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ISO 13485 Lead Auditor

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ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures, and techniques.

 

Why should you attend?

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  • During this training course, you will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and ISO/IEC 17021-1 certification process.

  • Based on practical exercises, you will be able to master audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution.

  • After acquiring the necessary expertise to perform this audit, you can sit for the exam and apply for a “PECB Certified ISO 13485 Lead Auditor” credential. By holding a PECB Lead Auditor Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices.

 

Who should attend?

 

  • Auditors seeking to perform and lead Medical Devices Quality Management System (MDQMS) certification audits

  • Managers or consultants seeking to master a Medical Devices Quality Management System audit process

  • Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements

  • Technical experts seeking to prepare for a Medical Devices Quality Management System audit

  • Expert advisors in Medical Devices Quality Management

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Learning Objectives

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  • Understand the operations of a Medical Devices Quality Management System based on ISO 13485

  • Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks

  • Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011

  • Learn how to lead an audit and audit team

  • Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit

  • Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011

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Educational approach

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  • This training is based on both theory and best practices used in MDQMS audits

  • Lecture sessions are illustrated with examples based on case studies

  • Practical exercises are based on a case study which includes role playing and discussions

  • Practice tests are similar to the Certification Exam

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Prerequisites

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  • A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.

 
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