Audits are a necessary and potentially difficult reality for device manufacturers. Ensuring that your organization has the ability to successfully manage an audit is pivotal, and involves an examination of the ongoing business processes as well as current audit management capabilities. When deciphering the criteria needed to pass an audit we can look at 4 key factors; the culture, system, logistics and people.
The culture and system are internal components dictated by how the business is managed. Having systems, policies and procedures in place that a focus on quality, compliance, enterprise risk management and change control are critical. To quote John Daley (Multi-Site Vice-President Quality, Boston Scientific) “The real key is to manage the business so you don’t have to manage the audit!”.
In this second part of our infographic series, we look at the human element involved in successful audit management.
For more in-depth information on successful audit management, consider attending the American Medical Device Summit taking place this September in Chicago.