Champion Manufacturing receives ISO 13485 Certification
Champion Manufacturing, Inc., a leading manufacturer of healthcare seating, is proud to announce that it has received certification from Perry Johnson Registrars, Inc. (PJR) that its Quality Management System conforms to the requirements of the ISO 13485:2003 Medical Device Manufacturing standard.
In pursuing the certification, Champion set out to provide its customers with further assurance that they are consistently receiving safe and effective medical devices and services that meet regulatory requirements and customer expectations. Our customers can be confident that Champion Manufacturing is dedicated to maintaining the highest efficiency and responsiveness in achieving our ultimate goal – customer satisfaction.
To achieve this milestone, Champion demonstrated that all of its activities conform to both the ISO standard and the current good manufacturing practices required by federal medical device regulations. To this end, the company was subjected to a pre-assessment readiness review followed by a thorough 10-day two stage certification audit, both of which were conducted by PJR, an internationally recognized ANAB accredited certification body.
ISO 13485:2003 is an internationally recognized standard built on the foundation of ISO 9001 that has been enhanced to meet the stringent regulations and demanding requirements of the medical device industry. It is more prescriptive and requires a more thoroughly documented Quality Management System than the generic ISO 9001 standard.