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Life-Sciences eQMS 15 items

ISO 13485 QMS Internal Audit Checklist

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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