ISO 13485 Lead Auditor Training Course
Eurotech ISO 13485:2016 Lead Auditor Training Course competency based 4 day seminar Guide a general understanding of the concepts of the ISO 13485 standard and the principles and practices of leading management systems and process audits in accordance with ISO 19011, Guidelines on Auditing Management Systems. Experienced instructors explain the clauses of ISO 13485 in detail and guide candidates through the entire audit process, from managing an audit program to reporting on audit results. Candidates gain necessary auditing skills through a balance of formal seminar tutorials.
ISO 13485 Lead Auditor Training Course enables participants to develop the necessary expertise to audit a Quality Management System for Medical Devices with Medical Devices Quality Management System manufacturers and to manage a team of auditors by applying widely recognized audit principles, procedures and techniques. During this 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 17021-1 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 and conflict resolution necessary to efficiently conduct an audit.
Who should attend ISO 13485 Lead Auditor Training Course?
ISO 13485 Lead Auditor Training seminar is designed for Management Representatives, ISO 13485:2016 Implementation Teams, Auditors and others who would like to learn the widely-used international management systems auditing process.
- Internal auditors
- Individuals interested in conducting first-party, second-party, and third-party audits
- Management Representatives
- Quality Directors in Medical Device
- Managers
- Engineers
- Consultants
- Auditors wanting to perform and lead Medical Devices Quality Management System certification audits in the medical device industry
- Project managers or consultants wanting to master the Medical Devices Quality Management System audit process
- Persons responsible for the quality or conformity in an organization
- Members of a quality team
- Expert advisors in Medical Devices Quality Management Systems
- Regulatory affairs managers
- Technical experts wanting to prepare for a Quality audit function in the medical device industry
Learning objectives of ISO 13485 Lead Auditor Training Course:
- To acquire expertise to perform an ISO 13485:2016 internal audit following ISO 19011 guidelines
- To acquire expertise to perform an ISO 13485:2016 certification audit following ISO 19011 guidelines and ISO 17021 specifications
- To acquire the expertise necessary to manage a Medical Devices Quality Management System audit team
- To understand the operation of an ISO 13485:2016 conformant Medical Devices Quality Management System
- To understand the relationship between a Medical Devices 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 Medical Devices Quality Management System
- Understand the application of Quality Management Principles in the context of ISO 13485:2016.
- Understand quality management definitions, concepts, and guidelines
- Understand the purpose of the ISO 9000 series
- Understand the requirements of the ISO 13485:2016 standard
- Understand the roles and responsibilities of the auditor
- Apply ISO 19011 definitions, concepts, and guidelines
- Recognize the principles, practices, and types of audits
- Conduct all phases of an internal audit
- Prepare and present effective reports
- Understand the role of objectives, scope and criteria in the audit process
- How to plan audits
- Conduct audit team selection
- Initiate the audit and conducting opening meetings
- Understand audit team leader responsibilities
- Relate the quality management system to the organization’s medical devices and provision of related services.
- Understand the application of the principles, procedures and techniques of management systems auditing.
- Understand the conduct of an effective audit in the context of the auditor’s organizational situation.
- Understand the application of the regulations, and other considerations that are relevant to the management system, and the conduct of the audit.
- Practice personal attributes necessary for the effective and efficient conduct of a management system audit.
- Establish, plan and task the activities of an audit team.
- Communicate effectively with the audited and audit client.
- Organize and direct audit team members.
- Understand conflict management principles.
- Prepare and complete the audit report.
- Communicate effectively during the audit
- Conduct on-site activities
- Prepare audit conclusions
- Conduct closing meetings
- Report audit results
SO 13485 2016 Lead Auditor Training Course gives an introduction to the most widely used standard for Quality Management in the world. Enquiry today!
Interested Candidates Can write or call Us for More Information
Puneet Sharma | Call : 08196980555 | E-Mail ISO.Training.Eurotech@gmail.com
