PECB Certified Course: ISO 13485 Lead Auditor

Develop the skills to plan, lead and close audits of an ISO 13485 management system.

This advanced auditing course focuses on assessing medical devices quality management systems against ISO 13485. It applies recognized audit principles to audit preparation, evidence collection, on-site work, reporting, follow-up, audit-team leadership and audit-program management, with reference to ISO 19011 and the ISO/IEC 17021-1 certification process.

Course at a glance

• Provider and awarding body: PECB.
• Learning format: PECB Self-Study (official course materials).
• Language: English.
• Level: Lead Auditor.
• Examination and certification-application cycle: 12 months from purchase for the first examination attempt, the included free retake if needed, and the certification application.

What this course includes

• More than 450 pages of official PECB instructional materials containing explanations, guidance and practical examples.
• The first examination attempt and one free retake.
• The certification-application fee and the first year of the Annual Maintenance Fee, where applicable.
• A course-completion attestation worth 31 CPD credits, separate from the PECB professional credential.

What you will learn

After completing the course, the learner should be able to:

• interpret ISO 13485 requirements from an auditor's perspective;
• plan and initiate an MDQMS audit;
• conduct and document audit activities and findings;
• close and follow up an audit and support audit-program management.

Who this course is for

• Auditors preparing to perform or lead MDQMS audits.
• Managers and consultants overseeing ISO 13485 audit activities.
• People responsible for maintaining conformity with MDQMS requirements.
• Technical experts and advisers preparing organizations for audit.

Prerequisites: PECB expects a fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.

Course outline

• Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485
• Audit principles, preparation and launching of an audit
• On-site audit activities
• Closing the audit
• Certification Exam

Exam and credential pathway

The exam addresses MDQMS concepts and requirements, audit principles, audit preparation and conduct, closing an audit and managing an ISO 13485 audit programme.

Passing the course examination enables an application to the applicable PECB ISO 13485 Auditor pathway. The awarded designation depends on meeting the relevant professional and audit-experience requirements, together with the application and ethics requirements.

Course completion, examination success, certification application and credential issuance are separate stages; the credential is not issued automatically.

For official course details, see the PECB ISO 13485 Lead Auditor page.

Access and activation

The 12-month period for the first examination, included free retake and certification application begins on the purchase date.

Each order covers one learner. Wadi Solutions begins processing the PECB registration within one business day, and activation details are sent to the learner's email. Required enrolment details are shared with PECB for activation.

Continue your learning path

• ISO 13485 Foundation
• ISO 13485 Lead Implementer

Explore ISO 13485 — Medical device quality courses to see the available options.

Before you buy

• If you do not have a myPECB account, create one here.
• If your myPECB email differs from the email used for your Wadi Solutions order, add your myPECB email to the order notes.