NEW: the ISO 14001:2026, ISO/IEC 17020:2026 and FSSC 22000 V7 documentation kits are now available.
ISO/IEC 17011 accreditation requirement: ISO 17034:2016 is the international reference standard for accreditation of Reference Material Producers (RMPs).
Documentation kit · ISO 17034:2016

Your ISO 17034 documentation, without starting from scratch.

Word and Excel templates to structure your reference material production and prepare your accreditation assessment.

  • Clauses 4 to 8, from general requirements to the management system
  • Homogeneity, stability, characterization, uncertainty and certificates
  • 100 editable files, ANOVA and GUM calculation tools included
  • ILAC MRA: accreditation standard for reference material producers
Buy the kit · $489
License per legal entityInstant download30-day money-back guarantee
ISO 17034:2016 documentation kit
100
Documents included
5
Normative clauses covered
100%
Requirements mapped
ILAC
International recognition
Who this kit is for

Built for organizations that produce, characterize or certify reference materials.

Four profiles, one need: an ISO 17034 documentation base ready to adapt.

Reference material producers

Design, characterization, production and certification of RMs and CRMs for calibration and QC.

RMCRMCommercial RMPs

Testing and calibration laboratories

ISO/IEC 17025 labs producing their own RMs or extending their scope to RM production.

ISO/IEC 17025Scope extension

National institutes and agencies

Metrology institutes, federal agencies and research bodies producing RMs for regulatory mandates.

MetrologyRegulatory mandates

Consultants and advisory firms

A validated base to start engagements with reference material producers.

Client engagementsConsultant license on request

What is in the kit

100 documents organized by ISO 17034:2016 clause.

The kit covers the 5 normative clauses of ISO 17034:2016, from clause 4 to clause 8. The management system follows Option A of the standard.

Master document list · ISO 17034:2016

Version 1.0, May 2026
100 documents · 62 Word · 38 Excel

Clause 4 · General requirements

7 documents · Contract review, impartiality, confidentiality, quotation requests.
  • W
    Contract Review Procedure
  • W
    Impartiality Procedure
  • W
    Confidentiality and Data Security Procedure
  • W
    RM Customer Quotation Request Form
  • X
    Log of Signed Confidentiality Agreements
  • X
    Contract and Quote Review Log
  • X
    Impartiality Risk Assessment Register and Declaration of Independence

Clause 5 · Structural requirements

4 documents · Quality manual, legal status, QMS scope, org chart, communication.
  • X
    Internal and External Communication Matrix
  • W
    Description of Legal Status and Scope of the QMS
  • W
    ISO 17034 Quality Manual
  • W
    Organization Chart and Job Descriptions

Clause 6 · Resource requirements

20 documents · Personnel and authorizations, subcontracting, suppliers and equipment, facilities and environment.
  • W
    Competence, Awareness, and Training Procedure
  • W
    Outsourcing Procedure
  • W
    Purchasing and Supplier Evaluation Procedure
  • W
    Incoming Inspection of Consumables Procedure
  • W
    Equipment Calibration and Maintenance Procedure
  • W
    Infrastructure and Work Environment Procedure
  • W
    Access Control Procedure for Production Areas
  • W
    Individual Personnel Training and Qualification Records
  • W
    Job Description Sheets and Competency Assessment Form
  • W
    Business Continuity Plan
  • X
    Records of Periodic Competence Assessment
  • X
    Environmental Conditions Monitoring Records
  • X
    Log of Annual Evaluation and Requalification of Critical Suppliers
  • X
    Cleaning and Decontamination Records for Production Areas
  • X
    Incoming Inspection Register of Critical Consumables
  • X
    Subcontractor Evaluation Grid and Standard Contract
  • X
    Personnel Authorization and Qualification Matrix
  • X
    Annual Training Plan and Training Follow-up
  • X
    Subcontracted Tasks Register
  • X
    Equipment Logbook and Calibration Maintenance Register

Clause 7 · Planning, handling and preparation (7.1 to 7.5)

7 documents · Production planning and control, storage, stock inspection, preparation, batch records.
  • W
    Production Planning and Control Procedure
  • W
    Material Handling, Storage, and Identification Procedure
  • W
    Periodic Inspection Procedure for Stored Materials
  • W
    Material Preparation and Processing Procedure
  • W
    RM Production Batch Records
  • W
    RM Production Planning Form
  • X
    Periodic Inspection Register of Stored Materials

Clause 7 · Measurement, equipment and data integrity (7.6 to 7.8)

