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The PECB ISO 13485 Lead Auditor exam is designed to evaluate the knowledge and skills of individuals seeking to audit a Quality Management System (QMS) based on the ISO 13485 standard, which is specifically for medical devices. Here’s an overview of the exam format and topics covered:

Exam Format

• Type: The exam typically consists of multiple-choice and essay-type questions.
• Duration: The exam duration is generally three hours.
• Language: The exam is available in multiple languages, including English.
• Delivery Mode: The exam can be taken as a paper-based test (PBT) or online through a PECB partner.
• Open Book: The exam is open book, allowing candidates to use the ISO 13485 standard and other reference materials during the exam.

Exam Topics

The PECB ISO 13485 Lead Auditor exam covers a range of topics related to auditing a QMS for medical devices. These topics are organized into several domains:

1. Fundamental Principles and Concepts of ISO 13485
   • Understanding the purpose and structure of ISO 13485
   • Key concepts and quality management principles specific to medical devices
   • The regulatory environment and requirements for medical devices
2. Quality Management System (QMS) Requirements
   • Detailed knowledge of ISO 13485 requirements
   • Understanding the context of the organization and the needs of interested parties
   • Risk management in the design and implementation of QMS for medical devices
3. Fundamental Audit Concepts and Principles
   • Understanding the principles, processes, and types of audits
   • The role of an auditor in ensuring compliance with ISO 13485
   • Ethics and professional conduct in auditing
4. Preparing for an ISO 13485 Audit
   • Initiating the audit, including audit scope, objectives, and criteria
   • Developing an audit plan and audit checklist
   • Preparing audit documents and understanding the organization’s context and processes
5. Conducting an ISO 13485 Audit
   • Conducting opening meetings and interviews
   • Observing and gathering audit evidence
   • Document review and sampling techniques
   • Managing audit team roles and responsibilities
6. Reporting the ISO 13485 Audit
   • Preparing audit findings and conclusions
   • Writing clear, concise, and objective audit reports
   • Conducting closing meetings and communicating audit results
7. Follow-up on an ISO 13485 Audit
   • Verification of corrective actions taken to address nonconformities
   • Monitoring the implementation of corrective and preventive actions
   • Managing follow-up audits and reporting on the status of corrective actions
8. Audit Closure
   • Ensuring all audit objectives have been met
   • Finalizing audit documentation
   • Evaluating the effectiveness of the audit process

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