Putting ISO 9001:2000 to the Test

First Hand Experiences with the New Standard

By: Chris FitzGibbon

(Chris FitzGibbon, MMS, CSQE, CQMgr,CQA, is the Quality Manager at AMITA Corporation. AMITA Corporation, an Ottawa-based software development and consulting company, develops frontline database solutions for clients in government, and healthcare and travel industries, and is one of the first Canadian companies to achieve ISO 9001:2000 registration.)

ISO presentation

In December 2000, AMITA Corporation achieved registration through the Canadian General Standards Board (CGSB) to the new ISO 9001:2000 quality management system standard.

The new, more user-friendly ISO 9001:2000 addresses many of the concerns that users and skeptics of earlier versions of the standard had expressed. There is an increased focus on prevention of nonconformity, continual improvement, customer satisfaction and the principles of quality management. ISO 9001:2000 also places more importance on top management involvement and quality measurement, and less on documented procedures. These changes should increase the respect attributed to compliant organizations, and thus the value of ISO 9001 registration to organizations that achieve registration and their customers.

In 1996, AMITA became one of the first Canadian information technology (IT) companies registered to ISO 9001. The scope of the company's registration included ISO 9000-3 (guidelines for software development, supply, installation and maintenance) and ISO 9004-2, (guidelines for software servicing). In the fall of 1999, AMITA decided to continue its quality leadership position in the IT industry by becoming an early adopter of the anticipated ISO 9001:2000.

AMITA began the upgrade process to ISO 9001:2000 by performing a detailed gap analysis to identify the areas of non-compliance with the new standard. A thorough document review of its quality system produced a matrix that mapped, where possible, each of the ISO 9001:2000 requirements to an existing process. In addition to clearly identifying the degrees of compliance, the matrix also served as an excellent progress-tracking device and a helpful auditing tool.

The review enabled AMITA to make substantive improvements to its quality system, including:

  • Implementation of an improved measurement system, with measures of customer satisfaction, production efficiency and supplier performance;
  • Minor changes to the management review of quality system effectiveness;
  • Clearer definition of the process for continuous improvement;
  • Addition of regulatory and statutory considerations to the process for identifying requirements;
  • Modification of the design review process to include follow-up actions;
  • Inclusion in the design process of approval of design output prior to release;
  • Redesign of the internal audit procedure and schedule;
  • Addition to the quality manual of the scope of ISO registration (AMITA had no "permissible exclusions" as permitted by the new standard);
  • Several quality system improvements not directly related to ISO 9001:2000 compliance.

All AMITA staff received training on the modified processes as well as the underlying quality principles of ISO 9001:2000. Additional training on the new standard was also provided to the company's management team.

More than a month after implementation, an internal audit verified the effectiveness of the changed processes. AMITA was then ready for its formal ISO 9001:2000 audit.

The November 2000 audit by the CGSB focused heavily on the role of management, the identification and control of requirements, and the continual improvement process. Although ISO 9001:2000 is new, John Sargent, the CGSB auditor, demonstrated an excellent knowledge of the standard throughout the audit and especially during the closing meeting. The results of the audit were favourable, and Mr. Sargent recommended AMITA's registration to ISO 9001:2000.

The opportunity to put the standard to the test was exciting, and the exercise was a learning experience for all involved. The most time-consuming part of the entire process involved matching the requirements to existing processes. Investing in the development of an accurate matrix provides dividends throughout the upgrade process. In order to maximize the value of AMITA's quality system, our experience taught us that the new ISO 9001:2000 standard had to be properly interpreted and adapted for our own use.

For more information email Chris FitzGibbon at chrisf@amita.com or call (613) 742-6482 or visit the AMITA Corporation's Website at http://www.amita.com.


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