Transcription of ISO 15189:2012 WORKING DOCUMENT
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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.
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.
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