UK Akkreditering Forum Limited

ISO 15378 Certification

ISO 15378:2011 defines the necessities that have to meet by an organization when it is involved in primary packing materials related to medicinal products. The quality management system put forward by this certification constantly tries to meet the client necessities by taking care of the products to meet the International standards and regulatory needs that are applicable to the primary packing material. Overall ISO 15378:2011 is an application standard that holds good for manufacture, design and supply of the packing material associated to the medicinal products.

This standard specifies necessities for a quality management system where an organization requirements to demonstrate its ability to give primary packaging materials for medicinal products, which constantly meet client necessities, including regulatory needs and International Standards applicable to primary packaging materials.

ISO 15378 contains the needs set out in ISO 9001 quality management and is compatible with all other management system standards like ISO 14001 environmental management and OHSAS 18001 occupational health and safety, etc.

Benefits of ISO 15378

  • Presentation of the company's expertise
  • Time and cost savings
  • Creation of competitive advantages
  • Enhancement of the quality capability
  • Decrease and control of risks
  • Proof of compliance with statutory regulations and contractual agreements