Hi all,
Need advise - we have been molding parts for medical devices for a long time and most of our customers are happy with our quality management systems aligned as per ISO 13485.
Now, we are having a new cusotmer for whom, we will be molding parts for a vaginal applicator and he has told us to get certified as per ISO 15378 standard.
I checked the scope for ISO 15378 and it states - This International Standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products, while
ISO 13485 scope states - This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.
In the past, we have been producing some inhalers, plastic containers for Tablets etc but no customer insisted on this ISO 15378.
If thats the case, would all devices containing any medication fall under the scope of ISO 15378 ? Any guidance highly appreciated.
Need advise - we have been molding parts for medical devices for a long time and most of our customers are happy with our quality management systems aligned as per ISO 13485.
Now, we are having a new cusotmer for whom, we will be molding parts for a vaginal applicator and he has told us to get certified as per ISO 15378 standard.
I checked the scope for ISO 15378 and it states - This International Standard identifies Good Manufacturing Practice (GMP) principles and specifies requirements for a quality management system applicable to primary packaging materials for medicinal products, while
ISO 13485 scope states - This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.
In the past, we have been producing some inhalers, plastic containers for Tablets etc but no customer insisted on this ISO 15378.
If thats the case, would all devices containing any medication fall under the scope of ISO 15378 ? Any guidance highly appreciated.

