Cost-Effective QMS Maintenance Under DIN EN ISO/IEC 80079-34: Case Study Packwise Smart CAP Ex
What cost-effective QMS maintenance under DIN EN ISO/IEC 80079-34 looks like in practice: Renewal Audit No. 25TH0026_A1 with zero nonconformities — audit days only, everything included.
Packwise and the Smart CAP Ex: Explosion Protection Meets IoT
Packwise GmbH, based at Antonstraße 25, 01097 Dresden, develops and distributes the Smart CAP Ex — an intrinsically safe IoT sensor for monitoring industrial containers in potentially explosive atmospheres. The device measures the fill level, temperature and GPS position of IBCs, drums and other large containers, transmitting this data in real time — even in locations where conventional electronics cannot be used for safety reasons.
The Smart CAP Ex was developed to protection concept "i" (intrinsic safety) with Equipment Protection Level Gb and today holds three international certifications: ATEX (EU Directive 2014/34/EU, certificate IBExU22ATEX1071X), IECEx (IECEx IBE 22.00019X) and UKEX (certificate EPS 22 UKEX Q 378, issued by Bureau Veritas Consumer Products Services UK, Approved Body No. 8507 under UKSI 2016:1107). These three certifications enable Packwise to simultaneously distribute products in the EU, worldwide and in the United Kingdom — a clear prerequisite for international scaling.
Electronic component manufacturing takes place at ECD Electronic Components GmbH, Heidelberger Str. 7, 01189 Dresden, which is managed as a sub-contractor within the Ex quality system. Packwise itself employs around 20 staff; ECD around 70. This division of labour — design and QMS responsibility at Packwise, electronics manufacturing at ECD — is a common model in the Ex industry and places particular demands on the manufacturer's quality management system.
What distinguishes Packwise is that the company takes its QMS seriously. Documents are maintained, processes are lived, and management stands behind the requirements of the standard — not just on paper. As an external QMR, this means for me: I do not need to build foundations or push structures against internal resistance. I can work directly on the system — optimizing, updating, keeping it audit-ready. This attitude is not self-evident, but it makes system maintenance demonstrably more efficient and cost-effective. A QMS that is taken seriously internally requires less external correction.
Anyone wanting to bring an intrinsically safe device to market needs more than a type examination. They need a permanently functioning quality management system that holds up at every surveillance audit — otherwise certification can be withdrawn and market access lost. This is precisely the core task of QMS maintenance under DIN EN ISO/IEC 80079-34:2020. For over three years I have been performing this task for Packwise GmbH in Dresden as external quality management representative. In this article I show what cost-effective system maintenance looks like in practice — documented by real audit documents and a concrete case study from the supply chain.
My Role as External QMR: What System Maintenance Really Means
For over three years I have been active as External QMR for Packwise — a function officially documented in Bureau Veritas audit report No. 25TH0026_A1 from 20.08.2025. On page 8 of the report I am named in the list of interviewed representatives of the manufacturer as "QM-Consultant" for Packwise. This is not self-reported — it is attested by the certification body.
What does this mean concretely? I am not rebuilding QMS structures from scratch at Packwise, and I am not implementing process revolutions. My task is different: I ensure that the existing system permanently conforms to the standard requirements of DIN EN ISO/IEC 80079-34:2020 — while Packwise concentrates on what they are genuinely good at: developing and marketing innovative, intrinsically safe sensor solutions for the process industry. System maintenance is not consultancy with an open outcome, but a clearly defined function with a measurable result: maintain certification, pass the audit.
When needed, I also support with nonconformities and complaints — from root cause analysis through the derivation and implementation of corrective actions to standard-compliant documentation under VA-009 (handling of defective products). Especially in the Ex sector, where every deviation is potentially certification-relevant, structured handling is not administrative overhead but an effective instrument for risk minimization.
What Happens on an Audit Day: All Services Included
My service model is deliberately designed to be economically viable for small and medium-sized manufacturers: No monthly fee — billing is exclusively for the audit days that actually take place. On each of those days, all services necessary for professional system maintenance are included. This is not a marketing promise — it can be read directly from the document structure that Bureau Veritas also reviewed and assessed positively in audit report No. 25TH0026_A1.
