Establishing an Iso 17025 Compliant Laboratory at a University

Topics: Quality management system, Quality management, Quality assurance Pages: 19 (7232 words) Published: April 18, 2012
Paper # 059, IT 305

Establishing an ISO 17025 Compliant Laboratory at a University Karen Hullihen, Verna Fitzsimmons, and Michael R. Fisch Kent State University,,

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 road. Our laboratory, the Middlefield Research and Testing Laboratory, (MRTL) is located roughly 40 minutes from the Kent Campus within the NEO Beam facility. This facility is a joint venture between The Kent State University and a local plastics company, Mercury Plastics, Inc. NEO Beam has a 150 kW, 5 MeV electron accelerator that is used for production and research. This joint venture gives both parties access to an instruments and a facility that neither could justify individually. This arrangement allows our laboratory to provide basic and applied research to outside companies as well as for university projects. In light of our relationship with a plastic company we focus our external lab work on dosimetry (determining the dose a product absorbs) and the physical, chemical and mechanical properties of polymers and plastics. Internally, we have active research in a number of areas Proceedings of The 2008 IAJC-IJME International Conference ISBN 978-1-60643-379-9

[1]. The number of scientists and engineers at this facility varies over the year. It swells during the summer when students are present and is smaller during the academic year. Typically we have 5-6 professional scientists during the academic year and of this number, three to four are affiliated with the laboratory on a part time basis. Thus, we are a rather small laboratory and as we will discuss size is a determining factor in a number of our operational decisions. Why should a university laboratory have a quality system? The establishment of our quality system began when a company asked about our quality system. Our first response was of the nature, “We are competent scientists with advanced degrees from highly ranked programs. We work at a major university using state-of-the-art equipment; of course, we do quality work.” From the perspective of the company this answer is of the nature: true, true, true, but irrelevant. They want to know how it can be demonstrated. What is systematically being done...
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