Article

Putting ISO 9001:2000 to the Test
First Hand Experiences with the New Standard

By Chris FitzGibbon MMS, CSQE, CQMgr, CQA
Published in: Capital Quality News, November 2000.

As a keen observer of the development of ISO 9001:2000, I was delighted when an Orion Canada Inc. client accepted the challenge to be one of the first companies in Canada to upgrade its quality system to the new standard. Although official publication of the standard is not expected until later this year, the company’s registrar offered to perform an assessment using the latest draft. This article summarizes some of the experiences and results of putting ISO 9001:2000 to the test.

The new and more user-friendly ISO 9001 addresses feedback from users and skeptics of earlier versions of the standard. In addition to the prevention of nonconformity, there is an increased focus on continual improvement, customer satisfaction and the principles of quality management. Greater importance is placed on top management involvement and quality measurement, while less emphasis is placed on documented procedures. The changes contained in the new standard are expected to increase the respect attributed to compliant organizations and thus the value of ISO 9001 registration to the beholder and their customers.

Orion Canada began the upgrade process by performing a detailed gap analysis to identify the areas of noncompliance with the new standard. A thorough documentation review produced a matrix that mapped, where possible, each of the ISO 9001:2000 requirements to an existing process. In addition to clearly identifying degrees of compliance, the matrix also became an excellent progress tracking device and a helpful tool for auditing.

Orion Canada recommended solutions to each area of noncompliance identified during the gap analysis. In all instances, compliance to ISO 9001:2000 was achieved by modifying existing processes. The client’s quality system required no new procedures to comply with the new standard. The following are examples of quality system improvements that were implemented as a result of the ISO 9001:2000 gap analysis:

• Implementation of an improved measurement system that includes measures of customer satisfaction, production efficiency and supplier performance;
• Minor changes to the management review of quality system effectiveness;
• Revisions to the process for continuous improvement;
• The addition of regulatory and legal considerations during the process for identifying requirements;
• The design review process was modified to include recording subsequent follow-up actions;
• Approval of design output prior to release was added to the design process;
• A system for verifying the effectiveness of training was implemented;
• The internal audit procedure and schedule were redesigned to fit the new standard;
• The scope of ISO registration was added to the quality manual (there were no ‘permissible exclusions’ as permitted by the new standard);
• The documentation review also resulted in several quality system improvements not directly related to ISO 9001:2000 compliance.

Training was provided to staff on the modified processes as well as the underlying quality principles of ISO 9001:2000. Additional training on the new standard was provided to the client’s management team. More than a month after implementation, an internal audit was performed to verify the effectiveness of the changed processes. Upon completion of the internal audit, the client was ready for their external ISO 9001:2000 audit.

A copy of the gap analysis matrix was provided to the registrar for use during their documentation review and audit preparation. The audit was performed at the end of May and focused heavily on the role of management, the identification and control of requirements, and the continual improvement process. The audit produced two findings:

• The client’s system for verifying the effectiveness of training did not meet the intent of the standard. The auditor found that the client’s use of ‘employee evaluations of training’ actually measured the appropriateness of the training rather than its effectiveness;
• The auditor also recommended a review of the ISO Management Representative responsibilities to ensure consistency with some related procedures.

Despite the findings, the results of the audit were favourable. However, the registrar advised that no claims of registration to ISO 9001:2000 could be made until after the standard had been officially published and a certificate issued. Because changes to the standard remain a possibility, the registrar reserved the right to conduct an additional onsite audit.

The opportunity to put the standard to the test was exciting and the exercise was a learning experience for all involved; in fact, it was even the registrar’s first audit using the new standard. The most time consuming part of the entire process was matching the requirements to existing processes. Investing in the development of an accurate matrix provides dividends throughout the upgrade process. And, ensuring that the new standard is properly interpreted and adapted for the specific organization is crucial to maximizing the value of the quality system.

The ISO 9001 upgrade concluded with the client reconfirming that compliance to the new standard was a solid investment. The Orion Canada website contains more information on upgrading to ISO 9001:2000, including links to the underlying principles of quality management and guidelines on the transition to the new standard.

Chris FitzGibbon is a Quality System Consultant with Orion Canada Inc. Through proven quality principles, Orion Canada Inc. assists its clients to improve efficiency, effectiveness and customer satisfaction. Orion Canada clients include World Heart, First Air, Plaintree Systems, AMITA Corporation, Department of National Defence and many other leading high tech, medical device and public service organizations. For more information contact Chris at chris@orioncanada.com or call (613) 563-9000.