Re-certification ISO 9001, 15378 and FSSC 22000.
With the completion of the annual audit and the review of the audit reports, EMPAC was re-certified for ISO 9001, ISO 15378 and FSSC 22000. Thus, our company remains one of the few FIBC manufacturers with ISO 15378 certificate and once again strengthens the quality standards which we set for ourselves.
ISO 15378 describes the standard for the manufacturing of primary packaging materials which are intended to come in direct contact with pharmaceuticals. In addition to the requirements of ISO 9001, the principles of Good Manufacturing Practice (GMP), such as batch traceability, risk management, validation and controlled environmental conditions, must also be fulfilled. These are required by all legal regulations for the pharmaceutical and medical device industry at an international level.
FSSC 22000 is based on ISO standards and is the certificate for a comprehensive food safety management system. Recognition by the GFSI (Global Food Safety Initiative) shows that this certification achieves the highest standards in the world and is an internationally recognized credential.