Quality

European reference EURL

Designated EU private clinical reference laboratory

With the designation of the five EURL¹, the European Commission aims to ensure that the placing on the EU market, the placing on the market and putting into service of diagnostic medical devices in vitro for human use, is produced with full health and quality guarantees for EU citizens.

1. EU Referenzlabor für In-vitro-Diagnostika am Paul-Ehrlich-Institut (ALE); Instituto de Salud Carlos III (ESP); Consorcio gestionado por el Servicio Madrileño de Salud (Hospital General Universitario Gregorio Marañón, Hospital Universitario la Paz and Hospital Universitario Ramón y Cajal) (ESP); Consulting Químico Sanitario SLU (ESP); and RISE Research Institutes of Sweden AB (SUE).

Designation

The designation of CQS as EURL occurs in two categories of class D medical devices: (i) products intended for the detection or quantification of herpesvirus markers, and (ii) products for the detection and quantification of markers of bacterial infections.

Products for which CQS will be responsible, inter alia, for:

Verification of the manufacturer’s declared performance and compliance with the common specifications.
The analysis of samples or batches.
Scientific advice to selected European and domestic institutions.
Recommendation on reference materials and measurement procedures.

Process

In this sense, the significant previous experience in Spanish and European R&D&I projects, the high capacity of our team and the advanced technical means at our disposal, as well as our comprehensive commitment to quality in healthcare environments (including our own software solutions such as the SmartQMS) have been our best letter of introduction.

The appointment was the culmination of a long and extremely demanding process. CQS has had to accredit the knowledge and experience of its staff; the necessary equipment and reference materials; integration and compliance with international standards and best practices; economic viability outside the EURL network; and professional independence.

ENAC quality

First private clinical laboratory in Spain to be accredited by ENAC

The CQS Laboratory (Consulting Químico Sanitario) is the first private clinical laboratory accredited in Spain by ENAC (Entidad Nacional de Acreditación) according to the international standard UNE-ISO 15189:2013 and also has one of the widest scopes (number of accredited products/services) of all.

In contrast to certification according to ISO 9001, which is the confirmation that a company has established a quality management system in accordance with certain requirements, this accreditation confirms the technical competence of the laboratory and guarantees reliable test results.

Only this accreditation can provide the highest degree of confidence in the technical competence of the laboratory, guarantee the complete reliability of the test results and confirm that the laboratory has the human resources, materials, experience and capacity necessary to provide a final product/service with criteria of excellence, optimum and maximum quality.

Such is the level of demand required to access this accreditation that we have been automatically recognised in more than fifty countries around the world, including all the countries of the European Union, the United States, Australia and Japan, through international mutual recognition agreements (MLA) established within ILAC (International Laboratory Accreditation Cooperation) and EA (European Cooperation for Accreditation).

See Accreditation See scope

ENAC ISO 15189 accreditation means:

Quality Policy

The CQS Laboratory, as an analysis and testing laboratory, is aware that it is vital to guarantee the quality of the analyses and tests it carries out and its awareness of the environment in an efficient manner and within the limits of current legislation, preventing non-compliant work from occurring during the performance of its activities and that if, at any time, non-compliant work does occur, it must be detected and corrected as quickly as possible, for the benefit of internal and external clients, offering a high level of respect for the environment and a commitment to sustainability. This commitment is established in the Quality and Environmental Policy of the CQS Laboratory, according to UNE-EN ISO 15189:2013 “Clinical laboratories.

Particular requirements relating to quality and competence”, and according to UNE-EN ISO/IEC 17025: 2005 “General requirements for the competence of testing and calibration laboratories” and according to UNE-EN ISO 14001:2004 “Environmental management system. Requirements with guidance for use”, based on the following principles:

Work, at least in the activities subject to accreditation, at the level of importance set by the international standards UNE-EN ISO 15189:2013 and UNE-EN ISO/IEC 17025:2005 and UNE-EN ISO 14001:2004.

Only the costs of sample collection, processing and storage are passed on to researchers.

Ensure that your staff work according to good professional practice.

Participate in interlaboratory tests covering all families of analyses and tests subject to accreditation, to ensure the quality of analyses and tests.

Ensure that the CQS Laboratory is independent of any design, manufacturing, supply, installation, use and maintenance activities that may compromise its independence of technical judgement in the analyses and tests it carries out.

To establish as a requirement to be fulfilled by all personnel integrated in the CQS Laboratory, who participate in activities related to the UNE-EN ISO 15189:2013, and UNE-EN ISO/IEC 17025: 2005 and UNE-EN ISO 14001:2004 standards, that they assume and abide by the provisions of the Quality Manual, and the Quality Management System developed therein, and the Environmental Management System.

To provide the material and human resources necessary to achieve this Policy, continuously evaluating consumption levels and waste management, so that the impact on the environment is minimal.