ISO 13485:2016 Lead Auditor Training Course

Level Lead auditor Duration 5 days

Available to book: Instructor led training £2995 + VAT View dates and book now

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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
Gain 40 CPD points on completion of the course

On completion of this training, participants will be able to:
- Gain the skills to plan, conduct, report and follow up an audit in accordance with ISO 19011
- Identify the purpose and benefits of an ISO 13485:2016 QMS
- Explain the role of an auditor in planning, conducting, reporting and following up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate)
- Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
- Management representatives
- Quality directors, managers, and engineers
- Consultants
We are:
- A full scope Notified Body
- A full scope UK Approved Body
- A national Standards Body
- An accredited ISO 13485 Certification Body
- A recognized Auditing Organization under the Medical Device Single Audit Program
- A globally recognized Certification Body
The residential and non-residential courses both include:
- You will gain 40 CPD points on completing the course
- Course notes
The residential option also includes 4 nights accommodation and evening meals from the first day of the course.

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