ISO 13485 is an international standard that focuses on quality management systems for medical devices. It is designed to ensure that medical device manufacturers meet the regulatory requirements for quality management and safety while meeting customer expectations.
AS9100. on the other hand. is an international standard for aerospace manufacturers. It is designed to ensure that aerospace companies adhere to strict quality controls throughout the entire supply chain. including design. development. manufacturing. and maintenance.
The main difference between ISO 13485 and AS9100 lies in their scope and application. ISO 13485 is tailored to the medical device industry. while AS9100 caters to the aerospace sector.
ISO 13485 places a strong emphasis on factors critical to the medical device industry. such as product safety. airworthiness. and traceability. It ensures that medical device companies adhere to strict quality controls throughout the entire supply chain. including design. development. manufacturing. and maintenance.
AS9100. on the other hand. focuses more on risk management and regulatory compliance specific to the aerospace industry. It ensures that aerospace companies adhere to strict quality controls throughout the entire supply chain. including design. development. manufacturing. and maintenance.
In summary. ISO 13485 and AS9100 both aim to enhance quality and customer satisfaction. but they have distinct focuses and applications. ISO 13485 is tailored to the medical device industry. while AS9100 caters to the aerospace sector.
Nina She