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 Internal 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
Internal Auditor, which focuses on developing 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 internal auditing 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:

• Prove to your management, organization, and clientele that you have been
  recognized as a competent individual who knowledgeable in auditing medical
  device quality management systems
• Add value to your personal CV/resume and elevate your professional career as
  an 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 audit
  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 auditor
• Complete all stages of an internal 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 internal audit activities within their organization, specifically those auditing Quality Management Systems.

Duration

4 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 Internal Auditor, walks you through
the auditing process from start to finish, leveraging case study to help you apply
your knowledge. Finally, the Advanced Auditor course will home in 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 Internal 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.