ISO/IEC 17025 - ENHANCING THE COMPETITIVENESS OF CALIBRATION AND TESTING LABORATORIES J. Graham Cameron Standards Council of Canada Program for the Accreditation of Laboratories-Canada Specialist Tel: (613) 238-3222, ext. 496 Fax: (613) 569-7808 [email protected] Abstract: ISO/IEC 17025 – 1999 is the "Base Standard" that has been adopted on a global scale for testing and calibration laboratories. It is an integral component of the Mutual Recognition Arrangements and Agreements that enable calibration certificates and test reports to gain acceptance by Accreditation Bodies and their accredited laboratories in many countries. The proposed "8 Principles of ISO/IEC 17025" are provided. Comments from laboratory managers and laboratory assessors are presented along with a study illustrating the relative performance of "Accredited" and "Non-Accredited" laboratories. The paper highlights the growing utilization of accredited laboratories by specifiers, such as government agencies and the community served by QS 9000.

INTRODUCTION The aim of this paper is to identify and discuss the advantages to laboratories for the transition from ISO/IEC Guide 25 [1], which was introduced in 1990, to ISO/IEC Standard 17025 [2], which became available in 2000. It captures the main reasons for this change and discusses the added values this recent document brings. Concurrent with this development is the establishment of Mutual Recognition Arrangements (MRAs) that have been put in place in the past two to three years. The power of these "Technological Linkages" in the context of global trade has become an important "outreach tool" for countries like Canada and Mexico that rely on the timely acceptance of components and systems they produce. The system of MRAs between Accreditation Bodies enables accredited laboratories to achieve a form of international recognition. As the persons in our audience today are aware, laboratory accreditation has been a growing activity that started many years ago and moved from the point of "Should we become accredited?" to "What is the best strategy we can adopt to become accredited?".

ISO Guide 25 came on the scene in 1978 followed by ISO/IEC Guide 25 in 1982. The latter document was revised in 1990 and was superceded by the "standard" ISO/IEC 17025 in 1999.The dates for transition from ISO/IEC Guide 25 to ISO/IEC 17025 vary depending where you are in the world and the mechanisms different countries can or are required to utilize to adopt the new standard. Some Accreditation Bodies can adopt and readily establish a schedule for its implementation while others must initiate action to amend their legislative documents to introduce it. The International Laboratory Accreditation Cooperation (ILAC) organization has set time lines for the implementation of ISO/IEC 17025 - all labs to meet criteria by December 2002. Components and sub-systems made in a country, like Mexico, that are critical to the performance of systems in Canada or the USA need to conform to fit and performance criteria. 17025 provides the laboratory conducting these tests and measurements with a sound operating framework, which enables the reports and certificates flowing from that facility to gain acceptance throughout the greater part of the world.

CANADIAN CONFORMITY ASSESSMENT SYSTEM The Standards Council of Canada (SCC) is a federal Crown corporation that oversees Canada's National Standards System. Its work falls into three principal areas. Standards Development, Conformity Assessment and Intergovernmental Affairs and Trade. This presentation focuses on the Conformity Assessment aspects, particularly Laboratory Accreditation. Those who brought the SCC into being in 1970 established its organizational placement to best benefit our nation and its citizens. It reports to the Canadian Parliament through the Minister of Industry thus giving it a close interface with Canadian industry with sufficient latitude for close cooperation but with the "government" connections necessary for its functions and the establishment of formal relationships with regional and international organizations.

The SCC delivers laboratory accreditation services with the help of a number of partner organizations, each with specialized competency and capability. Of interest to this audience is our partnership with the National Research Council of Canada. The Standards Council of Canada, together with the Calibration Laboratory Assessment Service of the National Research Council of Canada (our national metrology institute), operate an accreditation program for secondary calibration laboratories. INTERNATIONAL AND REGIONAL ACCREDITATION LINKAGES

Figure 1 depicts the Conformity Assessment System and the Testing/Calibration Laboratory element on the left-hand side formed by some 329 accredited laboratories, recognized facilities and ProfficiencyTesting providers with 90 applications in progress.

