ISO 15378 Quality Management System

TÜV SÜD tests and certifies Quality Management Systems (QMS) for Medical Packaging Materials in accordance with ISO 15378. This standard specifies requirements for QMS systems applicable to primary packaging materials for medicinal products. These materials include glass, rubber, plastics, aluminium, films, foils and laminate containers. Manufacturers of these materials need to demonstrate their ability to consistently meet customer expectations and regulatory requirements. A reliable test by a third party such as TÜV SÜD can help them do just that.

Primary packaging materials for medical devices come in direct contact with medicinal products. This makes it vital that these materials demonstrate safety, efficacy and reliability. For example, the materials should reduce safety hazards, minimise product contamination, and extend product efficacy and shelf life. ISO 15378 helps you meet the necessary standards and comply with legal requirements. It integrates the requirements of ISO 9001 and GMP, a regulatory requirement as per all international regulations. Adhering to GMP principles boosts the efficiency of your production processes.

TÜV SÜD offers auditing and certification services to support manufacturers of primary packaging materials in addressing specific requirements to meet the quality objectives as per ISO 15378. 

We assist the pharmaceutical and medical device industries to assess suppliers of primary packaging materials and increase overall product quality, thus enabling them to develop business excellence. 

Our team of over 1500 medical experts are situated in major markets around the world and serve on many standards development committees, giving them insight into the industry’s technical standards. 

We also employ a group of medical doctors to assess evaluations of new treatment methods and products, and a scientific advisory board comprised of scientists from world-class universities. 

We leverage our comprehensive in-house medical competencies and thorough understanding of regulations worldwide to serve your needs. 

There are four steps to ISO 15378 certification: 

1. TÜV SÜD auditors perform a preliminary evaluation with a site inspection to identify gaps. 
2. Auditors perform certification audit. 
3. Auditors review and perform closure of any non-conformances. 
4. Following approval by the committee, auditors provide audit report and certification, and initiate annual surveillance audits.