Training Course Content
Awareness Training for ISO 13485:2016 Medical Devices – Quality Management System (QMS)
Course Duration: 2 Days (Typical: 09:00 – 17:00)
Target Audience: Top management, QA/RA, production, engineering,
purchasing, warehousing, service, internal auditors, and
support functions.
Training Method: Interactive lecture, group discussion, workshops, and
practical examples
Assessment: Knowledge checks, workshop outputs, and end-of-course
quiz
Course Overview
This 2-day awareness program provides participants with a practical understanding of ISO 13485:2016
requirements, the intent behind each clause, and how the requirements translate into day-to-day controls
for medical-device organizations (including design and development, production, and servicing). The training
emphasizes process approach, risk-based thinking, documentation discipline, and regulatory alignment.
Learning Outcomes
• Explain the purpose, structure, and key principles of ISO 13485:2016 and its relationship to regulatory
requirements.
• Interpret ISO 13485:2016 clauses 4 through 8 and identify objective evidence typically expected during
audits.
• Apply process approach and risk-based thinking to QMS planning, controls, and decision-making.
• Describe core QMS elements: document control, records control, CAPA, change control, supplier control,
and validation.
• Recognize common nonconformities and practical compliance tips to avoid them.
• Use simple tools (process mapping, risk log, traceability, and QMS metrics) to strengthen
implementation.
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