Quality
Looking for a manufacturing partner that meets the highest standards of quality, traceability and precision?
Quality assurance and quality control
Quality is embedded throughout our entire value chain – from product development and tool design to manufacturing, inspection and delivery. We produce precision metal components for industries where consistency, traceability and documented quality are essential.
Our quality management approach is built on proven methodologies such as PPAP, APQP, FMEA, vision inspection, optical measurement and Statistical Process Control (SPC). For medical device applications, we also provide process validation and documentation, including IQ, OQ and PQ, ensuring compliance with applicable regulatory and customer requirements.
If your project requires a specific quality level or documentation package, we tailor our quality assurance processes to meet your exact requirements.
Quality management system and certifications
A robust Quality Management System is the foundation for stable manufacturing processes, consistent product quality and complete traceability throughout the entire product lifecycle. Continuous improvement, documented procedures and regular internal and external audits ensure that our processes consistently meet customer and regulatory requirements.
Stansomatic is certified to ISO 9001 and ISO 13485. These internationally recognized certifications demonstrate that our Quality Management System complies with the requirements for both general quality management and the manufacture of components for the medical device industry.
PPAP
Risk analyses help us prevent defects and misunderstandings. PPAP ensures that we have understood the customer’s design and production specifications and that we have the necessary production processes needed to deliver the perfect product.
Six Sigma
Six Sigma methods optimize and improve our production processes. We make decisions based on its data-driven management process to meet customer needs and strengthen quality decision-making throughout the business.
Vision inspection
Our production and packaging lines have vision inspection installed to make sure that we always deliver uniform parts of high quality. These systems will automatically sort out flawed parts. We regularly control that all our measuring equipment works.
Talk to an expert
If you want more information on our quality assurance, please contact our quality manager Jesper. He will answer all your questions.