ISO/IEC 80079-34 · IECEx · ATEX

Your ISO 9001 system is not enough for an Ex audit.

ISO/IEC 80079-34 does not replace ISO 9001 — it adds to it. Roughly forty requirements that a general quality system has no reason to contain: conformity to type, routine verification of every unit, control over Ex‑relevant components, notification to your certification body before a change, an Ex document dossier that has to be complete on the day the auditor asks.

Get the free self-assessment See the Delta Kit

Free self-assessment: no purchase, no email gate beyond the download.

48 / 71

questions in the self-assessment with no ISO 9001 counterpart

editable Word and Excel documents in the Delta Kit

procedures, each with its own forms and register

macros, passwords or vendor branding in any file

FREE

Ex QMS Readiness Self-Assessment

Where your quality system stands against ISO/IEC 80079-34 — in about twenty minutes.

Forty-eight of the seventy-one questions in this workbook have no counterpart in ISO 9001 at all. Conformity to type. Routine verification of every unit shipped. Control over Ex-relevant components. Notification to your certification body before a change, not after it. An Ex document dossier that has to be complete on the day the assessor asks for it.

This is a spreadsheet that asks all of them, scores your answers, and hands back a ranked list of what to fix first. One Excel workbook, seven sheets, no macros, nothing to install.

Sheet	What it does
10-minute check	Twelve questions, answered from memory. Every one of them has stopped a certificate somewhere. If you only have ten minutes, this is the whole product.
Self-assessment	71 questions across 13 sections, each tied to a clause area and weighted by what a gap actually costs. Yes / Partial / No / N/A.
Dashboard	Calculated, not typed: overall readiness, critical and high gaps, a score per section, and how you did on the Ex-only questions specifically.
Action list	Fills itself. Every No and Partial, ranked heaviest first, with owner and target date.
Evidence log	Where each answer's proof lives, so the next person does not start over.
Start here / Licence	How to use it, and what you may do with it.

A filled example is included, so you can see what a completed assessment looks like before you start your own.

The 10-minute check sheet, filled in — Twelve questions, answered from memory. Each one has stopped a certificate somewhere.

The readiness dashboard of a filled assessment — Calculated, not typed. Thirteen sections, scored, with the Ex-only questions counted separately.

The ranked action list — Every No and Partial, heaviest first. The list writes itself.

Download the free self-assessment

Yours to keep, free to pass on to colleagues, suppliers or clients — see the Licence sheet inside.

Get the gap analysis sent to you

Download the self-assessment above, work through it, and we will send you a short follow-up series: what the Ex-specific gaps usually look like, how the three tiers compare, and a one-time discount code.

Your email is used only for this series and the file you asked for. No purchase needed. We do not sell or rent it.

PAID · THE FULL SYSTEM

Ex Manufacturing QMS Delta Kit

The ISO/IEC 80079-34 documents your existing ISO 9001 does not have — written out as an editable, working system that fits on top of the ISO 9001 system you already run.

46 editable Word and Excel documents. No macros. No branding to strip out. A clause matrix that shows an auditor, line by line, where each requirement of the standard is answered.

Three ways to buy

STARTER

Starter

€149

Know where you stand before you spend anything else.

Gap analysis worksheet
Getting-started guide
Ex manual chapter
Clause cross-reference matrix
Quality plan & submission pack
Credited in full against Core or Complete within 30 days

Choose Starter

CORE

Core

€590

The system itself.

All 46 editable templates
8 procedures · 20 forms · 14 registers
9 figures
Everything included in Starter

Choose Core

COMPLETE

Complete

€890

Core, plus every template filled in.

Everything in Core
46 filled worked examples, one manufacturer carried end to end
One example deliberately fails a test, so you can see the nonconformity route used
Examples live in their own folder — delete in one step to keep the templates clean

Choose Complete

Compare the three tiers

	Starter	Core	Complete
Gap analysis worksheet	✓	✓	✓
Getting-started guide	✓	✓	✓
Ex manual chapter	✓	✓	✓
Clause cross-reference matrix	✓	✓	✓
Quality plan & submission pack	✓	✓	✓
8 procedures · 20 forms · 14 registers	—	✓	✓
9 figures	—	✓	✓
46 filled worked examples	—	—	✓
Deliberately failing example (nonconformity walkthrough)	—	—	✓
Credited in full toward an upgrade within 30 days	✓	—	—
Price	€149	€590	€890

What is inside

The assessment layer:

Document	What it does
EXC-G-02 Gap analysis worksheet	64 questions, each traced to a clause. Answer them and you have a written statement of where you stand and what is missing.
EXC-G-01 Getting started	Six pages and a package map. Read this one first; it tells you what order to do everything in.
EXC-M-01 Ex manual chapter	The chapter your quality manual is missing, ready to adopt.
EXC-R-01 Clause cross-reference matrix	80079-34 → your documents, and the reverse view: ISO 9001 clause → what the Ex standard adds to it.
EXC-G-03 Quality plan & submission pack	What to send the certification body, in what order, and what they will ask for next.

The system: eight procedures, each with its forms and its register.