Fig 2 Figure 2 shows the organizations in which the SCC holds memberships - The Interamerican Accreditation Cooperation (IAAC) and the North American Calibration Committee (NACC) on the left side. SCC holds memberships and has met the criteria to become signatory to the Arrangement and Agreements of the other four organizations. Regional organizations have solid outlines and International organizations are identified by dotted outlines. Fig 1

As the SCC Delegate to the NACC, I work closely with the CENAM Delegate and the entidad mexicana de acreditación (ema) delegate. In addition to serving on NACC, the National Research Council of Canada, acts as the Coordinating laboratory for many of the Interlaboratory Comparisons (ILCs) that has enabled Canada, Mexico and the USA to sample the performance of its accredited calibration laboratories. CENAM and the National Institute of Standards and Technology contribute in the same way. The National Cooperation for Laboratory Accreditation (NACLA) represents the US Laboratory Accreditation System on the committee. I represented the SCC on the IAAC WG 5 (Calibration and Testing) Committee meeting held last year. MAIN ISSUES OF THE PAPER The BaseStandard ISO/IEC 17025 is the Base Standard accepted by these Regional and International organizations for laboratory accreditation. It is the document being used by practically all national metrology institutes in the development of their quality systems. Those familiar with the ISO 9000:2000 and ISO 9004:2000 will be familiar with their 8 principles [3,4]: •

Customer Focus

• • • • •

Leadership Involvement of People Process Approach System Approach to management Continual improvement

• •

Factual Approach to Decision Making and Mutually Beneficial Supplier Relationships

Work is currently underway by the International Organization for Standardization's Committee on Conformity Assessment (ISO CASCO) Working Group 25 [5] to similarly state the eight principles of ISO/IEC 17025. [Figs 3-11]

An examination of the principles that follow gives us the insight needed to comprehend why this standard has been so well crafted to serve: • the laboratory community, • the laboratory accreditation and assessment organizations establishing that laboratories conform • the various conformity assessment, specifiers and regulators that rely upon tests and measurements and • the national metrology institutes supporting the top echelon of national measurement systems. Figs 3 to 11

Capacity Concept that a laboratory has the resources (PEOPLE with the required skills and knowledge, the ENVIRONMENT with the required facilities and equipment, the QUALITY CONTROL, and the PROCEDURES) in order to undertake the work and produce competent results.

Exercise of Responsibility Concept that persons in the organisation have the authority to execute specific functions within the overall scope of work – and that the organisation can demonstrate accountability for the results of the work.

Scientific Method Concept that the work carried out by the organisation is based on accepted scientific approaches, preferably consensus-based, and that any deviations from accepted scientific approaches can be substantiated in a manner considered generally acceptable by experts in that field.

Objectivity of Results Concept that the results produced within the scope of work of the organisation are mainly based on measurable or derived quantities. Concept that subjective test results are produced only by persons deemed qualified to do so and that such results are noted as being subjective or are known by experts in the field of testing to be mainly subjective.

Impartiality of Conduct Concept that the pursuit of competent results through the use of generally accepted scientific approaches is the primary and overriding influence on the work of persons executing tests - all other influences being considered secondary and not permitted to take precedence.

Traceability of Measurement Concept that the results produced, within the scope of work of the laboratory, are based on a recognised system of measurement that derives from accepted, known quantities (SI system) or other intrinsic or well-characterised devices or quantities.

In summary, the Key Word in the title of ISO/IEC 17025 is competence, and requirements for technical competence is the primary purpose of this Standard. These principles and the fact that this standard is clearly divided into two main sections: 4 - Management (Quality System) Requirements and 5 - Technical Requirements, make it easy for us to realize that assessors working in each section must have open communication. Section 4 supports Section 5 by giving the requirements for a Quality Management System that is best designed to support the production of competent results. Examples are: • The Technical Assessor (TA) should assess the 4.12.2 Technical Records • The goals with respect to education and training under 5.2.2 Personnel require the attention of both assessors.

