You Asked, We Answered: What's the deal with ISO/IEC 17025?
To those of you who joined our Webinar: "The Impact of 2015 Revisions to EU GMP Annex 15 on GDP" on June 25th, thank you for participating! For those who missed it, please view the recorded version. In this week's blog, our regulatory expert Piritta Maunu will focus on questions she received during or after the webinar about ISO/IEC 17025.
But first... ISO/IEC 17025 in Brief
The ISO (International Organization for Standardization) / IEC (International Electrotechnical Commission) quality standard 17025 is internationally recognized and sets out general requirements for the competence of calibration and testing laboratories. According to its introduction, the standard contains "all of the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate a quality system, are technically competent, and are able to generate technically valid results."
The standard covers audit management, quality systems and technical competence and formally recognizes compliance by issuing a certificate of accreditation. Last reviewed in 2010, ISO/IEC 17025 is the international standard used to accredit testing and calibration laboratories for measured quantities.
Internationally recognized accreditation bodies for ISO/IEC 17025 include organizations such as the A2LA, PJLA, ANAB, the Finnish Accreditation Service (FINAS), the United Kingdom Accreditation Service (UKAS), the China National Accreditation Service for Conformity Assessment (CNAS), and the Japan National Laboratory for Accreditation (JNLA). For more information, please see: "Participants in the ILAC MRA Signatory Arrangement, and How it Works"
Here's an interesting document from the A2LA called:
"A2LA Explanations for the ISO/IEC 17025 Requirements"
Plus here's an article from Quality Magazine on what accreditation means for calibration laboratories and how to obtain it.