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Commitment to quality - Certificates

The excellence in diagnostic services

We are committed to provide high quality medical diagnostic tests and ultimate services to customers worldwide. We will go further than our competitors to make the difference. 

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. We want to excel on customer orientation, flexibility and services.

We have a solid experience for more than 30 years in the development and manufacturing of clinical in-vitro diagnostic products and use the same rigorous and reliable processes for manufacturing and quality control of research products.

On the road to excellence, we do not just guard and assure quality of our products and services, but we promote Continuous 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.

In order to design, manufacture and provide compliant, effective and safe products for diagnostic markets worldwide,
we maintain a Quality Management System fully in accordance with the following requirements:

  • ISO 9001:2015;
  • ISO 13485:2016;
  • 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);
  • TG(MD)R Sch 1 and 3 (Australia);
  • RDC ANVISA 16/2013, 23/2012, 56/2001 and 67/2009 (Brazil);
  • MHLW MO169 and 128 (Japan). 

Our Quality Management System is designed to continuously improve customer satisfaction, the quality of our products as well as the effectiveness and the efficiency of our processes. The QMS is reassessed during Management Reviews and  Executive Quality Committees (EQC).

To fulfill our commitment to Quality, we are staffed by a competent, professional and continuously trained workforce.

Our objectives for the coming years are to maintain the ISO9001: 2015 certification, to  pass the Medical Device Single Audit Program (MDSAP) as well as to comply with the IVD 2017/746. 

Established in Louvain-La-Neuve (Belgium) on 09 July 2019.

QUALITY POLICY

English version - French version

QUALITY CERTIFICATES

Certificate of approval ISO 9001: 2015

- Certificate of approval ISO 13485: 2016

- Certificate MDSAP-0079246

EXTERNAL CONTROL CERTIFICATES

BIORADBIORAD 2016 - BIORAD 2017 - BIORAD 2018

DEQASDEQAS 1.25OH 2015-2016 - DEQAS 1.25OH 2017-2018  //  DEQAS 25OH 2015-2016 - DEQAS 25OH 2017-2018

INSTANDINSTAND 092019-Hormones VirilizationINSTAND 092019-Tumor MarkersINSTAND 102019-Hormones VirilizationINSTAND 102019-Tumor Markers 

PREVIOUS INSTAND CERTIFICATES : on request

UK NEQAS:  UK NEQAS registration certification 2016  //  UK NEQAS registration certification 2017 //  UK NEQAS registration certification 2018

Coordinates

DIAsource ImmunoAssays SA
BE 0457.934.723
Rue du Bosquet, 2 | 1348 Louvain-la-Neuve - Belgium
Tel +32 10 84 99 11 | Fax +32 10 84 99 90

CLOSING DAYS 2019 : 1/01-22/04-01&30/05-10/06-21/07-15/08-01&11/11-25/12

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DIAsource ImmunoAssays (formerly BioSource), experienced diagnostic manufacturer of RIA-ELISA-LIA immunoassays, validation on automates, large scale production of Antibodies-Point of Care Tests.

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