The real ISO 17034:2016 documentation set we deliver: 202 controlled documents and 10 validated Excel calculators that form a complete reference material producer management system. It is written for the Option A route, for a producer that subcontracts all measurement to approved laboratories, and it covers matrix, petroleum and fuel, and biological reference materials. You get a clause-mapped Quality Manual, 46 procedures, 28 work instructions, 79 forms, 7 output templates and a 13-document accreditation readiness pack, all editable in Word and Excel, so you can build an accreditation-ready system without hiring a consultant.
Preparing the documentation is the slowest and most confusing part of getting certified to ISO 17034:2016. You have to work out what the standard asks for, decide what to write, and turn it into a manual, procedures and records that an auditor will accept. Done from a blank page it takes months, and paying a consultant to do it can cost thousands.
The ISO 17034:2016 Documentation Toolkit gives you that whole system, already written and ready to edit. It is built by practitioners around the exact structure of the standard, so nothing an auditor expects is missing. You add your company details, adapt anything specific to your operation, and you have a complete, consistent reference material producers system that is ready for audit. Every single document you receive is listed and explained further down this page, so you know precisely what you are buying before you spend anything.
The system satisfies Clause 8 of ISO 17034 directly, as a standalone management system, so you do not need a separate ISO 9001 certification behind it.
It is written for a producer that does not run its own testing laboratory. All characterization, homogeneity and stability measurement is subcontracted to approved laboratories under your technical direction, while the five value-assignment activities that may never be subcontracted stay in house.
Generic procedures plus family-specific work instructions for matrix solids, for petroleum, fuel and gas, and for biological, microbiological and in vitro diagnostic materials.
Working calculators, not blank sheets, for homogeneity ANOVA, stability regression, consensus value, the combined uncertainty budget, outlier tests, the traceability chain, subcontractor scoring and a certificate self-check, each with its own validation tab.
Each document ends with a clause coverage annex, and a clause-by-clause cross reference matrix shows an assessor exactly where every requirement of ISO 17034 is met.
Thirteen documents carry you to the assessment, including a gap analysis, a self assessment, a mock assessment, an assessor question bank, and worked first internal audit and management review records.
Each tier answers a different question and is approved at a different level, and every requirement is owned in exactly one place.
No hidden contents and no vague claims. Here is the complete document set, with a short description of what each file is for and the clause it helps you meet.
A complete document set, fully editable in Microsoft Office.
The spine of the system. It maps every clause of ISO 17034:2016 to where it is satisfied, describes the thirty-step production process (P01 to P30) in Annex B, and points to the procedure that carries out each requirement. This is the document an assessor opens first.
The writing is done. You edit instead of authoring from a blank page.
Get a professional system for a fraction of the cost of hiring one.
Mapped clause by clause so every requirement is covered.
Easy to read, easy to adapt, no jargon you have to decode.
Forms and registers capture exactly what an auditor asks to see.
A perpetual licence for your whole team, with free updates.
The full set arrives by email in minutes, in Word and Excel.
Swap the highlighted placeholders for your own company details.
Roll out the procedures and capture evidence on the forms.
Use the internal audit checklist and management review templates.
Face the auditor with a complete, consistent system.
Files sent securely within 24 working hours of payment.
Microsoft Word and Excel, with placeholders to fill in.
If the standard is revised, you get the update free.
One organisation, unlimited internal users, perpetual.
| What matters | From scratch | Hire a consultant | isofolder kit |
|---|---|---|---|
| Time to a full document set | Months | Weeks | The same day |
| Typical cost | Your time | Thousands | $199 once |
| Written by experts | No | Yes | Yes |
| Mapped to every clause | Risky | Usually | Yes |
| You keep full control | Yes | Limited | Yes, fully editable |
| Free updates on revision | No | Extra fee | Included |
isofolder is a team of auditing and consulting professionals with more than 80 years of combined experience. Our kits are written by practitioners and reviewed by working auditors, then refined across many real certification projects. When you buy from us, you are buying a system that has already helped companies pass their audits.
If you ever need a document that is specific to your operation and not already in the kit, our team will prepare it for you.
The documents were well structured and easy to adapt. We cleared our certification audit with no major findings.
Saved us weeks of writing. Everything was mapped to the clauses, so we knew nothing was missing.
Clear, professional and fully editable. Far better value than the consultant quotes we received.
Preview 11 real pages from the ISO 17034:2016 toolkit right here, including a full form and part of an actual procedure. Judge the quality and writing style for yourself, with no sign-up.
Download the complete, editable toolkit and start building an audit ready system in minutes, with a free sample available before you buy.