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| Author | Gertrude Lanzon |
| Abstract | For a laboratory to be in a position to apply for accreditation, it must develop, implement and maintain a quality system in conformity with the pertinent standard. Most accreditation bodies around the world including the local National Accreditation Body, NAB-MSA, are assessing laboratories seeking accreditation against the requirements stipulated in the international standard ISO/IEC 17025 (1999), also known as ISO 17025. The Public Health Microbiology Laboratory (PHML) was primarily chosen as the subject of this research because of the need for this laboratory to demonstrate competence through accreditation particularly in view of its important role in food control and monitoring of water quality in the Maltese Islands. In addition, it has been proposed by the Government of Malta as the laboratory which should aim for accreditation of its microbiological testing services so as to be recognised as an official food control laboratory once Malta joins the European Union. The PHML laboratory practices were evaluated against the ISO 17025 requirements as at the end of December 2001 and a gap analysis was produced. The evaluation and the gap analysis revealed that the PHML complied with 26% of the standard's requirements, partially complied with 33% and did not comply with 31%. The majority of the partial and non-compliances consisted of the lack of quality system documentation. The remaining 10% of the ISO 17025 requirements were not applicable to the PHML. The actions to be taken by the PHML in order to conform to this standard were subsequently identified and listed. Furthermore, the quality manual, the main document describing the quality system, as well as a number of support quality system documents, i.e. procedures, work instructions and record sheets were developed and documented. It was concluded that according to the findings made until the end of December 2001, a significant number of actions are to be addressed and implemented for the PHML to set up a quality system conforming to ISO 17025 and eventually apply for accreditation. The compiled list of actions and the recommendations forwarded may be used by the management of the PHML as a basis for drawing up an achievable plan of action. In addition, the documentation produced may be integrated with the quality system documents already employed at the PHML and may serve as examples for the other documents to be prepared. |
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| Key words | Environmental Health, Thesis, ISO, Laboratory, Quality Assurance |