ISO 13485:2003 is a quality system standard designed specifically for medical device companies. The ISO 13485 standard supplements ISO 9001 and has many of the same requirements. However, there are additional requirements for process control, design control, retention of records, accountability, traceability and more.
The standard strongly infers that clients should consider using ISO Standards: 2000 to ensure understanding of the Process Model, definitions and other items of concern, too.
Our ISO 13485 quality systems can meet all European CE Marking, Canadian, Japanese and Australian regulations...and are FDA GMP compliant.
The benefits of an ISO 13485:2003 compliant quality management system to the thousands of companies worldwide includes:
QMS ISO consists of full-time trainers and consultants having huge international experience and exposure in ISO 13485 consulting, implementation and training.
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