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Home > ISO 13485:2016 Quality Management System Compliance Checklist

ISO 13485:2016 Quality Management System Compliance Checklist

Management Responsibilities

Ensure top management commitment to the QMS

Appoint a management representative for the QMS

Establish a quality policy and quality objectives

Ensure resources are allocated for the QMS

Quality Planning

Establish quality objectives and processes

Develop a quality manual

Plan and document QMS processes

Identify and document risks and opportunities

Resource Management

Provide necessary resources for the QMS

Establish competency requirements for personnel

Ensure infrastructure and work environment are suitable

Implement training programs for personnel

Product Realization

Establish product requirements

Develop product design and development processes

Conduct product testing and validation

Implement production and service provision processes

Measurement, Analysis, and Improvement

Establish monitoring and measurement processes

Conduct internal audits of the QMS

Implement corrective and preventive actions

Continuously improve the QMS through management review meetings and feedback from stakeholders

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