ISO 17034 Management System
ISO 17034 Management System
Every measurement made against a reference material inherits the producer's rigour; ISO 17034 is where that rigour is written down.
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Written by practising auditors with 20+ years in the field.
By document type
| Category | Files |
|---|---|
| Manuals | 2 |
| Procedures & SOPs | 31 |
| Forms & Records | 56 |
| Checklists & Audit Tools | 12 |
| Registers, Logs & Matrices | 4 |
| Training & Awareness | 4 |
| Guides & Work Instructions | 8 |
Key documents
| Reference | Document | Format |
|---|---|---|
| QM-01 | Quality Manual | Word |
| D132 | ISO 17034-2016 Compliance Matrix | Word |
| QP-29 | Assessment of Homogeneity | Word |
| QP-30 | Assessment and Monitoring of Stability | Word |
| QP-31 | Assignment of Property Values and Estimation of Uncertainty | Word |
| F-QCD-05 | Reference Material Certificate | Word |
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Overview
ISO 17034 sets the general requirements for the competence of reference material producers. Reference materials, certified reference materials among them, are the working tools of calibration, method validation, quality control and metrological traceability, so their reliability propagates into measurements across science, industry and conformity assessment. The standard applies to producers in every field, whether they run the whole production process or manage parts of it, and it reaches into planning, production, characterisation, the assignment of property values, the assessment of homogeneity and stability, and the estimation of uncertainty.
Here that framework is documented end to end. A quality manual and a reference material production scheme sit above procedures for characterisation, assessment of homogeneity, monitoring of stability, assignment of property values, reference material documents and labels, handling and storage, distribution, subcontracting of production and complaint handling. Production plans, batch manufacturing records and reference material certificates carry the evidence. Guidance covers metrological traceability of certified values, uncertainty estimation, the design of homogeneity and stability studies and the content of certificates, and a compliance matrix maps the system to ISO 17034:2016, the ground an accreditation body operating under ISO/IEC 17011, within the ILAC arrangement, will cover.
What this system covers
- Production planning and batch control — production plans, batch manufacturing records and in-process checks
- Characterisation — the measurement approaches used to assign property values to a material
- Homogeneity and stability — study design, between-unit and long-term monitoring, and their contribution to uncertainty
- Assignment of certified property values and estimation of measurement uncertainty
- Metrological traceability of certified values and calibration periodicity for the equipment behind them
- Reference material documentation — certificate content, labels and the information issued with each material
- Handling, storage, identification, labelling, packaging, distribution and delivery of materials
- Impartiality, confidentiality, subcontracted production, nonconforming work, complaints and appeals
Who it's for
Reference material producers of every kind: commercial suppliers, national and institutional producers, and laboratories preparing their own quality control materials. Producers already accredited to ISO/IEC 17025 will recognise much of the structure and can run the two together. The trigger is an accreditation application or an assessment date; the end state is production, characterisation, homogeneity and stability, and certification documented as one controlled process.
Everything you get
Every toolkit gives you a full set of working documents for your standard, ready to edit and use.
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Frequently asked questions
What exactly do I receive?
A downloadable ZIP containing the full set of ready-to-use documents for this toolkit — manuals, procedures, forms, records, checklists, guidance and training material, all in editable Word and Excel format. The exact document count is shown at the top of this page.
Are the documents really editable?
Yes. Every file is native Microsoft Word or Excel — no locked PDFs. Add your logo, change wording, and tailor the content to your organisation. The toolkit is yours to keep and reuse.
Does this certify my organisation?
No. These are documentation toolkits aligned to the relevant standard to help you prepare. Certification itself is issued by an accredited certification body after their audit. Our toolkits give you a strong, audit-ready starting point.
How is it delivered?
Instantly and digitally. There's no physical shipment — you download the files right after payment and receive a backup link by email.
Do I get updates?
Yes. If we revise this toolkit, you're entitled to the updated version at no extra cost — just contact us with your order details.
What is your refund policy?
These are digital products, so once a toolkit has been downloaded we cannot take it back. If you have not downloaded yet, contact us and we will cancel the order and refund you in full. We also refund in full if the files are damaged, incomplete, or not what the product page described.
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