[Gap Analysis] ──> [QMS Structuring] ──> [Employee Training] ──> [Internal Audit] ──> [Certification]
Risk management is no longer confined to product design. ISO 13485:2016 requires a risk-based approach to all QMS processes, including outsourced operations, software validation, and training. Organizations must align their QMS risk activities with (Application of Risk Management to Medical Devices). 2. Stringent Documentation Requirements
Clause 4.1.6 requires validation of any software used in the QMS (like an ERP, eQMS, or issue tracker) before its first use. Do not forget to validate these internal tools.
Documented Information
[Gap Analysis] ──> [QMS Structuring] ──> [Employee Training] ──> [Internal Audit] ──> [Certification]
Risk management is no longer confined to product design. ISO 13485:2016 requires a risk-based approach to all QMS processes, including outsourced operations, software validation, and training. Organizations must align their QMS risk activities with (Application of Risk Management to Medical Devices). 2. Stringent Documentation Requirements
Clause 4.1.6 requires validation of any software used in the QMS (like an ERP, eQMS, or issue tracker) before its first use. Do not forget to validate these internal tools.
Documented Information