The excellence at the service of diagnostic
DiaSource and its team are committed to provide high quality medical diagnostic tests and ultimate services to customers worldwide.
Our ambition is to provide first-in-class diagnostic products for patient health assessment. The values and processes of our organization are fully tuned to optimize products quality. Furthermore, our commercial, technical and scientific teams are attentive to implicit and explicit needs of our current and future customers.
On the road to excellence, we do not just guard and assure quality of our products and services but we promote improvement at all levels of the company. As part of that, we also evaluate, challenge and follow up on the quality of the products and services of our suppliers.
How do DiaSource achieve its quality objectives ?
- To improve customer satisfaction, the quality of our products as well as the effectiveness and the efficiency of our processes, DiaSource has designed a robust Quality Management System (QMS) that is periodically reassessed.This QMS is maintained fully in accordance with the following requirements :
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- ISO 9001:2015 - Quality Management System for Design, development, production and sales of IVDs and related reagents.
DIAsourse-Certificate ISO 9001-2015
- ISO 9001:2015 - Quality Management System for Design, development, production and sales of IVDs and related reagents.
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- ISO 13485:2016 - Design, development, manufactured and distribution of in-vitro Diagnostics test kits related to immunochemistry, infectious immunology and other immunology markers. Distribution of in-vitro diagnostids test kits.
DIAsource-Certificate ISO 13485-2016
- ISO 13485:2016 - Design, development, manufactured and distribution of in-vitro Diagnostics test kits related to immunochemistry, infectious immunology and other immunology markers. Distribution of in-vitro diagnostids test kits.
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- Medical Device Single Audit Program (MDSAP) certification : Design, development, manufactured and management of outsourced of in vitro diagnostic test kits used in the diagnosis of endocrinology, infectious diseases, immunology, autoimmunity and cancer markers.
DaSource - Certification of approval for Medical Device System for Design (MDSAP)
- Medical Device Single Audit Program (MDSAP) certification : Design, development, manufactured and management of outsourced of in vitro diagnostic test kits used in the diagnosis of endocrinology, infectious diseases, immunology, autoimmunity and cancer markers.
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- IVD Directive 2017/746
- IVD Directive 98/79 EC (European Union)
- SOR/98-282 (Canada)
- 21 CFR Part 803, 21 CFR Part 806, 21 CFR Part 807 and 21 CFR Part 820 (US)
- (MD)R Sch 1 and 3 (Australia)
- MHLW MO169 and 128 (Japan)
- Law No. 16433 - Act on in vitro diagnostic medical devices (South Korea).
2. A risk based approach is used for all our decision.
3. Finally, to fulfill our commitment to quality, we are staffed by a competent, professional and continuously trained workforce.
If you want to consult the previous certificates, please don't hesitate to send us an email :