Regulatory Auditing Strategy

This document gives guidance to regulators and auditing organizations conducting audits of quality management systems of medical device manufacturers based on the process approach to quality management system requirements (e.g., ISO 13485:2003 and 21 CFR Part 820). Potential benefits for the regulators or auditing organizations include: improved auditing, leading to improved quality management systems and product quality achievement of greater consistency in audits both among auditors within an auditing organization and between auditing organizations promotion of greater collaboration between regulators in regard to audits increased confidence in audits performed by an auditing organization and acceptance of those audits by other regulators more efficient use of auditing resources guidance for countries intending to develop a strategy for auditing quality management systems.