- Describe the purpose of a quality management system.
- Understand the structure and key requirements of ISO 9001/13485.
- Interpret requirements of ISO 9001/13485 in the context of an audit.
- Describe the role of the internal audit in the maintenance and improvement of management systems.
- Understand the different types of audits.
- Describe the roles and responsibilities of auditors and lead auditors.
- Plan and conduct an audit in accordance with ISO 19011, demonstrating ability to…
- plan and prepare effectively
- gather objective evidence, through effective interviewing, observation, sampling and note taking.
- analyse and interpret information in order to determine conformance with requirements, effectiveness, and areas for improvement.
- Report the audit, including writing valid, factual and value-adding audit reports.
- Undertake audit follow-up activities, including evaluating the effectiveness of corrective actions.
- Professionally liaise with external auditors.
During the two days participants will acquire knowledge and skills in auditing. However, auditing like any other acquired skill requires practice. The best place to practice and extend your experience is during actual audits.
- Martin Reddington
- Dan Boland
- Eamonn Molloy
- Bob Cumbers
- Management Systems & Quality Management Systems
- aPlan-Do-Check-Act cycle
- Structure of ISO 9001/13485 and other relevant standards
- Understanding process management
- Audit objectives
- Auditing conformance, effectiveness and improvement
- How auditing can be used for improvement
- Exercise on objectivity
- Scheduling of the audit programme on key processes and not areas of the Standard
- Audit preparation – understanding the organisation and its key processes
- exercise on preparing a checklist
- exercise on preparing an audit plan
- guidelines for productive meetings
- Opening Meeting exercise
- Improvement Audits
- Carrying out the audit…
- collecting information
- human behaviour
- audit sampling
- evaluating the effectiveness of the Quality System in addition to conformance audits
- audit findings
- Exercise on Closing Meeting
- Case Study
- Participants put into practice what they learnt on Days 1 and 2
- Learning points from Case Study
- Writing the audit report
- Taking corrective action
- Management of the audit programme
- Course evaluation