常规食品微生物实验室为 ISO/IEC 17025:2017 认证目的制定设备校准计划时应考虑的要点

IF 0.8 4区 工程技术 Q4 CHEMISTRY, ANALYTICAL Accreditation and Quality Assurance Pub Date : 2024-06-15 DOI:10.1007/s00769-024-01606-w
Han-Min Ohn
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引用次数: 0

摘要

对于遵循 ISO/IEC 17025:2017 标准的实验室来说,根据第 6.4.7 条的规定,必须制定校准计划。ISO/IEC 17025:2017 标准第 6.4.6.条规定,当测量设备的测量精度或测量不确定度影响检测结果的有效性和/或需要建立检测结果的计量溯源性时,必须对其进行校准。常规食品微生物实验室常用的设备包括生物安全柜或层流柜、天平、稀释器、均质器或搅拌器或混合器、pH 计、高压灭菌器、培养箱、冰箱、冷冻箱、深冷冻箱、恒温水浴箱、灭菌炉、温度计等温度监测设备、微量移液器、分液器、涡流搅拌器、离心机、热板和秒表。ISO 7218:2007/Amd 1:2013 标准为哪些设备需要校准提供了指导,但有时认证机构会制定更严格的准则,合格评定机构需要遵循这些准则。因此,不同认可机构认可的传统食品微生物实验室需要校准的设备可能会有所不同。在本从业人员报告中,作者讨论了传统食品微生物实验室在制定校准计划时需要考虑的要点。
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Points to consider when establishing an equipment calibration programme in a conventional food microbiology laboratory for ISO/IEC 17025:2017 accreditation purpose

For a laboratory following the ISO/IEC 17025:2017 standard, establishing a calibration programme is a requirement as per Clause 6.4.7. Clause 6.4.6. of the ISO/IEC 17025:2017 standard states that measuring equipment shall be calibrated when its measurement accuracy or measurement uncertainty affects the validity of the test results and/or when establishment of the metrological traceability of the test results is required. Equipment commonly used in a conventional food microbiology laboratory include biosafety cabinets or laminar flow cabinets, balances, diluters, homogenizers or blenders or mixers, pH meters, autoclaves, incubators, refrigerators, freezers, deep freezers, thermostatically controlled water baths, sterilizing ovens, temperature-monitoring devices such as thermometers, micropipettes, dispensers, vortex mixers, centrifuges, hot plates, and stop watches. The standard ISO 7218:2007/Amd 1:2013 provides guidance on which equipment requires calibration but sometimes, the accreditation body establishes more stringent guidelines which the conformity assessment body needs to follow. So, equipment that requires calibration may differ between conventional food microbiology laboratories accredited by different accreditation bodies. In this practitioner’s report, the author discusses the points a conventional food microbiology laboratory needs to consider when establishing a calibration programme.

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来源期刊
Accreditation and Quality Assurance
Accreditation and Quality Assurance 工程技术-分析化学
CiteScore
1.80
自引率
22.20%
发文量
39
审稿时长
6-12 weeks
期刊介绍: Accreditation and Quality Assurance has established itself as the leading information and discussion forum for all aspects relevant to quality, transparency and reliability of measurement results in chemical and biological sciences. The journal serves the information needs of researchers, practitioners and decision makers dealing with quality assurance and quality management, including the development and application of metrological principles and concepts such as traceability or measurement uncertainty in the following fields: environment, nutrition, consumer protection, geology, metallurgy, pharmacy, forensics, clinical chemistry and laboratory medicine, and microbiology.
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