ISO 13485 Medical Devices Quality Management System (QMS)

Lead Auditors Course

Summary:
This five-day intensive course enables participants to develop the necessary expertise to audit a Quality Management System (QMS) based on ISO 13485:2003 and to manage a team of auditors by applying widely recognized audit principles, procedures and techniques. During this ISO TRAINING, the participant will acquire the necessary knowledge and skills to proficiently plan and perform internal and external audits in compliance with the certification process of the ISO 19011 and ISO 17021 standards. Based on practical exercises, the participant will develop the skills (mastering audit techniques) and competencies (managing audit team and audit program, communicating with customers, conflict resolution, etc.) necessary to efficiently conduct an audit.

Who should Attend?

• Internal auditors
• Auditors wanting to perform and lead Quality Management System (QMS) certification audits in the medical device industry
• Project managers or consultants wanting to master the Quality Management System audit process
• Persons responsible for the quality or conformity in an organization
• Members of a quality team
• Expert advisors in Quality Management Systems
• Regulatory affairs managers
• Technical experts wanting to prepare for a Quality audit function in the medical device industry

Learning Objectives:

• To acquire expertise to perform an ISO 13485 internal audit following ISO 19011 guidelines
• To acquire expertise to perform an ISO 13485 certification audit following ISO 19011 guidelines and ISO 17021 specifications
• To acquire the expertise necessary to manage a QMS audit team
• To understand the operation of an ISO 13485 conformant Quality Management System
• To understand the relationship between a Quality Management System and compliance with customer and regulatory requirements
• To improve the ability to analyze the internal and external environment of an organization, and audit decision-making in the context of a QMS

Course Contents: (5 Days Course)

• Four days intensive classroom ISO TRAINING
• Exclusive access to trainer for after ISO TRAINING query clarification
• In-house certification exam on the last day of the ISO TRAINING
• Prepares participants to take and pass the ISO 13485 LA Certification examination successfully.
• Introduction to Environmental Management System (FSMS) concepts as required by ISO 13485
• Planning and Initiating an ISO 13485 audit
• Conducting an ISO 13485 audit
• Concluding and ensuring the follow-up of an ISO 13485 audit

Exam Details:
The "Certified ISO 22000 Lead Auditor" exam fully meets the requirements of the PECB Examination and Certification Program (ECP). The exam covers the following competence domains:

• Four days intensive classroom ISO TRAINING
• Exclusive access to trainer for after ISO TRAINING query clarification
• In-house certification exam on the last day of the ISO TRAINING
• Prepares participants to take and pass the ISO 13485 LA Certification examination successfully.
• Introduction to Environmental Management System (FSMS) concepts as required by ISO 13485
• Planning and Initiating an ISO 13485 audit
• Conducting an ISO 13485 audit
• Concluding and ensuring the follow-up of an ISO 13485 audit

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