Standards New Zealand has piloted a faster streamlined approach to adopt and publish the new laboratories testing standard, NZS ISO/IEC 17025:2018 General requirements for the competence of testing and calibration laboratories.
NZS ISO/IEC 17025:2018 was developed using a faster streamlined approach, as part of a pilot to improve the time it takes to publish a standard. As part of this pilot, we:
- trialled committee participation in a virtual capacity
- streamlined the process by running certain stages of the development process at the same time
- successfully adopted ISO/IEC 17025:2017 in three and a half months from the date of its publication, which included an eight-week public consultation period.
We’ll be reviewing the learnings from the pilot, with an aim to establish a fast identical international adoption as our usual development approach for these kinds of standards.
International Accreditation New Zealand (IANZ) is helping New Zealand laboratories adopt the updated standard by offering access to a limited number of free copies. To request a copy, please contact IANZ.
General requirements for the consistent operation of laboratories
NZS ISO/IEC 17025:2018 specifies the general requirements for the competence, impartiality, and consistent operation of laboratories. The standard, used globally, is an identical adoption of ISO/IEC 17025:2017 and:
- applies to all organisations performing laboratory activities, regardless of the number of workers
- is a prerequisite for many regulators and industry bodies, who require products to be tested in an accredited laboratory before they will allow or approve those products to enter the domestic market. Over 50% of New Zealand's exports are required to be tested in accredited laboratories as conditions for access to overseas markets.
Laboratory customers, regulatory authorities, organisations and schemes using peer-assessment, accreditation bodies, and others use this standard to confirm or recognise the competence of laboratories.
IANZ uses NZS ISO/IEC 17025:2018 for laboratory accreditation
IANZ use NZS ISO/IEC 17025:2018 as the general criteria for testing and calibration laboratory accreditation. The standard is not used for the accreditation of medical testing laboratories. They are instead accredited to NZS/ISO 15189:2007 Medical laboratories – Particular requirements for quality and competence.
Additional requirements for accreditation are included in the following IANZ publications:
- General criteria for accreditation: Procedures and conditions of accreditation (AS 1).
- Specific criteria for accreditation, relevant to the laboratory. These include, where relevant, requirements for signatories, proficiency testing or traceability of measurement, and calibration.
- Supplementary criteria for accreditation, relevant to the laboratory.
Changes from the previous edition
This new edition of the standard, NZS ISO/IEC 17025:2018, supersedes NZS ISO/IEC 17025:2005. The main changes compared to the previous edition are as follows:
- The risk-based thinking applied in this new edition has enabled some prescriptive requirements to be reduced and replaced by performance-based requirements.
- There’s greater flexibility than in the previous edition in the requirements for processes, procedures, documented information, and organisational responsibilities.
- A definition of ‘laboratory’ has been added.
Image by Yakuzakorat (Own work) CC BY 4.0 (http://creativecommons.org/licenses/by/4.0), via Wikimedia Commons