ISO 13485:2003 specifies necessities for a quality management system where an organization requirements to demonstrate its ability to give medical devices and related services that constantly meet client necessities and regulatory requirements applicable to medical devices and related services.
ISO 13485: 2003 represents the necessities that medical device manufacturers must incorporate into their management systems. The present document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488. Though based on ISO 9001, 13485 remove 9001’s emphasis on repeated development and client satisfaction. In its place is an emphasis on meeting regulatory as well as client necessities, risk management and maintaining effective procedures.
Our ISO 13485:2003 certifications ensure produced, tried and tested within International standards. ISO 13485 is a Quality Standard governed by the International Organization of Standardization in Geneva, Switzerland, and is known and practiced in over 160 countries around the world. ISO 13485 is the quality standard for medical devices and is necessary by Health Canada for all medical device manufacturers global. It has been designed to make sure that companies follow strict guidelines for the highest quality of products, as well as meeting applicable government necessities.