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