V
Viki N.
Hi All,
We are a contract manufacturer that molds plastic components for use in a finished device that we also assemble to customer's specifications and send to the OEM. We do not do design.
Currently, our Assembly areas are certified to ISO 13485, but our molding areas are certified to ISO 9001. We want to go ISO 13485 across the board, but are unsure what kind of controls for the molding areas we really need vs. what we already do for device assembly. Surely, molding the components can't be held as stringently. Off the top on my head, I would think more controls in the following would be required: Work Environment, Supplier Control, Risk Mgmt., Product Contamination Control, Batch Records, Identification & Traceability & Status, Non-conforming Product Control, and Complaint/Corrective Action.
Has anyone had experience with external auditing of component molding and what areas of the ISO 13485 Standard was concentrated on?
Thanks for any feedback,
Viki
We are a contract manufacturer that molds plastic components for use in a finished device that we also assemble to customer's specifications and send to the OEM. We do not do design.
Currently, our Assembly areas are certified to ISO 13485, but our molding areas are certified to ISO 9001. We want to go ISO 13485 across the board, but are unsure what kind of controls for the molding areas we really need vs. what we already do for device assembly. Surely, molding the components can't be held as stringently. Off the top on my head, I would think more controls in the following would be required: Work Environment, Supplier Control, Risk Mgmt., Product Contamination Control, Batch Records, Identification & Traceability & Status, Non-conforming Product Control, and Complaint/Corrective Action.
Has anyone had experience with external auditing of component molding and what areas of the ISO 13485 Standard was concentrated on?
Thanks for any feedback,
Viki