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FORMATION
ISO 13485 – Quality management system auditor for medical devices – #321
1,790.00 € HT
Context
Your organisation has a quality management system built to ISO 13485: 2016 and you would like to train internal auditors to audit the conformity of your quality management system (or that of your suppliers) to the requirements of ISO13485: 2016, in accordance with the audit principles of ISO 19011.
Objectives
Understand all aspects of auditing a quality management system in accordance with ISO 13485: 2016, and be able to audit it effectively:
- Knowing how to prepare, conduct and close an audit in accordance with the requirements of ISO 19011.
- Understand the auditor’s mission and its impact on the continuous improvement of the system.
- Know how to audit the application of the requirements of ISO 13485: 2016 as well as the regulatory requirements and those of the interested parties applicable to the company.
- How to construct an audit questionnaire using the V approach and CAPDo® logic.
- Knowing how to apply communication techniques useful in an audit, in order to effectively manage the interview.
- Knowing how to formulate the findings and report the conclusions of the audit.
Recommanded for
Anyone wishing to become an internal and supplier quality auditor in accordance with ISO 19011 and ISO 13485.
- Internal auditors.
- Supplier auditors.
- Quality managers, engineers and technicians.
Prerequisites
Have a good understanding of the ISO 13485 standard.
(*) ½ day preparation: preparation with the QMS manager to target the audit topics to be carried out, the conditions for organising these audits (availability of the audited parties, and specificities to be taken into account) and the adaptation of the materials to the company’s subjects and the duration of the training as required.
Pedagogy
- The teaching methods used are fun and varied, to help you master the job of a systems auditor by process, in accordance with the requirements of the standard.
- Practical exercises are used to construct an audit questionnaire that will enable you to find evidence of the effectiveness and continuous improvement of your processes.
- In-house : Based on the principle of training-action, this course includes practical application in the field, enabling participants to test their mastery of their audit technique in a real-life situation.
- Open: Practical application on a case study, with trainees alternating between the role of the audited and that of the auditor.
Evaluation mode
- Qualification awarded on the basis of the assessment of aptitude during the audit carried out during the training course.
Course materials
- Participant file containing the presentations given during the course and the exercise materials.
Session 1 : Audit as a tool for continuous improvement
- Internal audit objectives
- Types of internal audit
- Internal audit PDCA
- ISO13485 audit requirements
- The 6 steps
Session 2 : The preparation
- The 8 stages of preparation
- Key points on how to take account of the requirements of the ISO 13485 standard
Session 3 : The internal audit function
- Responsibilities
- Role and behaviour
- Expected qualities
- Verbal and non-verbal communication
- Questioning techniques
- Managing conflict in an audit
Session 4 : The field audit
Session 5 : Reporting and distributing the report
- Preparing conclusions
- Drafting a non-conformity
- Closing meeting
- The audit report
Session 6 : Follow-up of actions and audit closure
Session 7 : Evaluating your audit practice
- SWOT
About Instructor
Stéphanie BAZIN
Speciality: as a EURO-SYMBIOSE consultant for 20 years, Stéphanie excels in the optimisation and development of QSE management systems!