Quality Assurance Unit
In 1998 Echevarne Laboratory became accredited in compliance with GLP and ISO 9001:1994. Since then, Echevarne has offered its customers a service based on a Quality Assurance System. Currently, compliance with the commitment to quality acquired in benefit of society and to our customers, has led to a change in management style and to under a certified Quality Assurance System. The cornerstones of this system are process management, based on a dynamic cycle that we "plan", "make", "check" and "act", and establish a targeted approach to customer satisfaction that enables the assessment of our services to check if they meet customer’s needs and to what extent. This new approach centered at our quality assurance unit, provides the Laboratorio Management Board with information to support the establishment of a solid basis that takes into consideration the needs and interests of different organizations and customers.
Quality Assurance Management - Certifications and Accreditations
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. 121325-2012-AQ-IBE-ENAC.
Scope: Research, design and development of clinical analysis techniques, veterinary testing, pathology, industrial and toxicity and biological assays.
As laboratory listed in the program of compliance with Good Laboratory Practices, with BPL013CAT number, from June 4, 1998, has certified compliance with the principles of Good Laboratory Practice (GLP), established by Royal Decree 822 / 1993 (1), in the conduct of clinical drug studies of human and veterinary use: analytical and clinical chemistry (2) *: Analysis of levels of drugs and metabolites in biological specimens
(1): Royal Decree 822/1993, of May 28, which establishes the principles of GLP. Amended by Royal Decree 1369/2000 of 19 July.
for analysis of levels of drugs and metabolites in biological specimens, by the Department of Health of the Generalitat de Catalunya, with the number BPL013CAT
(2) *: Areas established certification according to the OECD Decision C (89) 87.
GMP
As a pharmaceutical laboratory licence number 3214-E, 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 17025
ENAC (National Accreditation) according to criteria in the ISO / IEC 17025:
511/LE1092 for TESTING in the ENVIROMENTAL SECTOR.
511/LE1876 for TESTING FOOD PRODUCTS.
511/LE1947 for TOXICOLOGY AND MICROBIOLOGY TESTING.
Defined in the corresponding Technical Annexes. Look up ENAC catalog
OHSAS 18001
Management system health and safety at work in accordance with BS OHSAS 18001. Certification Scope: Research, design and development of techniques for analyzing clinical, veterinary, pathological, toxicological industrial and biological assays. Collection and sampling for analysis.
Certification Authority: DEKRA Certification S.L.U
PERMITS AND APPROVALS
Listed 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
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)
- Items of Hygiene products (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
Technical assistant institution to the Catalan water agency for activities related to analysis and control of water or waste products
(Art. 14 of the act of May 19, 1995)
Original date 1988. Renewal 2012
Generalitat de Catalunya. Catalan Water agency
Files property of Laboratorio Echevarne. Strict confidentiality. Do not copy or disclose without authorization from Echevarne Laboratory
File Name: INDUSTRY TECHNCAL REPORT Print Date: 03/08/2012 Page: 10/45
Laboratorio Echevarne • Tel: 902 525 500 • informacion@echevarne.com • www.echevarne.com
Laboratory quality control of drinking water
Original date 2012
Ministry of Health. Directorate General of Environmental and Occupational Health
Laboratory environmental and food health (Authorized and Accredited) (R8-054-95)
Original date1995. Renewal 2010
Generalitat de Catalunya. PROTECTIVE Health agency
Control Types:
- Microbiological Analysis
- Basic physicochemical analysis
- Instrumental chemical analysis (high resolution liquid chromatography, gas chromatography, atomic absorption spectroscopy, Mass spectrometry
and infrared Spectrophotometry)
Agri-foodstuffs
Agri-food Laboratory (32)
Original 1998. Renewal 2012
Generalitat de Catalunya. General Directorate for Food, Quality and Food industries.
Accredited Activities:
- Tests for other laboratories, companies or individuals
- Environmental Microbiology
Acknowledged Sectors:
- General groups
- Tests for other laboratories, companies or individuals
- Analysis of trace levels of metals
- Analysis of pesticide residues
- Water Testing
- Food Microbiology
- Analysis for agricultural production
- Materials in contact with food
- Food additives and flavorings
- Animal feed products
- Organic Pollutants
- Diagnosis of animal diseases
- Basic analysis of food products
- Basic general analyses
