ISO 13485 Certified, 21 CFR Part 820 & Part 11 Compliant – FDA RegisteredCách nghịch DJ sốcCustomers trust Sanmina’s medical chất lượng & regulatory system which is developed centrally, deployed globally và audited independently by the FDA, notified bodies & customers.
Sanmimãng cầu Medical has proven experience with high-volume medical device design, packaging, manufacturing automation and turnkey functional thử nghiệm solution.
Cách nghịch DJ sốcThe Quality Management & IT Systems have sầu been developed over đôi mươi years. Their robustness has been successfully tested for manufacturing all types of medical systems. The systems have sầu been fully validated providing customer’s with confidence in regulatory compliance & accelerated time to market. One system worldwide ensures a consistent approach in all Sanmimãng cầu facilities.
A combination of our Manufacturing Execution System (MES) & Performance Excellence program provide customers with manufacturing excellence. The MES ensures that each sản phẩm is manufactured according khổng lồ the thiết kế và manufacturing specification through parts traceability & forced process routing features. It also provides component traceability & hàng hóa genealogy.
Cách đùa DJ sốcSanmina’s Performance Excellence program ensures that each facility operates lớn defined procedures & monitors performance using Key Process Indicators. The program uses integrated requirements & monitoring systems in customer management, purchasing, materials management, production scheduling, shop-floor control and chất lượng management. Processes are developed centrally, deployed globally và audited independently by a corporate audit team.
Lean Six Sigma is the foundation of continuous improvement at Sanmimãng cầu. The DMAIC Model is used lớn standardize the approach for each continuous improvement project. A combined network of 22,000 master black belts, blaông chồng belts, green belts & white belts support the continuous improvement process at each location worldwide.
Systematic investigation of discrepancies is conducted using 8D methodology và mandatory 5-Why root cause determination focused on closed-loop remediation và prevention. Our fully validated CAPA system features: Search and retrieval with report generation capabilities, 21 CFR Part 11 electronic signature capabilities, Worldwide access và timely response tracking. Every CAPA is reviewed and approved at a corporate cấp độ by a dedicated global CAPA team.
Cách đùa DJ sốcThe Quality Management System is maintained & monitored by a global independent Quality Assurance / Regulatory Affairs team of medical professionals. Compliance is monitored through visibility lớn key data, performance indicators & independent internal audits. The organization has developed a robust system for FDA audits & the system has been successfully audited numerous times over the past ten years.
Cách đùa DJ sốcSanmimãng cầu has implemented a Quality Management System that is ISO 13485 certified & 21 CFR Part 820 & Part 11 Compliant. The QMS utilizes medically trained personnel, standardized metrics, a best in class CAPA system và validated software tools that ensure management throughout a medical product’s lifecycle. The system is maintained và monitored by a dedicated global RA/QA organization.