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Safety Precautions and Operating Procedures in an ABSL-4 Laboratory: 4. Medical Imaging Procedures
Published on: October 3, 2016
New ISO standards for medical biology laboratories, prescriptions and deviations
1Italian Society of Clinical Pathology and Laboratory Medicine, National Commission for Quality and Accreditation. SIPMeL, Castelfranco Veneto, Italy
Abstract:
ISO published the draft for final approval of the revision of ISO 15189 standard. Following ISO directives, ISO 15189 must be aligned with ISO/IEC 17025:2017 and should be less prescriptive. Draft ISO/DIS 15189 deviates in some points from ISO 17025 and the ISO indications to limit prescriptiveness: equipment, uncertainty, quality control. This do not seem to be justified by medical specificities and could complicate the understanding of the new requirements in medical laboratories.
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