It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this International Standard. However, this International Standard enables an organization to align or integrate its own quality management system with related management system requirements. This International Standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, or financial management.
Iso 13485 2003 pdf iso#
This International Standard follows the format of ISO 9001 for the convenience of users in the medical device community. ISO/TR 14969 is a Technical Report intended to provide guidance for the application of ISO 13485.Ġ.4 Compatibility with other management systems The nature and reasons for the text changes are noted in Annex B. Where the text of this International Standard is not identical to the text of ISO 9001, the sentence or indent containing that text as a whole is shown in italics (in blue italics for electronic versions). The fact that these subclauses are presented unchanged is noted in Annex B. Those clauses or subclauses that are quoted directly and unchanged from ISO 9001 are in normal font. While this is a stand-alone standard, it is based on ISO 9001. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the "process approach". Often the output from one process directly forms the input to the next. This International Standard is based on a process approach to quality management.Īny activity that receives inputs and converts them to outputs can be considered as a process.įor an organization to function effectively, it has to identify and manage numerous linked processes. There is a wide variety of medical devices and some of the particular requirements of this International Standard only apply to named groups of medical devices. It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation. The design and implementation of an organization's quality management system is influenced by varying needs, particular objectives, the products provided, the processes employed and the size and structure of the organization. The adoption of a quality management system should be a strategic decision of an organization. It is emphasized that the quality management system requirements specified in this International Standard are complementary to technical requirements for products. Information marked "NOTE" is for guidance in understanding or clarifying the associated requirement.
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It can also be used by internal and external parties, including certification bodies, to assess the organization's ability to meet customer and regulatory requirements.
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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. This edition of ISO 13485 has a revised title and addresses quality assurance of product, customer requirements, and other elements of quality system management.
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Those organizations which have used ISO 13488 in the past may use this International Standard by excluding certain requirements in accordance with 1.2. It also cancels and replaces ISO 13488:1996. This second edition cancels and replaces the first edition (ISO 13485:1996), which has been technically revised. ISO 13485 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices.