Quality

SAHPRA and ISO 13485

Bakoena Medical supplies devices and consumables with traceability, complaint handling and a quality file in view. The controlled documents below are the placeholders the quality desk will publish. They are not certificates yet.

SAHPRA establishment

Licence number and scope — to be filed here when the current SAHPRA medical-device establishment licence is loaded.

ISO 13485

Quality manual, device list and certificate — placeholder until the quality system is uploaded.

Complaints and lots

Lot register and complaint log will sit with each order so a buyer, sales person or admin can trace a supplied line.

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