The maintenance of regulatory compliance relies on audits. What frequent problems arise during internal or external audits of a QMS and how can companies prepare to avoid these pitfalls?
During audits of a Quality Management System (QMS), common issues that pop up include incomplete documentation, non-conformities with procedures, and missing or outdated training records. Companies often face challenges with risk management or ineffective corrective actions as well. To avoid these pitfalls, it's important to keep documents up to date, conduct regular internal audits to catch problems early, and ensure employees are properly trained with records to prove it. A good risk management process and making sure corrective actions are actually working can go a long way in preparing for a smoother audit.
