BS EN ISO 13485:2003 supersedes BS EN ISO 13485:2001 and BS EN 1S0 13488:2001 which will be withdrawn in July 2006. To maintain their certified status all organisations within the medical devices industry must adopt BS EN 13485:2003
Major differences between BS EN IS013485: 2003  and ISO 9001:2000 are the requirement to maintain the effectiveness of the system rather than improve it; emphasis on meeting customer and regulatory requirements as against increasing customer satisfaction and a greater requirement for documented procedures which include:
Those documents required by regulation
Responsibility and authority
Training procedure, if required
Maintenance requirements
Health, cleanliness, clothing
Environmental conditions
Control of contaminated product
Risk management
Customer requirements
Design and development
Purchasing process including traceability records and records of verification
Reference materials and reference measurement procedures
Labelling and packaging
Installation and verification
Sterilization process validation
Identification and validation
Preserving product including shelf life
Monitoring, measurement and measuring devices
Sterilization records, servicing records, batch records, validation
Differences in research and development activities:

Determine design transfer activities
Document design planning outputs
Include risk management in input
Approve inputs
Document design outputs
Include specialist as needed in design review
Complete validation before delivery
Include clinical trial as required
Added programs to consider:

Clinical evaluation
Risk management
Clinical trials
Cleanliness of product and contamination control
Requirements for implantable devices
Communication of advisory notices
Lewis Conquer Consultancy Services specialise in putting in simple uncomplicated quality management systems, that meet the requirements of the BS EN ISO 13485 medical devices standard, without unnecessary administration.