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Certifications and standards HomeAbout usCertifications and standards

Chemical Company is a manufacturer of Medical Devices (IVD), having obtained registration certificates for a number of IVDs from the Ministry of Health / National Agency for Medicines and Medical Devices. The certificate granted to Chemical Company represents the recognition of the Quality Management System in accordance with the requirements of SR EN ISO 13485:2012.

The guarantee of the control over the products made and services provided by Chemical Company is also ensured by obtaining the certification of the Integrated Management System according to the requirements: SR EN ISO 9001:2008, SR EN ISO 14001:2004 and SR OHSAS 18001:2007, which contributes directly to the satisfaction of the customers’ demands with quality products and services, resulted in the context of their employees’ heath, as well as the safety of the environment.

During the 23 years of activity in the production of chemicals, Chemical Company has developed an anticipative attitude, designed to provide with the means to respond to market’s challenges. In this respect, the company’s development strategy aims at the production of intermediate substances for APIs, the company being in the process of obtaining the GMP certification at European level.

Quality Management System ISO 9001:2008

Certificare ISO 9001: 2015 pentru implementarea Sistemului de Management al Calităţii

Environment Management System ISO 14001: 2004

Occupational Health and Safety Management System - OHSAS 18001:2007

Certificare OHSAS 18001:2007 pentru implementarea Sistemului de Management al Sănătăţii şi Securităţii Ocupaţionale

Certificare ISO 13485:2012 pentru comercializare și depozitare dispozitive medicale

Certificare ISO 13485:2012 pentru comercializare și depozitare dispozitive medicale
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