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Home > ISO 13485:2016 Quality Management System Compliance Checklist

ISO 13485:2016 Quality Management System Compliance Checklist

Management Responsibility Section

Has top management established a quality policy?

Is there evidence of management commitment to meeting customer and regulatory requirements?

Management should demonstrate their commitment to meeting customer and regulatory requirements through actions such as allocating resources, setting objectives, and monitoring performance.
Evidence can include meeting minutes, communication materials, and performance reports.

Are responsibilities and authorities defined within the organization?

Clearly define roles, responsibilities, and authorities within the organization to ensure accountability and effective decision-making.
Document these responsibilities and authorities in an organizational chart or job descriptions.

Resource Management Section

Are resources allocated appropriately to support the QMS?

Is there evidence of competence among personnel?

Are training needs identified and addressed?

Product Realization Section

Is there a documented process for product realization?

Are customer requirements determined and met?

Are there controls in place to ensure product meets regulatory requirements?

Measurement, Analysis, and Improvement Section

Are processes in place for monitoring, measurement, analysis, and improvement?

Is there evidence of continual improvement within the organization?

Are corrective and preventive actions taken when necessary?

Documentation and Record Control Section

Is there a documented QMS in place?

Are records maintained to demonstrate conformity to requirements?

Are documents controlled to prevent unintended use or distribution?

Internal Audit Section

Are internal audits conducted at planned intervals?

Are audit results documented and reviewed by management?

Are corrective actions taken to address audit findings?

Supplier Management Section

Are suppliers evaluated and selected based on their ability to meet requirements?

Is there a process for monitoring and evaluating supplier performance?

Are supplier agreements in place to ensure compliance with QMS requirements?

Regulatory Compliance Section

Are regulatory requirements identified and monitored for changes?

Is there a process in place for ensuring compliance with applicable regulations?

Are regulatory submissions accurate and complete?

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