What are some of the Benefits?

There are many parts of the system that we absolutely love, but there are three in particular. These are the non-conformance system, our quarterly internal audits and the effect on suppliers.

The non-conformance system is a way of documenting problems occurring within the company. All staff at our firm are encouraged to use the system. They all know that initiating a Non-Conformance Report describing the problem will result in management action. The paperwork is also an excellent way of documenting the followup (corrective or preventive action, as it is referred to in ISO jargon).

Our internal audits are conducted quarterly. All staff are included. By agreement within our own organization the company owners may not be internal auditors, but they are audited by staff.

We have found that these two systems drive most of our internal improvement efforts. Internal audits are also a great learning tool for new staff. We have found that if we wish a staff member to learn a new skill, you couldn't ask for a better training tool than to have them perform an audit of someone else doing the job.

The effect of registration on our suppliers has been interesting. Knowing how the ISO 9000 systems work definitely helps you to get the most out of your suppliers. Here's an example. Recently two of our automatic pipettors failed suspiciously in the same way, about a month apart. We contacted the Canadian supplier, who is not ISO registered, and were told that yes, there was a design problem but they could be repaired for about $200 each.

We noticed that the original manufacturer was ISO 9001 registered. We contacted them. Two new pipettors were delivered, free of charge, in a few days.

Most of our chemical or equipment suppliers are now ISO 9000 registered. Many laboratories have adopted ISO 9002, ISO 25 or similar standards. Fewer of our professional service providers have adopted the standards. Our legal counsel saw value in the process for his own business but our accountant was horrified at the suggestion that her signature was not enough proof of her competence. None of our consulting colleagues are registered. Our internet service provider could sorely use the lessons taught by ISO.

What are the downsides?

For us, there is one major downside - the registrars! One of the strengths of the ISO 9000 system is that a third party, called a registrar, verifies that your system meets the standard and is in continuous use. In our view, however, they are the weak link in the process in Canada.

The problems begin with the auditors. There is clearly a shortage of lead auditors with enough experience in consulting chemistry or laboratory science to conduct a meaningful audit. In our experience with two different registrars, there is also a problem with staff turnover. One registrar had such a problem keeping auditors that they actually told us it was their policy to use a different auditor each visit. On checking with other registrars, we learned that no one else had such a policy.

As a result of a general dissatisfaction with the service provided by our first registrar, we chose to change registrars for our second three-year term. Although the changeover went smoothly, six months later, the gentleman with whom we had developed a good working relationship was let go in a management shuffle. Clearly in making their "business" decision, they did not consider that we had invested considerable time helping the auditor understand our company.

There is also the issue of confidentiality. In three cases, disgruntled ex-auditors subsequently became consultants who were in a position to directly compete with us. The take-home lesson is that you need to have confidentiality agreements that bind each auditor personally before you open your soul to them. Of course, the registrars expect us to bear the cost of this.

Unfortunately, there is stiff competition between registrars for your business. As a result, most engage in practices, such as offering training courses or consulting, which should be off-limits to them. In our experience with two registrars, the front office service, the part you deal with, is often chaotic. In more than one case, memos and faxes from us were lost. Overall, in our four year experience, the service of our registrars has been less than stellar.

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