Quality Assurance Systems

Fully integrated Quality Assurance Systems dedicated to the total customer satisfaction

 

QUALITY

Sebia operates in a very strict regulatory environment with a high level of requirements. While meeting these stringent requirements, Sebia focuses its Quality Management Systems to meet customer’s total satisfaction.

Quality is fully integrated into the company’s culture and operations.

Sebia is organized around fundamental departments: Research & Development, Manufacturing, Quality Assurance, Regulatory Affairs, Commercial and Customer Support. These departments are located on the same industrial site.

These different departments are closely interconnected through our Quality Management Systems with objectives to improve and exceed the customers, employees and other stakeholders’ satisfaction. This consequently leads to business efficacy.

Sebia operates under the ISO 13485 : 2003, ISO 13485 : 2012 and ISO 14001: 2015 standards.

The main components of the Quality Management Systems are:

  • Total customer satisfaction
  • Implementation by all employees
  • Process based activities
  • Fully integrated system
  • Business driven approach
  • Continuous improvements
  • Efficient product information communication

Sebia implements a stringent policy of control and traceability throughout the production and distribution chains. This provides customers a high and constant quality of products and services, as well as the capability for Sebia to communicate rapidly to customers any relevant product information.

All Sebia in vitro diagnostic devices are CE marked and are registered in many countries around the world*.

At the end of the Research and Development step, the device/test (new or upgraded) are validated according to the harmonized and CLSI standards. The established performances are published in the instrucyion sheets for each device/test.

ENVIRONMENT

Sebia is ISO 14001 certified. This demonstrates the company’s commitment to respect the environment and sustainable development.

Sebia provides customers with the most efficient techniques and the best know-how, along with an ethical behaviour and a commitment to protect the environment through sustainable development.

Our specific commitment to pollution prevention and respect for the environment goes through:

  • Resource management improvement
  • Promotion of  eco-friendly behaviour
  • Stringent control of  waste management, with active  recovery and/or recycling.

WEEE/ROHS REGULATIONS

One of the challenges of sustainable development is equipment recycling and recovery at the end of its life. In this context, the electrical and electronic equipment components (EEE) and their associated waste (WEEE) are regulated by two directives:  

The RoHS** and WEEE***

These regulations have three objectives:

  • Reduce toxicity and amount of WEEE
  • Promote recycling and recovery
  • Incorporate environmental goals in the design of products.

To address these objectives, Sebia headquarter (based in France) is member of an eco-body: RECYLUM

An example of action taken under RECYLUM recommendations is the integration of the RoHS directive at the very early stages of new analyzer’s development. 

* Contact your Sebia representative for more information

** Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (“RoHS 2”)

*** Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (“WEEE 2”)