检测实验室的内部审核技术:ISO/IEC 17025:2017观点

IF 0.8 4区 工程技术 Q4 CHEMISTRY, ANALYTICAL Accreditation and Quality Assurance Pub Date : 2024-04-16 DOI:10.1007/s00769-024-01592-z
Han-Min Ohn
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引用次数: 0

摘要

内部审核是 ISO/IEC 17025:2017 标准的重要组成部分。ISO/IEC 17025:2017 标准第 8.8 条描述了检测和校准实验室在内部审核方面需要遵循的要求。然而,该标准并未说明在进行内部审核时应使用哪种技术,而 ISO 19011:2018 标准(管理体系审核准则)也仅提及审核员可使用的审核方法,缺乏实用性。根据所使用的内部审核技术,存在的不符合项可能会被发现,也可能不会被发现。例如,分析人员的技术能力不可能仅通过彻底审查培训记录等相关文件就能完全确定。因此,内部审计师必须在内部审计过程中使用适当的技术,这样才能确保内部审计的有效性。不同的内部审计师在审计过程中会使用不同的技巧。内审员最常用的方法是制定一份检查表(通常是实验室所属的认可机构使用的检查表),用于审核 ISO/IEC 17025:2017 管理体系的符合性和见证技术人员的技术能力。本文旨在分享作者在对 ISO/IEC 17025:2017 认可的检测实验室进行内部审核时使用的技术。
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Internal audit techniques for testing laboratories: ISO/IEC 17025:2017 perspective

Internal auditing is an important part of the ISO/IEC 17025:2017 standard. Clause 8.8 of the ISO/IEC 17025:2017 standard describes the requirements that the testing and calibration laboratories need to follow in the area of internal auditing. However, the standard does not describe which technique to use when conducting internal audits and the ISO 19011:2018 standard (Guidelines for Auditing Management Systems) only mentions the audit methods that can be used by an auditor, lacking practical aspects. Based on the internal auditing technique used, non-conformities that are present may or may not be detected. For example, technical competency of an analyst cannot be completely ascertained by just thoroughly reviewing the related documents such as training records. Therefore, it is important that internal auditors utilize appropriate techniques during an internal audit for it to be an effective one. Different internal auditors use different techniques during the audit. The commonest way internal auditors use is to develop a checklist (usually the one used by the accreditation body to which the laboratory is affiliated) for auditing the compliance to the ISO/IEC 17025:2017 management system and witnessing the technical competence of the technical staff. The aim of this article is to share the techniques utilized by the author during the internal auditing of ISO/IEC 17025:2017 accredited testing laboratories.

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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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