eQMS Ilmu Hayati 15 butir

ISO 13485 QMS Internal Audit Checklist

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Evaluates conformance of a medical device quality management system to ISO 13485:2016 across documentation, management, resources, realization, and improvement. Use for internal audits and certification readiness.

ISO 13485:2016ISO 19011

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Quality Management System (Clause 4)

Is the QMS documented, including a quality manual and defined processes? *
Is a medical device file maintained for each device type/family? *
Are documents and records controlled per documented procedures? *

Management Responsibility (Clause 5)

Is there a quality policy and measurable quality objectives? *
Is management review conducted at planned intervals with documented outputs? *
Are responsibilities, authorities, and a management representative defined? *

Resource Management (Clause 6)

Is personnel competence established with training records maintained? *
Are infrastructure and work environment/contamination controls defined? *

Product Realization (Clause 7)

Is risk management applied throughout product realization? *
Are design and development controls (planning, inputs, outputs, V&V, transfer) documented? *
Is production controlled with process validation where output cannot be fully verified? *
Is identification and traceability maintained per requirements? *

Measurement, Analysis & Improvement (Clause 8)

Is a feedback and complaint handling process in place, including post-market surveillance? *
Are internal audits conducted per a documented program? *
Are nonconforming product, corrective, and preventive action processes implemented? *

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