ISO 15189:2012 WORKING DOCUMENT

_____ Form # Issued: 1/17 Rev LF-56- medical Page 1 of 91 ISO 15189:2012 WORKING DOCUMENT NOTES: 1. This WORKING DOCUMENT is intended as a checklist for the assessor when conducting medical Testing Laboratory Accreditation Assessments according to ISO 15189:2012 . This standard incorporates all elements of ISO 15189:2012 , ISO 22870:2016, ISO 9001:2008, and ISO/IEC 17025:2005 relevant to medical testing laboratories. 2. Please make notes in the Comments column any deficiencies in the laboratory s management system identified during the assessment. These observations may be useful when preparing the assessment report and indicate to the reviewer that a thorough assessment was conducted. It is also imperative to note evidence of compliance, making reference to procedures/work instructions, dates, and other specific observations. At a minimum should be 1 comment per major element of the checklist.

medical laboratory service, including budget planning and financial management, in accordance with institutional assignment of such responsibilities? 4.1.1.4 b) relate and function effectively with applicable accrediting and regulatory agencies, appropriate administrative officials, the healthcare community and the patient population served and

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