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13485academy ISO 13485 Implementation Process Diagram en
13485academy ISO 13485 Implementation Process Diagram en
Note: This diagram shows the steps for ISO 13485 (2016 revision)
implementation and certification; it does not show the complete
Obtain
Plan-Do-Check-Act (PDCA) Cycle.
Management
Support
To learn more about ISO 13485 click here.
Identify
Customer and
Other
Requirements
Define Scope,
Management Quality
Commitment Quality Policy Quality Manual
Objectives
and Text
Responsibilities
Implement
Procedures for production, design
process
and development, purchasing, etc.
procedures
Monitoring & Measurement with Records of Results
Communication with Interested Parties
Perform
Training and Training
Awareness Records
Programs
Operate the
MDMS Records
(Medical Identified by
Device MDMS
Management
System)
Management
Management Review
Review Minutes (or
equivalent)
Choose a
Certification
Body