ISO 13485
OVERVIEW:
ISO 13485* (and variations such as DIN EN ISO 13485) is an internationally recognized quality standard which states the requirements of the uality Management System (QMS) for the design and manufacture of Medical Devices. While it remains a stand-alone document, ISO 13485 is based on ISO 9001 with some additional clauses as well as the removal of some requirements.
ISO 13485 / DIN EN ISO 13485 2012 requires more attention to regulatory requirements and the exception of 9001 requirement of continuous improvement. ISO 13485 only asks for the QMS to be implemented and maintained.
Benefits of ISO 13485
ISO 13485 is recognized by the Global Harmonization Task Force (GHTF) and has become the model QMS standard for the medical industry. ISO 13485 certification provides:
Global Recognition - ISO 13485 Standard is recognized in major markets around the world
United States of America
Europe
Canada
Japan
Australia
Meet legal, regulatory, contractual and marketing requirements
Although not fully harmonized, an ISO 13485 Quality Management System (QMS) is very close to the Food and Drug Administrations (FDA) QSR standards.
Improved product safety
Like ISO 9001, a solid QMS provides:
Increased Efficiency
Cost Savings
More Effective Risk Management
Increased likelihood of meeting Customer Requirements
ISO 13485:2007 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 ISO 13485:2007 is to facilitate harmonized 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 systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2007 reflect exclusion of design and development controls.
If any requirement(s) in Clause 7 of ISO 13485:2007 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.
The processes required by ISO 13485:2007, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system.