Last 12 septembre ISO 13485 certificate has been confirmed.
ISO 13485:2004 namely “Medical Devices – Quality Management System“ is an International standard conceived to be used by enterprises as a point of reference for the Quality Management Systems, within the field of design, production, installation and putting on the market of medical devices or services closely related to them, from surgical gauzes to more sophisticated devices.
ISO 13485 certification is a garantee that Loccioni humancare can ensure to its clients since:
- the products and services supplied, besides living up to the users’ expectations, are also in keeping with National and International laws;
- the configuration of its products/services remains unchanged in time;
- its products/services are presented ethically;
- it makes a good use of all the feedback received from its clients concerning its products and services, aiming to obtain further suggestions and ideas that add to our ameliorative strategies.
Next are all the features that have been verified during the inspection visit:
- the correct analyse and Management of the quality System
- the continuous implementation of ameliorative activities
- the correct management of resources
- the activity of design
- the control of production
- the activities related to customer service
- the correct management of measurement devices
- the marketing of disposables.
Extremely interesting apperaed to be APOTECA Community, namely a group of experts made up of all the users of the System who meet periodically to talk about daily problems and difficulties in order to implement the system by making changes which are adaptable to different working contexts. The Community proved to be a useful experience to acquire all information coming from clients in order to continuously improve the solutions offered by Loccioni Humancare, a business unit of Loccioni Group.
The audit showed that Loccioni humancare Quality System is in compliance with all requirements of the ISO 13485 certification concerning: design, production, service for systems of compounding of injectable drugs and marketing of sterilized disposables.
Thanks to this result, clients are sure that the processes and procedures followed by Loccioni humancare will offer top-level service.
The certification, adopted in Europe, is a point of reference for Canadian Medical Device Regulations (CMDR), it is aknowledged as existing in all Asian nations, including Cina and the American regulations FDA (QSR), even though independent, follow the same structure.