Accreditations,
Certifications and Licenses
Cordlife has the most accredited cord blood banks in Asia
All Cordlife laboratories and processes are audited and accredited or certified by the following quality assurance organisations. We ensure that we adhere to the best practices for the services we provide.
Cordlife Singapore
GDPMDS (SS620:2016)
Cordlife Hong Kong
AABB
HealthBaby
AABB
FACT
CAP
Cordlife India
AABB
ISO 9001:2015
CAP
NABL
WHO GMP
DCGI
Cordlife Philippines
AABB
ISO 9001:2015
DOH
Cordlife Indonesia
AABB
ISO 9001:2015
MOH
StemLife Malaysia
AABB
MS ISO15189
MOH
GDPMD
AABB
AABB also known as Association for the Advancement of Blood & Biotherapies, is an international, not-for-profit Association representing individuals and institutions involved in the fields of transfusion medicine and biotherapies. The Association is committed to improving health through the development and delivery of standards, accreditation and educational programs that focus on optimizing patient and donor care and safety.
Cordlife Hong Kong, Cordlife India, Cordlife Indonesia, Cordlife Philippines, HealthBaby Hong Kong and StemLife Malaysia are accredited by AABB.
Foundation for the Accreditation of Cellular Therapy (FACT)
FACT is a non-profit corporation, co-founded by the International Society for Cellular Therapy (ISCT) and the American Society of Blood and Marrow Transplantation (ASBMT) in 1966.
FACT is the leader in the international standards for cellular therapy used in Europe, USA, Canada, Australia and New Zealand. The FACT accreditation, a symbol of excellence, has stringent standards, with rigourous and thorough inspections across organisations’ processes and practices.
HealthBaby Hong Kong is accredited by FACT.
College of American Pathologists (CAP)
CAP is the leading organisation of board-certified pathologists that serves patients, pathologists and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide.
The CAP accreditation program focuses on four key areas which include reliability, correctness, quality care, lab management and safety. The accreditation is awarded to facilities after a rigorous on-site inspection as well as examination of the facility’s records and quality management system.
Cordlife India and HealthBaby Hong Kong are accredited by CAP.
ISO 9001:2015
ISO 9001:2015 is an international quality management system built to demonstrate an organisation’s ability to consistently provide and improve products and services that meet customer statutory and regulatory requirements.
Cordlife India, Cordlife Philippines and Cordlife Indonesia are ISO 9001:2015 certified.
MS ISO 15189
ISO 15189 is an international standard developed by the International Organisation for Standardisation’s Technical Committee 212 (ISO/TC 212). This standard is adhered by medical laboratories in developing quality management systems and assessing their own competence. It can also be used for confirming or recognising the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
StemLife Malaysia is MS ISO 15189 certified.
Good Distribution Practice for Medical Devices in Singapore (GDPMDS)
GDPMDS certification ensures that the certified company has a quality management system, with procedures and facilities that adhere to the current good distribution practices.
Cordlife Singapore is GDPMS certified.
Good Distribution Practice for Medical Devices (GDPMD)
GDPMD is a set of regulations or standards that ensure the quality and safety of medical devices throughout the supply chain, from manufacturing to distribution and storage.
StemLife Malaysia is GDPMD certified.
National Accreditation Board for Testing and Calibration Laboratories (NABL)
The NABL is a Constituent Board of Quality Council of India and was established with the objective of providing government and industry associations with a scheme of Conformity Assessment Body’s accreditation, which involves third-party assessment of the technical competence of testing including medical and calibration laboratories, proficiency testing providers and reference material producers.
Cordlife India is accredited by NABL.
WHO GMP
WHO GMP (World Health Organization Good Manufacturing Practice) certification signifies compliance with the stringent quality standards set by the World Health Organization (WHO) for pharmaceutical manufacturing.
This certification ensures that our manufacturing processes adhere to international guidelines, guaranteeing the safety, efficacy, and quality of our products. It is a testament to our commitment to delivering pharmaceuticals of the highest standard to patients worldwide.
Cordlife India is certified by WHO GMP.
Local Government Health Regulators
Ministry of Health (MOH) – Malaysia and Indonesia
Department of Health (DOH) – Philippines
Drug Controller General of India (DCGI) - India
Cordlife’s facilities are licensed by local regulators, wherever required. Our facilities are subject to regular inspections and audits to ensure that we meet or exceed the requirements of local regulators.
Cordlife Indonesia, Cordlife India, Cordlife Philippines and StemLife Malaysia are regulated by their local healthcare authorities.