Wedge Manufacturing Achieves Certification to ISO 13485 And ISO 9001 Standards
March 20, 2009 (PRLEAP.COM) Health NewsWedge Manufacturing, Inc. today announces achieving certification to ISO 13485, the International Standard for Medical Devices, and ISO 9001, the International Standard for Quality Management Systems. Both ISO 13485 and ISO 9001 are internationally recognized management system standards developed by the International Organization for Standardization (ISO). The scope of certification to ISO 13485 standards at Wedge covers the machining, assembly, and inspection of medical components and devices, while quality assurance to ISO 9001 certifies that Wedge processes meet rigorous ISO quality management standards.
Wedge Manufacturing is committed to investing in the capability and capacity to serve our customers at the highest level. Our credibility is earned from complying with requirements, meeting quality objectives, and maintaining the effectiveness of our quality management system. Achieving certification to ISO 13485 and ISO 9001 strengthens Wedge Manufacturing's commitment to customer quality and service, and positions the company for further expansion in the medical device sector.
"Preparing a company to meet the requirements of two ISO standards takes a team effort. Support and participation from top management is critical to achieving certification, and daily participation from Wedge personnel at all levels is paramount in retaining the certifications," said Chris Hughes, Quality Manager.
The rigorous certification process consisted of three audits by an independent certifying body, British Standards Institute (BSI): a Pre-Assessment, Registration Audit Level I, and Registration Audit Level II. Through these three audits, the certifying body determined the overall readiness of Wedge Manufacturing's Quality Management System (QMS) to meet the requirements of ISO 13485 and ISO 9001, compliance of the Wedge QMS documentation to the requirements of the standard, and a final audit to determine the effectiveness and execution of the Wedge QMS.
About Wedge Manufacturing
Machining superior quality, high-precision, small, complex parts, Wedge was established to deliver this expertise to the medical, aerospace and other high-precision industries. Wedge also provides engineering and contract manufacturing services for proprietary parts and assemblies. We offer part inspections, reverse engineering, and prototype development, as well as production services. www.wedgeinc.com