This course provides learners with the knowledge and skills 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.
This will be done in accordance with ISO 19011.
This course does not address ISO 13485 in detail and does not aim to equip learners with the knowledge and skills to determine conformity, or otherwise, with ISO 13485. Learners requiring the knowledge and skills to conduct entire medical device quality management system audit against ISO 13485 should be directed to attend a CQI and IRCA Certified MD-QMS ISO 13485:2016 Lead Auditor (PR369) course.
Who is it for?
This course is for those who audit an organisation's processes as part of the internal audit programme.
1. With reference to the PDCA cycle, explain the process-based quality management system model for ISO 13485 and the role of an internal audit in the maintenance and improvement of quality management systems.
2. Explain the role and responsibilities of an auditor to plan, conduct, report, and follow-up an internal quality management system audit, in accordance with ISO 19011.
3. Plan, conduct, report, and follow-up an internal audit of part of a quality management system based on ISO 13485, and in accordance with ISO 19011.
Recommended prior knowledge
- An understanding of the requirements of ISO 13485 and the commonly used quality management terms and definitions, which may be gained by completing a CQI and IRCA Certified MD-QMS ISO 13485:2016 Foundation (FD132) course or equivalent.
Medical device management systems audit
- The Plan, Do, Check, Act (PDCA) cycle.
- The core elements of a management system and the interrelationship between top management responsibility, policy, compliance with regulatory authority requirements, objectives, planning, implementation, measurement, review, and continual improvement.
- The fundamental concepts and the seven quality management principles (see ISO 9000).
- The relationship between quality management, regulatory authority, and customer requirements.
- The ISO 19011 audit process.
- Regulatory authority requirements not directly covered in ISO 13485.
Learners must demonstrate acceptable levels of performance in the three learning objectives to complete the course successfully. Learners will be assessed through a short, written quiz/quizzes or tests. As well as performance in a practical audit situation.