ISO 13485 certification

Internatonal standards and regulations

International standards published by the International Organization of Standards (ISO) and AS9100 published by SAE can be purchased and downloaded through ANSI. They are under copyright protection and CANNOT be circulated to others neither in hardcopy nor in softcopy. Also beware of publishing the content or part of their content on your websites.

Before purchasing a document, make sure it is the correct one that you need. I.e. ISO 9000 is different than ISO 9001. The same applies for ISO 14000, which is different than is 14001. The ones that you probably need are ISO 9001 and ISO 14001 which are the actual standards that set requirements for Quality and environmental management systems.

Download international standards

FDA and USDA regulations can be found on their websites and are public documents that can be circulated and consulted for free. They can be obtained form U.S. Government Printing Office via GPO Access.

Books about implementation of standards such as ISO 9001, ISO 13485, GMP, GLP, ISO 14001, ISO 22000, ISO 16949, can be purchased through this link to our bookstore in collaboration with Amazon.

Useful overview and training videos can be accessed through this video library link in collaboration with YouTube.