LMQA ISO 15189

ISO 15189:2007 (Introduction)

ISO 15189:2007 is a quality management system and an accreditation program that focus to improve patient safety and reduce risk. ISO 15189:2007 outlines the stated requirements and standards for quality and competence in medical laboratories
(Collage of American Pathologists, 2008)1. This international standard is utilized by medical laboratories to develop their quality management systems and evaluate their own competence. Accreditation bodies use this to validate or recognize the competence of medical laboratories (The British Standard Institution, 2008)2. ISO 15189:2007 has 23 quality system elements and is divided into 2 major segments; Management Requirements and Technical Requirements (Bio-Rad Laboratories Quality Systems Division, 2004)3.

Management Requirements:

1.Organization and management

Responsibility of laboratory management to provide enough resources, design, execute, maintain quality system and select quality manager. (Bio-Rad Laboratories Quality Systems Division, 2004)3.


2.Quality management system

Shows the need of having a Quality System which includes quality manuals, quality policy and quality assurance etc. (Westgard QC, 2004)4.

(110 words excluding in-text citations and references)


References:

1. Collage of American Pathologists.(2008).What is Accreditation to ISO 15189:2007.Retrieved 14 June, 2008.from http://www.cap.org/apps/cap.portaL?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt%7BactionForm.contentReference%7D=laboratory_accreditation%2Fiso%2Fiso_faq.html&_state=maximized&_pageLabel=cntvwr

2. The British Standard Institution.(2008).Medical laboratories, particular requirements for quality and competence.Retrieved 14 June, 2008.from http://www.bsi-global.com/en/Shop/Publication-Detail/?pid=000000000030146737

3. Bio-Rad Laboratories Quality Syetems Division.(2004).Preparations and considerations when seeking laboratory accreditation under ISO 15189.Retrieved 14 June, 2008.from http://www.sacb.org.sg/documents/PreparinglabforISO15189-GCooper.pdf

4. Westgard QC.(2004).Guest Essay: ISO Standard in Clinical Laboratories.Retrieved 13 June,2008.from http://www.westgard.com/iso3.htm

Done by: Rachael Ngiam
0606168C
Tg01