Amsterdam – 22 october 2018 – The ISO 13485 internationally recognized medical device quality management systems standard, was festively awarded to Matthias Marivoet and Marc Gielis from BlueBee BVBA during the certificate ceremony at the headquarter of notified body BSI in Amsterdam on October 12th.
BlueBee is convinced that the certified ISO 13485:2016 quality management system will help the company to expand their market access and improve their products and processes.
‘’Obtaining ISO 13485:2016 certification helps BlueBee to open doors to untapped business opportunities and shows proof to potential clients that BlueBee complies with best practices and regulatory requirements in the medical device industry,’’ states Matthias Marivoet, Compliance and QA Officer of Bluebee. ‘’Implementation of ISO 13485 has driven continual improvement throughout the company and increased the control over our processes.’’
Professional and expert guidance
When asked about the overall collaboration with BSI Group The Netherlands Matthias Marivoet states: ’’Achieving ISO 13485 certification was facilitated through the professional and expert guidance provided by BSI.’’
Management commitment is key
Matthias gives the following advice for companies that are in the certification process: ‘’Management commitment is a key factor throughout the entire certification journey. Their involvement is crucial to ensure the availability of resources by providing training opportunities to ensure personnel performing work affecting product quality achieve the necessary competence. As part of BlueBee’s certification journey, we called upon the BSI training courses service, to ensure our internal auditor achieved the required competence.’’