In the medical business, quality is not optional, it is a mandatory requirement and a core ethical responsibility. Medical products must be designed and manufactured to support safety, reliability, and compliance with applicable regulations, such as MDR 2017/745, 21 CFR 820, and international pharmacopeias.

Because patients' health and lives may be directly affected by our materials and our customers' products, quality is not just and added value - it is a core principle guiding everything we do.

Quality as a Foundation of Safety

Quality and safety are our top priorities. As emphasized in the Westlake Code of Conduct, our products must comply with applicable laws, regulations, and internal quality procedures, and our vendors must be held accountable for the quality and safety of the products and services they supply.

At Westlake Global Compounds, our medical grade compound resins are used by customers in applications that may involve direct contact with the human body, such as:

• Infusion and transfusion tubing
• Renal therapy systems
• Respiratory masks and components
• Other life critical medical devices and disposables

A Robust Quality Management System

To uphold these expectations, we have adopted strong Quality Management Systems (QMS) that ensure continuous control and traceability of every production batch. Our systems are designed to support:

• Batch level traceability – from raw materials through to finished compounds
• Process control – defined, monitored, and documented manufacturing processes
• Risk management – systematic identification and mitigation of product and process risks
• Bio‑compatibility – evaluation and verification of material biocompatibility (e.g., ISO 10993‑5)

These elements work together to support safe, reliable medical grade compounds that our customers and end users can trust.

ISO 13485 and ISO 9001 Certifications

To ensure and demonstrate our high standards, Westlake Global Compounds certifies each of our plants that manufacture compounds for medical applications—currently in Italy, Vietnam, and Mexico—in accordance with ISO 13485 and ISO 9001.

ISO 13485 – Medical Device Quality Management

ISO 13485 is the key international standard for quality management systems in the medical device sector. Certification to ISO 13485 shows that Westlake operates a QMS that has been independently audited and verified to meet the standard’s requirements.

This helps us to:

• Consistently provide medical compounds that meet customer requirements and applicable regulations
• Focus on product risk management (ISO 14971)
• Maintain product traceability across the supply chain
• Implement rigorous process control in manufacturing
• Ensure accurate documentation at every production stage

ISO 9001 – General Quality Management

ISO 9001 is the globally recognized reference standard for quality management systems across all industries. Based on a High-Level Structure (HLS), it places strong emphasis on:

• Continuous improvement
• Customer focus and satisfaction
• Process based management
• Integration with other standards, including Health, Safety and Environment

Our ISO 9001 certification confirms our commitment to operational excellence, business continuity, and consistent quality in the products and services we deliver 4567.

Building Trust Through Quality

Both ISO 13485 and ISO 9001 certifications are fundamental tools for:

• Building and maintaining market trust
• Strengthening long term customer relationships
• Supporting compliance with increasingly strict global standards
• Reducing the risk of mistakes, defects, and non‑conformities

At Westlake, quality is a core value and a key part of our identity. It is non‑negotiable—especially in the medical field, where our materials support products that may be used in critical and life sustaining applications.

Quality as an Ongoing Commitment

Quality is not a one-time achievement, but a continuous journey. Through constant commitment to quality and ongoing improvement of our processes, systems, and competencies, we can:

• Protect people’s health and safety
• Support our customers in meeting their regulatory and technical challenges
• Consolidate and enhance Westlake’s reputation over time

In the medical business, quality is more than a technical requirement—it is our promise to patients, customers, and society.