Establishing an Iso 17025 Compliant Laboratory at a University
Paper # 059, IT 305
Establishing an ISO 17025 Compliant Laboratory at a University
Karen Hullihen, Verna Fitzsimmons, and Michael R. Fisch Kent State University khullihe@kent.edu, vfitzsim@kent.edu, mfisch@kent.edu
Abstract The continuing need for industry to follow and use International Standards Organization (ISO) standards puts pressure on university organizations, which perform laboratory testing for outside organizations, to insure that their results satisfy the required standards of the requesting organizations. The amount of outside testing of many university facilities makes full ISO 17025 certification economically unfeasible; however, such labs can be compliant to this standard thus satisfying those that use the university’s laboratory services. In this paper we discuss our experiences in bringing our laboratory up ISO 17025 compliance. The problems, time commitment and personnel requirements as well as the advantages, both internally to the organization and to outside users will be discussed. The contributions of our quality program to students as well as the students’ contribution to the quality system are significant and benefit both parties. Finally, the need for continuous work on such a program will be discussed and put into perspective. Introduction There is a continuing and accelerating need for industries to demonstrate that their products or services meet a certain minimum standard. To minimize the number of different standards most companies that have standards conform to those of the International Organization for Standardization (ISO). University laboratories are increasingly performing testing for outside companies and as such they are under increasing scrutiny and may be encouraged to obtain ISO certification. In this paper we discuss some of the many aspects of establishing an ISO 17025 compliant laboratory in a university setting, with the goal of providing guidance to other university labs that may need to travel down the same
Establishing an ISO 17025 Compliant Laboratory at a University
Karen Hullihen, Verna Fitzsimmons, and Michael R. Fisch Kent State University khullihe@kent.edu, vfitzsim@kent.edu, mfisch@kent.edu
Abstract The continuing need for industry to follow and use International Standards Organization (ISO) standards puts pressure on university organizations, which perform laboratory testing for outside organizations, to insure that their results satisfy the required standards of the requesting organizations. The amount of outside testing of many university facilities makes full ISO 17025 certification economically unfeasible; however, such labs can be compliant to this standard thus satisfying those that use the university’s laboratory services. In this paper we discuss our experiences in bringing our laboratory up ISO 17025 compliance. The problems, time commitment and personnel requirements as well as the advantages, both internally to the organization and to outside users will be discussed. The contributions of our quality program to students as well as the students’ contribution to the quality system are significant and benefit both parties. Finally, the need for continuous work on such a program will be discussed and put into perspective. Introduction There is a continuing and accelerating need for industries to demonstrate that their products or services meet a certain minimum standard. To minimize the number of different standards most companies that have standards conform to those of the International Organization for Standardization (ISO). University laboratories are increasingly performing testing for outside companies and as such they are under increasing scrutiny and may be encouraged to obtain ISO certification. In this paper we discuss some of the many aspects of establishing an ISO 17025 compliant laboratory in a university setting, with the goal of providing guidance to other university labs that may need to travel down the same
References: [1] The activities of the electron beam program at Kent State University are described at out website http://www.kent.edu/ebeam/. [2] Rodima, A, Vilbaste, M, Saks, O, et al., “ISO 17025 quality system in a university environment,” Accreditation and Quality Assurance, Vol. 10, 2005 pp 369-372. [3] Zapata-García, D, Llauradó, M, Rauret, G., “Experience of implementing ISO 17025 for the accreditation of a university testing laboratory,” Accreditation and Quality Assurance, Vol. 12, 2007, pp 317-322. [4] Pritizkow, J, “Practical experience of the laboratories in implementing the ISO/IEC 17025,” Accreditation and Quality Assurance, Vol. 8, 2003, pp 325-26. [5] Halevy, A, The benefits calibration and testing laboratories may gain from ISO/IEC 17025 accreditation,” Accreditation and Quality Assurance, Vol. 8: 2003, pp 286-290. [6] Islin, H and Andersen, T, “The process of management review,” Accreditation and Quality Assurance, Vol. 13, 2008, pp 157-160. [7] Štajdohar-Pađen, O, “Education and training of laboratory staff as a part of laboratory competence,” Accreditation and Quality Assurance, Vol. 13, 2008, pp 267-270. [8] Standards on Dosimetry for radiation processing, (ASTM International, West Conshohocken, Pa, 2004), pg 328. [9] Tech 50000 “Quality Standards.” The Kent State University Graduate Catalog. Proceedings of The 2008 IAJC-IJME International Conference ISBN 978-1-60643-379-9 Biographies KARNEN HULLIHEN is the lab coordinator and quality manager of the university laboratory described in this paper. She has a BS in Chemistry and is working to earn an MS in Technology at Kent State University. VERNA FITZSIMMONS, Ph.D., is an Associate Professor and Interim Dean of the College of Technology at Kent State University. She has over 15 years of experience working with businesses; she has also taught at several universities. MICHAEL FISCH, Ph.D., is director of the program on electron beam technology at The Kent State University. He has over 25 years of experience working with businesses. Proceedings of The 2008 IAJC-IJME International Conference ISBN 978-1-60643-379-9