Procedure	Covers
EXC-P-06 Change control & notification	What counts as a change, who decides, and when the certification body has to be told before you ship.
EXC-P-07 Conformity to type	Keeping the built unit identical to the certified type: type reference records, in-process checks, marking and nameplate verification, special-process validation.
EXC-P-08 Routine & type verification	Overpressure, dielectric strength, ingress protection: what is tested on every unit, against what criterion, recorded how.
EXC-P-05 Ex-relevant components & suppliers	Component classification (including the U and X suffixes), supplier assessment, incoming inspection, shelf life and pot life of Ex-relevant materials.
EXC-P-09 Internal Ex audit	An audit programme and checklist aimed at the Ex requirements, not a generic 9001 walk-through.
EXC-P-10 Nonconformity, deviation & corrective action	Including concessions, and a register that tracks external audit findings and whether the body accepted the response.
EXC-P-11 Competence, training & authorisation	Who is authorised to sign off Ex work, on what evidence, reviewed when.
EXC-P-12 Repair, overhaul & modification	The route a returned unit takes, and when repair turns into a change that has to be notified.

Plus management review, the Ex KPI sheet, the measuring and test equipment register, the Ex certificate register, the document master list, the form and record index, and the Ex technical dossier contents list.

Worked examples (Complete)

Forty-six of the templates come filled in, one fictional manufacturer carried end to end: the same company, the same product, the same certificate number across every form and register. One of them fails a test on purpose, so you can see what the nonconformity route actually looks like when it is used.

The examples live in their own folder tree, so the templates stay clean and the examples can be deleted in one step.

The Requirements sheet of the gap analysis worksheet — What the Ex delta asks of you, next to what your ISO 9001 system already gives you.

Filled nonconformity register with one overdue row — A worked example, not an empty template. Overdue is red because it is overdue.

First page of the conformity-to-type procedure — Eight procedures, written to be adopted as they stand.

Register summary sheet with its chart — The registers count themselves. One number on this sheet has to be zero.

Filled special-process validation record — The sample deliberately fails a run, so you can see what the record looks like when it goes wrong.

Clause cross-reference matrix — Clause by clause: what the standard asks, what closes it, what is still open.

First page of the Ex manual chapter — The chapter your quality manual is missing.

Who this is for

Both the free assessment and the Delta Kit assume the same starting point: a manufacturer with a working quality system who needs the Ex-specific part.

This is for

A manufacturer of Ex equipment applying for an IECEx QAR or an EU Quality Assurance Notification for the first time.
A manufacturer who already holds one and got findings against the QMS at the last surveillance audit.
A quality manager told to "sort out the Ex side" with no budget for a consultant and no template to start from.
A consultant who wants a defensible starting structure instead of rebuilding the same eight procedures for every client.

This is not for

Anyone looking for a certificate. This is documentation and a self-score, not conformity. You still implement it, run it, and get audited on it.
Anyone who does not already have a functioning ISO 9001 system. Both products are the Ex delta on top; neither is a complete quality system on its own.
Anyone who wants the standard itself. The text of ISO/IEC 80079-34 is copyrighted by IEC/ISO and is not included, quoted at length, or reproduced. You need your own licensed copy.

Boundaries — please read before buying

Not optional marketing softness. This is the line that keeps both products legally clean, and it applies the same way to the free assessment and the paid kit.

Not certification, and not a route to it by itself. Both products are documentation and self-scoring you adopt, populate and operate. A certification body audits your practice, not your file names or your spreadsheet score.
Not affiliated with, endorsed by or reviewed by IEC, ISO, IECEx, any certification body or any notified body.
The standard is not included. No clause text is reproduced or quoted. The text of ISO/IEC 80079-34 is copyrighted by IEC/ISO; you need your own licensed copy to use either product properly. The clause matrix points to clause numbers, not to quoted requirements.
Not legal or regulatory advice. Scheme rules, national implementations and your own certificate conditions take precedence over anything on this page or inside the files.
Every document has to be edited, and every score is only as honest as the answers behind it. Company name, scope, responsibilities, acceptance criteria and retention periods are yours to set; the Kit's templates mark where.

Frequently asked

Is the self-assessment really free?

Yes. No email gate beyond the Gumroad download, no trial, no expiry.

Do I need ISO 9001 certification first?

Not certification, but you do need a functioning quality system. 80079-34 is written as an addition to ISO 9001. If nothing is documented today, the self-assessment and the Kit will show you the Ex-specific gaps and none of the general ones.

Word and Excel, or PDF?

Editable .docx and .xlsx, in both products. No macros, no password protection, no vendor logo. Some registers include charts that update from the cells as you type.

Will an auditor recognise these documents?

They will recognise the structure — procedure, form, record, clause reference — because that is how the standard expects a system to be laid out. They will judge whether you actually run it. That part is not for sale.

Does the self-assessment work in LibreOffice or Google Sheets?

It is built and tested in Excel. The formulas are ordinary (SUMIF, COUNTIFS, IF); LibreOffice opens it. Google Sheets will import it but is not tested.

Can I pass the self-assessment on to colleagues or clients?

Yes. The licence is free to use and free to pass on: fill it in, adapt it to your own processes, put the results in front of your certification body, and give unmodified copies to colleagues, suppliers or clients. The Licence sheet inside has the exact wording.

Can I use the Delta Kit for more than one site or more than one client?

One legal entity per licence. For a group with multiple manufacturing sites, or a consultant using it with clients, message the seller through the Gumroad product page before you buy and we will sort out a licence that fits.

Updates?

Buyers get corrections and revisions to the edition they bought at no charge. A new edition of the standard would be a new product, not a free upgrade.

Refunds?

Digital files, so a refund means you delete them. Within 14 days, ask and it is refunded — no argument, no questionnaire. If the Kit does not match what this page describes, say what is missing; that is more useful than the money.