Tips to take the mystique out of the internal audit process. The examples provided give you insight into the 3^rd party auditor’s perspective.

The quality environment has evolved to require the use of a risk based approach throughout the quality management system.

New changes to ISO 13485, published this spring as EN ISO 13485:2016, mean U.S. medical device companies that sell in Europe will need to integrate risk-based approaches throughout their quality management systems. The emphasis on risk management is the biggest of several changes in the third version  of ISO 13485.