ISO 13485

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The Centre for Tissue Engineering recently became the first tissue bank in South Africa to obtain an international ISO 13485 accreditation. This standard specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide consistent, safe, high-standard and quality bone tissue allograftes to the medical fraternity.

The International Organisation for Standardisation, widely known as ISO is an international-standard-setting body composed of representatives from various national standards organisations.

According to Ria Karakatsanis, (General Manager) of the CTE-Bone Bank, compliance with ISO 13485 is often seen as the first step in achieving conformity with European regulatory requirements.

“ISO 13485 contains requirements that are essential for any organisation operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organisations whose services support medical device manufacturers. The standard contains specific requirements for manufacture, installation and servicing and calls for the implementation of a Quality Management System with several enhancements, 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.”

According to Ria obtaining ISO 13485 accreditation holds an array of benefits for not only the clients of the CTE but also to staff: “Probably the most important benefit of obtaining the standard is customer satisfaction through the delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements. Of course this filters down the organisation and through continual improvement of processes and resulting operational efficiencies one can expect not only a reduction in operating costs but also improved risk management.”

“What sets the CTE apart from other bone banks is that it now has enhanced business credentials - through independent verification against recognised standards as well as the ability to win more business - particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.” says Ria.

Over the last 7 years the CTE has procured more than 1050 bone tissue donors, prepared 10's of thousands of allografts for transplantation and made it possible to surgeons all over the country to treat thousands of patients and in so doing improved quality of life for ordinary South Africans! Offices and new state of the art laboratories are located at the CSIR in Lynnwood Pretoria and the CTE employ 15 full time staff members and 6 part-time, off site, personnel.

The CTE-Bone Bank operates actively in 4 provinces; are now members of the South African Transplant Society; the Organ Donor Foundation; the European Association of Tissue Banks and work in close collaboration with Netcare Transplant division and the Wits Donald Gordon Transplant Clinic.

Apart from procuring bone tissue it is also part of the CTE’s mission to inform and educate the SA public about the importance of organ and tissue donation through various media.

It is a priority to obtain tissue, to pursue excellence by supplying the best possible
product, quality and service to clinicians in South Africa who
routinely use such products and services.

    To respect and protect the dignity of the donor and the donor family