was created to ensure that medical device manufacturers are meeting compliance and regulatory standards as set forth by their customers. Certification to ISO 13485 is now a direct requirement for some markets such as Australia and Taiwan; an indirect requirement for others such as Europe; and can form the basis of GMP compliance in the United States. Though based on ISO 9001, ISO 13485 removes ISO 9001’s emphasis on continual improvement and customer satisfaction and instead places emphasis on meeting regulatory and customer requirements, risk management and maintaining effective processes. To read more about ISO 13485, feel free to review the following link.
- AQA International is currently in process of achieving accreditation to ISO 13485 through the ANAB.