Implementation walkthrough
How to implement ISO 17034: video walkthrough
A walkthrough of preparing a reference material producer for ISO 17034 accreditation, material by material.
Key takeaways
- Reference material producers are accredited to ISO 17034, not certified.
- Accreditation covers defined materials, properties and value ranges.
- Homogeneity and stability must be assessed for each material.
- Certified values need assigned uncertainties and metrological traceability.
- Subcontracted measurements must be controlled.
Values laboratories rely on
ISO 17034 is the international standard for the competence of reference material producers. It sets the requirements under which reference materials, certified ones included, are produced: impartial governance, competent and authorised people, controlled subcontracting, planned production, assessed homogeneity and stability, characterisation, values assigned with their uncertainties, traceable certified values, and the documents that travel with each material. Laboratories calibrate, validate methods, control quality and compare performance with these materials, so a flawed value travels into every dependent result.
Producers are accredited, not certified: an accreditation body reviews the documents, assesses the producer on site and grants accreditation for a defined scope of materials, properties and value ranges. This short film walks through how a producer prepares.
Size is no barrier: a producer is defined by responsibility, not by having a laboratory of its own, and several activities can be subcontracted to evaluated providers.
From production plan to accreditation
Decide what goes on the scope and who will assess it: the reference materials and certified reference materials, the properties and value ranges, whether measurements are made in-house or subcontracted, and the accreditation body, usually the national body where it accredits producers. Each body publishes its own procedure, but the sequence is common.
A gap analysis then checks the producer clause by clause, and the production requirements material by material. Implementation establishes contract review, impartiality and confidentiality; resources and controlled subcontracting; and the production process that follows each material from the production plan to the customer: production planning, material processing and preparation, assessment of homogeneity and stability, characterisation, assignment of property values and their uncertainties, metrological traceability for certified values, and the reference material documents and labels. The management system supports it all. An internal audit and a management review come before the application; assessors then visit, and the accreditation body takes the decision.
Sterling's expert and experienced consultants support preparation and implementation with your people under Sterling OS™. ISO 17034:2016, which replaced ISO Guide 34:2009, is the current edition, and a second edition is in development.
ISO 17034 at a glance
- Purpose
- Competence and consistent operation of reference material producers, so the values laboratories rely on can be trusted
- Relevant to
- Any organisation that produces reference materials or certified reference materials, with its own laboratory or with subcontracted measurements
- Edition
- ISO 17034:2016, which replaced ISO Guide 34:2009; a second edition is at committee draft stage (July 2026), with no publication date announced
- Accreditation
- Granted by an accreditation body for a defined scope of materials, properties and value ranges, then maintained through surveillance and reassessment
- Sterling's role
- Implementation with your people, Effivity, training, internal audit and assessment readiness, then Sustain™
- Cost and timing
- Total investment for an ISO 17034 management system for reference material production depends on the current maturity of your processes, the scope, locations and number of employees. The process typically takes 9 to 15 months
ISO 17034: questions people ask
Is ISO 17034 accreditation the same as certification?
No. An accreditation body assesses the producer's competence and grants accreditation for a defined scope, published on its register. The only certification ISO 17034 refers to is the producer's certification of its own materials. An "ISO 17034 certificate" from a certification body is not accreditation.
What is the difference between a reference material and a certified reference material?
A reference material is sufficiently homogeneous and stable for specified properties and fit for its intended use, and is issued with a product information sheet. A certified reference material is also characterised by a metrologically valid procedure and carries a certificate giving the value, its uncertainty and its traceability. Certified values are kept distinct from other assigned values, such as indicative values.
Do we need ISO/IEC 17025 accreditation before we apply for ISO 17034?
No. ISO/IEC 17025 is the only normative reference in ISO 17034 and your measurements must meet its relevant requirements, but laboratory accreditation is not a condition of producer accreditation. Holding both makes the evidence easier to show; check your body's rules for subcontracted measurements. For tests in the medical field, the standard accepts ISO 15189 in place of ISO/IEC 17025.
Can we subcontract processing, homogeneity and stability testing or characterisation?
Yes, with subcontractors selected and evaluated on evidence of competence. Five things cannot be subcontracted: production planning, the selection of subcontractors, the assignment of property values and their uncertainties, their authorisation, and the authorisation of RM documents.
Which accreditation body should we apply to, and will our materials be recognised abroad?
Normally your national body, if it accredits producers: UKAS (United Kingdom), A2LA and ANAB (United States), NABL (India) and NATA (Australia) do, for example, but not every national body offers this scope. Confirm on the Global ACI register that the body is a signatory for reference material production; signatories recognise one another's accreditation as equivalent, except when prohibited by regulation or law.
Keep exploring
Related to this video
The complete guide
Everything on ISO 17034
Start with the ISO 17034 page, or go straight to the guide you need.
On the ISO 17034 page
- What are the main ISO 17034 requirements?
- How do you get ISO 17034 accredited?
- How much does ISO 17034 accreditation cost?
- How long does ISO 17034 accreditation take?
- Who needs ISO 17034 accreditation?
- How ISO 17034 accreditation supports your materials and your customers
- Frequently asked questions about ISO 17034
Often combined with ISO 17034
More videos: Laboratories, inspection and accreditation
- How to implement ISO/IEC 17043Implementation walkthrough · 3 min 15 s
- ISO/IEC 17043 requirements explainedTwo-minute brief · 2 min
- 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
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