Successful Implementation of the ISO 9001 Quality Standard in a Five Person Scientific Consulting Firm

Advice on ISO registration from consultants who have been through the process. Written By: Peter Child, MCIC and James Ford, MCIC.

In our business we often need to describe our policy and practice regarding quality to our clients, many of whom are not familiar with the local regulatory agencies that may have applicable standards. In Canada, the situation is made worse by the reticence of many of our government agencies to provide documented standards. In addition, we found that there are few accreditations or registrations that are applicable to firms offering scientific consulting services and fewer still that are internationally recognized.

We were initially drawn to the ISO 9001 standard because it covers not only the general aspects of conducting business but also the design of solutions - a focus of our firm. It is also internationally recognized. Having decided to strive to achieve the ISO 9001 standard in our own firm, the next step was to find out how. We found help in some unexpected areas and our experiences led to this article.

The Search For Help

As the ISO 9001 standards are primarily written for large manufacturing firms, it was not immediately obvious how to adapt many of the elements to a five person service company. We had heard that courses were available that qualified for a 50% government rebate. On looking further, we found that the courses typically cost in the $20 000 range (about $10 000 with the rebate), but provided no guarantee of success. We reasoned that for $10 000, we should be able to find a consultant that would come to our facility to help us directly.

The Canadian Manufacturers Association sells an ISO 9000 guidebook that contains the names of 45 consultants in Ontario advertising ISO experience. We contacted 28 of these in our area and quickly found that a significant number had less experience with ISO 9000 that ourselves. We put together a short list of six of the most promising and proceeded with interviews.

Our criteria for choosing a consultant were simple - they should have successfully implemented ISO 9001 in a small firm and they should be ISO 9000 registered themselves. In the group interviewed, only one met these criteria. All six submitted quotes. These ranged in price from $4500 to $30 000. The ISO-registered consultant gave a quote on the spot: $4500, providing a clearly defined set of deliverables and a guarantee of registration. This consultant also had experience with companies smaller that ours. They got the job.

Developing the System

ISO 9000 quality system is based on four tiers of documentation. The first is the Quality Assurance Manual - a general document outlining the company position with respect to quality with sections giving an overview of each ISO 9001 element. The second level is made up of a set of 20 Quality Assurance Procedures, each describing in more detail the quality system elements. The third level of documentation consists of hands on work instructions. The fourth level contains the forms used to document all of the quality related activities conducted by the firm.

The first two levels, the Manual and Procedures, are driven by the ISO standard themselves and are less apt to change than are the work instructions and forms. That being the case, our consultant was able to provide a boilerplate of a Quality Manual and associated procedures as a starting point. Our first step was to walk through the draft manual and modify it to fit our organization. In this way, a customized draft was finished in about four days of meetings over four weeks.

We found that it was not necessary for the consultant to have a complete understanding of the operation of our business in order to complete the manual and procedures. In areas where we were completely deficient, the consultant recommended a working system. Where we had an existing system in place, the test of the draft documents were modified to reflect our current system. This was a fairly painless procedure and did not require the detailed "flow-charting" and writing proposed by several consultants. The work instructions describing the day to day technical operations of our business were largely already written and needed only to be brought into a common format which allowed for control of any revisions. The necessary forms were created as we needed them in a commonly available word processing package.

The development of the documentation was largely complete in about three months. By that point, the Quality Assurance Manual, twenty Quality Assurance Procedures, about sixty work instructions and seventy forms had been prepared without seriously disrupting our normal business.

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