The ISO 13485:2016 training course presents a key market opportunity for medical device organizations to enhance their quality management systems, ensuring compliance with industry and regulatory ...

The U.S. FDA’s October 2025 draft guidance for quality management system information in premarket filings may have struck some observers as an example of regulatory overreach, given the robust ...

All firms that perform accounting or attest engagements must have their new quality management system in place by Dec. 15, 2025. These new standards require firms to develop quality objectives around ...

Opinions expressed by Digital Journal contributors are their own. In today’s environment, the need for a quality management system is not merely a luxury. Still, instead, it is an essential ...

Fabasoft, a leading European cloud vendor for document and business process management, has been positioned as a Challenger ...

How often and how much does your firm think about quality? Every auditor is, by nature, committed to quality. Every firm has final quality control steps built into its production process. However, ...