ISO 13485:2016 – Internal Auditor (2 days)
This highly interactive two-day training programme is designed for those people who require a sound understanding of the techniques and principles of quality auditing. It also covers the role of the internal auditor in the development and improvement of an effective quality management system for this medical devices standard.
Internal auditing is changing and it is no longer enough that internal audits check conformance. Auditors now need to be able to audit processes with emphasis on risk and performance improvement. Delegates will learn that they play a key role in the development and improvement of working practices across the organisation. Delegates will also learn how to apply the 7 quality management principles.
By attending and completing this course, successful delegates will:-
- Benefit from a highly interactive course with extensive use of team-based exercises which is both challenging and stimulating
- Gain the technical skills and knowledge required to plan, conduct and report internal quality audits
- Have a key understanding of management systems and the processes involved
Tutors have extensive quality management systems design and improvement experience. They are qualified and experienced auditors with extensive practical management experience across a wide range of business sectors
- To teach delegates the importance and purpose of an effective quality management system
- To give delegates and understanding of the role and responsibilities of an auditor in planning, conducting, reporting and following up on a Quality Management System audit to comply with standard ISO 13485:2016.
- To be able to produce audit reports that will help to improve the effectiveness of the quality management system for medical devices
- To understand how to use the results of internal audits to help drive improvements
- Structure of an internal audit
- Key activities in the audit process
- Business process auditing
- Effective auditing techniques and good audit practice
- Preparation for an audit and producing an effective audit checklist
- Gathering evidence during an audit (interviewing, observation & document review)
- Evaluation of the evidence obtained during an audit
- Writing non-conformance reports
- Agreeing corrective actions and verifying their effectiveness
09.00 – 17:00
All successful participants will be issued with a certificate on behalf of QA International (Training) Limited.
Who should attend
This training programme is specifically designed for delegates with an interest in the quality auditing process including principles and techniques involved with a medical devices quality management system and those who are looking to gain a key understanding of management systems and the processes involved. The course will also be relevant for those who are involved in internal auditing of ISO 13485:2016 quality management systems, whose processes and procedures will be audited.
It is essential that delegates have a sound understanding of the requirements of ISO 13485 – if not, then it is recommended that delegates complete our one day ISO 13485:2016 Foundation course before attending this course.
The fee includes course materials, delegate notes, lunch and refreshments. It does not include a copy of ISO 14001:2015 which you will need for the course.
To enquire about this training course, please complete the course enquiry form. This form can also be used to enquire about holding this course at your premises.
For other enquiries about training, please contact us by telephone on 01325 384272 or email us at firstname.lastname@example.org