QUALITY MANAGEMENT FOR MEDICAL DEVICES ISO 13485:2003
What is ISO 13485?
ISO 13485 is a standard for identifying the control of a quality management system, which has been developed specifically for medical devices. It is an international standard subscribed to by the UK, USA, Japan, Europe and most of the rest of the World.
Its purpose is to demonstrate an organisation's commitment to meeting customer requirements and work towards customer satisfaction through continuous improvement and to error prevention.
ISO 13485 supersedes previous medical Quality Assurance Standards, BS EN ISO9001:1994 and BS EN EN46000 and the previous issue of ISO 13485:2000.
ISO13485 helps an organisation introduce the tools to implement and maintain continuous improvement programmes, that will ultimately translate into good product and service quality.
The requirements are for a fully documented set of procedures linked to the appropriate European Directive, etc.
The standard contains clauses identifying areas of any business that the Company must address when developing a management system to demonstrate regulatory compliance for medical devices
ISO13485 implementation is an investment into the future. Its disciplines create a useful structure from which continuous improvement programs can be implemented and progressed. The monies spent on implementing and maintaining the disciplines of ISO13485 are recovered when the organisation uses the standard as intended...a tool for continuous improvement. The full benefits of introducing such a system can take time to be fully realised.