Walk into your audit ready.
Most manufacturers do not fail a QAN or QAR audit because they do not know their products. They fail because the procedures, records and competence evidence behind those products were never written down in the way the standard expects.
ISO/IEC 80079-34 is the quality system standard behind ATEX and IECEx certification for equipment used in explosive atmospheres. We take manufacturers from a first honest gap analysis to a system that holds up on audit day.
If you hold a certificate, you hold an obligation
A product certificate proves the design. Your quality system is what proves every unit you ship still matches it.
Seven clauses, one system
ISO/IEC 80079-34 builds on ISO 9001 and adds the Ex-specific requirements. If you already run a quality system, much of this will be familiar. It is the Ex layer on top that findings usually come from.
Quality management system
The documented system itself: scope, processes, records and the documentation describing how Ex conformity is controlled.
Management responsibility
Top management commitment, the quality policy, and appointment of the Ex Authorised Person with a written mandate.
Resource management
The people, infrastructure and work environment needed to produce conforming Ex equipment.
Product realisation
Design change control, purchasing from approved sources, competence of every role affecting conformity, and calibration of the instruments that prove it.
Production and control
Ex-critical manufacturing steps, routine inspection and test, product release criteria, and the records behind your Declaration of Conformity.
Measurement and analysis
Inspection and test records, internal vertical audits, and the monitoring that shows the system works rather than merely exists.
Improvement
Non-conformity handling, corrective action, and the route by which a finding leads to a change in the system.
Clause numbering follows ISO/IEC 80079-34. Annexes A and B cover the technical and manufacturing requirements referenced throughout.
Four stages, no surprises
You can stop after any stage. Most manufacturers start with a gap analysis and decide from there how much of the rest they want to do themselves.
Gap analysis
We read your existing quality system against ISO 80079-34 clause by clause and tell you honestly where you stand. You get a written findings report, not a sales document, and it is yours to use with or without us.
- Clause-by-clause findings report
- Prioritised action list
- A realistic view of the work involved
Competency matrix
Every role that affects Ex conformity is mapped to the competence the standard expects and the evidence an assessor will ask for, using the ten roles defined in Note 1.
- Role-by-role competence map
- Evidence requirements per role
- The training plan that follows from it
Documentation and training
We build or rework the procedures, work instructions and records the standard requires, then train the people who have to use them. Training runs through insightEx one, so the evidence sits in one place.
- Procedures and work instructions
- Records and templates
- Training delivered and evidenced
Audit readiness and support
A dry run before the real thing. We walk the system as an assessor would, close what is open, and stay with you through the QAN or QAR audit itself and any findings that follow.
- Internal vertical audit
- Pre-audit readiness review
- Support through the audit and its findings
Two names for the same system
Which one you need depends on the market you sell into. The quality system underneath is the same, which is why manufacturers holding both only build it once.
Start with where
you already are
Before a gap analysis, score yourself. A short set of questions shows which roles already hold competence evidence and which do not, and it is a useful thing to bring to a first conversation.
Take the scorecardThree levels of support
Pick the level that matches where you are today. Many clients start with a readiness audit and step up as the audit date gets closer.
Readiness audit
On-site audit
Premium implementation
Prices exclude VAT, and travel and accommodation outside mainland UK. The figure depends on the size of your operation, the number of certificates you hold and how much of a system is already in place. A readiness audit is what turns that into a fixed proposal.
Questions we are asked most
Still not covered? Send us the question. An engineer answers, not a chatbot.
What is ISO 80079-34?
ISO/IEC 80079-34 is the quality system standard for manufacturers of equipment for explosive atmospheres. It sets out what your quality management system must control to keep Ex products conforming to their certificates: documented competence for every role affecting conformity, control of Ex-critical manufacturing steps, calibration, routine inspection and test, and the records that support your Declaration of Conformity.
Is ISO 80079-34 mandatory under ATEX?
In practice yes for most manufacturers. ATEX 2014/34/EU requires a production quality assurance route for Category 1 and 2 equipment, and ISO/IEC 80079-34 is the standard notified bodies assess against when issuing a Quality Assurance Notification. If you hold or need a QAN or a QAR, you are being assessed to this standard. If you self-certify, you are stating that you have conducted an assessment against this standard yourself. Have you?
What is the difference between a QAN and a QAR?
A Quality Assurance Notification is issued by an ATEX notified body, or a UK approved body under UKCA, and covers equipment placed on the EU or UK market. A Quality Assessment Report is the IECEx equivalent, issued within the IECEx scheme for international certification. Both assess your quality system against ISO/IEC 80079-34, and many manufacturers hold both.
How long does implementation take?
It depends where you start. A manufacturer with a working ISO 9001 system and some Ex knowledge is usually looking at months rather than a year. Starting from nothing, or responding to findings already raised, takes longer. The gap analysis is what turns that into a real timeline, which is why it comes first.
What is a gap analysis?
A structured read of your current quality system against each clause of ISO 80079-34, ending in a written report saying what conforms, what does not, and what to do about it in priority order. It is a deliverable in its own right, and plenty of clients take the report and act on it themselves.
Do we have to use your training?
No. Competence has to be evidenced, but the standard does not say who provides it. We use insightEx one because it keeps the training and the evidence in one place, which makes an audit simpler. If you already have training you are happy with, we will work with it.
Find out where you stand.
A gap analysis gives you a clause-by-clause picture of your quality system and a prioritised list of what to fix. Whether we do the fixing is your decision afterwards.
Ex training and compliance support for hazardous area equipment manufacturers.
Morpeth
NE61 6JN
Bellingham, Hexham
NE48 2AZ
