Instron's quality systems, measurement standards and procedures meet or exceed the requirements of ISO/ANSI/ASQ 9001:2000
TickIT augments the general ISO 9000 certification process with an infrastructure that supports and facilitates the achievement of quality in the software development process:
Instron's software design activities have been assessed by SGS Yarsley ICS Ltd. to the requirements of ISO 9000-3:1997 and meet the DTI's TickIT scheme requirements.
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Calibration Laboratory Management System Compliance
CALIBRATION LABORATORY ISO/IEC 17025 ACCREDITATION
Australia |
Europe |
North America, Asia, and Japan
Australia
Instron Pty's Calibration Laboratory is also accredited to ISO 17025 for Force and Extension by the National Association of Testing Authorities (NATA), Laboratory Number 3037. NATA holds the original of the certificate on their site at:
http://www.nata.asn.au/Europe
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 and India. UKAS holds the original of the certificate on their site at: http://www.ukas.org/
Download Certificate 0019
North America, Asia, and Japan
Instron's North American Field, Force and Wilson Hardness Calibration laboratories are accredited to ISO/IEC 17025 by the National Institute of Standards and Technology (NIST) under the National Voluntary Laboratory Accreditation Program (NVLAP), Laboratory Code 200301-0.
Download Instron's current scope of accreditation and certificate of accreditation below:
Instron's Current Scope of Accreditation
Instron's Certificate of Accreditation
Note that Instron has recently combined two separate NVLAP certifications 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 accreditation also covers SATEC™ products, which had previously been accredited by A2LA, as well as our calibration operations in Canada, China, Japan,Korea, Singapore, Thailand, and Taiwan. 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/
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Codes of Federal Regulations (CFR) Statements
10 CFR §21 & §50 Appendix B Statement
The 10 CFR §21 & §50 Appendix B Statement provides information on Instron's calibration certificate.
FDA Compliance Statements
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.
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CE Marking of Instron Equipment
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.
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