NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
NOTE 1 In this International Standard, the terms 'product' or 'service' only apply to products and services intended for, or required by, a customer. ISO 15378:2017 specifies requirements for a quality management system when an organization:Ī) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, andī) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.Īll the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
