BIONER complies with all Quality standards applicable to the Medical Device sector.
The company Quality management system is based on the ISO 13485:2016 standard “Medical devices. Quality management systems”, and it is periodically audited by an authorised notified body.
This , along with the maintenance of the License granted by the Spanish Agency for Medicines and Health Products (AEMPS), guarantee that BIONER products are manufactured, controlled and marketed, complying with the quality standards of the sector.
Currently, BIONER complies with the new Regulation (EU) 2017/745, entered into force on May 2021, having obtained the CE certificate through the notified body CE0051 (IMQ). This fact positions Bioner at the highest level among companies in the dental sector.
BIONER, S.A., developing its line of activity in terms of Quality and with the aim of being as efficient as possible when serving its customers, bases its Quality policy on:
► Contributing to the development of spanish implantology, providing professional dentists, lab technicians and dental hygienists with access to implant products of high and proven quality and technologically innovative.
► Becoming a valid interlocutor between the industrial technological world and the scientific world (Universities, researchers, educational centers).
► Increase the quality of life of patients with the quality and reliability of the products we design and manufacture.
Bioner ‘s policy is to offer COMPETITIVE PRODUCTS AND SERVICES that meet the expectations of its CUSTOMERS, with the high QUALITY requirements, following the applicable regulations; but also to look for PROFITABILITY and to look after the PERSONNEL satisfaction. For this reason, thre senior Management establishes, declares, assumes and transmits the following principles:
- The quality of the product is the result of planned and systematic actions of PREVENTION, DETECTION, CORRECTION and IMPROVEMENT throughout the service.
- The contractual demands, the customer desires and specifications as well as the observance of the current Regulation, are the criteria to establish the QUALITY STANDARD of our services.
- The Quality and contractual requirements must be objectively translated into specifications that will be delivered to those responsible for carrying out the service and subcontractors, COMPLETELY AND PROPERLY.
- Quality affects ALL departments of the company and each worker is RESPONSIBLE for the Quality of their work.
- The Quality Manager is responsible for promoting the IMPLEMENTATION of the policy and the achievement of all quality objectives, VERIFYING its execution through audits.
- The application of this policy requires the active integration of the entire human force of the company. For this reason the management considers MOTIVATION and TRAINING to be important.
- Respect for the ENVIRONMENT and SOCIAL RESPONSIBILITY must be considered as one more part of the quality of the company.
- PRODUCTIVITY and COMPETITIVENESS must be adapted to the market.
- In order to always be aligned with Quality requirements, a CONTINUOUS IMPROVEMENT PLAN encompassing all processes will be followed.
This Quality Policy was approved by Bioner Board of Directors in September the 4th, 2008 and ratified by the same Board in March 2022.Download the Quality Policy