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 provided 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 $7500 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 forums 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 $7500 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 submissions 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 system audit.

The On Site System Audit

While the desk review confirms that your quality system meets the standard, it cannot verify that they system is implemented in your workplace. This is done in the registration audit.

To convince ourselves that 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 as picking up deficiencies in our quality system. The exercise also served as a 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 ($4500), registrar fees ($7500 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.

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