Sunday, December 20, 2009

Introduction to QMS

The idea that quality is something to be achieved, that it is a goal to strive for, is fully entrenched within the industries that manufacture things. As a matter of fact, in most cases it’s made explicit that you shall have a goal, and you shall measure and monitor quality in order to achieve that goal. In the manufacturing world, most companies won’t even consider doing business with you unless you have some formal Quality system in place; in this case that formal system may be one of the following:

AS9000, for aerospace manufacturers
ISO/TS 16949:2002, automotive
ISO 13485:2003, Medical
ISO9001, I’ll call this general manufacturing

All of these systems differ in very specific ways, but as a dogma, they all have 5 main elemental requirements in common. Those requirements I’ll spend some time digging into as I travel along this path I’ve chosen. For now, understand that every time you board a plane, hop into a motor vehicle, use a medical device, crack open a bag of chips, drink a can of pop, play a video game, type on the computer, throw a Frisbee to your dog, squat over a urinal, cook over a stove, etc. you’re are using a product that was manufactured within a Quality Management System (QMS). This QMS is an industry standard for manufacturing “things”.

My path within the next few months (I’m hoping) is to demonstrate how this QMS has divorced us as human beings from what it is we do. It is the very essence of a QMS that quality is an object to be attained. But let me take a step back here and ask a question; “What does Quality mean to the QMS?” In essence it means that we (as a given organization) have delivered a product that meets the customer’s expectations with respect to legal and regulatory requirements, operating specifications, dimensional characteristics, surface appeal, etc. Further, that it was delivered on time to their request, and at a price that fits their needs and expectations. That’s Quality to the QMS; and it should be noted that it’s a future state.

If you work in a manufacturing environment, or have ever had the opportunity to tour a facility that takes pride in their QMS, you’ll often find posters or banners on the wall that preach this mantra. I’ve even seen companies that place a mirror at the entrance to their manufacturing floor which states (with some variations) “Quality Starts Here.” How flippin’ witty is that? Hey, isn’t that me in that mirror? Let’s put mirrors outside of churches that say something like, “Jesus loves…” or, “The face of a sinner…” or, “God lives here…” Of course, the QMS doesn’t agree with your mirrored statement, and it doesn’t care about you. It only cares about achieving its goal – but more on that later.

The fundamental issue that I hope to make clear is that, as the result of the QMS being goal focused, it sees itself as trying to arrive at something, rather then simply traveling. As a further result of this focus, it can never arrive without (again) continually traveling down the path of divorcing the human. So there’s a clear distinction to be made here:

A.)The QMS “arrives” at Quality as the result of traveling down the path of human alienation. i.e. divorcing the human from the process.

B.)The human “arrives” at Quality as the result of forging and developing a relationship with the QMS, and in this way never truly arrives at anything, but always achieves.

In the post to follow, I’d like to start by talking about what the QMS is. My argument will simply be that the QMS is the institutionalization of Quality. By that (Quality) I don’t simply mean the institutionalization of “making ‘good’ widgets”, but the institutionalization of capitol “Q” Quality itself.

I’ll end (here) with an anecdote that perhaps I’ve shared here before, as I think it sets my trajectory along the right path:

We buy assemblies from a company located in India, and as of late, we’ve been experiencing a rash of quality issues with them; partly because much of what they’re doing is start up, or rather, it’s simply the first time they’ve made a given part and they don’t have the experience. The representative of the company comes to visit us every so often, and on one occasion I had been looking forward to a face to face as the result of a specific issue I had been trying to have formally addressed. Essentially I had been looking for “objective” evidence that a particular problem they were having was fixed. i.e. I wanted updated procedures and control plans. For reasons I didn’t quite fully understand at the time, he continually skirted the issue (seemingly not wanting to provide the information) and he stated, “Andy, we don’t look at Quality as you do, we look at it as peace of mind.”

I can’t tell you how happy I was to hear that. You’ll never hear a western organization speak in such ways. It’s not that they didn’t have a QMS (they actually do, and it’s the same as ours) it’s simply that their focus is not on the demands of the system, but on their relationship to it… Peace of mind.


  1. Anonymous8:23 PM


    I read a same topic 2 month ago. The topic helps me to improve my competency.

    Apart from that, below article also is the same meaning

    ISO 13485 standard

    Tks again and nice keep posting

  2. ...?
    the link is just a standard, not an article?

    If there's an article there (following the same line of thought as I'm headed towards), I'd be interested in reading it.

    Understand that my goal isn't to talk about QMS systems per se, but rather to talk about the consequences institutional thinking, rational thought, etc.