Traceability of Measurement (Continued) Concept that the chain of comparison of measurement between these accepted, known quantities or intrinsic devices or quantities, and the device providing the objective result, is unbroken for the transfer of measurement characteristics, including uncertainty, for the whole of the measurement chain.

Repeatability of Test Concept that the test which produced the objective results, will produce the same results, within accepted deviations during subsequent testing, and within the constraints of using the same procedures, equipment and persons used during a previous execution of the test.

Transparency of Process Concept that the processes existent within the laboratory producing the objective results, are open to internal and external scrutiny, so that factors which may adversely affect the laboratory's pursuit of objective results based on scientific method, can be readily identified and mitigated.

Since technical performance is primary, the quality system has to be focussed on the laboratory and its operation. Development of ISO/IEC 17025 The accreditation bodies in Canada and the USA and the accredited/interested laboratory communities worked closely with the national representatives to the ISO Working Group during the development of this standard. The National Conference of Standards Laboratories - International (NCSLI), a non-profit international association of laboratories and organizations that maintain or have an interest related to measurement standards and calibration facilities, solicited and collated inputs from its member organizations. NCSLI is an American National Standards Institute-accredited Standards Development Organization. Perspectives on Standard ISO/IEC 17025 The following perspectives on changing systems from ISO/IEC Guide 25 to ISO/IEC 17025 were obtained.

Canadian Calibration Laboratory Manager's perspective: My first contact said that there was not that much difference between the two documents and only minor changes were required. He and his laboratory supervisor met for five consecutive Friday afternoons addressing the requirements of each clause in 17025 and modifying or enhancing the sections of their quality manual. His strategy was to restrict the number of pages in his quality manual to about 30 (50 at most) keeping the document generic while using procedures documents for the specific operations. The procedures should only be 1-2 pages that can be changed if a new instrument is acquired or a new procedure adopted. This strategy results in few subsequent changes to the quality manual and lowers the need for hiring outside consultants. The difficulty he continues to face is the lack of good templates for uncertainty analysis of common calibration processes. Author's comment: The Calibration Laboratory Assessment Service staff has learned that laboratories usually find the identification of the elements of uncertainty and quantification of the significant contributors are the most problematical. Comments from other Canadian Laboratory Managers: "I never realized how many people paid attention to the VALID TO date on our Scope of Accreditation which appears on the SCC website [6]. Ours did not get changed - it was one week out-of-date - we received 42 telephone calls from our clients and ISO 9000/ QS 9000 auditors in a one-week period." "I find 17025 less prescriptive than ISO/IEC Guide 25." US Calibration Laboratory Manager's perspective: A seasoned calibration laboratory manager, who has worked for several organizations, found that

17025 does a much better job of differentiating between certificates and reports in the reporting of calibration and test results. He found that the 17025 requirements are clearer, fit much better into operational procedure documents. In the case where an organization already has an ISO 9002 system in place it is relatively easy to make links to the elements that relate to 17025 requirements without recreating them for laboratory operations and accreditation purposes. 17025 is a much better template to follow in putting in place a quality system, since it accommodates the needs of the organization much better than 25.

Laboratory Accreditation Team Leader and ISO 9000 Auditor's perspective: I interviewed a well-qualified person who audits ISO 9000 operations and assesses a broad range of testing laboratories against ISO/IEC 17025 criteria. He observes that: • the 17025 standard is now very compatible with ISO 9000 (a benefit for organizations having to meet both requirements) • it really helps larger laboratories in their business transactions with medium to large customer populations and • has raised the reliability of results in testing laboratories.

Laboratory Assessor's perspective: A colleague of mine is in constant touch with mature laboratories currently registered (certified) to ISO 9000 that are considering laboratory accreditation. The laboratory staff initially had the perception that it will be a major step to modify their quality documentation to meet 17025 requirements. After discussing the incremental work necessary, the laboratory comes to the conclusion that modification of its administrative and operational documents will not be a great task.

