Certificates

To satisfy the needs of its current customers and respond positively to the expectations of its future clients, adhe-els must remain constantly listening to them, to use means and manufacturing processes at the cutting edge of technology and respect regulatory requirements prescribed by the standards in the pharmaceutical sector.

Thus, adhe-els, straddling quality, has set up an appropriate organization including CEO Quality function with autonomy and authority to implement a Quality Management System performance.

Thus, adhe-els, straddling quality, has set up an appropriate organization including CEO Quality function with autonomy and authority to implement a Quality Management System performance.

The Director General Quality Management has the confidence and the unconditional support of senior management, to maintain and continually improve the quality level, overriding purpose for which has involved all the adhe-els of staff.

The Directorate General Quality therefore ensures the implementation and maintenance of Quality Management and reports to senior management in order to perfect it.

For its part, and as the first responsible for the decision-making center, Mr Bechir Gaaloul as CEO is committed to consolidate and secure, and in collaboration with all the staff, respect the integrated management system (quality, environment , health and safety) according to the different standards of the industry and provide all the necessary resources to train and develop a spirit of continuous improvement.

The strategic direction of the company is as follows:

1-The customer satisfaction by trained and qualified personnel.
2- Increase profitability by measuring and optimizing performance and staff productivity.
3- Control and reduction of the cost of obtaining quality product and service.
4-Control of the company’s workforce.
5-monitor budgets and expenditures for all directions and work for their reductions.
6-Controlling energy and essentially all the natural resources consumed measures and work to reduce this consumption.

 

 

  • To ensure the best development of our quality management system, our quality policy, in 6 points our quality policy has been determined as follows:
  • Continuously improve customer satisfaction by ensuring the best for its needs;
  • Increase the company’s activities;
  • Design and develop new products and ensure their marketing
  • Continually improve the effectiveness of the Quality Management System;
  • Improve the profitability of the company’s activities;
  • Improve the development of internal communication to involve and empower all staff to benefit from continuing education.

 

Safety and hygiene of work stations, the environmental protection, conservation of energy and natural resources are key elements of our company policy.

In this context Adhe-els has the ambition to position itself as a key partner by its customers.

Thus the environment plays an essential role; to meet these expectations Adhe-els is committed to implement the following policy:

Provide a framework on the point of view of hygiene and safety and ensure that staff are properly trained and have the safety equipment and appropriate emergency

 

Conserve natural resources by reducing as much as possible the consumption of energy, water, and raw material and please that waste is all in circuits facilitating recycling.

Ensure that manufacturing processes do not adversely affect the environment.

Ensure continuous improvement of operations to reduce waste and prevent pollution of the atmosphere, water and soil and control environmental impacts

The management of risks related to health and safety to reduce accidents in all Adhe-Els activities.

All these efforts in the eternal quest for quality eventually bear fruit, and rewards, Adhe-Els laboratories now have certifications and CE marking by the national metrology laboratory and -Gmed

body LNE tests 0459 and notified by ECM- ZERTIFIZIERUNGSGESELL SCHAFT notified body 0481 for angioplasty ranges.

1 / All of our products are certified according to Directive 93/42 / EEC of 14 June 1993 amended by Directive 2007/47 / whatever the class medical device Is, IIa, IIb and III.

 

2 / Quality management system:

NF EN ISO 13485 (2004) and ISO 13485 (2012): Medical devices: Quality management systems – Requirements for regulatory purposes.

NF EN ISO 9001 (2008): Management system of quality requirements.

3 / Sterilization with ethylene oxide:

EN ISO 11135-1 (2007): Sterilization of ethylene oxide health products Part 1: development requirements, validation and routine control of a sterilization process for medical devices.

4 / sterilization by gamma radiation and beta according to standard 11137-1 (2006):

Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices).
Activity carried out by a third party

5 / Certification of the environment and the health system and safety (OHS) from germany notified body DQS GmbH registered under number 430426.

NF EN ISO 14001 (2004) Environmental Management Systems: Requirements with guidance for use

BS OHSAS 18001 (2007) Management System Health and Safety -Requirements.
6 / registration on the basis of International Certification Network (IQ Net) under the number DE-430426.