ISO 13485:2003

Medical Devices

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.

ISO 13485 Benefits

The benefits of an ISO 13485:2003 compliant quality management system to the thousands of companies worldwide includes:

  1. Recognition by regulators around the world of ISO 13485:2003 as a good basis for addressing medical device design and manufacturing regulatory requirements
  2. Controlled consistency of manufactured products
  3. Managed productivity and efficiency, controlling costs
  4. Competitive advantage and increased marketing and sales opportunities.
  5. Improved customer perception of the organization’s image, culture and performance.
  6. Improved communications, morale and job satisfaction – staff understand what is expected of them and each other.

ISO 13485 Steps of Certification
  1. System Study & GAP Analysis
  2. Documentation- Preparation of Quality Manual, Quality Procedure, Work Instructions, Formats
  3. Records Generation, Implementation and Updating
  4. Trainings- Management & Work Force Level
  5. Internal Audit & MRM
  6. Guidance through the Certification Audit
  7. Closure of the Non-Conformities raised
  8. Annual Maintenance Contract(Optional)

How can QMS ISO help?

QMS ISO consists of full-time trainers and consultants having huge international experience and exposure in ISO 13485 consulting, implementation and training.