You can download a free PDF of ISO 15378 from the official ISO website or other online sources.
| Feature | ISO 9001:2015 | ISO 15378:2017 | | :--- | :--- | :--- | | Focus | Any product/service | Primary packaging for meds | | GMP integration | No | Yes (mandatory) | | Design control | Optional (clause 8.3) | Mandatory for packaging | | Cleanliness specs | Not defined | Defined in normative annexes | | Regulatory notification to customer | Not required | Required | iso 15378 key pointspdf free
: Mandatory lot-level tracking systems to trace a batch from raw starting materials through final distribution. Process Validation You can download a free PDF of ISO
ISO 15378 is an important standard for organizations involved in the manufacture of medical devices. By understanding the key points of the standard and implementing a QMS that meets its requirements, organizations can ensure the quality and safety of their products, improve customer satisfaction, and maintain regulatory compliance. By understanding the key points of the standard
The standard ensures that packaging—such as glass, plastic, rubber, or aluminum—meets the safety and quality requirements of the pharmaceutical and medical device industries. 🛡️ Key Points & Requirements
Implementation of systems to track every material and production step from raw material to delivery.