Whether you are auditing a critical supplier for compliance with 21 CFR Part 820 or conducting an internal MDSAP audit for another facility within your company, the audit report is the most important output of your hard work. The audit report represents the who, what, why, and how of the audit…and your primary goal is to get people to take action. How you go about crafting that report will make a big difference in what action is taken on your insights and recommendations.…» Read more
Management system standards such as ISO 13485:2016 define the requirements that auditors are reviewing for conformance – the what – but they don’t get into the details of how to audit against them. ISO 19011, on the other hand, does just that – it provides a methodology to guide auditors in doing their work by adding further context and guidance.
ISO 19011 was previously updated in 2011. Since then, the practice of auditing has evolved in the ways that audits are managed, planned, and executed.…» Read more
For decades, the medical device industry has largely viewed the US Quality System Regulation (QSR) as a regulatory speedbump on the path to market access. Despite the regulation’s name, product quality has typically taken a back seat to regulatory compliance for manufacturers.
That’s understandable, since FDA’s inspection-oriented approach has rigorously emphasized compliance with specific aspects of 21 CFR Part 820. In recent years, FDA has had an epiphany of sorts. FDA inspectors had been seeing a high volume of the same issues year after year and, after talking with numerous industry stakeholders, FDA concluded that the regulations simply were not sufficient on their own to ensure high product quality and patient safety.…» Read more