Do We Have To?

Every once in a while, when I’m doing an audit someone will ask me—in a whiney voice—about some ISO 9001 requirement. The whine sounds something like, “Do we really have to ________?” Fill in the blank with any of a number of “shalls” from the standard. They know they have to, but they’re hoping that I’ll give them some easy out so they can ignore the requirement or get by paying it minimal lip service.

The question ticks me off, and I bite my tongue because I like most of my clients, and I know they’re struggling to do the right thing. Also, like the vast majority of people, I need to work for a living.

Nevertheless, sometimes I really want to say, “No, you don’t have to do anything. You can choose to have a crummy, ineffective, minimally compliant system that creates no value and is a bloody waste of everyone’s time.” I don’t because I know that their question isn’t posed out of miserliness or indolence, but out of genuine confusion and frustration. They can’t figure out why some of this stuff is supposed to matter. Besides, good managers should be able to justify expenditures—even those originating from quality management systems (QMS) standards.

The fact is we haven’t demonstrated the value. Somewhere along the line we’ve failed to make the case. We’ve failed to show the return on investment.

How is it that some organizations have had systems for years and still don’t understand the “why” behind many of the requirements? How have we failed the market? What have we missed in all our publications, conversations, training, and conferences that make it possible for people to still ask the whiney “Do we have to?”

I think that, as consultants, we do a pretty good job of hammering in the requirements. We make sure that our clients know the “shalls,” so they can put together a compliant QMS. They can pass an audit and can perhaps even experience increased control and marginal improvement.

But, when it comes to ensuring that they’ve really internalized the myriad benefits they have a right to expect from their QMS, we are probably not as vigilant.

I divide effective QMS implementation into three categories:

• What you need to do to get through an audit
• What you should do so that your system is effective
• What you choose to do, using your QMS, to make your organization awesome

We need to do a better job of conveying just how cool an ISO 9001 system can be. It’s not just a matter of instructing them about the requirements. It’s also important for us to teach them how this will benefit their organization.

Let’s take, for example, the requirements relating to objectives. They’re sprinkled throughout multiple clauses. Why? Because they define the deliverables. This is the target we’re shooting for. If it relates to process it might be: “Decrease cycle time for new design to 18 weeks.” For a product, the objective might be to: “Increase the ambient temperature range in which the product can effectively perform by 15 degrees.”

Management communicates these objectives to the players who can influence the outcome. Further, they furnish the resources (time, tools, training, etc.) to facilitate the outcome. The process owners provide the data indicating progress toward the fulfillment of the objective, hence the need for the objectives to be measurable.

For the fulfillment of requirements relating to quality objectives to be compliant and value-added, there must be dialog with management and relevant process owners that connects the dots. We begin with the information that suggested the need for the identified objective. For the process, it was the need to shorten the design cycle to 18 weeks. Information indicates that the current cycle is 26 weeks. The cost of not addressing the objective could be loss of a customer or a sale. The value of the customer’s business or the individual sale creates the mandate for the objective. Periodic monitoring measures progress toward the goal. If you don’t measure, you have no way of knowing how you’re doing. You’re also lacking data that’ll help you determine how much it costs in time, resources, and manpower to achieve the objective. It’s basically a calculation of return on investment.

So, objectives are an effective and efficient tool to see how you’re doing. They can be communicated in easy charts and graphs, increasing the number of individuals who can grasp the effect of their contributions on the organization’s success.

The point is that most of the requirements in ISO 9001 can be presented with similar examples of cost benefit. Regardless of the clause—competence, document control, outsourcing, design, preventive action, etc.—there’s a benefit to be derived from effective implementation.

Management needs to know that the answer to the question, "Do we really have to _______?" is "No." The choice is theirs. The results of those choices will predictably fall into one of the following categories:

• If you have a barely compliant system, you have spent money
• If you have an effective system, you have invested money.
• If you have a robust system, you will make money.

The next time someone asks, “Do I have to?” remind them that the choice is theirs.

About The Author

Denise Robitaille

Denise Robitaille is the author of thirteen books, including: ISO 9001:2015 Handbook for Small and Medium-Sized Businesses.

She is chair of PC302, the project committee responsible for the revision to ISO 19011, an active member of USTAG to ISO/TC 176 and technical expert on the working group that developed the current version of ISO 9004:2018. She has participated internationally in standards development for over 15 years. She is a globally recognized speaker and trainer. Denise is a Fellow of the American Society for Quality and an Exemplar Global certified lead assessor and an ASQ certified quality auditor.

As principal of Robitaille Associates, she has helped many companies achieve ISO 9001 registration and to improve their quality management systems. She has conducted training courses for thousands of individuals on such topics as auditing, corrective action, document control, root cause analysis, and implementing ISO 9001. Among Denise’s books are: 9 Keys to Successful Audits, The (Almost) Painless ISO 9001:2015 Transition and The Corrective Action Handbook. She is a frequent contributor to several quality periodicals.