You Asked, We Answered: What's the deal with ISO/IEC 17025?

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Piritta Maunu
Life Science Industry Expert
Jul 03rd 2015
Industrial Measurements
Life Science
Science & Sensing Technologies

 

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"

More Resources:

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.

 

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The ISO 17025 standard came up in a few questions during the recent webinar, so here are the answers from our presenter, Vaisala Regulatory Expert Piritta Maunu.

Is it necessary to have a 17025 calibration certificate?

This is dependent on your customer requirements and quality systems demands whether the ISO 17025 accredited calibration certificate is required or not when calibrating sensors, instruments, and loggers.

Also, sometimes an ISO 9001 calibration certificate is all that is requested by the customer. In life science applications, we have observed that many of our customers require ISO 17025 accredited calibration services and certificates, so we recommend it.

Can we perform our own on-site calibration with Vaisala instruments that are calibrated in ISO17025 accredited laboratories?

The short answer is: yes, you can perform on-site calibrations with our instruments. If you need to write the ISO-17025 calibration certificate for that calibration work, then you need to co-operate with your national accrediting organization to obtain the ISO/IEC17025 certification for that work.

Vaisala provides ISO 17025 accredited calibration certificates for different kinds of instruments like handheld meter HM70, wireless transmitter HMT140/HMT330 or Vaisala data loggers such as DL2000 temperature and humidity logger and the DL1416 temperature logger.  To be able to perform the accredited calibrations you need to be accredited by a national authority in your area like A2LA, FINAS or UKAS.

Please put any questions you have on accredited calibrations email Piritta directly.

 

Author

Piritta Maunu

Piritta Maunu

Life Science Regulatory Compliance and Industry Expert​

Piritta Maunu has 15 years of experience in biotechnology, having worked in several quality management positions for FIT Biotech. Maunu holds a degree of M.Sc. (Cell Biology) and is certified to teach with a specialty in General Biology, both degrees from the University of Jyväskylä, Finland. In her role at Vaisala, she supports the sales department, assists the quality department with audits, creates educational content for life science customers, and provides application support to R&D teams creating solutions for monitoring critical environments.