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ISO 13485:2013 Consultants in Madikeri, Karnataka
ISO 134845:2013
BS EN ISO 13485:2003/BS EN ISO 13485:2012 Quality management system certification in the field of medical devices. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485:2003 reflect exclusion of design and development controls in Madikeri Karnataka India.
ISO 13485:2003 is the medical industry�s equivalent of ISO 9001:2000. Whereas the standards it replaces were interpretations of how to apply ISO 9001 and ISO 9002 to medical devices, ISO 13485:2003 is a stand-alone standard in Madikeri Karnataka India. Compliance with ISO 13485: 2003 does not necessarily mean compliance with IS0 9001:2000. ISO 13485:2013 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 in Madikeri Karnataka India.
ISO 9000 is a family of standards for quality management systems. ISO 13485:2003 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies in Madikeri Karnataka India . ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems in Madikeri Karnataka India.
Some of the requirements in ISO 13485 (which is one of the standards in the ISO 13485:2012 family) include:-
A set of procedures that cover all key processes in the business;
Monitoring processes to ensure they are effective;
keeping adequate records;
Checking output for defects, with appropriate and corrective action where necessary;
Regularly reviewing individual processes and the quality system itself for effectiveness; and facilitating continual improvement. ISO 13485:2003 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 in Madikeri Karnataka India.
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