ISO 13485 Lead Auditor Training Course

Thursday 9 February 2017

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!