REF. MQ05 – INTRA / INTER
QUALITY SYSTEM
COURSE DESCRIPTION
This course will allow you to acquire practical knowledge to prepare, conduct and document an internal audit or supplier audit based on the principles set out in ISO 19011:2018.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Become familiar with audit principles
- Learn techniques on how to communicate with audited entities
- Draft an audit plan
- Know how to draw up observations and the audit report
TARGET TRAINEES
- Medical Device manufacturers
- Quality Managers
- Auditors
PREREQUISITES
- Familiarity with the requirements applicable to quality management systems (ISO 9001, ISO 13485)
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Examples tailored to the company’s products
- ISO 19011
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Course objectives/Presentation of the course content.
- Requirements of the Quality Management System standards (ISO 9001, ISO 13485): a review
- ISO 19011:2018
- Scope – terms and definitions
- Organize the audit – collect information
- Prepare the audit plan and audit
- Conduct the audit: initial meeting and collection of information; communication with the audited entities
- Draw up audit observations
- Lead the audit closure meeting – communicate the results and audit conclusions
- Draw up the audit report
- Summary/Q&A
- Course evaluation and conclusion
EVALUATION METHODS
- Course evaluation quiz
- Satisfaction survey
- Attendance certificate
This training is assessed based on an evaluation of each individual’s acquisition of knowledge via quizzes during and at the end of the program (success criteria >= 75%).
