QMS Auditing:

QualiSure Consulting provides comprehensive Quality Management System (QMS) services tailored for medical device organizations seeking robust, compliant, and efficient systems that support regulatory approval and ongoing business excellence.

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QMS Internal Auditing and Gap Assessment

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• Full-scope internal audits to ISO 13485:2016 and ISO 9001:2015 standards, covering all lifecycle stages from design and development to production, distribution, and post-market activities.

• Gap analysis to identify areas of non-conformance or improvement, with actionable recommendations to achieve and maintain certification.

• Audit planning, execution, and reporting, including support for management review and corrective action processes.

 

QMS Implementation and Optimization

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• Design and implementation of new quality management systems or remediation of existing systems to align with ISO 13485 and regulatory requirements.

• Development and documentation of quality manuals, procedures, and records, ensuring clarity, traceability, and regulatory compliance.

• Integration of risk-based thinking throughout QMS processes, supporting continuous improvement and regulatory alignment.

 

Process Mapping and Improvement

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• Mapping and optimization of core and supporting processes, including design and development, supplier management, production, and complaint handling.

• Support in defining process interactions, responsibilities, and performance metrics to drive efficiency and effectiveness.

• Guidance on establishing and monitoring quality objectives, KPIs, and data-driven improvement cycles.

 

Supplier and Outsourced Process Management

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• Assessment and qualification of suppliers and outsourced partners, including development of quality agreements and monitoring programs.

• Implementation of robust purchasing controls, traceability, and verification of purchased products and services.

 

Management Review and Leadership Support

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• Facilitation of management review meetings, including preparation of inputs, analysis of QMS performance, and documentation of outputs.

• Support for top management in demonstrating commitment, setting quality policy, and fostering a culture of compliance and improvement.

 

Audit Readiness and Certification Support

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• Preparation for third-party certification or surveillance audits, including mock audits, documentation review, and staff training.

• Post-audit support for addressing findings and implementing corrective actions.

 

Why Choose Qualisure for QMS Services?

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• Deep expertise in ISO 13485 and ISO 9001 standards, with practical experience across the medical device lifecycle.

• Proven methodologies for efficient QMS implementation, maintenance, and improvement.

• Focused on both regulatory compliance and operational excellence, enabling clients to achieve certification and build a foundation for sustainable growth.

 

Let Qualisure Consulting help you establish, maintain, and continually improve a quality management system that meets regulatory demands and supports your business goals.