1. Customer requirements:
The needs and expectations of the parties concerned (customers, co-workers, etc.) are documented in a form, which is regularly reviewed. Quality policy is drawn up consistent with these needs and expectations.

2. Legal and statutory requirements:
The applicable legal requirements are the general requirements derived from Belgian or European law.
The specific requirements applicable to our activity are identified and updated. A regular review is carried out to check that activities conform to these regulations.

These requirements are:

• CE marking (registration with the Ministries of Public Health),
• Marketing approval by the Food & Drugs Administration,
• ISO 9001 certification,
• ISO 13485 certification,
• ISO 13485 certification (Canada),
• Rules of Good Manufacturing Practices,

3. Objectives and Strategy of CORIS BioConcept:
During the General Meeting, the general strategy and global objectives of CORIS Bioconcept are presented in the « Rapport de Gestion Annuel ». This annual management report contains:

• activity report of the year
• forecast for the following years
• the objectives & strategy for the futur

4. Mission and Quality Policy of CORIS BioConcept:
It is essential to prevent faults occurring in all the activities of CORIS BioConcept and to implement and sustain a Quality Assurance approach to guarantee customers that their expectations will be continuously fulfilled.
An effective quality policy requires a commitment to the Quality Assurance approach by each member of the team.
The quality, effectiveness and safety of the products and services of CORIS BioConcept will be safeguarded if everyone fulfils his or her expected role in the quality system.
Quality policy is put in a concrete form in the operating report of objectives and indicators contained in the ad hoc form.
It is communicated to all the personnel during monthly meetings.
It is regularly reviewed throughout the year to assess its effectiveness and appropriateness, either during monthly meetings, or at the time of the company seminar.
It is also the subject of assessment at management reviews scheduled at the end of the year.

5. Quality objectives and quality planning:
CORIS BioConcept sets out quality and/or strategic objectives consistent with its quality policy.
The implementation of these objectives, measurable as far as possible, is the subject of action plans, which take the place of quality planning.
Objectives and action plan are reviewed at regular intervals to assess whether they are pertinent and satisfactory.

6. Implementation of the Quality management system:

The Quality management system covers the following activities:

• Conception, development, production and marketing of rapid diagnostic kits in the field of biotechnology: research, health, environment and food industry.
• Micropipette validation service for laboratories.

7. Quality management system:
Responsibility for the implementation of the provisions of this manual and its annexes lies with the management committee.
A monitoring committee, composed of the RAQ (QA manager) and representatives of personnel and management, supervises that the rules and procedures laid down are properly applied, especially in the area of the competence and satisfaction of the parties concerned. The monitoring committee has documents at its disposal issued by the Management Review, Nonconformance Review and Improvements Review to monitor the smooth progress of its activities. The monitoring committee makes use of an operating report containing measurable objectives and their follow-up, as well as indicators for monitoring policy and strategy.
CORIS BioConcept has personnel with the skills necessary for providing company services. Their qualifications are defined, maintained, regularly checked and improved through continuous training.
As part of their activities on behalf of CORIS BioConcept, co-workers are responsible for applying the provisions of this manual and its annexes, which are available to them.
Quality management system documents are drawn up on the responsibility of the management committee and of the RAQ, who approve them. New versions are sent to the persons concerned who are responsible for updating their documentation.
Quality related records are kept at company head office, on the responsibility of the RAQ according to a plan and defined time scale.

8. Management review:
Once a year, the activities of CORIS BioConcept are submitted to a management review. Management reviews are chaired by the RAQ.
Management review reports are presented to the monitoring committee and to the General Meeting. They are accessible to the accreditation body.