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Department of Hematology & Transfusion Medicine Unit

MS ISO 15189

Certificate and Scope of Accreditation

Hematology Laboratory and Transfusion Medicine Unit have been accreditated with MS ISO 15189 since 2013. Since then, we have strive to maintain the certification from MS ISO 15189 version 2008 until the latest version 2014.
We are proud to offer our services in line with this highest standard of medical testing, MS ISO 15189 for the better care of our patients, quality of results and credibility of tests performed. 

{tab=ISO Certification}

{slide=MS ISO 15189 Certificate, valid until Oct 2019}


{slide=MS ISO 15189 Certificate, valid until Oct 2016}



{tab=ISO Scope of Accreditation}

Hematology Laboratory was awarded MS ISO 15189 accreditation on 19 Feb 2014. The accreditation covers most of the routine test and some of the special tests. For more info about our accreditation please contact our Head of Department.


{tab=ISO Documentation}

{slide=Laboratory Quality Manual (Level 1)}


{slide=Quality Procedure (Level 2)}


Control of Documents


Control of Quality Records

QP3 - Internal Audit

QP4 - Identification and Control of Non-Conformities

QP5 - Corrective Action of Non-Conformities

QP6 - Preventive Action and Risk Management

QP7 - Management Review Meeting

QP8 - Quality Objective and Quality Indicator Conformities

QP9 - Managament of Client Feedback and Suggestion

QP10 - Management of Computerized Laboratory Information

QP11 - Reporting of Laboratory Incident

QP12 - Orientation of New Staff

QP13 - Management of Laboratory Staff Training

QP14 - Equipment Procurement

QP15 - Receiving and Commissioning of New Equipment

QP16 - Calibration and Maintenance of Equipment

QP17 - Disposal of Asset and Item or Property

QP18 - Management of Consumable and Reagent

QP19 - Nil

QP20 - Selection and Evaluation of Suppliers

QP21 - Examination by Referral Laboratory

QP22 - Service Agreements



{slide=Quality Procedure (Level 3)}

QP1 - Receipt of Sample

QP2 - Sample Processing

QP3 - Pemprosesan Keputusan Ujian Makmal

QP4 - Assuring Quality of Test Results

QP5 - Process of Handling Interlaboratory Comparison Samples

QP6 -

QP7 - Prosedur Perolehan Vot 27000 dan Kawal Selia Inventori

QP8 - Penyimpanan & Pelupusan Rekod Melalui Arkib Negara



GP01 - Garis Panduan LIS Hematologi

GP02 - Garis Panduan Keselamatan

GP03 - Method Verification Guidelines

GP04 - Garis Panduan Kalibrasi & Penyelenggaraan Peralatan

GP05 - Garis Panduan Latihan Staf

GP06 - Garis Panduan Pengurusan Staf

GP07 - Thermoguard Facilities Monitoring System Guidelines


{tab=ISO Organization}

{slide=Organization Chart for MS ISO 15189 - Hematology Laboratory}


{slide=Organization Chart of Hematology Laboratory Sections}



{slide=Management of Sample, College of Pathologist}


{slide=Retention of Records & Materials, College of Pathologist}


{slide=Laboratory Safety Practices, College of Pathologist}


{slide=Nucleic Acid Detection & Analysis of Hematological Disorders, College of Pathologist}


{slide=International Council for Standardization in Haematology}

ICSH Guidelines


{slide=Laboratory Services, Department of Hematology & Transfusion Medicine Unit}