The BSI Training Academy offers Qualification Pathways for those seeking to earn
professional qualification from an internationally recognized standards institute.
This pathway is designed to equip participants with the knowledge and skills
required to achieve BSI’s prestigious Lead Auditor Professional qualification for
the ISO 13485:2016 standard. It consists of three sequential courses: ISO
13485:2016 Requirements, which provides an in-depth understanding of the
medical device quality management standard's framework; ISO 13485:2016 Lead
Auditor, which focuses on developing lead auditing skills to assess MD quality
compliance effectively; and Advanced Auditing Skills, which sharpens the ability to
handle complex auditing scenarios. Participants who complete all three courses
and successfully pass their respective qualification exams will earn a professional
qualification, symbolized by BSI’s “Mark of Trust” badge demonstrating their
advanced competency in leading audits for the ISO 13485:2016 standard. This
pathway is ideal for professionals committed to excelling in medical device quality
auditing and compliance.

How will I benefit? 

Earning this qualification will help you:

• Prove to your management, organization, and clientele that you have been
  recognized as a competent individual who knowledgeable in leading audits of
  medical device quality management systems
• Add value to your personal CV/resume and elevate your professional career as
  a lead auditor
• Ensure your organization remains compliant to the international standard for
  medical device quality management systems
• Equip you with the skills and technical information to elevate your lead auditor abilities to the next level

What will I learn?

By the end of this qualification pathway, you will be able to:

• Identify key concepts, principles, and structure of the ISO 13485 standard
• Recognize the terms and definitions used within a medical device quality
  management system
• Describe the process of auditing a medical device quality management
  system
• Recognize key audit activities and the roles and responsibilities of an
  auditing team from the perspective of a lead auditor
• Complete all stages of an audit in accordance with ISO 19011
• Understand a variety of approaches to conducting an audit
• Improve communications and reporting skills
• Demonstrate the value of auditing and gain buy-in across the business
• Make informed decision on the applicability and viability of remote, virtual,
  and hybrid audits
• Consider risk-based auditing when developing an audit program
• Effectively recognize and implement corrective action management
• Assess continual process improvement tools

Who should attend?

This qualification pathway is suited for anyone who currently is or will be
coordinating Lead audit activities within their organization, specifically those
auditing Medical Device Quality Management Systems.

Duration

6 days

How will I learn?

This qualification pathway is divided into three separate courses. The first course,
ISO 13485:2016 Requirements, will cover the ins and outs of the Information
Security standard, and provide an essential foundation for the rest of your auditor
training. The second course, ISO 13485:2016 Lead Auditor, walks you through the
auditing process from the perspective of an auditing team lead from start to
finish, leveraging case study to help you apply your knowledge. Finally, the
Advanced Auditor course will focus on auditing-best-practices and teach
techniques and methods that will lead to more efficient and effective internal
audits.

What will I gain?

On completion of the courses and after passing the three qualifications exams,
you will earn BSI’s ISO 13485 Lead Auditor Professional qualification, including BSI’s Mark of Trust qualification badge, which you can share on your CV, emails,
and social media sites such as LinkedIn.

Further information

Delegates that complete the individual courses without passing the necessary
qualifications exams will still earn receive certificates of attendance.

Course Materials

Soft Copy: You will receive an email prior to the course with instructions on how to access the online Student Handbook, which can be viewed, downloaded or printed.

NOTE: Copies of the standards are not included in the class fee.

BSI will make reasonable efforts to have loaner copies available for use during the class, but students are encouraged to have their own copy. Soft copies of the digital loaner standard cannot be printed or downloaded.

Course Logistics

If your class is Live Online:

• Students need to connect to the class from any internet accessible location.
• Webcam and Microphone are REQUIRED.
• ALL course times shown are US EASTERN TIME.

If your class is In-person :

• You are encouraged to bring a laptop with you to class.

*Session lengths could vary depending on amount of class discussion.