised when they start shipping you defective raw materials, thus impacting on your customer.

Once you have your interested parties identified, listing their individual requirements and concerns is important. These will help inform your QMS, meaning these issues should be considered when developing your processes and procedures. If a key supplier requires 90-day minimum lead time, you may well have to ensure that purchasing procedures require 100-day advance notice from your employees, when requesting materials to purchase. Sales folks will have to know not to promise a 60-day delivery for your products, too, for example. This stuff matters.

Later, when we get to clause 6, these issues and stakeholders will become the driving intellectual fodder for the exercise in determining risks and opportunities, so we will be coming back to this in the future.

At this point, though, 4.1 and 4.2 are largely mental exercises (although I recommend using my COTO Log to capture the information.) The thinking here is that if you do not consider stakeholders and their concerns, your QMS will be a mess no matter what you do later.

Clause 4.3

The next sub-clause is called “Determining the Scope of the Quality System.” As you can tell, this is intended again to be an informative, mental exercise.  For most smaller companies, this is simply a statement indicating what you are selling, and thus what products and services the QMS is intended to cover. This gets more complicated when you have multiple sites or want to have some products covered by ISO 9001, and others excluded. Developing a scope in such cases usually requires careful consideration by your management team, and sometimes the input of a consultant, unfortunately.

The intent here is to know ahead of time what the QMS intends to cover, and what it doesn’t, before you get much further into developing the QMS. If you only want the QMS to cover Pittsburgh and not the San Francisco office, it’s best to decide this before doing anything else. Maybe you want ISO 9001 for your automotive products, but not your medical devices; again, this exercise allows you to decide that.

The scope statement is one of the few mandatory documents required by ISO 9001:2015, so you will need to write this down.

Clause 4.4 

The final sub-clause of section 4 is titled “Quality Management System and Its Processes.” This represents an update to the original “process approach” first introduced in ISO 9001:2000, and is a complicated subject; full implementation of the clause is not the intent of this article. Suffice it to say that you have to decide how to divide your company’s activities into “buckets” called “processes,” each of which will then be managed by the requirements of the bulleted list items (a) through (h) included in this clause.

I suggest doing this before 4.3, as you may later decide to modify your scope statement to exclude some processes, where you are able. Regardless, you should end up with a list of processes that cover all the activities for all of the products and locations defined in your scope statement.

The bulleted list items then require that you manage those processes (so don’t include any activity as a “process” unless you intend to manage it), measure them, and improve them. A small company may have a single “manufacturing” process, while a large one may have six or seven separate processes that all provide different manufacturing steps. This is entirely up to you.

The most critical thing to come away with is specific controls for each of your processes, which means measurable metrics that you then actually measure (don’t give lip service here.) Then, from the measurement data, you can take actions to improve the process, and thus ensure your products and services are 100% perfect, 100% of the time. That’s the goal, anyway.


For Clause 4, then, we have four sub-clauses which, when implemented properly, should result in the following tangible benefits for your company:

  1. Your full and adequate understanding of who, exactly, is a QMS stakeholder — and their unique concerns — will result in a QMS that not only seeks to satisfy the customer, but then can adjust itself to accommodate the needs or limitations of other stakeholders, such as suppliers or regulators. This means you will never be surprised by what anyone throws at you, and you can keep supplying high-quality products and services no matter what.
  2. Your carefully crafted scope statement will clearly delineate what the QMS applies to, and what it doesn’t, so no one is confused. This includes your employees, of course, but also your customers and regulators.
  3. The process approach may be the single, biggest potential source of benefits in the entire standard. Once you have carefully identified your processes, you can begin to measure them internally, rather than waiting for product rejections or complaints from customers to tell you how good or bad you are doing. With smart and meaningful process metrics gathering data in real time, you will know when your processes are deviating before they result in actual nonconformities. Escapes will be minimized, and real improvements to product and service quality are within reach. Yes, this is a hard clause to understand, but priceless once you have implemented it well.

Click here for the full series of articles on The Benefits of ISO 9001:2015.



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