What If ISO 9001 is No Longer Providing Value?

This is a loaded question when you consider that I am in the business of selling ISO 9001 consulting services. So why would I even broach this topic and shoot myself in the foot? My main objective is to inform you of ISO 9001 in plain English and in an unbiased manner. That’s the whole point of this blog (soon to be a website…assuming the web developers ever get around to finishing the job…but that’s another story). If I am fortunate enough to earn someone’s business as a result of what I am conveying on this site, wonderful. Obviously I want to make a living based on my expertise and interpretation of ISO 9001. Let’s analyze this loaded question in more detail.

The topic came to my attention today in speaking to someone who works for a very large, global pharmaceutical company. Essentially, this company no longer saw value in maintaining ISO 9001 certification so they dropped it. The company operates in a very heavily regulated industry. They have audits for regulation A one day, audits for regulation B the next and audits for regulation C the next day after that. Senior management felt ISO 9001 audits were getting in the way and actually became counter-productive. They felt confident in maintaining compliance to other industry regulations and I can understand why. [NOTE: I can tell you that ISO 9001 clearly served a purpose for several years and greatly benefitted the company. Unless an organization has poorly implemented ISO 9001, I can guarantee you they will always come out ahead. And remember, if you have a poorly implemented ISO 9001 quality management system, you are not going to pass your annual audit by the 3rd party registrar].

When I think further on this conversation, I have to wonder if senior management might have mismanaged ISO 9001. Did their ISO consultant drop the ball and/or was the Management Representative asleep at the wheel? What of the fact that this company operated in a highly regulated environment? Who is to say that regulation A, B or C aren’t outdated, unnecessary, redundant, poorly designed and ISO 9001 took the bullet?

I also wonder about who is measuring and defining “value”? In the opinion of this company, was the value derived from ISO 9001 a quantitative measure or a gut feel? Personally, I believe it is a best practice and the obligation of any company to quantitatively measure their key performance indicators using balanced scorecards in order to illustrate if the company improved from implementing ISO 9001. But the reality is a brain freeze or lack of understanding or misunderstanding on behalf of senior management is enough to kill ISO 9001 sponsorship and certification (as well as any other voluntary initiative for that matter).

It is important to remember that ISO 9001:2008 registration is optional and you need to pay for the annual audits conducted by the 3rd party registrar. However, there is no cost for being compliant to ISO 9001. That is, you can act or operate your business in a manner that is demonstrative of what ISO 9001:2008 preaches but whether or not you choose to pass the litmus test and get audited so that you can get the certificate and proverbial stamp of approval is up to you. I would not force any of my clients to become ISO 9001:2008 registered. The choice is theirs.