Quality Commitment | Zign Group

Traceable design

Getting an electronic product to market, especially in regulated industries, means building a documented record of how it was designed, verified, and produced. Frameworks like EU MDR, CE marking, and FDA define what that record needs to contain. A meaningful part of it comes from how your development and manufacturing partners work. Because our quality management system is structured and independently certified, the work we contribute is traceable and audit-ready from the beginning. Design decisions are documented and changes go through controlled processes.

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Development and manufacturing under one certified QMS

Our certifications cover both product development and contract manufacturing, but what the QMS looks like in practice depends on your needs.

Product Development

When we develop electronics for your product, our QMS governs how requirements are documented, how design decisions are made and verified, and how risks are managed across the project. The work we produce, test records, design documentation, risk management inputs, is structured to go directly into your technical file. This is relevant whether you're pursuing a CE mark under EU MDR, submitting to the FDA, or simply need a development partner whose work won't create gaps in your regulatory documentation later.

Contract Manufacturing

When we manufacture your product, our QMS covers how we source, produce, inspect, and deliver against your specifications. For medical device customers, this includes quality agreements back-to-back with your own requirements, traceability to your Device Master Record, and documented handling of any deviations.Under EU MDR, Notified Bodies can extend unannounced audits to critical suppliers. As a contract manufacturer in the medical supply chain, our processes are set up for that, so your supplier qualification doesn't become a liability.

Controlled, traceable and verified built

Production is carried out in line with recognised industry standards, including IPC/WHMA-A-620 for cable and wire harness assembly. Ask for scope documentation if needed.

IPC/WHMA-A-620‍
Governs acceptance criteria for wires, splices, terminals, connectors and protective coverings. Three acceptance classes. Specify your required class in the drawing.

ISO 9001
Process-based QMS covering planning, production control, corrective action and continuous improvement. Applicable across all production activities.

ISO 13485
Relevant if your product is a medical device or sub-assembly. Adds traceability, risk management and stricter process controls.

Development and manufacturing under one certified QMS

One QMS covers both services. The core processes, all documented and internally audited:

Document control Every document has a named owner and version history. Reviewed annually (management process) or every three years. Obsolete versions archived, not deleted.

Change control Changes to processes, products, or work instructions require formal authorization before implementation, with documented rationale. Applies to supplier-side changes too.

Non-conformances Deviations are logged, root-caused, and resolved through corrective or preventive actions. Records are fully traceable and cannot be deleted.

CAPA & SCAR Internal issues go through CAPA. Supplier deviations go through a Supplier Corrective Action Request. Both tracked to closure in bi-weekly operational reviews.

Supplier quality Suppliers are evaluated before approval and monitored ongoing. Critical suppliers are audited periodically. For medical device production, quality agreements are in place back-to-back with customer requirements.

Audits & review Internal audits run across QMS processes. Annual management review covers performance trends, audit findings, and actions for the next cycle.

Record retention Medical device technical records: minimum 10 years post-market (15 for implantables), per EU MDR. Other QMS records: minimum 3 years or as agreed contractually.

For supplier qualification: we can provide certificates, scope documentation, and relevant QMS procedures. We enter quality agreements where required and accommodate on-site assessments.

Built on quality from the start

Traceable design

Development and manufacturing under one certified QMS

Product Development

Contract Manufacturing

Controlled, traceable and verified built

Development and manufacturing under one certified QMS

Discover our certified medical projects