Designing a state-of-the-science, accredited, commercially-successful biorepository utilizing ISO:9001(2008) quality management system requirements to construct the framework
The research community relies upon biorepositories’ ability to prepare for the scientific advancement that can precipitate the discoveries of the future. Furthermore, as the complexities, financial pressure, and quality issues biorepositories face continue to unfold, it is imperative to explore unmet needs researchers may have for biorepository services as well as evaluate the commercial potential, funding, and competitiveness of a new biorepository. With the goal of contributing to medical and scientific research and the biorepository field, this paper utilizes principles from ISO 9001:2008 “Quality management systems- Requirements” to outline and explore the challenges in establishing a state-of-the-science, accredited, commercial BSL-2 biorepository in order to support academic, clinical, and translational research. In addition, this paper provides detailed quality assurance strategies to meet investigator’s needs, ensure high quality, fit-for-purpose biospecimens, and, most importantly, protect and preserve the biospecimens entrusted to its care
