Understanding the Medical Device Risk based Approach in a QMS
Checklist | September 27th, 2021
Key uses of an ISO 13485 audit checklist:
Simplifies audit planning
Includes corrective action deadlines
Acts as a comprehensive document for third-party evaluation
Helps to identify process gaps
Aids with data consolidation
Reduces audit preparation time
ComplianceQuest has prepared an audit checklist for the ISO 13485 audit that helps quality leaders know the gaps, perform preventive action, and remain compliant with all regulations.
An ISO 13485 audit checklist is a comprehensive tool used to assess compliance with the ISO 13485 standard, which is a quality management system (QMS) standard tailored for medical devices and related products. Originally published in 1996, ISO 13485 was created to harmonize international regulatory requirements for medical devices. Significant revisions to the standard were introduced in 2003 and 2016 to reflect evolving industry needs and regulations.
A medical device audit checklist should include:
Regulatory compliance: Ensures adherence to FDA 21 CFR Part 820, ISO 13485, and MDR.
Quality management system (QMS): Covers policies, procedures, and document control.
Design controls: Includes DHF, verification, validation, and risk management.
Supplier and manufacturing controls: Tracks supplier qualification, production processes, and CAPA.
Post-market surveillance – Manages complaints, adverse event reporting, and recalls.
Noncompliance may result in:
Regulatory warnings or penalties (e.g., FDA 483, ISO nonconformance)
Product recalls or holds
Loss of certification or market access
Reputational damage and financial risks
Yes, the ISO 13485 audit checklist can be adapted for supplier audits. It helps evaluate supplier quality systems, documentation, and risk-based performance metrics aligned with the purchasing controls of ISO 13485.
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