USM Tissue Bank is certified in compliance to Quality Management System under ISO 9001 since 2004. In 2010, USM Tissue Bank started manufacturing all tissue grafts under controlled conditions (clean room facilities). This is one of the control measures to ensure the tissues are manufactured in a high level of hygienic environment in accordance to Good Manufacturing Practice (GMP) requirement to produce high quality and safe grafts, and to gain worldwide acceptability. USM Tissue Bank has then received Letter of Conformation to Good Manufacturing Practice (GMP) in accordance to the pharmaceutical inspection co-operation scheme (PIC/S) GMP Guide from National Pharmaceutical Control Bureau in 2012.
In 2013, USM Tissue Bank has been certified to ISO 13485 Medical Device Quality Management Systems-Requirements for Regulatory Purposes. Halal is good not only for business but also in medicine. To USM Tissue Bank, it is a form of social obligation to gain patients’ trust and confidence in the tissue grafts. USM Tissue Bank is certified compliant to MS 1900- Shariah-Based Quality Management Systems - Requirements with Guidance since 2013.
