Quality Policy

Commitment to Excellence in Quality Management

At Philtone, we are dedicated to delivering products and services that consistently meet or exceed our customers’ expectations, in compliance with the requirements of ISO 9001 and ISO 13485 standards. Our commitment to quality is central to our business operations and underpins our reputation for reliability, safety, and customer satisfaction.

Our Quality Objectives

  • To provide products and services that fulfil all applicable customer, statutory, and regulatory requirements, with a particular focus on medical device quality and safety.
  • To continually improve the effectiveness of our Quality Management System (QMS) through regular monitoring, measurement, analysis, and review of quality objectives and processes.
  • To foster a culture of quality awareness and continuous improvement among all employees through ongoing training, engagement, and communication.
  • To maintain robust processes for risk management, traceability, and product realisation, ensuring the highest standards of product safety and performance.

Commitment to Compliance and Customer Satisfaction

Philtone is committed to maintaining full compliance with the ISO 9001 and ISO 13485 standards, as well as all applicable legal and regulatory requirements relevant to our industry and markets. We actively seek feedback from our customers and stakeholders to improve our products, services, and processes, ensuring the highest levels of satisfaction and trust.

Leadership and Responsibility

Our management team demonstrates leadership and commitment to the QMS by ensuring that quality objectives are established, communicated, and understood throughout the organisation. We provide the necessary resources and support to empower our employees to contribute to the effectiveness and continual improvement of our QMS.

Continuous Improvement

Through regular internal audits, management reviews, and performance evaluations, Philtone is dedicated to identifying opportunities for improvement and implementing effective actions to enhance our quality performance. We encourage open communication, innovation, and teamwork to achieve our quality goals.

Policy Review

This Quality Policy is reviewed annually, or as required, to ensure its continued suitability and alignment with Philtone’s strategic direction and the requirements of ISO 9001 and ISO 13485.

Signed on behalf of Philtone Management:

Date: 06/01/2026