eQMS для наук о жизни Пунктов: 15
ISO 13485 QMS Internal Audit Checklist
Этот чек-лист на английском языке.
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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