ISO 13485:2003 Incorporating Key Requirements as a Quality Management System — Virtual Course

DETAILS (Return to Main)

Who Should Attend

• Quality managers, quality engineers and quality technicians involved in the development and manufacture of medical devices. 
• Professionals directly involved in meeting the FDA’s Quality System requirements such as those in regulatory affairs, quality assurance, process development or manufacturing. 
• To maximize the peer learning opportunity, this course is recommended for those who already have a basic understanding of Quality System regulation, including direct work experience.

Learning Outcomes

• Identify and appreciate the benefits of registration to a QMS standard.
• Gain knowledge of tools and approaches needed for organizational readiness for third-party registration (gap analysis and internal audits).
• Learn techniques that positively impact implementation of the QMS.
• Acquire an introductory understanding of process validation, risk management, proper internal audits, CAPA, and FDA inspections (design controls, document controls, purchasing controls, etc.).

Market Focus

• Research and development, manufacturing and field service (medical device and other regulated industries).
• The material will also apply to other industries and processes such as aerospace, electronics, healthcare and so on.

Related ASQ Bodies of Knowledge:
Many of the statistical techniques are covered in the CQE, CRE and CSSBB bodies of knowledge with some interest or linkage to HACCP certification.

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