ISO 17034 accreditation consulting for reference materials laboratories can trust.

What it is

What is ISO 17034 and what is it used for?

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.

The standard distinguishes two products. A reference material (RM) is sufficiently homogeneous and stable for the properties specified and fit for its intended use; it goes out with a product information sheet. A certified reference material (CRM) has also been characterised by a metrologically valid procedure and carries a certificate stating the value, its uncertainty and its metrological traceability.

ISO 17034 is an accreditation standard; the only certification it speaks of is the producer's certification of its own materials. An accreditation body working to ISO/IEC 17011 assesses the producer and grants accreditation for a published scope of materials, properties and value ranges. A material outside that scope is not covered, even when its producer is accredited for others.

Current edition. ISO 17034:2016, the first edition, published in November 2016, replaced ISO Guide 34:2009. ISO confirmed it in 2022 and on 3 December 2025 marked it to be revised; the project for a second edition was approved the following day, and the committee draft, ISO/CD 17034, went out for comment on 23 July 2026. No publication date has been announced and no transition period exists, so the 2016 edition remains the one you are assessed against. The guidance it cites has moved on: ISO 33401:2024 replaced ISO Guide 31 on certificates, and ISO 33405:2024 replaced ISO Guide 35 on characterisation, homogeneity and stability. Since 1 January 2026, international recognition runs through Global ACI (Global Accreditation Cooperation Incorporated) and its MRA, which replaced the IAF MLA and ILAC MRA and lists reference material production among its main scopes. ISO 17034 requirements explained, from contract review to distribution

Who it is for

Who needs ISO 17034 accreditation?

ISO 17034 applies to any organisation that takes full responsibility for producing reference materials: planning the project, assigning and authorising property values and their uncertainties, and issuing the certificate or other statement. That may be a commercial producer, a testing laboratory, a proficiency testing provider or a manufacturer, and it need not run a laboratory itself. Producers come to Sterling from four starting points:

• Your customers are accredited laboratories. Their assessors ask where each reference material came from. UKAS policy, for example, tells laboratories that a material from a producer accredited to ISO 17034 gives confidence in the producer's statements, and that a laboratory using any other producer must show the basis of its confidence.
• A distributor, customer or tender asks for an accredited producer. Settle which materials and properties must be covered, and whether certified values are expected, before the scope is fixed.
• Your laboratory has started supplying materials to others. Once you assign values and issue certificates or statements for materials other laboratories use, you are acting as a producer, and customers will ask how those values were established and how long they hold.
• You already hold ISO/IEC 17025 accreditation or ISO 9001 certification. Laboratory accreditation covers your measurements, not production planning, homogeneity, stability, value assignment, certificates or distribution. ISO 17034 adds them, and under Option B an ISO 9001 system can carry the management system clause.

The intended benefit is values other laboratories can use without re-establishing them. That depends on production, studies and people working together every day; accreditation records it, it does not create it.

Business benefits

How ISO 17034 accreditation supports your materials and your customers

A producer earns its reputation one certified value at a time. We start where a customer queried a value, a batch drifted in storage or a subcontracted result could not be explained, and build the system around those points.

• Materials your customers can citeA published scope, recognised through the Global ACI MRA, that an accredited laboratory can show its own assessor.
• Certified values that hold upHomogeneity, stability and characterisation built into every uncertainty, and a traceability statement on every certificate.
• Subcontracted work under controlLaboratories and processors evaluated on evidence, while the decisions the standard reserves for you stay with you.
• Values that stay valid on the shelfStability assessed before release and monitored afterwards, so drift is caught by your programme, not a customer's control chart.
• Documents users can act onCertificates and product information sheets that say what the material is for and how to handle and use it, with ISO 33401:2024 as the guide.
• A catalogue that can growProduction plans, study designs and value-assignment files built to one pattern, so the next material is a scope extension, not a new project.

Track what the programme should change: complaints about assigned values, nonconforming batches, unexpected stability results, overdue subcontractor evaluations. More procedures are not a result.

Requirements

What are the main ISO 17034 requirements?

ISO 17034 has five requirement clauses, 4 to 8, in the sequence it shares with ISO/IEC 17025, its only normative reference. Clause 7 carries most of the weight: eighteen sub-clauses that follow a material from the production plan to the customer, shown below in three rows. Requirements for reference materials come first, the additional ones for certified reference materials follow, and Annex A summarises which apply to each. The table is a plain-language map; during the programme your production is checked against the standard itself, material by material.

Accreditation process

How do you get ISO 17034 accredited?

First build a production operation that meets the standard and can prove it with records. Then apply to an accreditation body, which reviews your documents, assesses you on site and decides. Sterling provides consulting and preparation; the decision belongs to the body, and its independence is what makes the schedule worth showing a customer. Each body publishes its own procedure; step 05 follows the pattern UKAS, A2LA, ANAB and NABL describe.

