ISO 15378


It is a Quality Management System in Packaging Production for Medicinal Products. The standard specifies the requirements for the production of packaging used in the packaging of pharmaceutical products and cosmetics.

The implemented standard is proof that the manufactured packaging is made of high quality materials, ensure the safety and hygiene of medicinal products. The implementation and ownership of a certified system in accordance with the PN-EN ISO 15378:2018 standard results in benefits such as: ensuring storage of pharmaceutical products, the ability to continuously improve system efficiency, increase customer satisfaction, increase competitiveness and expand the market. Ownership of the PN-EN ISO 15378:2018 Certificate gives you the opportunity to obtain additional points in tenders, contract with the NFZ and apply for various types of subsidies.

Order of IMPLEMENTATION and stages:

  • organization analysis,
  • training of top management,
  • preparation of documentation for compliance with the standard,
  • at the customer's request, participate in the implementation of the requirements of the standard,
  • internal audit,
  • preparation for the certification audit.

PN-EN ISO 15378:2018 CERTIFICATION takes place in several stages:

  • pre-audit - an external auditor from the selected certification body gets acquainted with the organization's documentation in order to check whether all requirements have been implemented,
  • the auditor's assessment that all elements of the standard have been implemented,
  • audit - examining how the system functions in reality after implementation in accordance with the records in the documentation,
  • issuing a report,
  • issuing instructions on the possibility of awarding the Certificate.

Because the ISO 15378: 2015-12 Certificate, documenting the implemented Quality Management System in the Production of Packaging for Medicinal Products 2009, is issued for a period of three years, in the second and third year a supervision audit is carried out. After three years, the recertification audit is carried out.




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