Prepare your A2LA / ANAB RMP accreditation in weeks, not months.
The ISO 17034 package is for any Reference Material Producer (RMP) pursuing accreditation, whether an in-house lab in an industrial company, a national institute, a specialized startup, or a consulting firm.
Laboratories and organizations that design, characterize, produce, and certify reference materials (CRMs or RMs) used for calibration, quality control, and method validation. Includes commercial RMPs serving testing labs and industry.
Laboratories accredited under ISO/IEC 17025 that produce their own reference materials in-house for analytical needs (matrix-matched RMs for pharma, food, environmental testing), or that want to extend their accreditation scope to RM production.
National metrology institutes (NIST in the US), federal agencies (FDA, EPA, USDA), and government research bodies producing reference materials for regulatory mandates (NIST SRMs — Standard Reference Materials), and that must demonstrate competence under an international standard.
Quality consultants and accreditation specialists who want a validated documentation foundation to start client RMP engagements quickly (consultant license available on request).
ISO 17034:2016 contains 5 normative clauses (4 to 8) intertwining management requirements and technical requirements specific to reference material production: homogeneity, stability, characterization, metrological traceability, assigned values, uncertainty. Building the dossier in-house takes 4 to 8 months of writing work and exposes you to avoidable findings on accreditation assessment day.
Most online templates are derivatives of ISO 9001 or ISO/IEC 17025 adapted at the margins. They ignore RMP-specific requirements: between-bottle homogeneity studies, short-term and long-term stability studies, consensus assigned values, characterization uncertainty, metrological traceability to the SI through NIST or another NMI.
Accreditation assessments by A2LA, ANAB, NIST OWM, UKAS, DAkkS, or any other ILAC MRA member are rigorous and technically demanding. Without a complete, structured, standard-aligned dossier, findings can lead to denial, postponement, or scope limitation. Assessors are domain specialists who immediately spot weaknesses.
ISO/IEC 17025-accredited testing laboratories, regulated industries (pharma, food, environmental), and inspection bodies only purchase reference materials produced by ISO 17034-accredited RMPs. Without this accreditation, your commercial reach is severely limited — especially in the US market where A2LA and ANAB-accredited RMPs dominate.
A complete ISO 17034 implementation engagement billed by a specialized consulting firm represents 20 to 50 days of intervention. The documentation package gives you the complete written foundation — you keep your budget for field implementation and the technical studies specific to your reference materials.
The package covers the 5 normative clauses of ISO 17034:2016 — general (Clause 4), structural (Clause 5), resource (Clause 6), technical and production (Clause 7), and management system requirements per Option A (Clause 8). Each card below is aligned with the exact numbering of the standard.
ISO 17034:2016 is the international standard recognized by ILAC and accreditation bodies signatory to the Mutual Recognition Arrangement (MRA) for accreditation of Reference Material Producers. Below is the clause-by-clause mapping aligned with the exact structure of the standard (Clauses 4 to 8) and Annex A which summarizes requirements applicable to RMs and CRMs. This is what an A2LA, ANAB, or NIST OWM technical assessor expects to see first.
| Clause | ISO 17034 requirement | Documents provided in the package |
|---|---|---|
| 4.1 — 4.3 | General requirements: contract review, impartiality, confidentiality | Contract review Impartiality procedure Confidentiality & data security Personnel independence declaration Impartiality risks register |
| 5.1 — 5.4 | Structural requirements: legal status, organization, responsibilities, communication | ISO 17034 quality manual Legal entity Organization chart Job descriptions QMS scope Communication matrix |
| 6.1 | Personnel: competence, training, supervision, qualifications, authorizations, job descriptions | Competence & training Job descriptions Competence evaluation Training tracking Authorization matrix Annual training plan |
| 6.2 | Subcontracting: evaluation, selection, control of subcontractors, non-subcontractable tasks | Subcontracting procedure Subcontractor evaluation grid Quality Agreement template Subcontracted tasks register |
| 6.3 | Equipment, services, and supplies: selection, purchasing, verification, maintenance, calibration, consumable inspection | Purchasing & supplier evaluation Supplier evaluation form Consumable receiving inspection Calibration & maintenance Calibration record Maintenance register Equipment logbook |
| 6.4 | Facilities and environmental conditions: adequacy, monitoring, access control | Infrastructure & environment Environmental compliance check Environmental monitoring Zone access control Continuity plan |
| 7.1 — 7.3 | General technical requirements, production planning, and control | Production planning RM planning form Production control |
| 7.4 — 7.5 | Material handling, storage, and treatment: integrity, identification, segregation, periodic inspection, packaging, conservation | Handling & storage RM identification & segregation Periodic stock inspection Preparation & treatment Packaging procedure |
