Quality Policy

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Purpose

The purpose of this Quality Policy establishes our framework for quality management and continuous improvement, integrating ISO 9001 and ISO 27000 principles with ALCOA Plus data integrity requirements. Our policy applies to all aspects of our operations, from Platform development to customer support, ensuring consistent quality across our entire organisation.

 

Please note that we are not certified to ISO standards however our approved cloud provider is a certified organisation and we use best industry practice as a framework in guiding our decisions.

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Our Quality Commitment

Carelogix is committed to delivering exceptional quality in our digital healthcare solutions while maintaining the highest standards of data integrity and we are dedicated to transforming healthcare documentation through innovative technology while maintaining unwavering standards of quality and reliability. We achieve this by implementing robust quality management systems that ensure our products and services consistently meet or exceed customer expectations and regulatory requirements.

 

Quality Management Principles

Leadership and Commitment
Our leadership team demonstrates commitment to quality by creating and maintaining a quality-focused organisational culture that emphasises continuous improvement and excellence. Senior management actively participates in quality initiatives and provides necessary resources for maintaining effective quality management systems. We establish clear quality objectives aligned with our strategic direction and regularly review their achievement.

Customer Focus
Understanding and meeting customer needs drives our quality approach through conducting regular customer feedback sessions, analysing user experiences, and incorporating insights into product development. We maintain open communication channels with care providers and recipients, ensuring their voices shape our quality objectives. Quality metrics are directly tied to customer satisfaction and care outcomes.

 

Process Approach
We manage our activities as interconnected processes by mapping and optimising key processes across the organisation, establishing clear process owners and performance indicators. Documentation and standard operating procedures ensure consistency and reliability in all operations. Regular process reviews identify opportunities for improvement and innovation.

Evidence-based Decision Making
Our decisions are based on data analysis and evidence through implementing comprehensive data collection and analysis systems, establishing key performance indicators for all critical processes. We maintain robust documentation trails for all quality-related decisions and outcomes. Regular quality reviews inform strategic planning and operational improvements.

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Data Integrity Principles (ALCOA Plus)

Attributable
All data and system actions must be traceable to specific individuals through unique user authentication and access controls, digital signatures for critical operations, clear audit trails for all data modifications, and documentation of roles and responsibilities.

 

Legible
Information must be readable and permanently recorded by implementing clear data entry interfaces, maintaining consistent formatting standards, ensuring data accessibility across platforms, and preserving original records alongside any changes

 

Contemporaneous
Data must be recorded at the time of activity through real-time documentation capabilities, automated timestamping of all entries, prevention of backdating or future dating, and system controls for timely recording.

 

Original
Primary records must be preserved by maintaining original data entries, implementing version control systems, protecting against unauthorised alterations, and securing backup systems for all records.

 

Accurate
Data must reflect actual observations and activities through validation checks for data entry, regular accuracy audits, error detection and correction procedures, and quality control reviews.

 

Complete
Records must be complete and include all critical information through, mandatory field requirements, data completeness checks, documentation of any data gaps, and regular completeness audits.

 

Consistent
Data handling must follow established procedures through standardised workflows, consistent naming conventions, regular staff training, and process documentation.

 

Enduring
Records must be preserved for their required lifetime through secure long-term storage solutions, data retention policies, regular backup procedures, and archive management systems.

 

Available
Data must be accessible when needed through efficient retrieval systems, appropriate access controls, system availability standards, and disaster recovery procedures.

 

Risk-Based Thinking

We integrate risk management throughout our quality system by thoroughly understanding and addressing potential risks to quality and data integrity at every stage of our operations. Implementing preventive measures and contingency plans to ensure continuous service quality. Regular risk assessments inform our quality improvement initiatives.

 

Quality Objectives

Our key quality objectives include maintaining system availability above 99.9%, achieving customer satisfaction ratings above 95%, and completing all service requests within agreed timeframes. We regularly monitor and report on these objectives through our quality management system.

 

Continuous Improvement

We maintain a culture of continuous improvement through:
Regular system audits, performance reviews, and feedback analysis. Innovation initiatives are encouraged and supported at all levels of the organisation. Quality improvements are recognised and shared across the organisation.

 

Training and Competency

We ensure quality through comprehensive training by providing regular quality management training to all staff, maintaining current documentation of all procedures, and verifying competency through assessment programs. Professional development is supported and encouraged throughout the organisation.

 

Quality System Documentation

Our quality system is documented through maintaining comprehensive quality manuals, standard operating procedures, work instructions, and quality records. Documentation is regularly reviewed and updated to reflect current best practices and requirements.

 

Management Review

Senior management regularly reviews the effectiveness of our quality system through scheduled quality management reviews, performance analysis against objectives, and strategic planning sessions. Reviews ensure the continuing suitability and effectiveness of our quality management system.

 

Commitment to Excellence

This Quality Policy represents our commitment to excellence in healthcare technology. We regularly review and update this policy to ensure it continues to meet the evolving needs of our stakeholders and maintains alignment with industry best practices.