To achieve our Quality Objective, we are making three fundamental commitments to our customers, our employees and the environment in which we are growing.
Since its creation, Teknimed has been committed to a quality approach enabling it to ensure the performance and safety of its products.
Our quality system has been certified since 1996; it is based on a strategy of continuous improvement and meets national and international requirements, particularly through:
- benchmark standards ISO 13485 and CFR 21 part 820,
- compliance with current regulations (particularly FDA and European Directive 93/42/EEC),
- audits by our notified body and by our customers,
- ANSM, ANVISA, KFDA, FDA – 21 CFR Part 820 inspections.
To guarantee the safety of our products, our resources include the following:
- supply chain management (particularly supplier audit),
- document system providing full traceability of medical devices,
- efficient quality control laboratory,
- process validation subject to a validation master plan complying with 21 CFR part. 820 (IQ, OQ, PQ),
- staff training (GMP),
- product sterility, by controlling the production environment (qualification & monitoring) and by validating sterilisation processes.
We are committed to offering our customers and prescribers high quality products and services:
- by using our customer services department to take their expectations into account and by providing fast, appropriate responses,
- by working continually to optimise our production and distribution systems, to ensure the quality and constant availability of our products,
- by reducing deadlines for Management of Corrective Actions and Preventive Actions (CAPAs).
COMMITMENT, LISTENING AND ENHANCING THE SKILLS OF OUR EMPLOYEES
Constantly improving the company’s performance and the quality of life for the people making it up are inseparable objectives.
We are a socially-aware business committed to recognising our responsibility within the society in which we live and work. We are getting involved in improving quality and the environment we share.
TEKNIMED’s independent integrated French production and process serve as proof of quality. Quality control is at the heart of activities undertaken by all our operators.
Our partners can have complete confidence in the quality of TEKNIMED products manufactured and inspected in our French factories. The components required to manufacture our products are produced entirely in our own factories, ensuring traceability and control of the technology.