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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

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

Advances in Laboratory Medicine, 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 Mᵃ Liboria, Izquierdo Álvarez Silvia, Pons Mas Antonia R., Álvarez Domínguez Luisa, Marqués García Fernando, Rodríguez Mᵃ Patrocinio Chueca, Blanco Font Aurora, Bernabeu Andreu Francisco A., García Álvarez Ana, Contreras Sanfeliciano Teresa, Pascual Gómez Natalia, Sánchez Gancedo Lorena, Guiñón Muñoz Leonor   +12 more
doaj   +1 more source

Review of the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) version 2:2015

African Journal of Laboratory Medicine, 2020
Background: In 2011 the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) was launched, aimed at strengthening the quality and competence of African clinical, public health and reference laboratories.
Tjeerd A.M. Datema, Linda Oskam, Jacqueline E.W. Broerse, Paul R. Klatser   +3 more
doaj   +1 more source

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

Advances in Laboratory Medicine, 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 Mᵃ Libòria, Pons Mas Antonia R., Guiñón Muñoz Leonor, Izquierdo Álvarez Silvia, García Fernando Marqués, Blanco Font Aurora, Pascual Gómez Natalia F., Sánchez Gancedo Lorena, García Álvarez Ana, Bernabeu Andreu Francisco A., Chueca Rodríguez Mᵃ Patrocinio, Álvarez Domínguez Luisa   +11 more
doaj   +1 more source

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

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   +1 more source

Using the SLIPTA checklist to assess laboratory readiness for Joint Commission International accreditation

African Journal of Laboratory Medicine, 2023
Background: The Stepwise Laboratory Improvement Process Towards Accreditation (SLIPTA) helps prepare laboratories in low- and middle-income countries to achieve international accreditation aligned with the ISO 15189:2012 standards.
Abdul K. El Karaaoui, Nada Assaf
doaj   +1 more source

Excellence in clinical laboratories: the standard ISO 15189:2007

Microbiologia Medica, 2010
I laboratori clinici operano in stretto contatto con i pazienti e collaborano direttamente alla loro cura, in modo corresponsabile con i medici e i reparti ospedalieri.
Antonio Scipioni, Cristina Marangoni, Anna Mazzi, Antonietta Cavallaro   +3 more
doaj   +1 more source

Development of a robust blood smear preparation procedure for external quality assessment

Practical Laboratory Medicine, 2021
Introduction: The external quality assessment (EQA) scheme is particularly important for laboratory performance evaluation. Peripheral blood smears are necessary to identify morphological features, and the procedure for preparing such smears must be ...
Quang Huy Vu, Hy Triet Van, Van Thanh Tran, Thi Diem Phuc Huynh, Van Chinh Nguyen, Dinh Thanh Le   +5 more
doaj   +1 more source

Quality system for Medical laboratories

Journal of Pathology of Nepal, 2015
According to William Edwards Deming “Good quality does not necessarily mean high quality. Instead it means a predicable degree of uniformity and dependability at low cost with a quality suited to the market.” Whereas according to famous engineer and ...
Shiva Raj K.C.
doaj   +1 more source

Application of SQC model to optimize an internal quality control schedule for Haemoglobin A1c measurement on the Capillarys analyzer

International Journal of Medical Biochemistry, 2022
INTRODUCTION: In the context of the accreditation of medical laboratories according to the ISO 15189: 2012 standard, the optimisation of an internal quality control (IQC) schedule is an important element of analytical quality.
Claudio Ilardo, Amandine Verger
doaj   +1 more source