Results 1 to 10 of about 3,830 (84)

Challenges with the pursuit of ISO 15189 accreditation in a public health laboratory in Ghana. [PDF]

Afr J Lab Med, 2022
Background: Accreditation is important for all medical laboratories, particularly public health laboratories in developing countries. Several laboratories in Ghana implemented the requirements of the International Organization for Standardization (ISO ...
Attoh S, Tetteh FKM, McAddy M, Ackah K, Kyei R, Moroti M, Boateng C, Adusu-Donkor L, Boafo J, Yakubu A, Kwao S, Sarkodie E, Koranteng NB, Addo MA, Hobenu F, Agyeman-Bediako K, Fatchu RD.   +16 more
europepmc   +2 more sources

Management of postanalytical processes in the clinical laboratory according to ISO 15189:2012 Standard requirements: considerations on the review, reporting and release of results. [PDF]

Adv Lab Med, 2021
The objective of this paper is to share some considerations about the management of postanalytical processes in relation to the review, reporting and release of test results in accordance with UNE-EN ISO 15189:2013 Standard requirements.
López Yeste ML, Izquierdo Álvarez S, Pons Mas AR, Álvarez Domínguez L, Marqués García F, Rodríguez MPC, Blanco Font A, Bernabeu Andreu FA, García Álvarez A, Contreras Sanfeliciano T, Pascual Gómez N, Sánchez Gancedo L, Guiñón Muñoz L.   +12 more
europepmc   +2 more sources

Implementing and Transitioning a Laboratory Quality Management System from ISO 15189:2012 to ISO 15189:2022: Experience from the Malawi-Liverpool Wellcome Research Programme, Blantyre. [PDF]

Wellcome Open Res
Background The implementation of a Quality Management System (QMS) in line with ISO 15189:2022 is essential for clinical and research laboratories striving to achieve technical competence and consistent delivery of valid results.
Tembo D, Kaphika JS, Ahmadu A, Alufandika L, Kalilangwe V, Kukacha C, Kaphika D, Lipenga FT, Machonjo M, Manda S, Masina M, Mchoma EC, Mnyanga AC, Moyo IM, Mutala FP, Mzumara P, Shani D, Selemani GP, Denis B.   +18 more
europepmc   +2 more sources

Investigation of the long-term yield of auditing for conformity with the ISO 15189:2012 quality standard in a hospital pathology laboratory. [PDF]

Pract Lab Med, 2020
Introduction: Pathology laboratories are increasingly seeking accreditation to quality standards to assure Quality of Service (QoS). However, there is little data available regarding the value of this in laboratories with well-established Quality ...
Green AD, Kavanagh-Wright L, Lee GR.
europepmc   +2 more sources

Translating laboratory quality management system into practice: strategic opportunities and challenges for ISO 15189:2022 implementation in Nigeria's healthcare system. [PDF]

Front Health Serv
IntroductionLaboratory Quality Management Systems (LQMS) are fundamental to reliable diagnostic services and improved patient outcomes. Although Nigeria has made progress through quality improvement initiatives, implementation of internationally ...
Basil B, Okoro NI, Mba IN, Myke-Mbata BK.   +3 more
europepmc   +2 more sources

The road map for ISO 15189-laboratory accreditation: The Experience of Manhiça Health Research Centre (CISM) laboratory, in southern Mozambique [PDF]

African journal of laboratory medicine
Background: Accreditation is an effective way to recognise the quality and competence of a clinical laboratory. Here we describe the steps towards ISO 15189:2012 accreditation of the Manhiça Health Research Centre laboratory, in Mozambique. Intervention: 
Vubil D, Cossa A, Salvador E, Bene M, Manhiça G, Jairoce C, Mambuque E, Quimice L, Macete E, Saute F, Mandomando I.   +10 more
europepmc   +2 more sources

Implementation of the laboratory quality management system (ISO 15189): Experience from Bugando Medical Centre Clinical Laboratory - Mwanza, Tanzania. [PDF]

Afr J Lab Med, 2018
Background: Use of laboratory evidence-based patient health care in Tanzania remains a complex problem, as with many other countries in sub-Saharan Africa.
Beyanga M, Gerwing-Adima L, Jackson K, Majaliwa B, Shimba H, Ezekiel S, Massambu C, Majige D, Mwasegaka M, Mtotela W, Mateta P, Kasang C.   +11 more
europepmc   +2 more sources

Are accreditation standards fit for measurement uncertainty in clinical laboratories? An analysis of Saudi Arabia's accreditation. [PDF]

Front Med (Lausanne)
BackgroundMeasurement uncertainty (MU) is a fundamental aspect of laboratory quality management and is required by many international accreditation standards, including ISO 15189 and CAP ISO 15189. Nevertheless, its regulatory status under Saudi Arabia’s
Aljohani MA.
europepmc   +2 more sources

ISO 15189 Accreditation: Navigation Between Quality Management and Patient Safety. [PDF]

J Med Biochem, 2017
Accreditation is a valuable resource for clinical laboratories and the development of an International Standard for their accreditation represented a milestone on the path towards improved quality and safety in laboratory medicine. The recent revision of
Plebani M, Sciacovelli L.
europepmc   +2 more sources

Management of post-analytical processes in the clinical laboratory according to ISO 15189:2012. Considerations about the management of clinical samples, ensuring quality of post-analytical processes, and laboratory information management. [PDF]

Adv Lab Med, 2021
ISO 15189:2012 establishes the requirements for clinical sample management, ensuring quality of process and laboratory information management. The accreditation authority, ENAC in Spain, established the requirements for the authorized use of the label in
López Yeste ML, Pons Mas AR, Guiñón Muñoz L, Izquierdo Álvarez S, García FM, Blanco Font A, Pascual Gómez NF, Sánchez Gancedo L, García Álvarez A, Bernabeu Andreu FA, Chueca Rodríguez MP, Álvarez Domínguez L.   +11 more
europepmc   +2 more sources