1. 01
   Decide what goes on the scope, and who will assess it.Agree the materials, properties and value ranges for the application, as RMs or CRMs, and the sites; select a body that accredits producers and is a Global ACI MRA signatory for reference material production.
2. 02
   Gap analysis: review your production against clauses 4 to 8, material by material.From impartiality and subcontracting to homogeneity, stability, characterisation, value assignment, RM documents and the management system; what works is kept, and actions, owners, dates and resources are agreed.
3. 03
   Implement and produce the evidence.Write production plans, run the homogeneity and stability studies, characterise, assign values with their uncertainties, evaluate subcontractors, authorise staff and issue the documents, so records accumulate in daily use.
4. 04
   Audit, review and close every finding.An internal audit that follows a material from production plan to certificate as well as the management system, then a management review; we raise findings first and close them with evidence before the application.
5. 05
   Complete the accreditation body's assessment.Application with key policies, procedures and proof of legal status, documentation review, a pre-assessment where offered, then the on-site assessment, where a lead assessor and technical assessors review records and witness key activities; findings are closed by the body's deadline before it decides.
6. 06
   Maintain the accreditation.Stability monitoring, subcontractor evaluation, internal audits and management reviews continue, alongside the body's surveillance, reassessment on its cycle and scope extensions for new materials.

Check who will grant the accreditation before you compare prices. Only accreditation bodies working to ISO/IEC 17011 accredit reference material producers; an "ISO 17034 certificate" from a certification body or a consultant is not accreditation. Confirm on the Global ACI register that your body is a signatory for reference material production before you sign. How to choose a credible ISO 17034 provider · The accreditation buyer's checklist

Cost

How much does ISO 17034 accreditation cost?

ISO 17034 has no standard price. A producer of a few calibration solutions made and measured in-house needs a different programme from one with dozens of matrix materials characterised by subcontracted laboratories, and the accreditation body charges for the assessment days its scope requires. Our part is a proposal with every component visible and a fixed Sterling fee.

Timeline

How long does ISO 17034 accreditation take?

A first ISO 17034 accreditation typically takes nine to fifteen months, and three things set the pace. A batch has to be processed, its homogeneity and stability assessed and its values assigned before the records mean anything. Characterisation often depends on subcontracted laboratories, whose competence you must evaluate first and whose schedules you share. And the body needs time for documentation review, technical assessors for your materials, the on-site assessment and the closure of findings: A2LA, for example, gives a new applicant 30 days to respond and four months to resolve findings. Our plan follows those dependencies, with milestones tracked in Effivity.

If a customer, distributor or tender has set a date, tell us at the start. We will say what is achievable, which studies must start first and where an early scope decision saves months. Nobody can promise an accreditation date without first seeing your production and study records; a quote that does is guessing.

Challenges

Common ISO 17034 implementation challenges

Most producer programmes stall on the same five points, mostly technical rather than documentary. Each has a practical answer.

Your engagement

What your ISO 17034 engagement includes

Your agreed scope covers what an accreditation-ready producer needs: the management system, the production and study evidence, and a team that can explain both to an assessor. A Sterling engagement runs from the first scoping meeting to the accreditation decision, with one team and one all-inclusive proposal.

• Scope, gap analysis and implementation plan

  Material by material, with responsibilities, dates and decision owners agreed before work starts.

• Management system and production documentation

  Procedures, production plan and study templates, value-assignment records and certificate formats, built with your technical team.

• Effivity ISO & GRC software

  Your management system runs in Effivity from the first week, included with the engagement at no additional cost.

• Training for everyone

  Internal auditor training for the people who will audit production, as applicable to your standard, plus preferential Sterling Academy access, including complimentary awareness training for your people as part of the engagement.

• Internal audit and management review

  Conducted or facilitated as agreed, reaching into production and the technical records as well as the management system, with findings closed before the assessors arrive.

• Assessment readiness and support

  Preparation for the documentation review, a pre-assessment where the body offers one and the on-site assessment, then support until the decision.

Accreditation decisions remain with the independent accreditation body.

How we deliver

How Sterling supports your ISO 17034 implementation

Every ISO 17034 engagement runs on Sterling OS™, our delivery operating system: five phases, each with defined deliverables, decision owners and evidence. You choose the level of support; the method and the accountability stay the same.

1. 01
   Design™Guided implementation: your technical team plans production, designs studies and writes procedures with Sterling's structure and coaching.
2. 02
   Drive™Fully managed consulting: Sterling consultants take on the agreed documentation, study planning and evidence work with your staff.
3. 03
   Sustain™After accreditation: surveillance readiness, internal audits, stability monitoring reviews, refreshers and training for new staff, year after year.
4. 04
   Automate™The management system in Effivity: documents and records, competence, equipment, subcontractors, risks, complaints, audits, actions and management review in one workspace.
5. 05
   Revise™Scope extensions, new materials and sites, changes in your body's rules, and the move to the second edition of ISO 17034 once it is published.

At the outset we name the engagement team, fix a weekly working session and agree deliverables and decision owners, so a stability study that will not finish in time shows up in month three, not in the assessor's report.

Often combined with

Standards organisations pair with ISO 17034

• CAP accreditationCAP accreditation readiness for laboratories: checklist gap analysis, method records, self-inspection and peer inspection support.
• ISO 10012ISO 10012 Measurement Management certification consulting: measurement processes and equipment controlled for valid results, ready for a certification audit.
• ISO 14065ISO 14065 accreditation and requirements for bodies verifying environmental information: GHG statements, footprints, the route, cost and timing factors.
• ISO 15189ISO 15189 accreditation consulting for medical laboratories: quality and competence for reliable, timely results, prepared for the accreditation assessment.
• ISO 15190ISO 15190 laboratory safety for medical labs: gap and risk assessment, procedures, training and internal audit alongside ISO 15189.
• ISO 20387ISO 20387 accreditation and requirements for biobanks: competence, impartiality and sample quality, with expert consultants, Effivity and an all-inclusive proposal.