Training #07

Internal audit and supplier audit training for medical device manufacturers (ISO 13485 auditor)

Training methods

Prerequisites

  • Knowledge of current ISO 13485 and ISO 9001 requirements.

Target audience

People involved in :

  • Quality assurance
  • Anyone involved in the audit process and supplier management

Further information

Training content

Know the methodology to be used to conduct an internal audit or supplier audit in accordance with the current ISO 19011 standard based on the current ISO 13485 and ISO 9001 standards.

  • Post-training evaluation questionnaire
  • Training satisfaction evaluation questionnaire

Each participant will be able to :

  • Define the objective of an audit and the role of the participants
  • Conduct an opening and closing meeting
  • Carry out an audit report
  • Prepare an audit report
  • Follow up on findings after the audit

  • Detailed training schedule
  • Digital training materials
  • Training evaluation questionnaires
  • Results of trainee learning assessment
  • Training certificate

  • Definitions and objectives of an audit
  • Roles of people in auditing
  • Planning and preparing for an audit
  • Audit process
  • Audit report and follow-up of findings

Starting at €980
Price adapted to your needs, number of participants and type of training (inter / intra-company).
Contact us for a personalized quote

  • Teaching aids (course support presentation, extracts from standards documents, document templates, etc.)
  • Practical exercises, feedback, case studies based on your system

Interested in this course?

Contact us for details and deadlines!
If you'd like to register directly, we'll send you a detailed quote and schedule.

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