NAMSA Quality Policy: NAMSA delivers high quality, competitive, on-time medical research services. We help clients meet regulatory requirements and exceed their expectations, while continuously improving.

To successfully and consistently deliver our quality poilcy for global clients, we adhere to the following procedures, requirements and certifications:
 

I. Regulatory Requirements and Quality in Operations

NAMSA delivers high quality, competitive, on-time medical research services.  We help clients meet regulatory requirements and exceed their expectations, while continuously improving

  • NAMSA is certified to ISO 13485:2003 and ISO 9001:2008, and is accredited to ISO 17025:2005.
  • We perform testing according to the requirements defined in 21 CFR 58, 820 (U.S. Food and Drug Administration, Good Laboratory Practices and Quality System regulations).
  • We operate with full accreditation by AAALAC International.
  • We follow U.S. Department of Agriculture (USDA) regulations.

II. Protocols and Procedures

  • All samples submitted to NAMSA are tested according to established written standard operating procedures, or specific protocols or study plans, as appropriate.
  • Samples are assigned a sequential lab control number which is used on all associated raw data sheets, log books, laboratory notebooks, and NAMSA laboratory reports.
  • Traceability and test status are maintained and tracked through these control numbers and systems of physical segregation.
  • Strict laboratory quality guidelines are followed to assure valid data.
  • Each step of laboratory operations is carefully controlled to assure accurate and reliable testing programs.
  • Original data are recorded in ink on signed, dated record forms or notebooks and are approved by supervisory personnel.
  • Upon completion of a study, all data are stored in a central file in permanent archives.
  • Clients are promptly notified of adverse test results by telephone or facsimile, without charge.
  • Fees listed for each test include:
    • One copy of the final report to a designated individual
    • One copy of the final report and supporting data to NAMSA archives
    • One invoice to a designated individual or department

II. Auditing and Review

  • NAMSA has a robust internal audit program including process-based audits, facility audits, and testing-based audits from an independent quality assurance unit.
  • Members of NAMSA’s staff are selected and trained for specific job functions.
  • Laboratory equipment is entered in a central calibration and maintenance program for routine calibration.
  • Laboratory functions are audited by NAMSA’s quality assurance department staff.
  • Independent and regulatory auditors routinely visit NAMSA to verify compliance to quality system standards.
  • Performance of routine tests is monitored by periodic check samples and statistical process control.

IV. Registrations

ISO 13485

http://www.tuvamerica.com
ISO Certification OH and CA

ISO 9001:2008

ISO Certification MN
ISO Certification UK

ISO 17025

http://www.a2la.org/
ISO Certification OH — Biological
ISO Certification OH — Chemical

ISO Certification CA — Biological
ISO Certification CA — Chemical

Accreditation COFRAC  Lyon

U.S. FDA Establishment

http://www.fda.gov/
NAMSA is registered with the CDER and CBER divisions of the FDA. The FDA inspects contract laboratories as an extension of a manufacturer’s quality systems. NAMSA has been involved with focused inspections by CDRH under 21 CFR Part 820 as well as inspections by CDER under 21 CFR 211.

FDA Registrations
OH #1521876
CA #2020640
Lyon #3004495705

DEA Registration (Federal and State)
http://www.dea.gov/
DEA registration numbers are confidential.

Ohio Department of Health License for Radioactive Material
http://www.odh.state.oh.us/ License #03620880001

GLP and GMP
GLP Certification — Lyon
GMP Certification — Lyon

*Please note US FDA does not issue GLP certifications. Please see the ISO 17025 scope of accreditation for Northwood GLP assessment.