10 documents · Measurement methods and validation, measuring equipment, software, audit trail, backups.
  • W
    Measurement Methods and Validation Procedure
  • W
    Measuring Equipment Management Procedure
  • W
    Data Integrity and Evaluation Procedure
  • W
    Software and Spreadsheet Validation Procedure
  • W
    IT Data Security Procedure
  • W
    Measurement Method Validation Records
  • W
    Software and Spreadsheet Validation Records
  • W
    Standard Method Validation Report
  • X
    Audit Trail and Electronic Data Modification Log
  • X
    Data Backup and Restore Test Log

Clause 7 · Metrological traceability (7.9)

3 documents · Traceability of certified values, calibration certificates, traceability chains.
  • W
    Metrological Traceability of Certified Values Procedure
  • X
    Metrological Traceability Chain Matrix
  • X
    Calibration Certificates and SI Traceability Register

Clause 7 · Homogeneity, stability and characterization (7.10 to 7.12)

12 documents · Homogeneity and stability protocols and records, characterization, interlaboratory comparisons, calculation tools.
  • W
    Homogeneity Assessment Procedure
  • W
    Stability Assessment and Monitoring Procedure
  • W
    Material Characterization Procedure
  • W
    Interlaboratory Comparison Procedure
  • W
    Material Characterization Records
  • W
    Standard Homogeneity Study Protocol
  • W
    Standard Stability Study Protocol
  • X
    Between-Bottle Homogeneity Testing Record
  • X
    Register of Interlaboratory Comparisons Organized and Results
  • X
    Short-Term and Long-Term Stability Study Record
  • X
    ANOVA Homogeneity Tool (automatic uH, sH calculation)
  • X
    Stability Trend Tool (regression and confidence intervals)

Clause 7 · Values, certificates and distribution (7.13 to 7.15)

17 documents · Values and uncertainties, certificates and labels, transport, sales, customer notification, recall.
  • W
    Value Assignment and Uncertainty Procedure
  • W
    Distribution and Transport Conditions Procedure
  • W
    Customer Notification of Changes Procedure
  • W
    Withdrawal and Recall of an RM from the Market Procedure
  • W
    Opinions and Interpretations Management Procedure
  • W
    Sample Certificate of a Reference Material
  • W
    Sample RM Product Information Sheet and Labeling
  • W
    Sample RM Purchase Order
  • W
    Sample RM Labels
  • W
    Sample RM Safety Data Sheet
  • X
    Log of Issued RM Certificates with Version Number and History
  • X
    Uncertainty Calculation Files for Certified Values
  • X
    Register of Post-Sale Customer Notifications
  • X
    Transport Conditions Records
  • X
    Standard Uncertainty Budget (GUM template)
  • X
    Combined Uncertainty Calculator (GUM propagation law)
  • X
    RM Sales and Market Authorization Register

Clause 7 · Records, nonconforming work and complaints (7.16 to 7.18)

7 documents · Record control and archiving, nonconforming work, customer complaints.
  • W
    Control of Quality and Technical Records Procedure
  • W
    Management of Nonconforming Work Procedure
  • W
    Complaint Handling Procedure
  • W
    Record Archiving and Destruction Procedure
  • W
    Customer Complaint and Feedback Form
  • X
    Register of Nonconforming Work and Associated Decisions
  • X
    Customer Complaints Log with Analysis and Closure

Clause 8 · Management system (Option A)

10 documents · Quality policy, document control, management review, internal audit, risks, corrective actions, changes.
  • W
    Control of QMS Documents and Records Procedure
  • W
    Management Review Procedure
  • W
    Internal Audit Procedure and Annual Plan
  • W
    Risk Analysis, Corrective Action, and Continual Improvement Procedure
  • W
    Change Management Procedure
  • W
    Internal Audit Reports and Action Plans
  • W
    Management Review Minutes
  • X
    Log of Corrective Actions with Root Cause Analysis and Effectiveness Verification
  • X
    QMS Risks and Opportunities Log
  • W
    Quality Policy and Quality Objectives

Audit and control

3 documents · ISO 17034 audit checklist, quality KPI dashboard, master list.
  • X
    Master Document List
  • X
    RM Quality KPI Dashboard (QMS management)
  • X
    ISO 17034 Audit Checklist and Model Audit Report
Full master document list, implementation checklist and one complete procedure in the free sample.
Why this kit exists

A compliant RMP system cannot be drafted from a blank page.

5 normative clauses, management and technical requirements intertwined: homogeneity, stability, characterization, uncertainty.

