Accreditations
Integrated Management Policy
Laboratorio Echevarne's fundamental mission is to provide clinical, industrial and veterinary analysis services to our clients.
Consistent with this mission and in accordance with our values, in 1998 Laboratorio Echevarne obtained recognition of the appropriate management of the quality system, in accordance with the ISO 9001 standard and Good Laboratory Practices, establishing a cycle of continuous improvement that continues today.
At Laboratorio Echevarne we have never ceased to set ourselves new challenges to ensure our customers the best quality in the services we provide, extending the demands of our quality system to the requirements of the ISO/IEC 17025 and ISO 15189 standards and obtaining the recognition of the National Accreditation Body (ENAC). Laboratorio Echevarne is certified in Good Manufacturing Practices, expanding our technical competence day by day and involving and motivating the laboratory staff in order to seek their participation in the management and improvement of the System.
We know the value of information in our sector, both for our customers and for the continuity of our business, so beyond compliance with data protection legislation and in our efforts to provide the best services to our customers, in 2023 we obtained certification in the ISO/IEC 27001 standard to ensure the highest standards of security for the data that our customers entrust to us.
Also in 2023, Laboratorio Echevarne's commitment to preserving and respecting the environment led us to become ISO 14001 certified, because we know that our customers value it as much as we do.
The management system is an objective, a responsibility and a commitment of Laboratorio Echevarne. All the staff involved in the laboratory's activities are familiar with the documentation and implement the policies and procedures in their work, as our principle is to offer our clients (patients, companies, insurance companies, veterinary centres and health entities in general) maximum confidence in our services and in the quality of our reports and results.
Laboratorio Echevarne's integrated management policy forms a unit with the Quality, Environment and Health and Safety policy and the Information Security policy and is available to all interested parties.
Certifications and Accreditations
Accreditation from ENAC (National Accreditation Entity) according to criteria included in the UNE EN ISO 15189 Standard to carry out the tests defined in Technical Annex 511/LE2114.
Accreditation from ENAC (National Accreditation Entity) according to criteria included in the ISO/IEC 17025 Standard defined in the corresponding Technical Annexes. Consult ENAC's search engine:
- 511/LE1092 for TESTING in the ENVIRONMENTAL SECTOR.
- 511/LE1876 for TESTING AGRI-FOOD PRODUCTS.
- 511/LE1947 for PHARMACEUTICAL TOXICOLOGY AND MICROBIOLOGY TESTING.
Certificate of compliance with the principles of Good Laboratory Practice (GLP) established by Royal Decree 822/1993 in carrying out non-clinical studies of drugs for human and veterinary use: Analytical and clinical chemistry tests: Analysis of levels of drugs and their metabolites in biological specimens.
Certificate of compliance with Good Manufacturing Practice set out in Directive 2003/94/EC, issued by the competent authority of the Generalitat de Catalunya.
Quality management system certificate ISO 9001:2015 since 1998, initially certified by DEKRA CERTIFICATION GmbH, certificate no. 91299973, and currently, by IVAC-INSTITUTO DE CERTIFICACIÓN, S.L., certificate no. 2080-3/23.
Scope:
- Research, design, development and implementation of new analysis techniques.
- Clinical analysis service in all its phases, pre-analytical, analytical and post-analytical:
Hematology, Biochemistry, Immunology, Microbiology and parasitology, Genetics and Toxicology. - Industrial analysis service: Microbiology, Physicochemical Tests, Quality and food safety audits.
- Veterinary analysis service.
- Laboratory for health products testing for in vitro diagnosis.
Environmental management system in accordance with the ISO 14001:2015 standard, by IVAC-INSTITUTO DE CERTIFICACIÓN, S.L., Certificate no. 2080-9/23. Applied to the following activity: Clinical, veterinary and industrial analysis services carried out at the headquarters in Sant Cugat del Vallès - Barcelona.
ISO 27001:2013 Information Security Management System Certificate, certified by IVAC-INSTITUTO DE CERTIFICACIÓN, S.L.
Permits and Approvals
Permit for a facility: pharmaceutical laboratory (3214E)
Original date 1992
Ministry of Health and Consumer Affairs
Types of checks:
- Physical and Chemical
- Microbiological
- Pharmacological
Types of products:
- Pharmaceutical products
Laboratory registered with the US Food and Drug Administration (FDA) and facilities recognised by it
Permit for activities in a facility: control laboratory (2LC)
Original date 1990. Renewal 2010
Ministry of Health and Consumer Affairs. Spanish Agency of Medicines and Medical Devices
Types of checks:
- Physical and Chemical
- Microbiological
- Toxicological
Product categories:
- Cosmetics
- Toothpastes (2nd additional provision)
- Beauty products (2nd additional provision)
- Hygiene products (2nd additional provision)
Laboratory specialising in the determination of asbestos fibres for use in industrial hygiene (MT-HLA No. 19)
Original date 2001. Renewal 2012
Ministry for Employment and Social Affairs. General Subdirectorate for Labour Relations
Company registered in the registry of companies with risk of asbestos (RERA) (40/AB/09)
Original date 2009
Generalitat de Catalunya. Department of Employment. Section on Health, Safety, Prevention and Declaration of Risks
Auxiliary technical establishment of the Catalan Water Agency for action level A in the analysis and control of wastewater or waste products (art. 14 of the law from May 19, 1995)
Original date 1988. Renewal 2012
Generalitat de Catalunya. Catalan Water Agency
Laboratory for quality control of water for human consumption
Original date 2012
Ministry of Health and Consumer Affairs. General Subdirectorate for Environmental Health and Health Labour
Environmental and Food Health laboratory (authorised and accredited) (R8-054-95)
Original date 1995. Renewal 2010
Generalitat de Catalunya. Health Protection Agency
Types of checks:
- Microbiological analyses
- Basic physical and chemical analyses
- Instrumental chemical analysis (high resolution liquid chromatography, gas chromatography, atomic absorption spectroscopy, mass spectrometry and infrared spectrometry)
Agri-food laboratory. Accredited (591) and recognised (32).
Original date 1998. Renewal 2016.
Generalitat de Catalunya. General Directorate of Food, Quality and Agri-food Industries.
Accredited Activities:
- Analysis for other laboratories, companies or individuals
- Water analysis
- Food microbiology
- Wastewater
- Environmental microbiology
- Allergen analysis
- Analysis of atmospheric emission sampling media
- Analytical determinations of Legionella
Recognised Activities:
- Analysis for other laboratories, companies or individuals
- Analysis of traces of metals
- Pesticide residue analysis
- Materials in contact with food
- Food additives and flavourings
- Organic contaminants
- Diagnosis of animal diseases
- General basic analysis