In Europe, more and more medical labs pursue ISO 15189 certification. This standard is based on ISO 17025 (thus also on ISO 9001) but with more specific demands and guidelines specific to medical labs. In 2007, an updated/revised version was published for a standard dating from 2003. Despite the fact that it is not an obligation in Europe yet, the European medical world invests more and more to get certified. In the United States where FDA rules the medical world, it is a requirement. Therefore, companies that want to be active on both continents will be facing a double certification for a while.

A lot of companies are wondering why they should get accreditation for their quality system. Here are my top three reasons, not necessarily in the specific order of importance:

1. To give a (commercial) signal of trust to the market/customers about the qualitative approach of your organization.
2. To get external “objective” pressure (in order to force yourself to KEEP ON working on it).
3. Because a customer or the market requires you to.

The second reason is in fact the most important one to discuss, especially because it’s the only reason that comes out of free will. If a customer or the market demands it, you have no option. Opting consciously for accreditation is something you do in order to create that pressure. An objective authority checking up on you on a regular basis to see whether you’re still reaching your goals and demands makes sure you don’t lose focus. Whenever this external pressure is gone, companies tend to slide back to their old (bad) habits. All the previous excuses (too busy, too bureaucratic, we have to be “flexible”…) are stated again and cause a return to old ways of trying to meet quality requirements.

The draft for the new version of ISO9001 was brought to a vote until end of February 2008. In this version, ISO9001:2008, a few minor changes and amendments were added. A quite drastic change is the explicit statement that the management representative has to be chosen from the own organization. Does this mean interim quality management or outsourcing will come to an end?

I can understand the concerns of ISO about the “outsourcing” of quality management and control but I’m also afraid they added a demand that’s very hard to enforce. Such a statement leaves a lot of room for interpretation so all will depend a lot on the auditor how this will be evaluated. How will an auditor deal with a company where the official “QA Manager”, sharing this function with a lot of other functions, is assisted by an external QA Assistant (outsourcing)? Officially, the management representative is someone internal to the organization, fully complaint to the ISO9001:2008 guidelines but in reality the full quality system is set up and maintained by an external consultant.

The future will teach us how auditors will deal with this, at least if the text will be approved in full. Time will tell!

During the 13 years we’ve been developing and implementing software for quality assessment, I noticed an obvious evolution in the way people are working on achieving a quality standard.

Mid to late nineties a considerable number of companies were only trying to get a quality standard for the sole purpose of business growth. Especially subcontractors were required to obtain one or more to be able to provide services particularly to bigger companies. They wanted the sign up on the wall in the lobby and the reference on their website and correspondence.

Meanwhile, other companies were doing great efforts on getting accredited in order to really improve their business and customer experience. You could easily distinguish them by the vigorous way they were working towards their goals and how to perfectly apply the advantages of working on quality.

It would probably be bold to claim that the ratio was about 50/50. Still, that was my impression.

Needless to mention that the second kind was destined to grow more than the first kind.

Fortunately, things have changed. Today almost every company achieving a quality standard really appreciates the opportunity of staying up with the everyday more and more competitive market. They are truly looking at the advantages of constantly working on quality.

The demands of the ISO9001:2000 standard also are more focused on real quality improvements.

It took them more than a year but here it is:

The worldwide première of a video clip on the International Standard ISO 14001 took place on 24 June in Beijing, China, at the opening of the 14th plenary meeting of ISO technical committee ISO/TC 207, which is responsible for the ISO 14000 family of environmental management standards. ISO Secretary-General Alan Bryden introduced the clip as one of a number of initiatives undertaken by ISO and its national members since last year to celebrate the 10th anniversary of ISO 14001, the first standard in the family.

Launched in 1996 and republished as a new, improved version in 2004, ISO 14001 gives the requirements for an environmental management system (EMS), which is a tool for helping organizations to implement good environmental practice and to aim for continual improvement of their environmental performance. ISO 14001 has become the international benchmark for EMS, implemented in 138 countries and now thoroughly integrated with the global economy.

The movie can be downloaded from the ISO website: http://www.iso.org/iso/pressrelease.htm?refid=Ref1061