Since its inception, CRYOSTEM has placed its action in the framework of a quality approach respecting all the international standards from the management of its collection of biological resources to its governance.
The network governance decided to commit, in early 2014, towards a quality approach with the goal of ISO 9001 certification. ISO 9001 norm defines the requirements to meet quality management system (QMS), customer needs and satisfaction, processes control and continuous improvement. Benefits of ISO 9001 certification in a large multi-center cohort such as CRYOSTEM are felt mainly at two levels:
- Organizational level : structuring in processes, leading to more relevant identification of dysfunctions, facilitation of management toward transparent communication, monitoring of activity and efficacy through pertinent indicators.
- Strategic level : collection quality, partners’ commitment and focus on user expectations and satisfaction, international visibility.
Governance ISO 9001 certification was successfully obtained in February 2015, barely one year after QMS establishment. This certification clearly plays a role in the network success and cohesion. Since 2015, CRYOSTEM has set up 48 indicators, declined for each process. Moreover, in order to monitor and analyze network transplant units and BRC activities, CRYOSTEM invested in October 2015 in training for internal auditors. To date, 3 internal auditors are operational.
A quality system familiar with international standards for collection management
Annual controls were set up in order to check the homogeneity and the quality of samples processed and stored in the BRC in the CRYOSTEM network.
Several parameters are assessed :
- recovery rate and cellular viability on cells in DMSO after thawing,
- DNA purity on packed leukocytes, reflected by measurement of absorption ratio at 260 and 280 nm.
Our quality objectives are to reach bibliographic values of reference : cell viability value at a minimum of 90% and 50% cell recovery after thawing cells in DMSO and an absorption ratio 260/280 between 1,8 and 2 for DNA purity.
Assessment of samples
Cells in DMSO
Comparison of cell recovery and viability after thawing and washing according to the year of treatment of samples.
Comparison of DNA purity according the year of treatment of samples.
- 2016 : 2012 to 2016, 147 samples have been collected from 20 CRB (cells in DMSO and dried pellets).