Quality Training

ISO 13485: Internal Auditor

Objectives

This course aims to provide learners with the knowledge and skills required to perform an internal audit of part of a quality management system based on ISO 13485 and applicable international regulatory standards report on the effective implementation and maintenance of the management system in accordance with ISO 19011. During this practical course, participants will put into practice what they learned on days 1 and 2.

Content includes

Upon completion, participants will have the knowledge and skills necessary to conduct effective internal audits to check for effectiveness, conformance and improvements.
This includes:

• The key requirements of ISO 13485
• The purpose of a quality management system
• Interpreting the requirements of regulation/standards
• Understand the importance of internal audits
• Understand the various types of audits and the responsibilities of auditors
• Planning and conducting an audit
• Evidence gathering techniques
• Writing audit reports
• Conducting effective audit follow-up
  

Sample Schedule:
Day 1

• Management Systems & Quality Management Systems - Plan-Do-Check-Act cycle
• Structure of ISO standards & ISO 13485
• Understanding process management
• Audit objectives - Auditing conformance, effectiveness, and improvement
• Planning the audit programme
• Audit preparation – understanding the organisation and its key processes.
• Checklists, Audit plans, Productive meetings

Day 2

• Conducting the audit.
• Teamwork, Collecting information, Communications.
• Human behaviour, Audit sampling, Audit findings
• Evaluating the effectiveness of the Quality System in addition to conformance audits
• Opening and Closing Meetings
• Writing the audit report; taking corrective action; management of the audit programme.
• Examination.

Who should attend

All personnel involved in areas relating to internal auditing and self-inspection. This includes Quality Managers and Departmental Managers.

Qualification

IRCA certified

Upcoming dates: