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Commitment to quality - Certificates

DIAsource charter for excellence in products and 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 high quality 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 and Total Quality Management 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;

• Directive IVD 98/79 EC;

• FDA Regulation 21CFR820;

• CMDCAS Canada.

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 obtain and maintain the ISO9001: 2015 and ISO13485: 2016 certifications as well as the IVD 2017/746.

Established in Louvain-La-Neuve (Belgium) on 6 December 2017. 

QUALITY POLICY

English version - French version - Dutch version- Spanish version - German version.

QUALITY CERTIFICATES

 •  Confirmation of EN ISO13485:2016 certification

EXTERNAL CONTROL CERTIFICATES

•  BIORAD 2016 - BIORAD 2017 - BIORAD 2018

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

•  INSTAND 032017 Hormones-virilization - INSTAND 052018 Hormones-Virilization //  INSTAND 072017 Hormones-Calcium-Metabolism-Special Thyroid -  INSTAND 072018 Hormones-Calcium-Metabolism-Special Thyroïd -  //  INSTAND 092017 Tumor Markers - INSTAND 072018 Tumor Markers

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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