| 7.6 — 7.8 | Measurement methods, measuring equipment, data integrity and evaluation, IT data security | Measurement methods Method validation Measuring equipment management Data integrity & evaluation (ALCOA+) Software validation Data security (FDA 21 CFR Part 11) |
| 7.9 | Metrological traceability of certified values (CRMs only): SI linkage, references, secondary parameters | Certified value traceability (NIST) SI linkage record Calibration certificates register Traceability chain matrix |
| 7.10 — 7.12 | Homogeneity assessment, stability evaluation and monitoring, characterization (ISO Guide 35 aligned) | Homogeneity assessment Stability evaluation Characterization (single/multi-method/interlab) Interlaboratory study procedure Between-bottle homogeneity testing |
| 7.13 — 7.15 | Value and uncertainty assignment, certificates and labels, distribution, after-sales service (ISO Guide 31 aligned) | Value & uncertainty assignment (GUM) Standard RM certificate Product information sheet Labeling procedure Distribution procedure Lot release authorization RM sales register Customer notifications |
| 7.16 — 7.18 | Records control, nonconforming work management, complaint handling | Records control Nonconforming work management NC processing record Complaint handling Customer complaint form Customer feedback |
| 8.2 — 8.5 | Management system (Option A): quality policy, documentation, document and records control | Quality policy Quality objectives QMS documentation Document control QMS records control Master document list |
| 8.6 — 8.7 | Management review and internal audits: program, auditor qualification, reports, follow-up | Management review procedure Management review minutes Internal audit procedure Annual audit plan ISO 17034 audit checklist Standard audit report |
| 8.8 — 8.11 | Risks and opportunities, corrective actions (root cause analysis), continual improvement, customer feedback | Risk & opportunity analysis Risks & opportunities register Corrective actions (root cause) Corrective action request Continual improvement Customer feedback |
| Not included | Documents specific to each reference material and each production campaign — which must be drafted case by case by your technical team based on the nature of the RM produced | Per-material technical file Homogeneity report (per lot) Stability report (per material) Characterization protocol (per RM) Detailed uncertainty budget (per RM) Filled-in final certificate (per lot) Interlaboratory study results (per campaign) |
Beyond the clause-by-clause mapping, here are the technical rigor points that A2LA, ANAB, NIST OWM, UKAS, DAkkS, and other ILAC peer assessors systematically verify during ISO 17034 accreditation assessments.
ISO 17034 is recognized by ILAC (International Laboratory Accreditation Cooperation) as the international reference standard for accreditation of Reference Material Producers. ISO 17034 accreditation obtained from an ILAC MRA signatory is recognized in all participating zones.
| Criterion |
QSE Academy ISO 17034 $689 |
Free templates $0 |
RMP consulting firm $12,000 — $30,000 |
|---|---|---|---|
| RM production-specific (not generic ISO 9001 or 17025) | ✓ | ✗ | ✓ |
| Coverage of 5 ISO 17034 normative clauses | ✓ 100% | Partial | ✓ 100% |
| RMP technical procedures (homogeneity, stability, traceability) | ✓ Included | ✗ | Per engagement |
| Clause-by-clause mapping | ✓ Excel matrix | ✗ | Per engagement |
| Editable Word format, neutral charter | ✓ | Variable | ✓ |
| Delivery time | Instant | Instant | 4 to 8 months |
| Money-back guarantee | ✓ 30 days | ✗ | ✗ |
| RM-specific technical studies (homogeneity, stability, characterization) | On you | On you | Included |
Answer the 14 questions clause by clause to get your ISO 17034 maturity score. Instant result, free, no personal information required.
The package isn't just delivered. Here is the concrete path to bring it into production in your reference material producer organization, step by step.
Secure payment, immediate access to the full package as a ZIP. Within minutes you have the 100 Word documents, the ISO 17034 mapping matrix, the RM certificate templates, and the user manual.
Adapting the documents to your RMP organization: logo, organization chart, accreditation scope (RM types: organic, inorganic, biological, matrix-matched), real equipment, regular providers, target accreditation body (A2LA, ANAB, NIST OWM, UKAS, DAkkS). Plan 2 to 4 weeks for thorough customization.
Homogeneity studies, stability studies, characterization campaigns, uncertainty budgets, interlaboratory study coordination, mock assessment. The package gives you the framework; the technical work is yours (the highest-value RMP work).
Submit application to A2LA / ANAB / NIST OWM, document review, on-site assessment. Internal audit using the ISO 17034 checklist provided in the package. Identification of remaining gaps, corrective action plan, accreditation decision.
You have 30 days to download the package, review its content, open the documents, and verify that the writing quality matches your expectations. If something is off, you write us an email — no justification needed — and the refund is processed within 5 business days. That simple.
The RMP accreditation landscape evolves with new ILAC guidance, ISO Guide revisions, and emerging technical standards. The package you buy today shouldn't become obsolete in 6 months. That's why updates are included.
