Successful implementation of the ISO 9001 quality standard in a five person scientific consulting firm.
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 9000 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 than 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 $4,500 to $30,000. The ISO-registered consultant gave a quote on the spot: $4,500, providing a clearly defined set of deliverables and a guarantee of registration. This consultant also had experience with companies smaller than 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 standards 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 text 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.
Gaining Experience With The New System
A common rule of thumb is that a firm should have several months of experience using their ISO 9000 style quality system prior to seeking registration. In practice, we found that by the time we had completed all parts of the system, we had gained many months of experience with most of the elements and we continued to make minor modifications right up to the date of the registration audit.
Implementation of a new system is one of the few areas where a small firm has a distinct advantage over a large firm. A combination of one-on-one and group training sessions worked well. Where possible, the staff were invited to develop elements of the quality system, thus providing their training at the same time. This was particularly successful during the development of our internal auditing procedures.
Selecting a Registrar
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. As the registrar is essential to the long-term maintenance of ISO 9000 registration, it is an important choice.
We invited quotes from three registrars. They ranged from $7,500 to $15,000. The amounts were higher than our consultant expected so we asked our preferred registrar about the basis for their costing. We learned that their quotation was high because of the number of forms and work instructions used at our facility. This apparently gave the impression that we were a much larger operation. The price from our preferred registrar was subsequently negotiated to $7,500 for the desk audit, registration audit and five maintenance audits over three years.
The Desk Audit
The first stage of the process, the desk audit, involves submission of the Quality Assurance Manual and Procedures to the registrar for review. This process is to verify that your system meets the standard. At this point, the registrar does not review your work instructions or forms. After clarification of some points, the registrar informed us that our system met the ISO 9001 standard. We were then invited to set a date for the on site registration audit.
The On Site Registration Audit
While the desk review confirms that your quality system meets the standard, it cannot verify that the system is implemented in your workplace. This is done in the registration audit.
To convince ourselves that the we were ready, we undertook two trial audits using our own people and a readiness audit by our consultant. The internal audits allowed us to refine our audit procedures as well a picking up deficiencies in our quality system. The exercise also served as valuable training for our staff. The audit by our consultant helped us to get over our initial nervousness as well as having an outside opinion as to our readiness. The consultant said we were ready.
The registration audit was performed by two auditors over about seven hours. The rules are that you are allowed several minor non-conformances so long as they do not reflect a major failure of the system. Failure to implement any of the major elements of the ISO standard is a major non-conformance and in most cases will stop the audit or cause a conditional registration to be issued, subject to re-audit.
We successfully passed the registration audit with only one minor non-conformance, about eight months after beginning work on the system.
What Did it All Cost
In all, development and implementation of the system required about twenty one days time for the Quality Management Representative, our term for the individual responsible for management of the overall system. This involved time for management, meetings with the consultant, training and writing. An additional eleven days of staff time contributed to completion of the system. This was largely the development of forms and internal audit procedures. At standard consulting rates, this combined time was worth $16,500. The out of pocket expenses included consulting fees ($4,500), registrar fees ($7,500 over the next three years) and about $500 for miscellaneous supplies and documents. The combined cost of time and expenses was just under $30,000.
The time and expense commitment does not end there. There is ongoing management of the quality system and twice yearly external audits required to maintain the registration. In addition, there are quarterly management review meetings, twice yearly employee reviews and quarterly internal audits. We have estimated that the time required to maintain the system and registration will be about twelve person days per year for the technical staff and about sixteen person days for the principals of the company.
Was It Worth It?
In a word, yes. Despite the considerable cost of developing and maintaining an ISO 9001 quality system, there are many benefits. The company runs better. We feel we have gained ground when competing with larger, but non-ISO, consulting firms. The mechanisms for dealing with deficiencies in the quality system work and force continual improvement. We now have a mechanism to track the performance of our suppliers and subcontractors and they, knowing this, offer higher quality service. It is too early yet to determine whether we will generate any new clients directly as a result of the ISO 9001 registration but the response from our existing clients has been overwhelmingly positive. Should such registration become the norm in North America as it has in Europe, we will also benefit by having paid in advance the price of doing business in Canada. If not, well, the company still runs better.
Peter Child, MCIC, and James Ford, MCIC, are the co-founders of Investigative Science Incorporated (ISI), a consulting firm with offices and laboratories in Hamilton and Guelph, ON. The firm offers services in the areas of soil bioremediation, regulatory pharmaceutical research and development, quality assurance, forensic science and industrial problem solving. ISI is IS0 9001 registered.
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|Publication:||Canadian Chemical News|
|Date:||Oct 1, 1997|
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