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The PECB ISO 13485 Lead Implementer exam is designed to evaluate a candidate’s knowledge and skills in implementing a Quality Management System (QMS) based on ISO 13485, which is the international standard for medical device quality management systems. Here’s a detailed overview of the exam format and topics:

Exam Format

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

Exam Topics

The PECB ISO 13485 Lead Implementer exam covers various domains relevant to the implementation of an ISO 13485-based Quality Management System (QMS). Here are the primary topics:

1. Fundamental Principles and Concepts of ISO 13485
   • Understanding the structure and requirements of ISO 13485
   • Key concepts and principles of quality management for medical devices
   • The role of a QMS in ensuring product quality and regulatory compliance
2. Quality Management System (QMS) for Medical Devices
   • Understanding the context of the organization and its impact on QMS
   • Planning, establishing, and managing a QMS specific to medical devices
   • Documented information requirements for ISO 13485
3. Implementing an ISO 13485 QMS
   • Establishing the quality policy and objectives
   • Developing and managing QMS processes
   • Risk management principles in the context of medical devices
   • Product realization processes, including design and development, production, and service provision
4. Monitoring and Measuring a QMS
   • Internal audit planning, execution, and follow-up
   • Performance evaluation and monitoring of QMS processes
   • Measurement, analysis, and improvement practices
5. Continual Improvement of a QMS
   • Managing nonconformities and corrective actions
   • Continual improvement processes for QMS effectiveness
   • Role of management review in the improvement of the QMS
6. Preparation for the ISO 13485 Certification Audit
   • Understanding the certification process for ISO 13485
   • Preparing for and managing the certification audit
   • Addressing findings from the certification audit

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