NAMSA Accreditations & Certifications

 

Do you have questions about our certifications or accreditations?
Email quality@namsa.com

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CERTIFICATIONS

MINNESOTA USA

8945 Evergreen Boulevard, Minneapolis, MN – Expires MAY 6, 2028


ISO 9001:2015

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UNITED KINGDOM

Unit 9 & 11, Abbey Court, Benedict Drive, Selby – Expires JUN 1, 2027


ISO 9001:2015

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Belgium

Heggestraat 10, Diest – Does not expire


Good Laboratory Practice (GLP)

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France

115 Chemin de l’Islon, CHASSE-sur-RHÔNE – Does not expire


Good Laboratory Practice (GLP)

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OHIO USA

6750 Wales Rd, Northwood, OH – Expires FEB 21, 2027


ISO/IEC 27001:2022

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Georgia USA

1265 Kennestone Circle, Marietta, GA


EMA GMP Certificate (Sterility)

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Georgia USA

1265 Kennestone Circle, Marietta, GA – Expires FEB 1, 2026


International Safe Transit Association (ISTA) Membership

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ACCREDITATIONS

OHIO USA

6750 Wales Rd, Northwood, OH – Expires MAR 9, 2026


ISO/IEC 17025:2017

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OHIO USA

6750 Wales Rd, Northwood, OH – Expires MAR 9, 2026


FDA ASCA Program (Biocompatibility)

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Minnesota USA

8945 Evergreen, Minneapolis, MN – Expires MAR 9, 2026


ISO/IEC 17025:2017

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Minnesota USA

2520 Pilot Knob Rd., Mendota Heights, MN – Expires MAY 31, 2026


ISO/IEC 17025:2017

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Minnesota USA

2540 Executive Dr., St. Paul, MN – Expires JAN 31, 2027 (BIOLOGICAL TESTING)


ISO/IEC 17025:2017

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Georgia USA

1265 Kennestone Cir, Marietta, GA – Expires JAN 31, 2027 (BIOLOGICAL TESTING)


ISO/IEC 17025:2017

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Georgia USA

1265 Kennestone Cir, Marietta, GA – Expires JAN 31, 2027 (CHEMISTRY TESTING)


ISO/IEC 17025:2017

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CALIFORNIA USA

9 Morgan, Irvine CA – Expires MAR 9, 2026


ISO/IEC 17025:2017

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Germany

Industrie Center Obernburg – Certificate does not expire


DIN EN ISO/IEC 17025:2018

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France

115 ch de l’Islon, CHASSE SUR RHONE – Expires DEC 31, 2027


NF EN ISO/IEC 17025:2017

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BELGIUM

Heggestraat 10, Diest – Full accreditation issued on 11 JUN 2025


AAALAC Accreditation

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OHIO USA

6750 Wales Rd, Northwood, OH – Full accreditation issued 22 NOV 2024


AAALAC Accreditation

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FRANCE

115 ch de l’Islon, CHASSE SUR RHONE – Full accreditation issued 13 JUN 2025


AAALAC Accreditation

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MINNESOTA USA

8945 Evergreen Boulevard, Minneapolis, MN – Full accreditation issued 30 OCT 2025


AAALAC Accreditation

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REGISTRATIONS

ohio usa

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 11.


FDA Registration #1521876

CALIFORNIA USA

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 11.


FDA Registration #2020640

Georgia USA

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 11.


FDA Registration #1000511606

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Minnesota USA

2540 Executive Drive, St. Paul, MN – 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 11.


FDA Registration #3002199759

Minnesota USA

2520 Pilot Knob Road, Mendota Heights, MN – NAMSA is registered with the CDER division of the FDA. The FDA inspects contract laboratories as an extension of a manufacturer’s quality systems. NAMSA has been involved in inspections by CDER under 21 CFR 11.


FDA Registration #3011125228

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 policy for global clinical research organization (CRO) clients, we adhere to the following procedures, requirements and certifications:

  • NAMSA is certified to ISO 9001:2015, and is accredited to ISO/IEC 17025:2017.
  • NAMSA is committed, through our internal audit and management review processes, to ensuring continued compliance with all relevant regulatory and statutory requirements including but not limited to ISO 13485:2016, 21 CFR Part 11, and 21 CFR Part 820.
  • NAMSA is committed to the highest level of impartiality for all activities and dealings with our clients and other interested parties through its portfolio of services.
  • We operate with full accreditation by AAALAC International.
  • We follow U.S. Department of Agriculture (USDA) regulations.

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

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.