ISO 13485: 2016 has not been revised according to the new High Level Structure (HLS) like ISO’s other management system standards, which have been recently revised parallel to the HLS. Therefore to use it together with the ISO 9001: 2015 will not be easy for the manufacturers. 13485: 2016 still has the basic structure of the 2003 version. It has been revised in order to clarify some requirements and enhance product safety and compliance to the regulatory requirements. Highlights of these revised requirements can be listed as;
- Legal Requirements
- Risk management
- Verification, Validation and Design Transfer
- External Process Control
- Feedback and PMS
Risk management and compliance with regulatory requirements have been referenced in most of the requirements parallel to the applicable legislation, which have been set as the main market regulations.
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