Company · Quality
Quality you can check.
Sales, development and manufacturing of electronic and electromechanical assemblies and systems are certified to ISO 9001. Our information security management system is built to ISO/IEC 27001 and is currently going through certification.
Evidence
Certificates
Certification status with registration number, scope, validity and download.
ISO 9001:2015
CertifiedDetails of the ISO 9001:2015 evidence Issuer TÜV SÜD Management Service GmbH Registration no. 12 100 67760 TMS Scope Sales, development and manufacturing of electronic and electromechanical assemblies and systems Valid until June 18, 2027 ISO/IEC 27001:2022
In certification auditThe information security management system is built to ISO/IEC 27001 and is run and audited together with quality management. There is no certificate yet.
Evidence
Standards and management system
Standards we develop to
Our management system is aligned with the requirements of ISO 13485. IEC 62304 and ISO 14971 for medical devices, IEC 61508 and ISO 13849 for safety-related systems, IEC 62443 and the Cyber Resilience Act for connected devices: we work to these standards. That does not mean a product or the company is certified; regulatory approval of the product remains with the manufacturer.
Integrated management system
Quality and information security run in one integrated management system: one document control process, one joint internal audit per year, one management review. The manual is kept as Markdown in Git and is versioned and reviewed like source code.
Development
How quality is built into a project
Requirements traced to test results
Every system requirement leads to software requirements, and from there to test cases and their results. In medical and safety projects, this chain can be traced in both directions and is included in the evidence package as a baseline.
A second pair of eyes on every merge request
No code is merged unless a second person has reviewed it. The pipeline builds, runs static analysis and tests; if a step fails, it blocks the merge.
Reviews at phase transitions
Design reviews before architecture decisions, sprint or milestone reviews at a regular cadence. For medical devices, every phase transition is a documented gate review with entry and exit criteria.
Independent verification for safety
Whoever created a safety-relevant artefact does not verify it. Static analysis to MISRA, test coverage according to the SIL, FMEDA for the hardware. Who checks what is set out in the project's safety plan.
Release
When something ships to you
A release or an acceptance is only approved once four conditions are met. Every approval records who granted it, when, and for which version.
Criteria met
Definition of done met, no blocking errors in the pipeline, all code reviews completed, internal system test passed.
Open items assessed
Known defects are classified. No critical or major defect is left without a plan to fix it.
Release notes and evidence
Release notes and test report and, for medical and safety projects, the evidence package for the baseline, with version and commit.
Your acceptance
You approve after a successful system test. CE marking and the technical file remain with the manufacturer; we deliver our contributions to them.
Management system
What the system also covers
Suppliers
PCB assemblers, component suppliers and external service providers are assessed before they are engaged and listed in the supplier register. Every purchase order is approved, and from EUR 5,000 by two people.
Traceability
Every assembly carries a qde serial number and is tracked in Odoo, including those supplied by the customer. Software releases are tied to a Git tag; build artefacts carry the version and commit hash.
Customer property
Source code, keys, test equipment and data are stored with access limited to project members. When the project ends, we return them or delete them verifiably, as agreed in the contract.
Audit and improvement
Once a year, one internal audit covers quality and information security together, and the management review takes place in the fourth quarter. Anyone can log an improvement directly as a task, without approval.
Supplier audit
Questions purchasing and quality teams ask
Can we audit you?
Yes, on site in Offenburg or remotely. You see the management system manual and the evidence for your project: requirements, reviews, test reports and approvals.
Are you certified to ISO 13485?
We are certified to ISO 9001, and our management system is also aligned with the requirements of ISO 13485. As a supplier, we develop electronics and software for medical devices to IEC 62304 and ISO 14971. Manufacturer responsibility, the technical file and CE marking remain with you.
What happens if a defect shows up after delivery?
Every nonconformity is recorded and classified. A critical defect after delivery always triggers a root cause analysis, with a corrective action and a check that it worked.
Who is responsible for quality and information security?
Florian Seibold. As managing director, he is also the quality management representative. For safety projects, a functional safety manager is appointed in addition.
Your contact
Quality we are proud of.
Our management system is as short as the standard allows and as precise as the product requires. Auditors and customers tell us they appreciate that. Florian Seibold is responsible for the system as managing director. Write to him if you need the certificate, excerpts from the manual or an audit date.
