Delivered in-house, this interactive and practical workshop is designed to provide the latest information on Quality Systems Regulations (QSR) and product safety requirements, providing delegates with practical auditing techniques in order to conduct effective audits against the requirements of ISO 13485 and QSR requirements.

Course Objectives

Our course will equip delegates with effective auditing techniques and increase their understanding of audit principles in relation to ISO 13485, the FDA's QSR and other related standards, in order to prepare for FDA/Notified Body audits.

Key Skills / Learning Objectives

Through the combination of interactive tutorials and workshops, our course will enable the delegates to:

  • Interpret the requirements of ISO 13485 as it relates to management system standards.
  • Plan, manage and objectively assess the compliance of an organisation's management system in relation to ISO 13485 / QSR requirements.
  • Prepare for an FDA QSIT-type audit and add value to an organisation's management system.

Course Outline

Complying with FDA and CE Marking requirements - the requirements of ISO 13485 and QSR

  • Principles of auditing, the audit cycle and audit objectives
  • Auditing skills and techniques:
    • Planning - use of checklists, resources and timing
    • Selection of audit teams and training
    • Interviewing and evaluation of information and findings
    • Observation - objective evidence
    • Evaluating the significance of nonconformities
    • Communicating and presenting audit reports
    • Corrective actions and effective follow-up programmes
    • Effective improvement - planning, monitoring and results
  • Preparing for an FDA QSIT type audit.
  • Sources of information and further development

Who Should Attend?

This course is intended for anyone who will be conducting Internal and Supplier Audits for medical device manufacturers under FDA and MDD/IVDD requirements. Also those subject to internal and third party audits:

  • Executives and Senior Management
  • Design Engineering
  • R&D Managers/Engineers and Members of Design Review Teams
  • Regulatory Affairs/QA Managers and Management Representatives
  • Members of multi-discipline Design Teams
  • Sales and Marketing, Production, Shipping, MIS, Purchasing

Booking and Course Fees

Fees include:

  • Delegate workbook, including reference information
  • Training provided by qualified and experienced tutors with extensive practical management auditing experience across a variety of manufacture and service industries
  • Certificate verifying attendance and completion of course

This course is for delivery in-house only. Offering better value for money, in-house training can be customised and designed to meet specific individual and company needs.

Please Contact us to discuss your in-house requirements.

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