{"title":"检测实验室的内部审核技术:ISO/IEC 17025:2017观点","authors":"Han-Min Ohn","doi":"10.1007/s00769-024-01592-z","DOIUrl":null,"url":null,"abstract":"<div><p>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.</p></div>","PeriodicalId":454,"journal":{"name":"Accreditation and Quality Assurance","volume":"29 3","pages":"263 - 266"},"PeriodicalIF":0.8000,"publicationDate":"2024-04-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Internal audit techniques for testing laboratories: ISO/IEC 17025:2017 perspective\",\"authors\":\"Han-Min Ohn\",\"doi\":\"10.1007/s00769-024-01592-z\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>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.</p></div>\",\"PeriodicalId\":454,\"journal\":{\"name\":\"Accreditation and Quality Assurance\",\"volume\":\"29 3\",\"pages\":\"263 - 266\"},\"PeriodicalIF\":0.8000,\"publicationDate\":\"2024-04-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Accreditation and Quality Assurance\",\"FirstCategoryId\":\"5\",\"ListUrlMain\":\"https://link.springer.com/article/10.1007/s00769-024-01592-z\",\"RegionNum\":4,\"RegionCategory\":\"工程技术\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"CHEMISTRY, ANALYTICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Accreditation and Quality Assurance","FirstCategoryId":"5","ListUrlMain":"https://link.springer.com/article/10.1007/s00769-024-01592-z","RegionNum":4,"RegionCategory":"工程技术","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"CHEMISTRY, ANALYTICAL","Score":null,"Total":0}
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.
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.