The package already integrates ISO 17034:2016, ISO Guides 30, 31, 33, 35, ISO 13528, GUM (NIST TN 1297), ALCOA+ data integrity, FDA 21 CFR Part 11, and current A2LA / ANAB / NIST OWM accreditation requirements. In case of new ILAC guidance, ISO Guide revisions, accreditation body policy revisions, or significant new technical guidance, you receive package updates free of charge for 12 months after your purchase.
The package gives you the complete documentation foundation required by ISO 17034:2016 and aligned with the major US-relevant accreditation bodies (A2LA, ANAB, NIST OWM). To obtain accreditation, you also need to fill in the documents with your real data (homogeneity studies, stability studies, characterization campaigns, uncertainty budgets), demonstrate technical competence, and pass an on-site assessment. The package saves you the 4 to 8 months of writing work. Technical study work and assessment readiness remain your work (typically 12 to 16 additional weeks depending on RM scope and complexity).
All three are recognized signatories to the ILAC MRA, so any accreditation under one of them is internationally recognized. A2LA is the largest US lab accreditation body, with a strong RMP program covering matrix-matched CRMs and reference materials across analytical sectors. ANAB (ANSI National Accreditation Board) is a major alternative, particularly strong in calibration-grade reference materials and chemical CRMs. NIST OWM (Office of Weights and Measures) operates the National Voluntary Conformity Assessment Systems Evaluation (NVCASE) program and recognizes accreditation bodies. The package documents are agnostic and adapt to whichever body you choose.
Yes. ISO 17034:2016 covers both RMs (Reference Materials) and CRMs (Certified Reference Materials). The key difference: CRMs require metrological traceability of certified values (Clause 7.9 — only applicable to CRMs). The package documents address both, with Clause 7.9 procedures specifically for CRM production (NIST traceability chain, calibration certificates register, traceability matrix). Annex A of ISO 17034 summarizes which requirements apply to RMs vs. CRMs — the mapping matrix in the package highlights this distinction.
Most free templates are derivatives of ISO 9001 or ISO/IEC 17025 adapted at the margins. They ignore RMP-specific requirements: between-bottle homogeneity studies, short-term and long-term stability studies, consensus value assignment, characterization uncertainty, ISO Guide 31 certificate format, ISO Guide 35 statistical methods. The QSE Academy package is written specifically for ISO 17034:2016 + ISO Guides 30/31/33/35 + ISO 13528 and includes the verifiable clause-by-clause mapping.
Plan 2 to 4 weeks to customize the documents: logo, organization chart, accreditation scope (RM types, sectors, CRM vs RM), specific equipment, regular providers, target accreditation body. Then plan technical implementation: homogeneity studies, stability studies, characterization campaigns, uncertainty budgets — that's 12 to 16 additional weeks depending on RM scope and complexity.
All policies, procedures, and templates are delivered in fully editable Microsoft Word (.docx) format. Forms, registers, evaluation grids, the mapping matrix, and the uncertainty budget template are delivered in Excel (.xlsx) format for immediate operational use. No locked PDFs, no proprietary software dependency. The graphic charter is neutral, ready to receive your logo and colors.
The package includes a homogeneity assessment procedure (Clause 7.10, ISO Guide 35 aligned), a stability evaluation and monitoring procedure (Clause 7.11), a between-bottle homogeneity testing record, and the framework for evaluating between-bottle and within-bottle variance via ANOVA. It does NOT include filled-in homogeneity or stability study results, since these depend on your specific RMs, matrices, analytical methods, and equipment. The package gives you the structural and methodological framework; the technical study work remains yours.
Yes. The package includes a data integrity and evaluation procedure (Clause 7.8, ALCOA+ aligned), a software and spreadsheet validation procedure (Clause 7.8.2.a), and an IT data security procedure (Clause 7.8.2.d). For regulated RMPs (pharma reference materials, clinical CRMs, FDA-regulated diagnostics) the procedures align with FDA 21 CFR Part 11 (electronic records and signatures, audit trails, system access controls).
The $689 license covers a single legal entity, with unlimited internal use (all your RMP personnel can use the package). For multi-site rollout, a group with multiple subsidiaries, or consulting use across multiple clients, contact us for an adapted license.
Yes. The package already integrates the latest 2025-2026 RMP accreditation landscape (ISO 17034:2016, current ISO Guides 30/31/33/35, ISO 13528, GUM, A2LA / ANAB / NIST OWM requirements). In case of significant ISO Guide revisions, ISO 17034 revision (a new edition is in preparation), accreditation body policy revisions, or new technical guidance documents, you receive package updates free of charge for 12 months after your purchase.
You're covered by a 30-day money-back guarantee, no conditions. You write us a simple email — no justification required — and the refund is processed within 5 business days.
100 documents, 5 ISO 17034 normative clauses covered (4 to 8) + ISO Guide 31 / 35 alignment + clause-by-clause matrix included. Instant download after payment.
QSE Academy supports quality managers, SMEs, and consultants in accelerating their ISO standards implementation through ready-to-use documentation, targeted training programs, custom documentation services, and compliance tools.
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