By Biomedical research is increasingly regulated and reliant on robustness of results. Biological research is more complex, regulated, and diverse, requiring a quality management system to avoid biases and ensure the robustness of research results. QMS helps scientists prevent mistakes and identify biases, prescribe clear responsibilities, and build a common knowledge base to inform their research. This article will discuss some of the main benefits of QMS in biomedical research.
MoBiLab QMS
The MoBiLab quality management system (QMS) has led to tangible improvements in downstream processes and data output. Data generated by the MoBiLab project shows increased performance, more publications, and increased international collaboration. This quality management system (QMS) has contributed to MoBiLab’s vision to become a national leader in biomedical science infrastructure and enabling facility. By using an integrated approach to QMS, MoBiLab is making strides towards its vision of becoming an enabling facility for the scientific community.
PREMIER
The PREMIER quality management system is a proof of concept for systematic quality management in academic preclinical biomedical research. This quality management system biomedical science system has been designed to meet the unique needs of biomedical research laboratories without compromising research productivity or efficiency. It is a modular quality management system that facilitates continuous improvement in biomedical research, even in the smallest laboratory. Its modular structure is based on three quality aspects: reproducibility, quality assurance, and safety.
ReOmicS
ReOmicS is a quality management system for the biomedical science field. It aims to provide a robust and efficient quality assurance system for the field. It has been designed to meet the requirements of ISO 9001: the international standard for quality management systems. Its design incorporates risk analysis, a key element of the quality management system. The risks associated with each process step are assessed in terms of their severity (S) and probability (P). Once the assessment of each pitfall was complete, the team drafted operating procedures to implement those measures.
ISO 9001
For biomedical science companies, the ISO 9001 quality management standard can help them ensure consistent and high-quality products. The standard is recognized worldwide and sets out the requirements for an effective QMS. Companies can use the standard as a template for building their own systems. By following the quality management system guidelines, companies can show customers that they meet their requirements consistently. A quality management system can lead to increased sales and revenue.
ReOmicS effectiveness metric
In 2016, the ReOmicS quality management system was introduced to MoBiLab. The system was initially developed from scientific SOPs and is still under development, but there are a few limitations. First of all, it is difficult to pursue without an IT team. Second, it is difficult to measure the effectiveness of a quality management system without an appropriate LIMS, which is currently being developed. Third, the ReOmicS quality management system is a very high priority for MoBiLab, which has been subjected to a number of audits over the past three years. Nonetheless, the lab has already experienced concrete improvement. The quality management system is measured using a variety of metrics, including risk assessment, analysis throughput, number/quality of publications, external collaborations, satisfaction survey, etc.
