Implementation walkthrough
How to implement ISO/IEC 17043: video walkthrough
A walkthrough of preparing a proficiency testing provider for ISO/IEC 17043 accreditation, scheme by scheme.
Key takeaways
- PT providers are accredited to ISO/IEC 17043, not certified.
- Accreditation covers a defined scope of PT schemes.
- Performance is judged against criteria fixed in advance.
- ISO 13528 is the statistical reference for data analysis.
- Run at least one round under the system before applying.
Proficiency testing that participants can trust
ISO/IEC 17043 sets out what a proficiency testing provider needs to be competent and impartial and to run each of its schemes consistently. Proficiency testing judges each participant's performance against criteria fixed in advance, through interlaboratory comparisons: the provider prepares items, participants measure, test, calibrate, examine, inspect or sample them, and the provider evaluates the results. Participants, regulators, peer-assessment schemes and accreditation bodies use the standard to confirm the provider's competence.
A provider is accredited, not certified. An accreditation body examines how schemes are designed, how items are produced and checked, how data are analysed and how performance is evaluated, and grants accreditation for a defined scope of schemes. This short film walks through how a provider prepares.
Item production, homogeneity and stability testing, distribution and IT services can come from evaluated external providers; scheme design and performance evaluation stay with the provider.
Build the schemes, run a round, then apply
Choose the schemes and the body: which schemes and item types go on the application, who the participants are, and which accreditation body to use. Procedures vary by body, but the steps are common.
A gap analysis then checks the provider against every requirement, scheme by scheme. Implementation covers impartiality, with activities and relationships, including those of personnel, monitored for threats that are removed or minimised; confidentiality under legally enforceable agreements; competent personnel and controlled external providers; and the scheme itself, from contract to report, covering design, item preparation, homogeneity and stability checks where needed, instructions to participants, statistical analysis with ISO 13528 as the reference, performance evaluation and reporting, then complaints and appeals. At least one round is run under the system before applying. Internal audit and management review follow, and the accreditation body assesses and decides.
Sterling's expert and experienced consultants support scheme and management system implementation with your team under Sterling OS™. ISO/IEC 17043:2023, the second edition, is current, and the transition from the 2010 edition closed in May 2026.
ISO/IEC 17043 at a glance
- Purpose
- Competent, impartial PT providers and consistently run PT schemes, so each participant's performance is evaluated validly
- Relevant to
- Organisations that develop and operate PT schemes: commercial providers, metrology institutes, public health bodies, EQA providers, laboratory networks
- Edition
- ISO/IEC 17043:2023, the second edition; the transition from the 2010 edition closed in May 2026
- Accreditation
- Granted by an accreditation body for a defined scope of PT schemes, maintained through surveillance and reassessment
- Sterling's role
- Scheme and management system implementation with your team, Effivity, training, internal audit and assessment readiness, then Sustain™
- Cost and timing
- Total investment for an ISO/IEC 17043 PT provider management system depends on the current maturity of your processes, the scope, locations and number of employees. The process typically takes 9 to 15 months
ISO/IEC 17043: questions people ask
Is ISO/IEC 17043 a certification or an accreditation?
An accreditation. An accreditation body assesses the provider's competence for a defined list of schemes and publishes that scope on its register. Certification bodies certify management systems under ISO/IEC 17021-1; an "ISO 17043 certificate" from one of them is not accreditation.
Which accreditation body should we use, and will our schemes be recognised in other countries?
Usually your national body, for example UKAS (United Kingdom), A2LA or ANAB (United States), SCC (Canada), NATA (Australia), NABL (India) or EIAC (Dubai), all of which accredit PT providers, provided it is a Global ACI MRA signatory for proficiency testing provision. Signatories recognise one another's accreditation as equivalent, except where regulation or law provides otherwise; check the Global ACI directory and what your participants' regulators accept.
Does the laboratory that tests our PT items have to be accredited to ISO/IEC 17025?
Not by the standard itself. Measurements that characterise PT items or assess their homogeneity and stability must meet the relevant requirements of ISO/IEC 17025, those affecting the validity of results such as metrological traceability, not its management system requirements; in the medical area ISO 15189 applies instead. Accreditation is the simplest evidence; some bodies also accept your audit reports and may assess the laboratory themselves.
Which statistical methods do we have to use?
ISO/IEC 17043 requires valid, documented methods suited to each scheme's objectives, with statistical assumptions you can show are reasonable. ISO 13528:2022 is the usual reference: assigned values by formulation, from a certified reference material, from one laboratory or by consensus of experts or participants, evaluation criteria, and scores such as z, z′, zeta and En. ISO/IEC 17043 does not make it mandatory, but your choice must be documented and defensible.
Can we outsource parts of a scheme?
Yes, within limits. Item production, homogeneity and stability testing, distribution and IT services can come from evaluated external providers, and participants must be told in advance, in writing, where that affects validity. Scheme design and planning, performance evaluation and report authorisation cannot be outsourced, and you remain responsible to participants for whatever is.
Keep exploring
Related to this video
The complete guide
Everything on ISO/IEC 17043
Start with the ISO/IEC 17043 page, or go straight to the guide you need.
On the ISO/IEC 17043 page
- What are the main ISO/IEC 17043 requirements?
- How do you get ISO/IEC 17043 accredited?
- How much does ISO/IEC 17043 accreditation cost?
- How long does ISO/IEC 17043 accreditation take?
- Who needs ISO/IEC 17043 accreditation?
- How ISO/IEC 17043 accreditation supports your schemes and your participants
- Frequently asked questions about ISO/IEC 17043
Often combined with ISO/IEC 17043
More videos: Laboratories, inspection and accreditation
- How to implement ISO/IEC 17065Implementation walkthrough · 3 min 15 s
- ISO/IEC 17065 requirements explainedTwo-minute brief · 2 min
- How to implement ISO 15189Implementation walkthrough · 3 min 14 s
- ISO 15189 requirements explainedTwo-minute brief · 2 min
- How to implement ISO/IEC 17020Implementation walkthrough · 3 min 14 s
- ISO/IEC 17020 requirements explainedTwo-minute brief · 2 min
- How to implement ISO/IEC 17025Implementation walkthrough · 3 min 24 s
- ISO/IEC 17025 requirements explainedTwo-minute brief · 2 min
- How to implement ISO/IEC 17024Implementation walkthrough · 3 min 15 s
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