Quality – For us at ESA Biosciences, quality isn't
just a certificate on the wall; it is at the heart of everything we do. For our
products, we 'design in' quality from initial product concept, through
manufacture, delivery, and installation at the customer site. For our laboratory
services, quality starts with method development, through calibrations, analysis
of controls and spiked samples with every set of samples analyzed. We know that
customers count on our products and services as critical enabling tools for
their important work. And our goal is to meet and exceed their expectations with
the best, most cost-effective products and services available, delivered on
time, and as promised.
ESA’s products are regulated by the United States Food and Drug
Administration (FDA): when used for clinical applications, our instruments and
accessories are Class 1 and 2 medical devices. Therefore, these products
are designed and manufactured under the Medical Device Quality System
Regulation, also known as Current Good Manufacturing Practices (cGMP), and are
subject to periodic inspection by the FDA. ESA adheres to US FDA 21
CFR820. ESA has ISO 9001:2000 and ISO 13485:2003 certifications. For more
information about these policies, click here to contact ESA’s manager of quality
assurance.
ESA Laboratories operates under a quality system that encompasses ISO 17025,
CLIA, and AIHA regulations. See a selected list of our credentials,
certifications, and accreditations below.
Credentials and accreditations:
- Industrial Hygiene: American Industrial Hygiene Association
- Clinical Analyses: Health Care Financing Administration, CLIA Certificate
- Blood Lead: OSHA List of Acceptable Laboratories; ESA's LeadCare product is
a class 2 device
Proficiency programs:
- Blood Lead: CDC Reference Laboratory
- Blood Lead: PA Proficiency program
- WSLH Proficiency Testing Program
- Hematology: WSLH Proficiency Testing Program
- Micronutrient Measurement Quality Assurance Program (M2QAP)
- Industrial Hygiene: AIHA PAT Program
- Industrial Hygiene: WASP Formaldehyde Program
- Industrial Hygiene: Pharmaceutical Round
Robin
|
