The ISO 13485 Manual describes the quality management systems structure which has been implemented to meet the ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes.

The purpose of ISO 13485 Manual is to define and describe the quality system, powers and responsibilities of the management to define the operation of the system, and a general description of all processes that provide the quality system. This Manual is also used to present the quality of customers, suppliers, regulators and other external stakeholders, and to inform them about the specific checks that are performed in Services to ensure the quality of their system.

ISO 13485 Manual deals with the Quality System Regulation and the basic Good Manufacturing Practices require that all producers and distributors should consider when they plan to medical devices, including medical devices, kits, trays or packs, for manufacturing and distribution. The Quality System regulation outlines the minimum elements of a system for the design and manufacture of medical devices. Medical device manufacturers often find that their quality needs to be wider than meet these basic elements as a result of the additional need for Quality Company.

ISO 13485 Manual for Medical Devices also governs the creation of quality related documents. It will be revised, as necessary, to reflect the quality system currently in use. It is issued on a controlled copy basis to all internal functions affected by the quality system and on an uncontrolled copy basis to customers and suppliers. It may be issued to customers on a controlled copy basis upon customer request.

The management of any Organization is committed to implementing, and maintaining a documented quality system. This commitment includes: ensuring that customer, regulatory and legal requirements are understood and appropriately addressed, the quality policy is understood and implemented at all levels of the organization, quality objectives and plans are established as necessary and that the responsibilities of all functions affecting quality are clearly defined. In addition of this, the management Organization establishes annual key initiatives, which include quality objectives. The objectives are established via the Management Review Procedure and communicated to all levels of the organization for use in establishing each function’s and employees annual key objectives. Quality objectives are measurable, include business performance indicators reflecting requirements for products/services, and are consistent with the quality policy. Hence, on the basis of these necessary requirements ISO 13485 Quality Manual enables Management that will make provisions for the necessary resources and personnel to maintain the system, including a management representative, who will ensure that the requirements of this manual are met. Management will review the system annually to determine its effectiveness.

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