Our Quality System
The literal translation “Quality System” from the Italian “Sistema Qualità” stands for us as the organisational structure, the responsibility, the procedures, processes and resources designated to manage all the activities that contribute to ensuring the safety of our product, directly and indirectly.
The system we implement aims at satisfying the highest standards and regulations:
- UNI EN ISO 9001:2015 “Quality Management System – Requirements”
- Good Tissue Practice GTP and Good Manufacturing Practice GMP
- National and International directives, norms and guidelines for quality management systems in tissue banking
- “Minimum organisational, structural and technological requirements for all tissue banks regarding the quality and safety in the donation process, the procurement, control, processing, conservation, banking and distribution of human tissues and cells”, approved by the State-Regions Italian Conference on March 8 th , 2018.
Certificates and Authorisations
Certificate from the National Transplant Centre CNT
In the year 2003, the Musculoskeletal Tissue Bank BTM of the Rizzoli Orthopaedic Institute has been recognised as a “bank of national interest”. Since 2004, we have earned the mandatory certificate from the National Transplant Centre CNT, for the procurement, processing, conservation and distribution of musculoskeletal tissue.
The ISO 9001:2015 Certification
Since the year 2003, our quality system has obtained the UNI EN ISO 9001:2015 certificate of compliance from the auditing body Certiquality. Certiquality holds an international recognition (IQNet) for the selection, procurement, processing, validation, conservation, allocation and distribution of musculoskeletal tissue, third-party consultancy and processing of musculoskeletal tissue, and project and development of new products and services.
Quality of the Donation
The donor of musculoskeletal tissue, alive or deceased, following informed consent, must undergo a wide range of clinical examinations to verify that they are suitable for donation by excluding transmittable diseases as per national and European standards. The removal of tissue is performed by qualified and experienced personnel in the surgery room, so to guarantee the sterility and integrity of the tissue. Particular care is given to the process of reconstruction of removed bone grafts in cadaver donors. Respect for the body is fundamental and the removed bone grafts are substituted with prosthetics.
The processing of tissue is carried out in a controlled contamination area (cleanroom), according to the requirements listed in Annex 1 of the Good Manufacturing Practice GMP. The environmental conditions to ensure the sterility of the processed tissue are controlled through the constant monitoring of critical parameters. The equipment is designed to guarantee excellent performance and undergoes thorough and regular inspections and monitoring.
Highly Skilled Personnel
The training of our personnel is ongoing, periodically revised and updated. Each operator is aware of their responsibility and is skilled and qualified to carry out the duties assigned to them. Our team is aware of the organisation, quality system and safety standards of our bank and is furthermore, aware of any ethical and legal implications involved in the work. The team is trained on the norms regarding their field of work and has acquired and maintained their scientific and technical skills.
Quality of the Tissue
The processing of the tissue is carried out in a class A cleanroom with a class B background in accordance with Annex 1 of the Good Manufacturing Practice GMP. The processing is constantly monitored in its critical parameters according to the GMP. For every batch of processed tissue, process and product monitoring is carried out regularly. The microbiological screening is carried out in the IOR SSD (Rizzoli Orthopaedic Institute, Scientific Disciplinary Sector) laboratory as per quality control according to GMP.
The cold chain for tissue conservation is strictly maintained at every step. The areas where the tissue is processed have controlled access and they are divided into several parts according to the processing stages (suitable for transplant, separate waiting for donor suitability confirmation or separate waiting for results of quality control).
The tissues that have been declared suitable for transplant are distributed to the medical facilities or surgeons for orthopaedic surgery, maxillofacial surgery, neurosurgery or orthodontics. The conservation guidelines, the characteristics and instructions for the use of tissue are explained in detail in the brochure provided. The cooperation with orthopaedics, dentists and other users allows an indirect follow-up for the recipients and direct feedback on the product performance.
The full traceability of tissues, from donation to implant, is realised through a regional software “Donor Manager” used by all Tissue Banks of the Emilia-Romagna Region.