Marco Pradella - Italian Society of Clinical Pathology and Laboratory Medicine (SIPMeL), National Commission on Quality and Accreditation
Keywords: accreditation; medical laboratories; ISO 15189
Quality and competence requirements for medical laboratories are defined by ISO document 15189.
Alongside this, ISO has a substantial package of standards for medical laboratories.
These months ISO 15189 is undergoing revision, expected conclusion at the end of 2022. The revision takes ISO/IEC 17025:2017 as a model and inherits from ISO 9001:2015 innovations such as risk-based thinking, from ISO 17025 impartiality, confidentiality, complaint handling, management systems. Thus, there is a deep connection between the requirements of medical, forensic, anti-doping and food laboratories. In addition, the new text should be less prescriptive, risk-based, and more patient care-oriented.
ISO/CASCO (Committee on Conformity Assessment) recommends the inclusion of ISO 22870 (POCT) and references to ISO 15190 (health and safety), ISO 22367 (risk management), ISO/TS 20658 (withdrawals). In addition, the new 15189 should be less prescriptive, risk-based, and patient care-oriented, linked to ISO documents such as 17511 (calibrations), 20914 (uncertainty), and the molecular methods package developed by ISO/TC/212 WG4.
Other important ISO documents affecting medical laboratories are ISO 15198 (quality control), ISO 21151 (calibrations), ISO 15193 (reference methods), ISO 15195 (reference laboratories), ISO 35001 (biohazard), ISO 17822 (genomics in microbiology), ISO 20776 (antibiograms), ISO 17518 and ISO 19001 (dyes), ISO 17593 (anticoagulant monitoring), ISO 22583 (POCT supervisors), ISO 11073-90101 (POCT informatics), ISO 23640 (reagent stability), the ISO 18113X series (instrument and reagent documentation), ISO 20416 device aftermarket surveillance).
SIPMeL has long been committed to raising awareness and understanding of ISO requirements in medical laboratories. Dedicated articles are collected on the Internet page https://bit.ly/ISO15189RIMeL.
Other references in: http://dx.doi.org/10.13140/RG.2.2.19680.97286
