FAKKEL-bvba

Quality Management Systems for Health Care Services

FAKKEL is an organization that is specialized in the setting up of Quality Management System (QMS) for Medical Device Industry and Health Care Organization. It applies the EN15224 as the basis for the QMS and helps setting up and implementing this system. It helps setting and assessing the quality indicators that are relevant for a Health Care Organization. It provides advice on how to achieve the quality goals and provides support to implement the right 'quality oriented culture' within anorganization. More information can be obtained on the website www.fakkel-bvba.com.

Activities

FAKKEL offers the expertise that is required to set up and implement a quality system according the current regulatory guidelines and in an efficient way. It helps to determine all the processes that are valid for an organization, it determines the input and output requirements of each of these processes, it helps to determine and assess the clients' expectations for a quality system, it helps to set quality objectives, to define quality indicators and to assess the effectiveness of the Quality Management System. 

In view of the EN15224, each health care organization should function according a well established quality system. This way quality is build up in your organization from the bottom up, which is a guarantee to sustain and to acquire accreditation when appropriate.

Products and services

FAKKEL has expert knowledge in specific ISO and EN standards and norms: specifically related to the establishment of quality management systems in medical industry, clinical laboratories and health care organzations.

Quality handbooks, operating procedures... can be provided as standard tools or custom made for your organization. Implementing a working process in the most effective and most efficient way is the goal of FAKKEL: working with employees, providing advice, setting quality objecitves, measuring quality indicators, executing performance assessments, providing different kinds of workshops... all helps to establish the right 'quality oriented culture' within an organization. The right culture is essential to assure sustainability and compliance with authority requirements.

Projects

Currently some projects are ongoing in the fields of:

- setting up quality managagement systems for Elderly Homes & Service Flats

- developing products to reduce decubitus 

Area of interest

Contacts/acquaintance, Cooperation, Projects in Flanders