How does it work?

Certified Professional certification is the next step in recognizing and building upon your accomplishments in the ISO 13485: 2016 LeadAuditor qualification pathway. There are no additional training or assessment components required to achieve Certified Professional certification.

To qualify, you must have completed an ISO 13485: 2016 Lead Auditor qualification and have at least three years’ professional experience in industry.

Certified Professional certificate is valid for three years, after which you will need to reapply to maintain your certification.

What will you achieve?

Upon successful completion, you’ll receive the Certified Professional ISO 13485: 2016 Lead Auditor Mark of Trust, which you can share with your professional network.

Prerequisites 

The prerequisites to become a certified  professional are as follows:

• A BSI ISO 13485: 2016 Lead Auditor qualification pathway or equivalent. All equivalent qualifications must be submitted to and approved by BSI as Recognized Prior Learning (RPL).
• At least three full management system audits conducted within the last three years from the date of application, against the standard for which the applicant is seeking certification.
• At least three years of relevant industry experience.

The prerequisites for renewal of certified status are as follows:

• Valid and active certified status for the last three years
• Three annual declarations of CPD: one for each year of the valid certified status period

How do you apply?

To apply, please complete the following:

• Enroll in the application and pay the application fee.
• Complete the application form and updoad it into the system. 

To maintain your certification, you must submit an annual declaration confirming that you have completed at least 15 hours of relevant Continuing Professional Development (CPD) each year to uphold your Certified Professional status.