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ISO 15378 Quality Management System for Medical Devices

Efficient medical device quality management and testing

Meet quality objectives for your primary packaging materials for medicinal products

Pharmaceutical and medical device primary packaging materials include glass, rubber, plastics, aluminium containers/components, films, foils and laminate containers. As these materials come in direct contact with medicinal products, they need to comply with safety, efficacy and reliability requirements. Suppliers of primary packaging materials have to meet the expectations of medicinal product manufacturers and demonstrate compliance with expected quality levels by integrating quality management systems (QMS) and good manufacturing practice (GMP) in their production processes. 

What is ISO 15378?

ISO 15378:2011 specifies requirements for a quality management system for manufacturers of pharmaceutical and medical device primary packaging materials. These organisations need to demonstrate their ability to consistently meet customer requirements, including regulatory requirements and international standards applicable to primary packaging materials for such medicinal products. The standard delineates GMP principles and specifies QMS  requirements applicable to primary packaging materials for medicinal products.

Why is it important?

The ISO 15378 standard enables you to comply with legal requirements for pharmaceutical and medical device primary packaging materials. ISO 15378 integrates the requirements of ISO 9001 as well as GMP, a regulatory requirement for the pharmaceutical and medical device industries as per all international regulations such as Code of Federal regulations (U.S.), European directives and Indian regulations. Adhering to GMP principles boosts the efficiency of your production processes. The standard also helps to reduce the risks of safety hazards and product contamination, and ensure product efficacy and shelf life. 

How can you prepare?

You can understand the requirements of ISO 15378 by performing a GAP analysis, and implementing QMS and GMP requirements as per ISO 15378.

TÜV SÜD ISO 15378 expertise

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.

Steps for certification

Why choose TÜV SÜD

TÜV SÜD Product Service has the highest number of medical experts, with a team of over 400 international specialists situated in major markets around the world. Our experts serve on many standards development committees, giving them insight into the industry’s technical standards. Besides our highly trained regulatory experts, we also employ a group of medical doctors for assessing evaluations of new treatment methods and products, as well as 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.

Your benefits at a glance

  • Save money and time – with a service provider that eliminates the need for multiple assessments and improves productivity through process optimisation.
  • Minimise risk – by achieving documented compliance with safety standards, thereby avoiding costly liability.
  • Gain a competitive edge – by demonstrating the ISO 15378 compliance of your organisation to all stakeholders with a trusted third-party certification partner.
  • Profit from an expert partnership – with TÜV SÜD’s global network of highly skilled experts in Medical and Health Services (MHS).
  • Benefit from complete solutions – with TÜV SÜD’s comprehensive support, from testing to auditing and certification.

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