Gain the confidence to effectively audit a QMS in accordance with internationally recognized best practice techniques against the requirements of ISO13485:2016. Consolidate your expertise with the latest developments and contribute to the continuous improvement of your quality system, leading to greater patient safety. You’ll grasp the key principles and practices of effective QMS audits in line with ISO 13485:2016 and ISO 19011 “Guidelines for auditing management systems”.
Using a step-by-step approach, you’ll be guided through the entire audit process from initiation to follow-up. Over 5 days, you’ll gain the knowledge and skills required to undertake and lead a successful management systems audit. Learn to describe the purpose of an ISO 13485:2016 QMS audit and satisfy third-party certification. You’ll acquire the skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance.
Prerequisites
Before attending this course, delegates are expected to have:
- Knowledge of the following quality management principles and concepts:
- The Plan, Do, Check, Act (PDCA) cycle
- The relationship between quality management and customer satisfaction
- Commonly used quality management terms and definitions and the 8 Quality Principles as given in ISO 9000
- The process approach used in quality management
- The Model of a Process Based Quality Management System, the structure and content of ISO 13485
- Knowledge of the requirements of ISO 13485
It is advisable that delegates have either attended an internal auditors course, or had experience with conducting internal or supplier audits.
Pedagogical objectives
Successful completion of this CQI and IRCA certified training course by passing the relevant CQI and IRCA examination and skills assessment, will demonstrate knowledge and basic skills to undertake and lead a management system audit.
Skills to be acquired
Upon completion of this training, delegates will be able to:
- Describe the purpose of a quality management system, of quality management systems standards, of management system audit and of third-party certification
- Explain the role of an auditor to plan, conduct, report and follow up a quality management system audit in accordance with ISO 19011 (and ISO 17021 where appropriate)
- Plan, conduct, report and follow up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485 and in accordance with ISO 19011 (and ISO 17021 where appropriate)
Targeted audience
- Medical Device professionals interested in conducting first-party, second-party, and/or third-party audits
- Management Representatives
- Quality Directors
- Consultants
Pedagogical, technical and framing means
Course materials including :
- Introduction to the training, detailed programme and security assignments
- Course presentation, theory and activities/ role plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the activities
- Attendance sheet to be signed
Assessment specifics
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
What is included ?
- Course materials, provided electronically
- Letter of attestation
- Official certificate
Do you need more information?
If you have any concerns, please do not hesitate to contact our service department on the following numbers:
Telephone: 01 89 79 00 40
Email: training.france@bsigroup.com Or via the webchat service on our website: bsigroup.com
You will be put in touch with our team if necessary.
