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Quality issues in tissue banking: quality management systems - a review
R Von Versen1, H J Mönig, M Salai
1DIZG German Institute for Cell and Tissue Replacement, Robert-Roessle Str. 10, 13125 Berlin, Germany; (Tel.: (+49-30)9415430; Fax: (+49-30)9415439;
Cell and Tissue Banking
|July 17, 2004
Summary
Tissue banking has evolved due to increased demand and scientific advancements. Implementing a Quality Management System (QMS) based on ISO 9000 standards is crucial for harmonizing global practices and ensuring quality assurance.
Area of Science:
- Biotechnology
- Medical Sciences
- Quality Management
Background:
- Tissue banking radically transformed in the 1990s due to rising demand for biological materials and rapid scientific progress.
- Biotechnology has become integral to modern tissue banking operations.
- Increased demand necessitates national and international cooperation in ethical principles, quality assurance, and regulations.
Purpose of the Study:
- To present the use of the international standard ISO 9000 as a general Quality Management System (QMS) for tissue banking.
- To explain the individual elements of the ISO 9000 QMS and provide examples relevant to tissue banking.
- To highlight the QMS as an indispensable instrument for harmonization and international cooperation in tissue banking.
Main Methods:
- Explanation and definition of quality terminology.
- Description of the ISO 9000 standard as a general QMS.
- Application of QMS elements to tissue banking, including R&D, design control, training, documentation, traceability, management control, and corrective actions.
Main Results:
- The ISO 9000 standard provides a framework for a comprehensive QMS in tissue banking.
- The QMS integrates specific methodologies and general quality management aspects.
- Implementation of such a QMS demonstrates a commitment to world-class operations.
Conclusions:
- A Quality Management System (QMS) is essential for tissue banking to meet increasing demands and scientific advancements.
- The ISO 9000 standard offers a suitable framework for harmonizing ethical principles, quality assurance, and regulations.
- Adoption of a QMS signals a commitment to quality and regulatory compliance to authorities and the public.