ISO : 13485:2003 (Medical Devices)
ISO 13485 is based on ISO 9001 and supplemented with additional quality Management requirements relating to design, special processes, documentation, records, traceability, documentation records, and regulatory actions. Unlike ISO 9001, which requires organizations to demonstrate continual improvement, ISO 13485 requires only that an organization demonstrate that the quality system for medical device manufacturing is implemented and maintained.
Although being registered does not fulfill the requirements of the various industry regulators, such as those of the U.S. Food and Drug Administration (FDA), ISO 13485 is commonly used as the basis for regulatory requirements. As such, the ISO 13485 standard is an essential consideration not only for exporters but also for the local market, global suppliers, and subcontractors to prove that their edical device products are of the highest quality.
ISO 13485 international standard specifies requirements for a quality Management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of this international standard is to facilitate medical device regulatory requirements for quality Management systems. As a result, It includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory Requirements. Because of these exclusions, organizations whose quality Management a system conforms to this international standard cannot claim conformity to ISO 9001 unless their quality Management systems conform to all the requirements of ISO 9001.
The organization shall establish, document, implement and maintain a quality Management system and maintain its effectiveness in accordance with the requirements of this International Standard.
Monitor, measure and analyze these processes, and Implement actions necessary to achieve planned results and maintain the effectiveness of these processes.
These processes shall be managed by the organization in accordance with the requirements of this International Standard.
Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality Management system (see 8.5.1).
Processes needed for the quality Management system referred to above should include processes for Management activities, provision of resources, product realization and measurement.
Where this International Standard specifies that a requirement, procedure, activity or special arrangement be documented, it shall, in addition, be implemented and maintained.
For each type or model of medical device, the organization shall establish and maintain a file either containing or identifying documents defining product specifications and quality Management system requirements. These documents shall define the complete manufacturing process and, if applicable, installation and servicing.
The extent of the quality Management system documentation can differ from one organization to another due to