Document Management
The quality management manual (QMH) of Packwise, currently at revision A013 (dated 29.09.2024), forms the backbone of the entire system. I review and update it regularly — as well as the associated procedural instructions: VA-003 (retention periods, with a minimum retention period of 10 years per IEC 80079-34), VA-006 (management of design changes, with mandatory ex-authorized person release), VA-009 (handling of defective products and risk assessment) and VA-011 (internal audit). Added to these are forms such as FB-003 (traceability), FB-014 (management review) and FB-016 (list of applicable standards and legislation). All document updates are part of the audit day — no separately billed position.
Training and Competence Records
DIN EN ISO/IEC 80079-34 requires that all persons with influence on explosion protection are demonstrably competent. I conduct training on the relevant standard requirements and document these in the training record FB-005 "Training and Competencies." Bureau Veritas confirmed in the audit report (Observation 7.2): "Training planning is present. All persons having influence on the Ex protection are trained and competent." This is not a self-assessment — it is the judgement of the independent certification body.
Internal Audit under IEC 80079-34
The internal audit programme (FB-015) and the associated procedural instruction VA-011 form the basis for systematic self-checking of the QMS. I plan, coordinate and conduct these internal audits — aligned to the requirements of DIN EN ISO/IEC 80079-34 and the Ex-specific requirements of Annex A. Bureau Veritas reviewed the audit documents and confirmed: "Audit program FB015 is present. Audit was conducted, audit result is present. Process for internal audit is shown in VA-011. The last internal audit reports were assessed in the audit."
Legal Register: Keeping Standards and Legislation Current
One of the most sensitive topics in system maintenance is the legal register. In the Ex sector, standards, directives and national implementing legislation change regularly — from IEC 80079-34 through ATEX 2014/34/EU to national regulations. I maintain form FB-016 "List of Standards and Legislation" and ensure that Packwise's documentation always reflects the current state. Bureau Veritas explicitly noted in the recommendations for the follow-up audit (Section 10, item i): "We recommend to specify the process of annual check of the validity of standards and regulations." I have integrated this recommendation directly into the ongoing system maintenance process.
Preparing the Management Review
The management review is the annual mandatory meeting in which management evaluates the QMS — a central element of every Ex audit. I prepare all inputs: results of internal and external audits, customer feedback, product quality metrics, status of corrective actions and improvement proposals. The minutes are archived as FB-014 "Management Review." Bureau Veritas most recently reviewed the MMR minutes of 28.12.2023 and assessed them positively.
Monitoring Quality Objectives
Clause 6.2 of DIN EN ISO/IEC 80079-34 requires quality objectives to be measurable, verifiable and resourced. Together with Packwise I monitor the defined quality objectives — for example error rates, complaint rates or timely processing of corrective actions — and document the status in the management review (FB-014). Bureau Veritas explicitly checks Clause 6.2 in surveillance audits; incomplete objective monitoring would be identified as a weakness. Through regular monitoring, a static document becomes an actually lived control instrument.
Bureau Veritas Renewal Audit No. 25TH0026_A1: The Result
On 20.08.2025 the renewal audit took place at Packwise — under ATEX (Annex IV) and IECEx. The audit covered a complete examination against the reference standard EN ISO/IEC 80079-34 and the Ex-specific requirements of Annex A.4 for intrinsic safety (A.4.1 to A.4.5: components, PCBs, assemblies, tests, intrinsically safe circuits).
The result in the exact wording from the Summary Report (page 2 of audit report No. 25TH0026_A1):
"As a result of the audit, Packwise meets the requirements of Directive 2014/34/EU and EN ISO IEC 80079-34. Packwise has a well-established QM-System. ECD was audited during the audit and found to be a professional producer of PCB's with improved capacities for moulding processes."
Important for the assessment: In audit report No. 25TH0026_A1 no nonconformities were documented. On the Nonconformity Sheet (page 15) "None" is explicitly noted. At the same time Bureau Veritas recorded two recommendations for the follow-up audit: for ECD a written process for calibration management (7.1.5) and for Packwise the systematic involvement of the ex-authorized person in design changes (8.3.6). The overall result for Packwise and the managed supplier model was thus positive; the QAR/QAN is maintained.
Bureau Veritas issued two recommendations for the follow-up audit, which I have already integrated into the ongoing system maintenance:
- 7.1.5 (ECD): A written process for calibration management is recommended.
- 8.3.6 (Packwise): The ex-authorized person should be systematically involved in design changes.
Supplier Audit: Stabilizing Encapsulation Processes
Supplier evaluation under Clause 8.4 of DIN EN ISO/IEC 80079-34 is a fixed component of system maintenance. Packwise does not manufacture its Ex devices in-house, but together with sub-contractor ECD — a Dresden company for electronic components that has been maintained in the supplier list VA-001 as an evaluated supplier since 17.12.2023. Quality responsibility for the entire supply chain rests with Packwise as the manufacturer.
In the course of a supplier audit I found that at one supplier, encapsulation processes for Ex-relevant components were taking place under insufficiently controlled environmental conditions. Encapsulation technology — the embedding of electronic assemblies in synthetic resin for mechanical fixation and electrical insulation — is a critical process for intrinsically safe devices: temperature and humidity fluctuations during curing can create microcracks, voids or changed insulation properties that can lead to failures or conformance problems in operation.
The corrective action initiated was precise and resource-efficient: the supplier relocated the encapsulation processes to air-conditioned, better-controlled environments. No new supplier needed to be qualified, no product designs needed to be revised — the existing process was stabilized through environmental optimization. This is the concrete benefit of a supplier audit as part of system maintenance: identify risks early, before they appear as a Nonconformity in the Bureau Veritas audit.
Why Audit Days Instead of Monthly Retainers
The fee model of most QM consultants is based on monthly flat rates — regardless of how much actual work is done in a given month. For a company like Packwise with 20 employees and a clear standard framework (DIN EN ISO/IEC 80079-34), this model is rarely the most economical solution. Phases with little normative need are charged the same as intensive audit preparation phases.
My approach is different: I bill exclusively for the actual audit days. All services — document maintenance, training, internal audit, legal register, management review, supplier audit — are fully included on those days. Between audit days there are no costs. This creates planning certainty and transparency, and it makes professional system maintenance under DIN EN ISO/IEC 80079-34 economically viable for SMEs in the first place.
- No monthly fee — billing only for actual effort
- All services included — no hidden additional items
- No lock-in — documents belong to the client and are accessible at all times
- No tooling overhead — collaboration via Microsoft Teams, all documents viewable and editable by the client at any time
Communication via Teams: Lean, Documented, Without Overhead
All operational communication between me and Packwise runs via Microsoft Teams. There is a practical reason for this: Packwise already uses Teams internally for daily collaboration. Integrating an external QMR via the same channel means no additional learning effort and no extra tool for the team. Questions about standard interpretation, status updates on open actions or quick coordination before an audit all run directly within the existing communication framework.
All QMS documents — QMH, procedural instructions, forms, audit reports — are viewable and editable by Packwise at all times. There is no proprietary access area managed only by the consultant. This is a deliberate design choice: a QMS that only the external QMR understands is not a well-maintained QMS — it is a dependency.
Who This Model Is Suited For
Cost-effective QMS maintenance as an external QMR is particularly suited for:
- Ex manufacturers under DIN EN ISO/IEC 80079-34 with small teams (approx. 10–50 employees)
- Companies with ISO 9001 certification that do not need or want to establish a full-time QMR
- Start-ups and scale-ups that need to maintain their ATEX, IECEx or UKEX certification without gaps during growth
- Manufacturers with a sub-contractor model that need to demonstrate a clear QMS responsibility structure to certification bodies such as Bureau Veritas
- Companies with a recurring surveillance audit requirement that want to handle it professionally without internally bound resources
How Sternberg Consulting Supports Your Company
As an external QMR I take on full system maintenance of your QMS under ISO 9001, DIN EN ISO/IEC 80079-34 or related standards — on the basis of audit days, without monthly commitment, with all services included. This covers document management, internal audits, employee training, legal register maintenance and management review preparation. If you want to maintain your certification without building a complete QM position in-house, get in touch.
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