ISO 13485 certification helps Beckman Coulter meet regulatory deadline for medical devices

摘要

Beckman Coulter, Inc., implemented ISO 13485 to meet a new medical device regulation requiring registration to the standard. However, although "registration was a goal", says the company, "we recognize that the pursuit of quality provides benefits well in excess of passing a registration audit," adding, "Robust, quality-imbued processes add immense value to development, manufacture, distribution and customer support." When you have your blood tested, you expect the result to be correct and rapid, especially in an emergency situation. By providing laboratories with high technology automated diagnostic systems, Beckman Coulter plays a vital role in fulfilling those expectations. Quality is paramount in a health care setting, and diagnostics manufacturers like Beckman Coulter must meet strict quality standards in an increasing number of countries. In response, we see our quality management system (QMS) as a perpetual work-in-progress. Before seeking certification to ISO 13485:1996, Quality systems - Medical devices - Particular requirements for the application of ISO 900], the company already had more than 30 facilities around the world certified to ISO 9000 - a mix of the 1994 versions and ISO 9001:2000 versions. We were also compliant with the quality system regulations in the countries in which our products are sold.