Lead Auditor IRCA Certified ISO13485:2016
During the 5 days participants will acquire knowledge and skills in auditing. However, auditing like any other acquired skill requires practice. The best place to practice and extend your experience is during actual audits.
By the end of the course participants will be able to:
- Describe the purpose of a quality management system and explain the 8 principles of quality
- Explain the purpose, content and interrelationship of ISO 9000, ISO13485, ISO 9004 and ISO 19011
- Interpret requirements of ISO 13485 in the context of an audit
- Manage an audit programme
- Understand the different types of audits.
- Describe the roles and responsibilities of auditors and lead auditors
- Plan and conduct an audit in accordance with ISO 19011, demonstrating ability to:
- plan and prepare effectively
- gather objective evidence, through effective interviewing, observation, sampling and note taking
- analyse and interpret information in order to determine conformance with requirements
- Report the audit, including writing valid, factual and value-adding non-conformity reports
- Undertake audit follow-up activities, including evaluating the effectiveness of corrective action
- Professionally liaise with external auditors
- During the 5 days participants will acquire knowledge and skills in auditing
Who should attend
Personnel involved in the internal auditing, developing and implementing QMS, quality department staff and also to those who wish to become practising auditors.
ISO13485 IRCA certification