Two-minute brief
ISO/IEC 17025 requirements explained: video brief
A two-minute brief on the five requirement clauses of ISO/IEC 17025:2017 and what each looks like in a testing or calibration laboratory.
Key takeaways
- ISO/IEC 17025 uses clauses 4 to 8, focused on the laboratory and its work.
- Impartiality risks are identified and addressed on an ongoing basis.
- Methods are verified or validated, and measurement uncertainty is evaluated.
- Quality control and proficiency testing show that results remain valid.
- Clause 8 offers Option A or Option B for the management system.
Five clauses about the laboratory and its work
ISO/IEC 17025 is organised in five requirement clauses, 4 to 8, rather than the harmonised structure of the management system standards. Clauses 4 to 7 are about the laboratory and its work; clause 8 covers the management system. This short film walks through them.
Clause 4, general requirements, asks the laboratory to carry out its activities impartially, identify and address risks to impartiality on an ongoing basis and keep customer information confidential; in practice, an impartiality risk assessment covering ownership, commercial pressure and staff relationships, and confidentiality commitments from staff and contractors. Clause 5, structural requirements, asks it to be a legal entity, define the range of laboratory activities for which conformity is claimed and give management the authority and resources to run them. Clause 6, resource requirements, covers competent personnel, suitable facilities and environmental conditions, equipment, metrological traceability and externally provided products and services.
The standard applies regardless of size: an in-house calibration room and a multi-site commercial testing group meet the same clauses.
Process requirements and the management system
Clause 7 holds the process requirements that make results trustworthy: reviewing requests and contracts, selecting, verifying and validating methods, sampling, handling test and calibration items, technical records, evaluating measurement uncertainty, ensuring the validity of results through quality control and proficiency testing, reporting results, and handling complaints and nonconforming work.
Clause 8 offers two options. Option A lists the minimum management system elements the laboratory must address; Option B recognises a system that meets ISO 9001 and supports clauses 4 to 7. ISO/IEC 17025:2017 is the current, third edition, confirmed by ISO in 2023. Competence is recognised through accreditation, granted by an accreditation body for a defined scope of tests or calibrations and maintained through surveillance and reassessment.
The scope of accreditation should list the tests or calibrations your customers rely on, not everything the laboratory can do, and each one is examined in its own right during the assessment.
ISO/IEC 17025 at a glance
- Purpose
- Competence, impartiality and consistent operation of testing and calibration laboratories, so their results can be relied on and accepted
- Relevant to
- Any organisation performing laboratory activities, from an in-house calibration room to a multi-site commercial testing group
- Edition
- ISO/IEC 17025:2017, the third edition, confirmed by ISO in 2023; no amendment and no transition running
- Accreditation
- Assessed and granted by an accreditation body for a defined scope of tests or calibrations, maintained through surveillance and reassessment
- Sterling's role
- Consulting with your team, Effivity, training, internal audit and assessment readiness, then Sustain™
- Cost and timing
- Total investment for an ISO/IEC 17025 laboratory management system depends on the current maturity of your processes, the scope, locations and number of employees. The process typically takes 6 to 12 months
ISO/IEC 17025: questions people ask
Is ISO/IEC 17025 a certification or an accreditation?
An accreditation. An accreditation body assesses the laboratory's competence for a defined scope of tests or calibrations and grants accreditation, publishing the scope on its register. Certification bodies certify management systems, they do not accredit laboratories, and a "17025 certificate" from one of them is not accreditation.
Which accreditation body should we apply to, and will our results be accepted abroad?
Normally the national body, for example PAB (Philippines), NABL (India), UKAS (United Kingdom), EIAC (Dubai), GAC (Gulf states), ANAB or A2LA (United States), NATA (Australia) or SAC (Singapore), provided it is a Global ACI MRA signatory for the scope you need. Signatory bodies recognise one another's accreditations as equivalent, except where regulation or law provides otherwise, so check the register and your customer's regulator.
We are ISO 9001 certified. Does that satisfy ISO/IEC 17025?
No. ISO 9001 covers the management system; ISO/IEC 17025 adds the technical requirements: impartiality, personnel authorisation, equipment and traceability, method validation, uncertainty, validity of results and reporting. Option B lets your ISO 9001 system serve as clause 8, but clauses 4 to 7 still have to be implemented and assessed.
What is a scope of accreditation, and can we extend it later?
The scope lists the tests or calibrations, methods, ranges and, for calibration laboratories, the calibration and measurement capability the body has assessed, at each site. Only results within it may be reported as accredited. Extending it is routine: the new method is validated or verified, uncertainty evaluated, staff authorised, proficiency testing arranged where available, and the body assesses the extension, often on a scheduled visit.
Do we have to take part in proficiency testing?
The standard requires the laboratory to monitor the validity of its results and, where available and appropriate, to compare them with other laboratories through proficiency testing or other interlaboratory comparisons. Accreditation bodies expect a plan covering the scope on a defined cycle and evidence that every result was reviewed and acted on. Where no scheme exists, an alternative comparison is agreed and documented.
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The complete guide
Everything on ISO/IEC 17025
Start with the ISO/IEC 17025 page, or go straight to the guide you need.
On the ISO/IEC 17025 page
- What are the main ISO/IEC 17025 requirements?
- How do you get ISO/IEC 17025 accredited?
- How much does ISO/IEC 17025 accreditation cost?
- How long does ISO/IEC 17025 accreditation take?
- Who needs ISO/IEC 17025 accreditation?
- How ISO/IEC 17025 accreditation supports your laboratory and its customers
- Frequently asked questions about ISO/IEC 17025
Guides
- ISO 17025 accreditation process
- ISO 17025 assessor questions
- ISO 17025 accreditation in Australia
- ISO 17025 benefits
- ISO 17025 case study
- ISO 17025 checklist
- Choosing an ISO 17025 accreditation body
- ISO 17025 common mistakes
- ISO 17025 accreditation cost
- Do I need ISO 17025? A decision guide to ISO/IEC 17025 accreditation for laboratories
- ISO 17025 documentation
- Effivity ISO 17025 guide
- ISO 17025 calibration and traceability
- ISO 17025 gap analysis
- ISO 17025 implementation plan
- ISO 17025 accreditation in India
- ISO 17025 internal audit
- ISO 9001 vs ISO 17025
- ISO 17025 management review
- ISO 17025 measurement uncertainty
- ISO 17025 method validation and verification
- ISO 17025 accreditation in the Netherlands and Europe
- ISO 17025 nonconformities
- ISO 17025 proficiency testing
- ISO 17025 requirements explained
- ISO 17025 scope of accreditation
- ISO 17025 accreditation in Singapore and South East Asia
- ISO 17025 for small laboratories
- ISO 17025 surveillance and reassessment
- ISO 17025 assessment
- ISO 17025 accreditation in the Philippines
- ISO 17025 accreditation in the UAE and GCC
- ISO 17025 accreditation in the UK
- ISO 17025 timeline
- ISO 17025 training
- How to verify ISO 17025 accreditation and a laboratory's scope, and spot a false claim
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