The Centre for Tissue Engineering became the first cadaveric tissue bank in South Africa to obtain the ISO 9001:2015 certification. This standard dictates the Quality Management System required of the Centre to demonstrate its ability to consistently deliver a high standard of safe, quality human tissue allografts to the medical fraternity.
The International Organisation for Standardisation, known also as ISO is an international-standard-setting body comprised of representatives from various national standards organisations. Compliance with ISO 9001 is recognised as the first step towards achieving conformity with the requirements of International Standards.
ISO 9001 specifies requirements for a Quality Management System when an organization aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer requirements. The standard also calls for the implementation of a Quality Management System with several enhancements, most notably a Risk Management approach to product development and product realisation, validation of processes, compliance with statutory and regulatory requirements and effective product traceability and recall systems amongst others.