Clause 7

Generic templates ignore RM production

ISO 9001 or ISO/IEC 17025 derivatives: nothing on between-bottle homogeneity, stability, characterization or SI traceability.

A2LA, ANAB, UKAS

Accreditation assessments are demanding

An incomplete dossier, or one inconsistent with the standard, can lead to denial, postponement or a limited scope.

Accredited customers

Customers expect an accredited producer

ISO/IEC 17025 labs, regulated industries and inspection bodies: without ISO 17034 accreditation, commercial reach shrinks.

$12,000 to $30,000

A consulting engagement is costly

20 to 50 consultant days. The kit provides the written base, your budget goes to the technical studies on your materials.

Clause-by-clause mapping

Every ISO 17034:2016 requirement → one document in the kit.

Clause by clause, the normative text and the documents provided. This is what a technical assessor asks to see first.

4.1 to 4.3
General requirements: contract review, impartiality, confidentiality
Contract reviewImpartiality procedureConfidentiality & data securityPersonnel independence declarationImpartiality risks register
5.1 to 5.4
Structural requirements: legal status, organization, responsibilities, communication
ISO 17034 quality manualLegal entityOrganization chartJob descriptionsQMS scopeCommunication matrix
6.1
Personnel: competence, training, supervision, qualifications, authorizations, job descriptions
Competence & trainingJob descriptionsCompetence evaluationTraining trackingAuthorization matrixAnnual training plan
6.2
Subcontracting: evaluation, selection, control of subcontractors, non-subcontractable tasks
Subcontracting procedureSubcontractor evaluation gridQuality Agreement templateSubcontracted tasks register
6.3
Equipment, services, and supplies: selection, purchasing, verification, maintenance, calibration, consumable inspection
Purchasing & supplier evaluationSupplier evaluation formConsumable receiving inspectionCalibration & maintenanceCalibration recordMaintenance registerEquipment logbook
6.4
Facilities and environmental conditions: adequacy, monitoring, access control
Infrastructure & environmentEnvironmental compliance checkEnvironmental monitoringZone access controlContinuity plan
7.1 to 7.3
General technical requirements, production planning, and control
Production planningRM planning formProduction control
7.4 to 7.5
Material handling, storage, and treatment: integrity, identification, segregation, periodic inspection, packaging, conservation
Handling & storageRM identification & segregationPeriodic stock inspectionPreparation & treatmentPackaging procedure
7.6 to 7.8
Measurement methods, measuring equipment, data integrity and evaluation, IT data security
Measurement methodsMethod validationMeasuring equipment managementData integrity & evaluation (ALCOA+)Software validationIT data security
7.9
Metrological traceability of certified values (CRMs only): SI linkage, references, secondary parameters
Certified value traceabilitySI linkage recordCalibration certificates registerTraceability chain matrix
7.10 to 7.12
Homogeneity assessment, stability evaluation and monitoring, characterization (ISO Guide 35 aligned)
Homogeneity assessmentStability evaluationCharacterization (single/multi-method/interlab)Interlaboratory study procedureBetween-bottle homogeneity testing
7.13 to 7.15
Value and uncertainty assignment, certificates and labels, distribution, after-sales service (ISO Guide 31 aligned)
Value & uncertainty assignment (GUM)Standard RM certificateProduct information sheetLabeling procedureDistribution procedureLot release authorizationRM sales registerCustomer notifications
7.16 to 7.18
Records control, nonconforming work management, complaint handling
Records controlNonconforming work managementNC processing recordComplaint handlingCustomer complaint formCustomer feedback
8.2 to 8.5
Management system (Option A): quality policy, documentation, document and records control
Quality policyQuality objectivesQMS documentationDocument controlQMS records controlMaster document list
8.6 to 8.7
Management review and internal audits: program, auditor qualification, reports, follow-up
Management review procedureManagement review minutesInternal audit procedureAnnual audit planISO 17034 audit checklistStandard audit report
8.8 to 8.11
Risks and opportunities, corrective actions (root cause analysis), continual improvement, customer feedback
Risk & opportunity analysisRisks & opportunities registerCorrective actions (root cause)Corrective action requestContinual improvementCustomer 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 fileHomogeneity 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)
XDelivered in the kit in Excel: the master list of the 100 documents and the ISO 17034 implementation checklist.

Technical compliance

The points an experienced ISO 17034 assessor checks.

Ten technical requirements assessors verify first. The kit addresses them one by one.

Risk-based approach

Risks and opportunities identified, analyzed and treated, including material integrity.

8.8

Between-bottle homogeneity

Sampling plan, ANOVA, between and within-bottle variance, contribution to uncertainty.

