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CALA

S M L

Canadian Association for Laboratory Accreditation Inc.

Building Laboratory Excellence

17025 Amendments

Dear CAEAL Member:

CAEAL has been representing Canada at ISO/CASCO on the work to align ISO/IEC 17025 with the QMS language contained in ISO 9000:2000. Ned Gravel, CAEAL Quality and Training Manager, is the Canadian delegate to this ISO/CASCO/Working Group 25.

ISO/CASCO WG 25 worked for over three years to align the quality management wording of ISO/IEC 17025 with the wording in ISO 9000:2000. The results of this work are contained in the Adobe Acrobat pdf file.

The work of the WG was restricted to the QMS aspects only (mainly in Section 4 of the standard). Our options included simple citation to ISO 9000 to replace Section 4 (simplest method) and/or the verbatim plagiarism of ISO 9000:2000 (clause by clause) into Section 4 of ISO/IEC 17025. Whatever the solution, we needed to proceed on the assumption that:

ISO/IEC 17025 was going to retain its focus on technical competence, and not be a sector-specific application of ISO 9000, and Laboratories would continue to use only one standard (ISO/IEC 17025) to become accredited, instead of acquiring registration to ISO 9000 as a prelude to accreditation.

WG 25 met five times between January 2002 and July 2004. The authors of ISO 9000 accepted that our laboratory competence standard is based on different principles that those which govern ISO 9000 and they accepted our overall approach. The resulting modifications to ISO/IEC 17025 are relatively minor. You will note the addition of one clause to deal with "improvement" and some changes in wording to make 17025 more consistent with 9000. For example, a global change of the word "client" to "customer."

What this means to our laboratories is the following: No changes until the new standard is issued (Spring 2005), with an implementation period of up to three years.

There will be very little impact on the quality system implementation for most CAEAL laboratories - outside of a more rigorous consideration of "improvement."

A new standard may, or may not, be made available by the Standards Council of Canada (they hold the Canadian copyright to the standard).

If any member has any questions on this issue, and its impact on CAEAL, or on a member laboratory, please do not hesitate to contact CAEAL or Ned Gravel directly.