ISO 13485:2016 Lead Auditor

Level Lead auditor Duration 5 days

Available to book: Virtual classroom $4695 View dates and book now

From managing an audit programme to reporting on results, this lead auditor training course teaches you everything needed to conduct a quality management system (QMS) audit.

Led by experienced instructors over five days, the training is suited to quality managers, directors, engineers or consultants. It will help you fully identify the benefits of a QMS and explain the role of the auditor.

On completing this stage of your learning journey, you will be able to apply risk-based thinking, leadership and process management and understand the arrangements for BSI certification.

How will I benefit?

Identify the aims and benefits of an ISO 13485:2016 audit
Plan, conduct and follow up on auditing activities
Build stakeholder confidence by understanding the latest requirements

On completion of this training, participants will be able to:
- Interpret the requirements of ISO 13485:2016 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 13485:2016
- Manage the duties of a lead auditor in their organization or for a third-party
- Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
- Consultants
- Internal and external Auditors
- Anyone involved in implementing and/or auditing quality management systems for medical devices
- It is recommended that participants first attend the ISO 13485 Internal Auditor training course prior to completing the lead auditor course
Each delegate must demonstrate acceptable levels of performance against all course learning objectives, which is evaluated during course activities. Performance is recorded daily by the tutor using the Personal Continuous Assessment Record (PCAR). In order to satisfactorily complete the course, each delegate must complete/attend all elements of the course, pass the continuous assessment and written examination.

The written examination is an online examination which is done on day 5 of the course. Delegates will receive a link to access the exam and have 24hrs to successfully complete the examination. On successful completion, we’ll email you a copy of your Certificate of Achievement.

The examination permits access to the ISO 13485 standard and a dictionary during the exam. The pass mark is 56 or 70%
- A loan copy of the standard for use during the course
- Gain 40 CPD points on completion and comprehensive training notes
- Gain an internationally recognized BSI Training Academy certificate
Delegates who attend this course must have the following:
- Knowledge of the requirements of ISO 13485
- Knowledge of the following quality management principles and concepts -
- The Plan, Do, Check, Act (PDCA) cycle
- 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 structure and content of ISO 13485, based on the process approach and PDCA
- Knowledge of management systems auditing and ISO 19011
If you do not meet the requirements above, we highly recommend attending the ISO 13485 Clause by Clause and ISO 13485 Internal Auditor course prior to attending the lead auditor course.

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