Declaration of the quality policy

MEDITEST is ISO 9001: 2015 certified, across all of its businesses, including its metrology activity.

MEDITEST has been COFRAC-accredited since March 2014, according to the ISO 17025: 2005 standard. Scopes are available on the website www.cofrac.fr (accredited laboratory N ° 2-5602, N ° 2-6106, N ° 2-6471 and N ° 2 -6472).

The scope of the MEDITEST QMS includes all of the company’s activities, that is to say:

• Management
• operational management
  the sale of products and equipment, including sales administration and logistics
• calibration and verification
• repair and customer service
• design and development
• the activities of design, development, maintenance and improvement of the quality management system

MEDIX LAB services, in their entirety, are not subject to opinion or interpretation. MEDIX LAB does not subcontract its calibration services. Confidentiality and impartiality are guaranteed by regular awareness raising among staff and service providers, by a signed commitment, by a procedure and by this declaration.

MEDITEST dedicates itself to contributing to the guarantee of diagnostic quality in medical imaging through innovation and security requirements.

As such, technical medical imaging platform quality control is made possible through equipment sales activity.

The laboratory calibration activity helps ensure patient and healthcare professional safety with regard to X-ray doses received during diagnostic examinations.

Equipment sales activities have grown, with internationally renowned equipment. Since 2016, MEDITEST has strengthened its position on the radiotherapy market with innovative contention devices and the creation of reference sites.

The laboratory is a pioneer in low energy X-ray calibration as a secondary laboratory on the French market. The laboratory acquired and then extended its trade-related skills and knowledge in metrology, in the fields of photometry and electrical quantities.

Its strategic directions are to:

• Maintain equipment sales activity growth in the radiotherapy, radiodiagnostic, and nuclear medicine markets;
• Anchor and deploy the historic low energy X-ray calibration activity in the health sector, by enriching photometry and electrical magnitude services;
• Pursue metrology activity diversification at a European level; and
• Capitalize on its trade-related skills and knowledge, as recognized by COFRAC, for patient dose control in the health sector, in order to conquer new markets such as industry and construction.

These guidelines are followed through objectives and indicators defined elsewhere, and reviewed regularly.

The laboratory’s management team is committed to ensuring good professional practices and the quality of its tests and its calibrations for the benefit of its clients.

The quality system is fundamental to all MEDITEST employees and general management. It is led by two primary positions: the Quality Manager and the Laboratory Manager.

The level of service provided by MEDITEST concerns technical platform quality control in Radiology, Nuclear Medicine, Radiotherapy, and Research.

Some of its operational activities are deployed through the secondary metrology laboratory for low-energy X-ray calibration, in photometry in electrical quantities (direct current and low frequency / alternating current – direct current, and time and frequency).

MEDIX LAB measurement results are provided with respect to the international system of SI units.

The laboratory develops additional services adapted to specific client needs (development of new methods and procedures).

Tests and calibrations are and must always be carried out in accordance with stipulated methods and client requirements.

The purposes of the quality management system are to:

• ensure management system development and implementation for continuous improvement in efficacy.
• meet client demands as well as regulatory and legal requirements.
• ensure the quality of the test and / or calibration results.

The entire staff is involved in testing and calibration activities within the laboratory. As a result, all staff members are familiar with quality documentation and must apply SMQ policies and procedures in their work.

Thus, through this quality management system, Laboratory Management undertakes to comply with this International Standard and to continuously improve the efficacy of the management system.

In order to meet the requirements of confidentiality and independence, MEDITEST management ensures that the services that the company provides are free from any commercial, financial, or other pressures or influences, internal or external, which would be likely to jeopardize the quality of its work, and that all information related to its services is kept confidential. All information collected during the company’s services must be saved and kept confidential, except in cases of authorized disclosure. MEDITEST management ensures, via this signed declaration, that these requirements are met.

None of the people collaborating in MEDITEST’s activities may accept, from whatever origin, pressures linked to assistance, preferential treatment, obstruction, or delay in transactions between MEDITEST and its clients. Attempts to apply such pressure must be brought to the attention of MEDITEST management. Management must ensure that the appropriate actions are implemented, for example by replacing the personnel assigned to the file.

All information on laboratory and trading activities is considered confidential. MEDITEST staff, including laboratory staff, must maintain this confidentiality and treat all laboratory and company information as confidential. The term “laboratory” is characterized by the information contained in the “calibrate and verify” process sheet.

As the head of the laboratory, I am committed to:

– the laboratory’s activities are carried out with complete impartiality,

– laboratory activities are carried out impartially, structured and managed in such a way as to preserve impartiality,

– no commercial, financial or other pressures compromise this impartiality,

– the risks liable to undermine this impartiality are regularly identified,

– if a risk to impartiality is identified, appropriate actions are taken to eliminate or reduce it to a minimum

Signed in Buc, on December 8th, 2020

Bruno TORRÈS

_________________

President