Accreditations & Certificates

The 10 CFR §21 & §50 Appendix B Statement provides information on Instron's calibration certificate.

The FDA Compliance Statement provides information about how to integrate Instron's products according to your 21 CFR § 820, 21 CFR § 11, ISO 13485:2003 and IQ/OQ/PQ requirements.

ISO 9001 Compliance Statement, Scope & Registration Details

Instron's quality systems, measurement standards and procedures meet or exceed the requirements of ISO9001.

The registrars are:

SGS International Certification Services Inc. view certificate

Instron Quality Management System FAQs

SGS United Kingdom Ltd view certificate

TÜV SÜD Management Service GmbH view certificate

SGS International Certification Services Inc. view certificate

TUV Italia S.r.l. view certificate

Instron's European Calibration Laboratory is accredited to ISO 17025 for Force, Extension, Hardness and Impact by the United Kingdom Accreditation Service (UKAS), Laboratory Number 0019. This laboratory is based in our High Wycombe UK facility and offers site calibration services throughout Europe. UKAS holds the original of the certificate on their site at: http://www.ukas.org/

Instron's North American Field and Force Calibration laboratories are accredited to ISO/IEC 17025 by the National Voluntary Laboratory Accreditation Program (NVLAP) under Laboratory Code 200301-0. This accreditation also covers our field operations in China, Japan, Korea, Singapore, India, Thailand, and Taiwan.

Download Instron's current scope of accreditation and certificate of accreditation below:

Instron's Current Scope of Accreditation

Note that Instron combined two separate NVLAP accreditations into one. Previously, our field and factory operations were covered by NVLAP lab codes of 200301-0 and 105023-0. All of Instron North America's calibration facilities are now covered under one certificate and designated as lab code 200301-0.

Our NVLAP accreditation also covers our CEAST product verifications, which had previously been accredited by A2LA. The Signatory List, identifying all individuals qualified by NVLAP to perform 17025 calibrations, is available upon request.

NIST maintains an on-line register of certificates at: http://ts.nist.gov/

Instron's Brazil Field operation is accredited to ABNT NBR ISO/IEC 17025 for force, displacement and strain by Cgcre/Inmetro (CAL # 0443). Certificates can be found at: http://www.inmetro.gov.br/laboratorios/rbc

To fulfill the conformity requirements for CE marking of equipment across such a wide product range, Instron uses three main directives, the machinery directive, the low voltage directive, and the electromagnetic compatibility (EMC) directive. This article explains how these directives are used.