Instron Quality Manual
This document constitutes the highest level of quality documentation measures in Instron.
Download Instron's Quality Manual
Accreditations & Certificates
CFR Statements
Codes of Federal Regulations (CFR) Statements
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
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:
Instron, Electromechanical & Industrial Products Group, Norwood, MA, USA:
SGS International Certification Services Inc. view certificate
Instron Quality Management System FAQs
Instron- A division of ITW Ltd., United Kingdom:
SGS United Kingdom Ltd view certificate
Instron GmbH, Darmstadt, Germany:
TÜV SÜD Management Service GmbH view certificate
Instron Singapore, a Division of ITW Pte Ltd., Japan, Singapore, Korea, Taiwan:
SGS International Certification Services Inc. view certificate
ITW Test & measurement Italia S.r.l.
Instron CEAST Division, Italy:
TUV Italia S.r.l. view certificate
Calibration
Calibration Laboratory Management System Compliance
CALIBRATION LABORATORY ISO/IEC 17025 ACCREDITATION
North America, Europe, Asia, Japan, and Australia
Instron's calibration laboratory is accredited to ISO/IEC 17025 by the National Voluntary Laboratory Accreditation Program (NVLAP) under Laboratory Code 200301-0. This accreditation also covers our worldwide field operations, excluding Brazil.
Download Instron's current scope of accreditation and certificate of accreditation below:
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 Instron 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/
Brazil
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
CE Statements
CE Marking of Instron Equipment
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.