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Accreditation and Certification

Quality Management System

The Department of Pathology and Laboratory Medicine (DPLM) has a Quality Management System (QMS) to ensure that testing, operations and services provided by the laboratories meet and comply with applicable/relevant regulations and customers' expectations. The QMS safeguards the high standards of care KKH aims to provide patients by offering quality laboratory service that is accurate, reliable and holistic for women and children.


All laboratory sections in DPLM participate in external quality assurance (EQA) proficiency testing, and have established quality control programmes that monitor ongoing test performance. Laboratory sections also participate in regular quality and safety communication sessions, periodical review of section-specific policies and standard operating procedures, ongoing personnel training and competency assessments, and monthly operation meetings that include review of feedback given by customers. Feedback by customers are valuable inputs that enable the department to constantly improve.

Accreditations & Certifications

DPLM is licensed by Ministry of Health, Singapore under the Private Hospitals and Medical Clinics (PHMC) Act (Chapter 248). The specialized tests or services approved under Regulation 52(4) of the PHMC Regulations are as listed:

  1. Blood Group ABO and Rhesus (D) Type Tests
  2. Acid-Fast Bacilli (Smear) Test
  3. Human Immunodeficiency Virus (HIV) Test
  4. Malaria Parasite Test

Laboratories in DPLM are accredited or certified by the following locally and internationally recognized accreditation or certification programmes to meet the quality standards and competency requirements for medical laboratories.

Accreditation/Certification ProgrammeEffective SinceLaboratory Section Accredited or Certified
SAC-SINGLAS ISO 15189:2012 Medical Laboratory2003All laboratory sections in DPLM
Business Continuity Management (BCM)Prior to 2013Hospital wide, all laboratory sections in DPLM

ISO 45001 standards

(*Previously ISO 9001, ISO 14001, OHSAS)



Hospital wide, all laboratory sections in DPLM
College of American Pathologists (CAP)October 2021All laboratory sections in DPLM

Table 1: List of Accreditation and Certification Programmes in KKH

DPLM is committed to providing quality clinical laboratory service for women and children by engaging in locally and internationally recognized EQA programmes. EQA testings are conducted all year round with specified frequencies depending on the different laboratory sections. Results are monitored at specified frequencies.

The external quality programmes that are used for proficiency testing are listed in Table 2 below.

Laboratory SectionEQA Programme
Biochemical Genetics & National Expanded Newborn Screening
  • CAP Surveys
  • CDC Quality Assurance Programme (Newborn)
  • ERNDIM External Quality Assessment
Blood Bank
  • National Proficiency Testing Scheme for ABO Group/Rh Type
  • HSA External QAP for Immunohaematology
  • CAP Surveys
Clinical Chemistry
  • CAP Surveys
  • National Proficiency Testing for HIV
  • HSA HbA1C and Chemical Metrology External Quality Assessment
  • RCPA Quality Assurance Programs
  • RIQAS EQA Programme (NEFA)
  • UK NEQAS EQA (Down's Syndrome Screening)
  • CAP Surveys
  • CAP Surveys
  • CAP Surveys
  • National Proficiency Testing Scheme for Malaria Parasite
  • RCPA Quality Assurance Programs
  • CAP Surveys
  • NordiQC Immunohistochemistry Proficiency Testing
  • RCPA Quality Assurance Programs
  • UK National Gynaecological Pathology Scheme
  • UK NEQAS External Quality Assessment
Molecular Histopathology
  • CAP Surveys
  • CAP Surveys
  • National Proficiency Testing for AFB (Smear)
  • RCPA Quality Assurance Programs
Molecular Microbiology
  • CAP Surveys
  • RCPA Quality Assurance Programs
  • QCMD External Quality Assessment
Non-Invasive Prenatal Testing
  • CAP Surveys

Table 2: List of Proficiency Testing Specific to Different Laboratory Sections within DPLM.