BS EN ISO 15378:2015

1.1 General This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials. In this International Standard, the term “if appropriate” is used several times. When a requirement is qualified by this phrase, it is deemed to be “appropriate” unless the organization can document a justification otherwise. ISO9001:2008, Quality management systems— Requirements 1.1General 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 statutory and regulatory requirements, and b)aims to enhance customer 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 statutory and regulatory requirements. NOTE1In this International Standard, the term “product” only applies to a)product intended for, or required by, a customer, b)any intended output resulting from the product realization processes. NOTE2Statutory and regulatory requirements can be expressed as legal requirements. 1.2 Application This International Standard is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. It is also applicable for certification purposes. ISO9001:2008, Quality management systems— Requirements 1.2Application All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause7, and such exclusions do not affect the organization\'s ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.