ISO 13485:2016 sets the international standard for Quality Management Systems (QMS) in the medical device industry. Implementing and retaining an effective QMS is crucial for manufacturers to illustrate their dedication to affected patient safety and regulatory compliance.
One of the only ways to make certain a strong QMS is through comprehensive auditing. ISO 13485 lead auditor training equips individuals with the knowledge and capabilities necessary to conduct thorough and effective audits of medical device QMS. This training provides helpful insights into the intricacies of the standard, enabling auditors to identify ability non-conformities and recommend corrective actions.
