Results 1 to 10 of about 4,435 (200)

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]

Advances in Laboratory Medicine / Avances En Medicina De Laboratorio, 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.
Silvia Izquierdo Alvarez, Fernando Marques Garcia   +1 more
exaly   +4 more sources

Novelties in the ISO 15189:2023 standard [PDF]

Advances in Laboratory Medicine / Avances En Medicina De Laboratorio, 2023
de la Villa Porras Isabel
exaly   +5 more sources

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

African Journal of Laboratory Medicine, 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.
Medard Beyanga, Lisa Gerwing-Adima, Kahima Jackson, Benjamin Majaliwa, Henrico Shimba, Simon Ezekiel, Charles Massambu, Dickson Majige, Michael Mwasegaka, Wilson Mtotela, Patrick Mateta, Christa Kasang   +11 more
doaj   +4 more sources

Novedades de la norma ISO 15189:2023 [PDF]

Advances in Laboratory Medicine / Avances En Medicina De Laboratorio, 2023
de la Villa Porras Isabel
exaly   +3 more sources

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

African Journal of Laboratory Medicine, 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 ...
Seth Attoh, Francis K.M. Tetteh, Mary McAddy, Kingsley Ackah, Richmond Kyei, Marcus Moroti, Cynthia Boateng, Laurinda Adusu-Donkor, Joseph Boafo, Alhassan Yakubu, Sarah Kwao, Emmanuel Sarkodie, Nana-Banyin Koranteng, Monica A. Addo, Frederick Hobenu, Kwasi Agyeman-Bediako, Raymond D. Fatchu   +16 more
doaj   +2 more sources

International Organization for Standardization (ISO) 15189. [PDF]

Ann Lab Med, 2017
The College of American Pathologists (CAP) offers a suite of laboratory accreditation programs, including one specific to accreditation to the international organization for standardization (ISO) 15189 standard for quality management specific to medical laboratories.
Schneider F, Maurer C, Friedberg RC.
europepmc   +3 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]

Practical Laboratory Medicine, 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 ...
Alastair David Green, Lucille Kavanagh-Wright, Graham Robert Lee   +2 more
doaj   +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 [version 2; peer review: 2 approved] [PDF]

Wellcome Open Research
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.
Dumizulu Tembo, Joshua S Kaphika, Lovemore Alufandika, Ajisa Ahmadu, Christopher Kukacha, Vincent Kalilangwe, Funny T Lipenga, Dumisani Kaphika, Sekani Manda, Mirriam Machonjo, Brigitte Denis, Emmanuel C Mchoma, Mazuba Masina, Innocent M Moyo, Alice C Mnyanga, Patrick Mzumara, Fatsani P Mutala, George P Selemani, Doris Shani   +18 more
doaj   +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: 
Delfino C. Vubil, Anelsio Cossa, Ergel Salvador, Miguel Bene, Geraldo Manhiça, Chenjerai Jairoce, Edson Mambuque, Lázaro Quimice, Eusébio V. Macete, Francisco Saute, Inacio Mandomando   +10 more
doaj   +2 more sources

A Hybrid Qualitative-Quantitative FMEA Model for Risk Management in Clinical Laboratory Automation: A Case Study Integrating ISO 15189:2022. [PDF]

J Clin Lab Anal
This study integrates ISO 15189:2022 requirements with failure mode and effects analysis (FMEA) to establish a comprehensive risk management framework for multibrand total laboratory automation (TLA) systems. By combining quantitative operational data with expert evaluation, an objective and reproducible occurrence scoring strategy was developed ...
Wei M, Li M, Lin Y, Li B, Xue H, Xia Y.
europepmc   +2 more sources