scope:

This International Standard specifies requirements for a quality management system where an organization
a) needs to demonstrate its ability to consistently provide product that meets customer and applicable
regulatory requirements, and
b) aims to enhance customers satisfaction through the effective application of the system, including
processes for continual improvement of the system and the assurance of conformity to customer and
applicable regulatory requirements.
NOTE In this International Standard, the term "product" applies only to the product intended for, or required by, a
customer.