Accreditations

Echevarne Laboratory offers its customers a service based on a Quality Assurance System. The cornerstones of this system are Process Management, based on a dynamic cycle (plan, make, check and act), and establishing a targeted approach to customer satisfaction that enables the assessment of our services. 

CERTIFICATIONS AND ACCREDITATIONS:

UNE EN ISO 15189

ENAC (National Accreditation) according to criteria in the UNE EN ISO 15189 for the tests defined in the Technical Annex 511/LE2114.

ISO/IEC 17025

ENAC (National Accreditation) according to criteria in the ISO / IEC 17025:

Scope defined in the corresponding Technical Annexes. Look up  ENAC catalog: 

GLP

Certificate of compliance with the principles of Good Laboratory Practice (GLP), established by Royal Decree 822 / 1993, in the conduct of clinical drug studies of human and veterinary use: analytical and clinical chemistry: Analysis of levels of drugs and metabolites in biological specimens.

GMP

Certificate of compliance with GMP to which reference is made in the principles and guidelines of Good Manufacturing Practice laid down in Directive 2003/94/EC, issued by the competent authority of the Generalitat de Catalunya.

ISO 9001

System quality management certificate ISO 9001 since 1998, initially certified by DEKRA Certification GmbH, Certificate #: 91299973, and currently, by DNV Business Assurance, Certificate No. 182084-2015 AQ-IBE-ENAC.

Scope: Research, design and development of clinical analysis techniques, veterinary testing, pathology, industrial and toxicity and biological assays.

PERMITS AND APPROVALS:

Authorizations and approvals for the industrial sector

PHARMACEUTICAL PRODUCT

Premises authorization: pharmaceutical laboratory (3214E)
Original date: 1992
Ministry of Health
Control Types:

  • Physical-Chemical
  • Microbiological
  • Pharmacological

Types of products:

  • Pharmaceutical

Laboratory registered with the U.S. Food and Drug Administration (FDA) and recognized facilities by it

COSMETIC PRODUCT

Authorization of premises and activities: control laboratory (2LC)

Original date 1990. Renewal 2010
Ministry of Health and Social Policy. Spanish Agency for Medicines and Health Products
Control Types:

  • Physical-Chemical
  • Microbiological
  • Toxicological

Product categories:

  • Cosmetics
  • Toothpaste (2nd Additional Provision)
  • Plastic and Aesthetics products (2nd Additional Provision)
  • Hygiene products items (2nd Additional Provision)

ASBESTOS

Specialized laboratory for the determination of asbestos fibers in application to industrial hygiene (MT-HLA N º 19)

Original date 2001. Renewal 2012
Ministry of Labour and Social Affairs. Labor Relations Division

Company listed in the register of companies at risk of asbestos (RERA) (40/AB/09) 
Original date 2009
Generalitat de Catalunya. Department of Employment. Section on safety, health, prevention and risk report.

AGRI-FOOD PRODUCTS

Agri-food Laboratory. Accredited (591) and Acknowledged (32).

Original 1998. Renewal 2016.

Generalitat de Catalunya. General Directorate for Food, Quality and Food Industries.

Accredited Activites:

  • Tests for other laboratories, companies or individuals.
  • Water testing.
  • Food Microbiology.
  • Waste waters.
  • Environmental Microbiology.
  • Analysis of allergens.
  • Analysis of supports sampling of atmospheric emissions.
  • Legionella analytical determinations.

Acknowledged Sectors:

  • Tests for other laboratories, companies or individuals.
  • Analysis of trace levels of metals.
  • Analysis of pesticide residues.
  • Materials in contact with food.
  • Food additives and flavorings.
  • Organic Pollutants.
  • Diagnosis of animal diseases.
  • Basic general analyses.

Approval for analysis of dust in atmosphere (Silicosis)

01/07/2013 Authorization as a laboratory for analysis of dust samples in work atmosphere as ITC / 2585 / 2007-2.0.02 : "Worker protection against dust, regarding silicosis in extractive industries".