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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 line with our values, Laboratorio Echevarne obtained recognition in 1998 for the proper management of its quality system, according to the ISO 9001 and Good Laboratory Practices standards, establishing a continuous improvement cycle that continues to this day.

At Laboratorio Echevarne, we have continuously set new challenges to ensure our clients receive the highest quality in the services provided, expanding the demands of our quality system to meet the requirements of the ISO/IEC 17025 and ISO 15189 standards, thereby obtaining recognition from the National Accreditation Entity (ENAC). Laboratorio Echevarne is certified under Good Manufacturing Practices, continuously expanding our technical competence and involving and motivating laboratory staff to encourage their participation in the management and improvement of the System.

We understand the value of information in our sector, both for our clients and for the continuity of our business. Therefore, beyond complying with data protection legislation and in our commitment to providing the best services to our clients, in 2023 we obtained certification under the ISO/IEC 27001 standard to ensure the highest security standards for the data entrusted to us by our clients.

Also in 2023, Laboratorio Echevarne's commitment to environmental preservation and respect led us to certify under the ISO 14001 standard, because we know our clients value this as much as we do.

The management system is a goal, a responsibility, and a commitment of Laboratorio Echevarne. All personnel involved in laboratory 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 centers, and healthcare entities in general) the utmost 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 stakeholders.

Certifications and accreditations

ENAC Accreditation – UNE-EN ISO 15189 Standard

ENAC Accreditation (National Accreditation Entity) according to criteria set out in the UNE EN ISO15189 Standard for carrying out the tests defined in Technical Annex 511/LE2114.

Certificate Quality Management System ISO 9001:2015

Quality management system certified ISO 9001:2015, since 1998, initially certified by DEKRA CERTIFICATION GmbH, with Certificate No.: 91299973, and currently by IVAC-INSTITUTO DE CERTIFICACIÓN, S.L., Certificate No. 2080-3/23.

Scope of application:

  • 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 Testing, Quality and Food Safety Audits.
  • Veterinary analysis service.
  • Testing laboratory for "in vitro" Diagnostic Medical Devices.

Certificate | Annex

ENAC Accreditation – UNE-EN ISO 17025 Standard

ENAC Accreditation (Spanish National Accreditation Body) in accordance with the criteria set out in the ISO/IEC 17025 Standard.Scopes defined in the corresponding Technical Annexes. Please consult the ENAC search tool.

  • ENAC:511/LE1092 for carrying out TESTING in the ENVIRONMENTAL SECTOR. Acreditation | Anex
  • 511/LE1876 for carrying out TESTING of AGRI-FOOD PRODUCTS.
    Acreditation | Anex
  • 511/LE1947 for carrying out TESTING in PHARMACEUTICAL TOXICOLOGY AND MICROBIOLOGY. Acreditation | Anex
Environmental Management System Certificate – ISO 14001:2015

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.

Certificate of Compliance with the Principles of Good Laboratory Practice (GLP)

Certificate of compliance with the principles of Good Laboratory Practices (GLP), established in Royal Decree 822/1993, in the conduct of non-clinical studies with human and veterinary medicinal products: Analytical and clinical chemistry tests: Analysis of drug levels and their metabolites in biological specimens.

Information Security Management System Certificate – ISO 27001:2013

Information Security Management System Certificate ISO 27001:2013, certified by IVAC-INSTITUTO DE CERTIFICACIÓN, S.L.

Certificate of Compliance with Good Manufacturing Practices (GMP)

Certificate of compliance with the Good Manufacturing Practices established in Directive 2003/94/EC, issued by the competent authority of the Generalitat of Catalonia.

Autorizations and Certifications

PRODUCT PHARMACEUTICAL

Installation Authorization: Pharmaceutical Laboratory (3214E)
Initial 1992
Ministry of Health and Consumer Affairs

Types of control:

  • Physico-Chemical
  • Microbiological
  • Pharmacological

Types of products:

  • Pharmaceutical products

Laboratory registered with the American Drug Agency (FDA) and facilities recognized by it

COSMETIC PRODUCT

Authorization of installation activities: control laboratory (2LC)
Initial 1990. Renewal 2010
Ministry of Health and Social Policy. Spanish Agency of Medicines and Medical Devices

Types of control:

  • Physical-Chemical
  • Microbiological
  • Toxicological

Product categories:

  • Cosmetics
  • Toothpastes (Additional Provision 2nd)
  • Aesthetic Products (Additional Provision 2nd)
  • Hygiene Products (Additional Provision 2nd)
ASBESTOS

Laboratory specialized in the determination of asbestos fibers for its application in industrial hygiene (MT-HLA Nº19)
Initial 2001. Renewal 2012
Ministry of Labor and Social Affairs. General Subdirectorate of Labor Relations

Company registered in the asbestos risk companies registry (RERA) (40/AB/09)

Initial 2009
Government of Catalonia. Department of Labor. Section of Safety and Health, Prevention and Risk Declaration

AGRO-FOOD

Auxiliary technical establishment of the Catalan Water Agency for action level A, in the analysis and control of water or waste products (art. 14 of the order of May 19, 1995)

Initial 1988. Renewal 2012
Government of Catalonia. Catalan Water Agency

Laboratory for quality control of drinking water
Initial 2012
Ministry of Health and Consumer Affairs. General Subdirectorate of Environmental Health and Occupational Health

Environmental and food health laboratory (Authorized and Accredited) (R8-054-95)

Initial 1995. Renewal 2010
Government of Catalonia. Health Protection Agency

Types of control:

  • Microbiological analysis
  • Basic physicochemical analysis
  • Instrumental chemical analysis (High-performance liquid chromatography, Gas chromatography, Atomic absorption spectroscopy, Mass spectrometry, and Infrared spectrophotometry)
AGRI-FOOD PRODUCTS

Agri-food Laboratory. Accredited (591) and Recognized (32).
Established 1998. Renewal 2016.
Government of Catalonia. Directorate General 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 sampling supports for atmospheric emissions
  • Analytical determinations of Legionella

Recognized Activities:

  • Analysis for other laboratories, companies or individuals
  • Trace level metal analysis
  • Pesticide residue analysis
  • Materials in contact with food
  • Food additives and flavors
  • Organic contaminants
  • Animal disease diagnosis
  • Basic general analysis
HOMOLOGATION FOR DUST ANALYSIS IN ATMOSPHERE (SILICOSIS)

Authorization dated 07-01-2013 as a laboratory for the analysis of dust samples in the workplace atmosphere according to ITC/2585/2007-2.0.02: "Protection of workers against dust, in relation to silicosis in extractive industries".