ISO 13485:2016 Medical Devices Quality Management Systems Auditor/Lead Auditor Training Course
IRCA Certified Course (18190)
BSI’s “Medical Devices – Quality Management Systems Auditor/Lead Auditor Training Course (ISO 13485:2016)” course teaches the principles and practices of effective quality management system audits against ISO 13485, in accordance with ISO 19011, “Guidelines for auditing management systems” and ISO 17021, as applicable. Experienced BSI tutors will guide delegates through the entire audit process, from initiating the audit through to conducting audit follow-up.
Gain the confidence to effectively audit a QMS in accordance with internationally recognized best practice techniques against the requirements of ISO13485:2016. Consolidate your expertise with the latest developments and contribute to the continuous improvement of your quality system, leading to greater patient safety. You’ll grasp the key principles and practices of effective QMS audits in line with ISO 13485:2016 and ISO 19011 “Guidelines for auditing management systems”.
Using a step-by-step approach, you’ll be guided through the entire audit process from initiation to follow-up. Over 5 days, you’ll gain the knowledge and skills required to undertake and lead a successful management systems audit. Learn to describe the purpose of an ISO 13485:2016 QMS audit and satisfy third-party certification. You’ll acquire the skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.
Who should attend?
- Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
- Management representatives
- Quality directors, managers, and engineers
This course teaches auditing principles using ISO 13485, therefore a knowledge of ISO 13485 and its application within a Medical Device organization is strongly recommended together with internal audit experience.
What will I learn?
Upon completion of this training, delegates will be able to:
- Describe the purpose of a quality management system, of quality management systems standards, of management system audit and of third-party certification
- Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011 (and ISO 17021 where appropriate)
- Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485 and in accordance with ISO 19011 (and ISO 17021 where appropriate)
Our high impact accelerated learning approach increases learning by improving knowledge retention and skill application. This course is activity-based, resulting in a deeper understanding of the material and a greater impact on job performance.
How will I benefit?
Successful completion of this IRCA certified training course by passing the relevant IRCA examination and skills assessment, will demonstrate knowledge and basic skills to undertake and lead a management systems audit.
Before attending this course, delegates are expected to have:
- Knowledge of the following quality management principles and concepts:
- The Plan, Do, Check, Act (PDCA) cycle
- The relationship between quality management and customer satisfaction
- Commonly used quality management terms and definitions and the 8 Quality Principles as given in ISO 9000
- The process approach used in quality management
- The Model of a Process Based Quality Management System, the structure and content of ISO 13485
- Knowledge of the requirements of ISO 13485
It is advisable that delegates have either attended an internal auditors course, or had experience with conducting internal or supplier audits
- Training course notes
- Lunch & refreshments
- Loan copy of the standard (to be returned after the course)