The prefix of the standard provides clues as to which country it originates from. For example, ASTM stands for American Society for Testing and Materials and ANSI stands for American National Standards Institute. ASTM and ANSI are typically used in the United States. ISO, which stands for International Standard Organization, defines many standards which are […]
Month: April 2022
What is ISO 13485?
Although the ISO 9001 Quality System standard can be used by any industry, ISO 13485 is the go-to Quality System standard widely used (and recognized) in the medical device industry. ISO 13485 aims to facilitate global alignment between other medical device regulations such as the United States FDA’s Quality Management System Requirement 21 CFR 820. ISO […]