7.10

Short and long-term stability

Transport and storage assessed, stock monitored, validity period justified.

7.11

Metrological traceability to the SI

SI traceability when technically possible, otherwise to an appropriate reference.

7.9

Complete uncertainty budget

Characterization, inhomogeneity, storage and transport combined per the GUM, k=2.

7.13

Consensus assigned values

Documented method for the assigned value, statistical treatment of outliers.

7.13

Interlaboratory studies

Participant selection, harmonized protocols, statistical analysis per ISO 13528.

7.12

Certificates per ISO Guide 31

Minimum content, values and uncertainties, conditions of use, validity period.

7.14

Commutability

Assessed when relevant, information reported in the RM documents.

7.2.3, 7.14

Annual management review

Trends on lots, nonconformities, complaints, interlaboratory study results.

8.6
ILAC

ISO 17034: international ILAC recognition

ISO 17034 accreditation obtained from an ILAC MRA signatory is recognized in all participating economies.

United States (A2LA, ANAB)Canada (SCC)United Kingdom (UKAS)European Union (DAkkS, EA MLA)Asia-Pacific (JAB, CNAS, NATA)Latin America (INMETRO, EMA)South Africa (SANAS)ILAC MRA (worldwide)
RMP flash audit

Where do you stand today?

Answer the 14 questions clause by clause to get your ISO 17034 maturity score. Instant result, free, no personal information required.

Question 1 / 14
Clause 4: General requirements
0
/ 100

Buy the ISO 17034 Package · $489
Deployment process

From order to accreditation-ready, here is the route.

1
Day 1

Download

Full ZIP: 100 Word and Excel documents.

2
Weeks 1 to 4

Customization

Logo, org chart, RM types and scope, equipment, providers, accreditation body.

3
Weeks 5 to 16

Technical implementation

Homogeneity, stability and characterization studies, uncertainty budgets, mock assessment.

4
Weeks 16 to 24

Application and assessment

Internal audit with the kit's ISO 17034 checklist, corrective actions, application.

Typical timeline: 16 to 24 weeks to an assessment-ready state, 12 for the most structured organizations, up to 36 from scratch.
Need a hand? Our consultants can tailor the kit to your site and support the rollout, on quote.
Request a quote
They use the kit

What RMPs that adopted it say.

★★★★★

A real time saver on the writing. The homogeneity and stability framework gave us a base for our matrix-matched CRMs, the studies themselves were ours to run.

M
Megan
Technical Director · Reference materials producer, USA
★★★★★

The authors know RM production. The traceability procedure, the GUM uncertainty budget and the certificate template fit our CRM line after adaptation.

R
Robert
Quality Manager · Environmental RMP, USA
★★★★★

The ANOVA homogeneity tool and the interlaboratory comparison procedure are well thought out. Some procedures needed adapting to our materials.

D
David
Lab Director · Pharmaceutical RM producer, Canada
★★★★★

Word files that are easy to customize, neutral layout, vocabulary consistent with ISO 17034. A good starting point, the stability studies remain real work.

A
Amanda
R&D Manager · Clinical RM producer, UK
Risk-free

30-day guarantee, no questions asked.

30-day money-back guarantee

You test the package. If you change your mind, we refund you.

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.

Frequently asked questions

Answers to your most common questions.

Is the kit enough to get ISO 17034 accreditation?

No. It provides the documentation the standard requires. Accreditation also depends on implementation: homogeneity and stability studies, uncertainty budgets, interlaboratory studies, training.

Are the documents editable?

Yes. 62 Word files and 38 Excel files, no locked PDFs. Neutral layout, ready for your logo and references.

Does the kit cover both RMs and CRMs?

Yes. The procedures cover both, with the CRM-specific requirements: traceability of certified values (7.9), uncertainty, certificate per ISO Guide 31.

Does the license cover several sites?

It covers one legal entity, with unlimited internal use. Multi-site groups, national bodies or consulting firms: contact us for a suitable license.

When will I receive the files?

As soon as payment is confirmed: a link on the confirmation page and by email. ZIP organized in folders by document type.

What if the kit does not suit me?

You have 30 days to review it. Write to support@qse-academy.com explaining what does not meet your needs: the refund is issued to your original payment method, 4 to 5 business days after processing.

Take the next step

Your ISO 17034 RMP accreditation foundation. Ready today.

100 Word and Excel documents, instant download after payment.

Buy the kit · $489
30-day money-back guaranteeInstant download12 months of updates
ISO 17034:2016 documentation kit