How Not to Fail at ISO9001-Clause 4.1

Here is a rundown on How Not to Fail at ISO9001–Clause 4.1, External Issues. The requirement is: The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction.

The organization shall monitor and review information about these issues.

How to address this requirement:

Well, the verbs here are “determine,” “monitor” and “review.”

The standard doesn’t say who in the company is supposed to do this, or how often they are going to review it, or who is supposed to “monitor” them. That’s up to “you,” the organization, as part of your conformity plan.

The external issues are probably harder than the internal issues.

In all likelihood, if your organization is complex enough to have a corporate planning department, someone has already done this and is already reviewing it. So, it is possible that with a little investigation, you can come up with objective evidence that this happened.

If you can’t find existing evidence of that, the question becomes: “who, in your company, is empowered to do this kind of thing?” In most businesses it is in the sales department’s job to do this. Someone in your sales department could have a pretty good idea about market trends, industry trends, demographics among your customers.

Who Decides External and Internal Issues?

Can “you,” the implementer of the ISO program get the sales department to do this? We should have a talk about empowerment later on.

Barring either of these, you can try to do this “yourself.” Some companies are not brainstorming-friendly, but maybe you can make a list of potential external and internal issues. That satisfies “determine.” As to the monitoring and reviewing, these are typically done in the management review process, whatever that looks like to you.

Your possible conformance plan is to make a list of these, and every year during the internal audit monitor and review them to keep them up to date. “Pandemic” might be on your list.

If you’re stuck on this here is a little table. I’ve made a few suggestions of typical external and internal issues.  Feel free to add more. Check the boxes when you’re finished monitoring and reviewing them. Keep this list around as objective evidence.

How not to fail: Internal and External Issues ISO9001 Clause 4.1

I used to do an auditing job nearby. The company was located in the back of a pleasant office park.

The first time I visited, there were a dozen employees, all working hard. The second time I visited, a year later, they were down to five.

The third time, it was the company president, her son, and the founder, who were operating the limited equipment. Eventually the company went out of business. The founder had to get a part time job to bring in some cash.

What happened? Well, the company was in the business of building little staph infection test kits.  The product was FDA approved, and there were patents issued.

These test kits were produced using a serum, which was extracted from some sort of protein, which was in turn extracted from some or all of the by-product of Atlantic Salmon fishing.

Things were going wonderfully until they weren’t. The kits stopped working.

The company never could really figure out what the story was, but the working theory at the time was that there was some change in the raw material supply. This was potentially some contamination by trout. Who knew?

They launched some investigation, and redevelopment, and eventually got to the point of closing the doors. A second side issue was that the management was approaching retirement age. That was definitely an internal issue.

This was a highly technically complicated product dependent on one raw material supply. That would have been external issue #1, stability of raw material supply.

At any point in the past, would it have been possible to do work to qualify a second source? We will never know. But, the ISO standard, as the voice of the customer, is asking you, “the organization,” to at least consider it.

Customer Perspective: Business Reasons for ISO9001 Clause 4.1

From the customer’s point of view, do they care about this? Yes, they do. The whole purpose of this requirement, along with the requirement about “interested parties” is to keep some external force from blindsiding a supplier. The publicly traded companies are all required to do this as part of their quarterly and annual stockholder reports for the same reason.

They don’t want you, the supplier, to be blindsided.

PS: Here is a link to my course on ISO9001 in Udemy:

Here is my link to Udemy course, “How Not to Fail at ISO9001”

https://www.udemy.com/course/how-not-to-fail-at-iso9001/learn/lecture/34733460#content

Here’s the link to my Quality Systems Training. You can hire me to give this training in person, complete with questions and answers, and along with a few decades worth of horror stories about product quality, dangerous products, and why people don’t do their jobs.

www.jimshell.com/quality-systems-training/

• external and internal issues
• ISO9001
• ISO9001 Course