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ISO CONSULTANTS      ISO 9000/14000      CE MARKING                                

 ISO 13485:2003(E)

This 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 harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices & 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 can not claim conformity to ISO 9001 unless their Quality management systems conform to all the requirements of ISO 9001.

All requirements of this International Standard are specific to organizations providing medical devices. Regardless of the type or size of the organization.

If any 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 this International Standard reflect exclusion of design and development controls.

The process required by this International standard which are applicable to the medical devices (s), but which are not performed by the organization’s quality management system.

In this International Standard the terms “If appropriate” & “Where appropriate” are used several times. When a requirement is qualified by either of these phrases, It is deemed to be “appropriate” unless the organization can document a justification otherwise. A requirement is considered “appropriate” if it is necessary in order for

           The product meet specified requirements ,and/or
           The organization to carry out corrective action.

PROFILE  I  ISO 9000/14000   ISO 13485:2003 (E)     ISO 27001 :2005     ISO 22000