What is ISO 13485 Manual and Its Requirements for Medical Device Manufactures

Quality is a degree to which a set of inherent characteristics fulfills requirements. The term quality is also defined as a totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs. Similarly, quality manual defines the scope of the quality management system, including details of and justification for any exclusion. ISO 13485 Quality Manual references the procedures detailing the actual means by which the system operates and demonstrates the interaction between the processes which make up the system. Changes to the Quality manual that effect conformity to ISO 13485 or Regulatory requirements are submitted to the Registrar used by Systems.

The Quality Management Systems described in ISO 13485 Manual is specific to non-sterile and non-implantable medical devices components. Quality manual provides reference to the procedures established for the Quality Management System and also shows the relationship between the procedures and the requirements of the Quality Management Standards.  Measurable quality objectives are established at the appropriate functions throughout the organization that are relevant in supporting the quality policy, meeting the requirements for products and processes, improving quality and performance, and maintaining and enhancing customer satisfaction.

The quality management system for medical device manufactures is carried out in order to meet the requirements given in the quality manual as well as the quality objectives, and that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. Including, those needed to meet requirements for the product, are established for relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy and include the planning of product realization to include the quality objectives and requirements for relevant the product.

ISO 13485 Document Procedures

ISO 13485 is often compared to ISO 9001 and is a type of quality standard. It is an international standard that has to do with the quality management system for medical devices. This is a standard that meets the requirements of the regulatory effect and ensure that medical devices are manufactured in a correct manner and are out of good quality.

ISO 13485:2003 specifies requirements of 15 additional documented ISO 13485 procedures as listed bellow for use in the planning, operation, control and monitoring:

• Procedures for Maintaining facilities and equipment that affect the quality of medical devices.
• Procedure for Managing risk in the realization of medical devices (including their distribution, installation and servicing).
• Procedure for Designing and developing medical devices and associated installation, maintenance and disposal or recycling information.
• Procedure for Purchasing goods and services for the design, manufacture and distribution of medical devices.
• Procedure for validating the use of computer software.
• Procedure for validating sterilization processes.
• Procedure for Identifying and controlling medical devices according to their status.
• Procedure for maintaining the traceability of medical devices and their components.
• Procedure for Preserving medical devices and constituent parts.
• Procedure for controlling products requiring special storage conditions.
• Procedure for Using and calibrating monitoring and measuring equipment for manufacture, installation, use and servicing of medical devices.
• Procedure for Gathering and using medical device customer feedback.
• Procedure for Inspecting and testing medical devices and their components.
• Procedure for Determining, collecting and analyzing medical device QMS data.
• Procedure for Issuing and implementing Advisory Notices.