ISO 13485 - Auditing in medical quality management

About the training Auditing in medical quality management according to ISO 13485

This training on Auditing in medical quality management according to ISO 13485 helps you achieve and improve auditor knowledge and skills. You will also learn to choose the right approach for your audits to provide more added value for your organization. As a trainee, you will practically engage in auditing against ISO 13485 according to the principles of ISO 19011, under the guidance of an experienced trainer.

A good auditor not only contributes to achieving compliance with standards but also significantly contributes to improving business processes and thereby to business results. Upon completion of this training, you will be able to prepare, conduct, and report on internal or supplier audits. This is based on the quality management system in accordance with the ISO 13485 standard. Afterward, you will know:

• The key points of ISO 19011 (guidelines for auditing management systems)
• The steps to go through in the audit process
• The methods for preparation, execution, and reporting
• Various audit interview and reporting skills
• The new emphasis ISO 19011 places, including on risk-based audits

When conducting audits as part of your company's ISO 13485 certified quality management system, it is advisable to use the so-called "risk-based approach." The ISO 19011:2018 standard provides new insights that help improve your audit process. You will learn:

• Concept formation and definitions
• The new emphasis ISO 19011:2018 places on risk-based audits
• Audit requirements
• Basic principles of auditing
• Exercise: adopting the right attitude
• Audit objectives - at what level to audit?
• Pitfalls in developing audit programs
• Process audits versus (EN) ISO 13485
• Audits as a management tool and risk-based audits
• The audit process
• Interaction with the auditee(s)
• Interview techniques (including practice)
• Reporting
• Validation of findings
• Follow-up of audit findings
• Competence and evaluation of auditors
• Real-life cases (using provided documentation)

The training is packed with practical exercises covering all aspects of the audit process. The practice of preparing, conducting, and reporting audits is approached surprisingly realistically.