UNE-EN ISO 15378:2018

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.

ISO 9001:2008, Quality management systems Requirements

1.1 General

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.

NOTE 1 In 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.

NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.