CryoCord’s commitment to providing the best is proven through its certification by
many local and international regulatory bodies. Here are our list of accreditations
and certifications:
Regulatory Approval
Fully licensed stem cell bank under Malaysia’s Private Healthcare Facilities and Services (PHFS) Act 1998 since 2008, awarded by the Ministry of Health (MOH) Malaysia
Accredited and Compliant
GOOD MANUFACTURING PRACTICE (GMP)
CryoCord's laboratory has been certified to cGMP standards in accordance with Pharmaceutical Inspection Co-operation Scheme (PIC/S), awarded by Malaysia’s (National Pharmaceutical Regulatory Agency) NPRA in 2013. This accreditation ensures the consistency, safety, and quality of its stem cell processing by adhering to stringent facility controls, operational protocols, and quality assurance systems.
ASSOCIATION FOR THE ADVANCEMENT OF BLOOD & BIOTHERAPIES (AABB)
Accredited by AABB ; the global gold standard for cellular therapy and transfusion quality
since 2020, following rigorous on-site assessment to certify its technical, medical, and
administrative excellence.
CLASS 100 CLEANROOM
Houses 10 Class 100 cleanrooms certified by ISO 14644 (Class 5) in 2003, meeting NASA and US Federal Standard 209E, each engineered to maintain ultra-low particulate levels with no more than 100 particles per cubic foot of air with meticulously designed with HEPA-filtered airflow and controlled environments ensuring ultra-low particulate levels for the safe, consistent handling and storage of stem cells.
ISO 15189
Awarded ISO 15189 accreditation, an international standard emphasising both technical competence and rigorous quality management in medical laboratories since 2009 by the Laboratory Accreditation Scheme of Malaysia (SAMM).