Gain the confidence to effectively audit a Quality Management System (QMS) in accordance with internationally recognized best practice techniques against the requirements of ISO 13485:2016. 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.
BSI's CQI and IRCA ISO 13485 Medical Devices QMS Lead Auditor: Practitioner Package
This package is a structured learning pathway that combine carefully selected courses with rigorous assessments that guarantee their relevance. In this practitioner package, it includes:
- 4 hours on-demand eLearning ISO 13485 Medical Devices QMS requirements training course (available 24/7, complete flexibility and time-efficient) and;
- 5-days CQI and IRCA ISO 13485 Medical Devices QMS lead auditor training course (virtual instructor led training)
Assessment
Each course is followed by a mandatory online multiple-choice examination. Delegates must pass the examination to be awarded the qualification - BSI Mark of Trust.
Why practitioner package?
- This qualification focuses on building a strong understanding of the fundamentals of the subject, enabling you to increase your performance and effectiveness within your role to the standard expected.
- Unlimited access to ISO 13485 Medical Devices QMS requirements on-demand eLearning training course prior the lead auditor training course for better understanding.
- Opportunity to level up your achievements to professional level and the highest level of qualification, certified professional.
- Showcasing your expertise with BSI’s Mark of Trust on business cards, social media and official documents.
- Fully claimable under HRD Corp claimable course.
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
- Consultants
Prerequisites:
- 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
This course teaches auditing principles using ISO 13485, therefore a basic knowledge of ISO 13485 and its application within a Medical Device organization is strongly recommended together with internal audit experience.
It is advisable that delegates have either attended an internal auditors course, or had experience with conducting internal or supplier audits
What will I learn?
On completion of this training, participants will be able to:
- Interpret the requirements of ISO 13485 in the context of an audit
- Describe the purpose of a quality management system and explain the 8 principles of quality management
- Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011
- Plan, conduct, report and follow-up on a QMS audit in accordance with ISO 19011 and by interpreting ISO 13485
- Manage the duties of a lead auditor in their organization or for a third-party
What is included?
You will sit a 2 hour exam to test your knowledge and understanding. Detailed course notes and lunch provided. IRCA course reference number: A18190.
On completion, you will be awarded an internationally recognized BSI Training Academy certificate.
Benefits of completing ISO 13485 Medical Devices QMS lead auditor course
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 system audit.
Discover our ISO 13485 Qualifications
Our ISO 13485 auditor qualifications will give you a BSI Mark of Trust, reassuring your customers and suppliers that your skills have been validated. You can achieve Practitioner or Professional status by successfully completing courses, exams and demonstrating practical application.
