Premysis Consulting is a management consulting firm dedicated to support organizations in all sectors of business, industry and government, in envisioning change as well as undertaking change initiatives. To accomplish our objectives, we provide a wide range of consulting and training services in the areas of Strategic, Quality, Environmental, Healthcare, Occupational Health & Safety, Environmental, Human Resources, Leadership & Service Quality, and Food Safety.
OVERVIEW
In the field of medical products, devices, and components, regulatory requirements and customer expectations are demanding. Manufacturers and their supplier world-wide are expected to comply with the highest standards of quality and regulations.
ISO 13485 is the standard for organizations engaged in the manufacturing of medical devices. The standard is aimed to provide guidelines for the organizations that need to demonstrate its ability in providing medical devices and related services that consistently meet customer and applicable regulatory requirements.
According to the most recent survey by the International Organization for Standardization (www.iso.org, 2006), there were a total of 8,175 current ISO 13485 registrations across 82 countries in 2006. Approximately 30 percent of all ISO 13485 registrations were issued in the United States. According to the survey, the 2006 total represent an increase of 3,110 (61%) compared to 2005, when there were 5,065 registrations across 67 countries and economies. Other major markets include Europe, Japan, Canada, Sweden, and Israel. ISO 13485 is now commonly used as the basis of regulatory requirements. The standard is an essential consideration not only for exporters but also for the local market, global suppliers, and subcontractors to prove that their products are of the highest quality.
ISO 13485