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.
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.
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