ISO 13485

                                             

           This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.

             Some of the key issues addressed by ISO 13485 are

• Regulatory focus – Views motivation in a way that allows an understanding of the foundation way we approach a task or a goal.
• Process approach – Make it very clear that the organization must indentify and manage the processes that make the quality management system. The processes are interconnected. Develop a flowchart for each process ith input and output arrow to explain interaction.
• Focus on “meeting customer requirements” – To be competitive, we must meet their requirement in a timely and cost effective manner.
• Focus on “maintaining the effectiveness of the QMS” - An organization will benefit from establishing an effective quality management system (QMS). The cornerstone of a quality organization is the concept of the customer and supplier working together for their mutual benefit. For this to become effective, the customer-supplier interfaces must extend into, and outside of, the organization, beyond the immediate customers and suppliers.
• Maintenance of procedural documentation

             ISO 13485 drivers

• Device manufacturers seek registration to ISO 13485 to improve their internal management of medical device quality systems.
• Medical industry regulators use the ISO 13485 standard to standardize the evaluation of the quality systems of approved device manufacturers.
• Customers of medical device manufacturers such as health care providers have required device manufacturers to seek registration to ISO 13485.

Medical device component and service providers are also experiencing increasing demand for registration to ISO 13485 from their customers