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Continuous improvement is a way of life at Oliver Medical. By continuously improving our processes and products, we enable our customers to reduce costs while maintaining superior product quality.
Medtronic approves Dock-to-Stock
Oliver Medical has increased the scope of products approved for the Dock-to-Stock program at Medtronic's Juncos, Puerto Rico facility. Five new parts have been approved for the program.
To qualify for the Medtronic program, Oliver's quality team prepared a detailed FMEA, Process Flow Charts, and Inspection Plans, and passed a comprehensive process audit by Medtronic's Supplier Quality team. Qualification for Medtronic's dock-to-stock program requires successful completion of a rigorous approval process and attests to Oliver's track record and commitment to meeting the stringent quality standards of medical device manufacturers (MDMs) worldwide.
Kelly Kane obtains ASQ certification
Kelly Kane has been named an American Society for Quality Certified Quality Auditor (ASQ CQA). Kane, who is a quality specialist, CQA, at Oliver Medical, has reached a significant level of professional recognition, indicating a proficiency in and a comprehension of quality auditing tools and techniques, according to the ASQ. Successful ASQ CQA candidates must possess eight years of related on-the-job experience, and be able to apply a variety of auditing techniques in examining, comparing, and evaluating products, processes and quality systems to specific standards. A Certified Quality Auditor can plan, develop, communicate, and execute an audit within a defined scope.
Having ASQ-certified auditors is part of Oliver's ongoing commitment to providing the highest level of quality assurance for its customers.
Before joining Oliver Medical in early 2007, Kane worked as Quality Assurance Specialist for the American Red Cross/Great Lakes Region.
CATSWEB
Oliver Medical employs CATSWeb OnDemand for its global quality and compliance management system. The leading-edge software, designed specifically for the medical device and pharmaceutical industries, allows Oliver to better document change control, complaint handling, audits, and order entry.
CATSWEB helps Oliver's quality team collect, organize, analyze, and share information to better manage and improve quality and compliance performance. The all-in-one solution automates quality & regulatory compliance-related processes so issues—from detection to corrective action to trend analysis—can be globally managed.
ISO 13485 compliance—coming July 2008
As part of our commitment to meeting the same stringent quality standards as those practiced by our medical device manufacturer clients, Oliver Medical is working toward ISO 13485 registration.
ISO 13485:2003 outlines a quality management system specifically designed for organizations that provide medical devices and related services that consistently meet applicable customer and regulatory requirements. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.
Oliver Medical is currently ISO 9001:2000 registered.
On-line inspection—independent review of all coating lines
Oliver Medical QA technicians inspect production lines on all three shifts. This independent Quality Control inspection further ensures our customers receive the highest quality medical device packaging possible.
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