7.患者权益保护:实验室需要确保患者的隐私和权益得到充分保护,同时需要遵守相关的法律法规和伦理准则。 ISO15189:2012ENMedicallaboratories—Requirementsforqualityandcompetence是一套全面的标准,旨在确保医疗实验室提供高质量的医疗服务,并促进质量的持续改进。该标准对于医疗实验室的运营和管理具有重要意义。当前...
内容提示: raising standards worldwide™NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 15189:2012Medical laboratories —Requirements for quality andcompetence (ISO 15189:2012)Licensed copy: I P, The University of Leeds, Version correct as of ...
The Role of ISO 15189 The ISO 15189:2012 international standard is based on ISO/IEC 17025 and ISO 9001. It applies to all medical laboratories and is becoming the most widely accepted standard for accrediting the competence of clinical laboratories. ISO 15189 requirements are intended to help ...
ISO and CEN documents on quality in medical laboratories The forthcoming international standard ISO 15189 "Quality management in the medical laboratory" is a document of great importance for the development of qu... D Kenny - 《Clinica Chimica Acta》 被引量: 20发表: 2001年 ISO 15189:2012 Manag...
Häftad, 2012. Pris 3694 kr. Köp BS EN ISO 15189:2012 Medical Laboratories: Requirements for Quality and Competence (9780580607851) av British Standards Institution på Bokus.comBritish Standards InstitutionBritish Standards Institution (BSI) (2012). BS EN ISO 15189:2012 Medical L...
标准号:ISO 15189:2022 EN 标准名称:医学实验室 质量和能力要求 英文名称:Medical laboratories — Requirements for quality and competence 标准状态:现行 发布日期:2022-12-06 文档简介 1.背景和目的: ISO15189是一个国际标准,它为医疗实验室的质量和能力的建立和维持提供了一个框架。这个标准强调了临床质量和患者...
ISO 15189:2012 EU 2017/746 IVDR 5 (5) Primacy of local regulations (introduction, 1) Refers to ISO 15189 (5.5 c) Conditions requiring “validation” (5.5.1.3 a-d) Laboratory developed tests (5.5) Fit-for intended use (5.5.1.3) Intended purpose (5.5 d) Preferred procedures (5.5.1.1) ...
The requirements of ISO 15189:2003 are discussed in the context of a process- and outcome-based quality management model in which the user's needs are the central focus. The requirements of ISO 15189:2003 are examined in terms of organisation and a quality management system, stressing the impo...
After four years, Ben was appointed Section Head for Medical Laboratories and oversaw the transition of pathology laboratories from CPA accreditation to accreditation by UKAS to ISO 15189:2012. In his time as Section Head, Ben’s portfolio of responsibility was extended to includ...
(%) Acc vs Acc Cert None Cert P-value Acc vs None Cert vs None Management SOPs 100 99 69 1.00* r0.01 r0.01 Document control Diagnostic log books 100 93 62 0.06* r0.01 r0.01 98 82 58 r0.01 r0.01 r0.01 Quality manual Maintenance/calibration 98 78 43 r0.01 98 77 50 r0.01 r0.01 ...