It shouldn’t come as a surprise, but even after all these years the ISO9001 quality management system (QMS) requirements still come under attack and mostly from those in the quality profession. I recently read another super critical appraisal of ISO9001 from someone who commented they were on the “front lines.” I’m not sure what front lines they’ve been on, but it’s obviously not the same ones I’ve been on.
My experience with ISO9001 goes back to 1987 at a key division for a major company—so the journey has been a long one. I continued to be involved with ISO9001-based quality management systems for another 22 years that included corporate oversight and support of more than 60 registered facilities at a Fortune 50 company.
I never have stressed, and do not now, that ISO9001 is an end-all system. Experienced quality professionals should readily know ISO is just a beginning, not an end, to the journey. Any company that becomes certified and expects to have a fully effective QMS will likely be surprised and disappointed. The staff that helped drive the initiative, most probably the quality group and the managers, missed the point entirely.
There are those who envision the goal to be the certificate to hang on the wall, and there are those who understand ISO and strive to meet its intent as they move forward. It’s the former group that continually questions ISO’s usefulness and usually experiences frustration and ultimately realizes minimal benefits.
Taken by itself, ISO is not the entire QMS or the answer to all the issues confronting an organization. ISO is only the foundation on which to build an efficient and effective quality system. A house can’t be built without a solid foundation.
A solid foundation doesn’t equate to a 50 page quality manual that looks impressive but confuses everyone so nobody ever refers to it. Actually, ISO can be very flexible in allowing an organization to develop systems that meet their individual needs and greatly enhance their ability to improve and, maybe just as important, maintain their gains.
No one should really be surprised at the continuing pushback though. It’s really due to quality support and upper management lacking a thorough understanding of the ISO guidelines and their intention. One important example is excessive paperwork that seems to be the leading cause of disappointment. This is an indication that they implemented the ISO9001 requirements the wrong way.
While ISO does require a certain level of documentation, it absolutely doesn’t have to be a burden to an organization. It’s usually only a burden to those who don’t understand the requirements. A friend of mine works for a company who supplies to few major customers that have ISO9001 certificates. He often gets requests to complete long and complicated surveys. Their explanation is that they are mandated to do so by ISO requirements. Since there is no such requirement anywhere in the ISO requirements, this burden is entirely self-inflicted and can inflict more needless work on others.
Documentation can be plain, simple, and easily revised to meet challenging conditions, but only if it’s understood what’s required and how to deal with it effectively. That’s exactly why so many companies over-document and write procedures that are so broad and vague that they become absolutely useless.
Certainly the ISO requirements aren’t perfect so that’s why it’s updated every seven years or so. However, to gain a better understanding of current requirements I would suggest that those responsible for creation and deployment of an ISO9001-based QMS participate in training and open discussion with others with experience. The majority of companies have had positive outcomes from their experiences.
Those who continue to publish critical articles usually possess a narrow perspective. They not only do great disservice to their organizations but to the countless quality professionals who have spent so much time developing efficient and effective quality management systems.
It’s difficult to understand how people can develop their organization’s QMS, and then complain so hard about how much excess paperwork it contains! If you want a manageable QMS, then build it that way from the start.
When frustration or failure is experienced, it is usually due to lack of understanding. If you’re dissatisfied or frustrated with ISO9001, or considering implementing or revamping your QMS, it would be highly advisable to get some training and reach out to other quality professionals who’ve been successful in developing or managing an effective QMS. Doing your homework in the early stages is one way to achieve success.