Training #07

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

  • Location: Face-to-face or distance learning
  • Date: To be defined
  • Duration: 1 day (7 hours)

Training content

Know the methodology to use to carry out a supplier audit according to the ISO 19011 standard in force on the basis of the ISO 13485 and ISO 9001 standards in force.

  • 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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