DISCUSSION Do accredited laboratories perform better than non-accredited laboratories? One of the SCC's Partner organizations, the Canadian Association for Environmental Analytical Laboratories (CAEAL) had a study conducted to determine the Comparative Performance of Accredited vs. Non-Accredited Laboratories. CAEAL operate a Proficiency Testing program available to its members that are accredited and those that were not accredited. Figure 12 shows the differences in performance of laboratories in six rounds (three years) of the CAEAL Proficiency Testing Program, based solely on whether or not they were accredited. Six proficiency-testing studies performed (over three years) using five testing parameters, namely Biochemical Oxygen Demand, Total Suspended Solids, Chloride, Dissolved Iron and Fecal Coliform.

Laboratory Accreditation the Relevant International Guides and Standards Accreditation Bodies’ Code of Practice

ISO/IEC Guide 58

Proficiency Testing Principles for Both Laboratories and Accreditors

ISO/IEC Guide

43

Baseline Criteria for Laboratory Competence

ISO/IEC 17025

Fig 13 Figure-13 [7,8] identifies the three documents that are basic to Accreditation Bodies' utilization or compliance in order to undergo peer-review by Regional Organizations.

CONCLUSIONS Trends.

Fig 12 Five hundred and twenty-eight results from accredited laboratories were compared with the same number of results from non-accredited laboratories that received identical proficiency testing samples. It was found that accredited laboratories achieved higher scores, a greater number of perfect scores, and fewer unsatisfactory scores in each of the five parameters. The conclusion is an obvious one: accredited laboratories produce more consistent and competent results than non-accredited ones.

The SCC has seen major growth in Environmental laboratory accreditation, particularly in FY 2000/2001. A major expansion in the Forensic area took place in FY 2001/2002. Considerable growth in Agriculture and Food products occurred in the past three years and the first Proficiency Testing Provider was accredited in 2002 [9]. Many specifiers [10], like government agencies, have come to appreciate the importance of creditable accreditation programs based on internationally recognized standards. With restricted budgets, many Government agencies can no longer do it all themselves; increasingly, they must rely on thirdparty laboratories to support their regulatory efforts. When they do so they need a fair and meaningful basis for identifying qualified providers.

Accreditation provides that and the ILAC Arrangement provides a means for recognition of acceptable accreditation bodies. Industrial users of test and calibration data similarly can take advantage of the ILAC Arrangement by having greater confidence in the accuracy of the test or calibration report they are purchasing because it is being generated by a competent facility. Finally, as a Canadian citizen, I look to the robust laboratory accreditation programs in the countries with which our nation has strong trading relationships. Having confidence in the tests that support the products we import and, conversely, having a good range of calibration sources to provide "after delivery calibration services" to Canadian equipment entering or installed in these nations and territories is important to all of us.

[5]

ASQ ISO 9000:2000 Handbook, 2002, p 3546 www.qualitypress.asq.org

[6]

Gravel J.E.J. (Ned). "PRINCIPLES BEHIND THE REQUIREMENTS OF ISO/IEC 17025 A CANADIAN VIEW" Canadian Association for Environmental Analytical Laboratories (CAEAL). Nov.2001. [email protected]

[7]

Standards Council of Canada www.scc.ca - Laboratories - Accredited Laboratories & Accredited Calibration Laboratories.

[8]

ISO/IEC Guide 58 - 1993 Calibration and testing laboratory accreditation systems - General requirements for operation and recognition.

[9]

ISO/IEC Guide 43-2: 1997 Proficiency testing by interlaboratory Comparisons - Part 2: Selection and use of proficiency testing schemes by laboratory accreditation bodies.

[10]

"First Standards Council of Canada Accreditation of a Proficiency Testing Provider" Press release, January 2002

[11]

ILAC Arrangement, p.3 http://www.ilac.org/arrangement.htm

REFERENCES [2]

ISO/IEC Guide 25 - 1990, General requirements for the competence of calibration and testing laboratories

[3]

ISO/IEC 17025 - 1999, General requirements for the competence of testing and calibration laboratories.

[4]

ISO Quality Management http://www.iso , p 1-6

Principles

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