.svg)
ONE CERTIFIED QUALITY SYSTEM
Our quality management system covers both product development and contract manufacturing. That gives customers a controlled path from requirements and design decisions through industrialization, production and product changes — without quality becoming a separate activity at the end.
Requirements, design inputs and outputs, reviews, risks, verification activities and changes are managed through controlled processes. This creates a traceable development record that supports technical decisions and the documentation needed later in the product lifecycle.
Manufacturing requirements are reviewed before production and translated into controlled sourcing, assembly, inspection, testing and traceability. Changes and non-conformances are documented and handled through the QMS, with product-specific controls agreed for the scope.
STANDARDS & CERTIFICATIONS
ISO 9001 provides the quality-management foundation across our services. ISO 13485 adds requirements for medical-device-related development and manufacturing. For electronics assembly, IPC acceptance criteria are applied where relevant to the agreed product scope.
The quality-management framework used across Zign’s development and manufacturing activities, supporting controlled processes, corrective action and continuous improvement.
Additional quality-management requirements for medical-device-related work, including controlled design and development, risk-management inputs, supplier control, production and traceability.
IPC-A-610 acceptance criteria for PCBAs and IPC/WHMA-A-620 for cable and wire-harness assemblies, where applicable to the agreed scope and acceptance class.
Medical-device projects add specific requirements for design control, risk management, verification and documentation. Zign develops within an ISO 13485-certified QMS and provides agreed design, verification and risk-management outputs that can support the customer’s technical documentation and MDR / CE-marking process. Formal CE-marking responsibility remains with the legal manufacturer.
01
02
03
We can support your supplier qualification with current certificates and scope information, relevant QMS documentation where appropriate, and project-specific discussions about traceability, quality agreements and assessment requirements.
Zign’s quality management system is certified to ISO 9001 and ISO 13485 and covers product development and contract manufacturing. Request the current certificates to review the scope relevant to your project.
Yes, by supporting the development work that feeds into the process. We develop within an ISO 13485-certified QMS and provide agreed design, verification and risk-management outputs for the customer’s technical documentation. We can also help identify applicable development standards and plan the evidence needed during development.
For electronics manufacturing, Zign works with IPC-A-610 acceptance criteria for PCBAs and IPC/WHMA-A-620 for cable and wire-harness assemblies. The applicable class, inspection and test requirements are agreed for the product.
Yes. We can support supplier qualification with current certificates and scope information, relevant QMS documentation where appropriate, and project-specific discussions about traceability, quality agreements and assessment requirements.
