ISO 9001 for Medical Device Manufacturers

If you are a small Medical Device company you should not be using an ISO 9001 Quality Management System, you should be using ISO 13485 for Australia or QSR 820 for Medical Devices the US market.

Introduction

We have an affordable and practical approach to successfully implement ISO 13485 systems. Templates and consulting services can be provided to meet the needs of small / medium size medical device manufacturing companies. These systems ensure compliance to the TGA’s requirements.

Status of the ISO 13485 standard

The ISO 13485:2003 Standard was effective July 15, 2003.

The following standards expired July 15, 2006 ISO 13485:1996 / ISO 13488:1996.

ISO 13485, supersedes EN46001/2 for Medical Devices. In essence the procedure for certification is the same as that for ISO 9001 (as this scheme is based on the prime document ISO 9001, hence it is sometimes called "ISO 9001 Medical Devices").