Contract Manufacturing Quality

Our Commitment to Quality

As healthcare evolves patients needs are continuously increasing. Your customers expect more... and we deliver more. Today's quality standards are tomorrow's baseline. We embrace the concept of continuous improvement and maintain robust quality management systems to ensure future success. Nothing is more important to our business — and yours.

Our Pledge to You

We pledge that quality will always be our first objective. We utilize sophisticated management techniques, advanced technologies and highly trained personnel in every aspect of our business. We continually invest in these areas to ensure that every process, every machine and every employee produces the highest quality work. We promise to deliver compliant, precise, repeatable results — on time and within budget.

Our Quality Policy

Lubrizol Life Science Health (LLS Health) ensures quality manufacturing solutions for your medical device manufacturing needs, through:

  • Compliance with all customer requirements throughout production
  • Support of GMP principles
  • Strict adherence to our ISO13485 certified Quality Management System
  • Embracement a culture of continuous improvement
  • Empowered employees and advanced technologies working together to produce quality medical devices

Design for Compliance

Quality means a lot of things; in medical device manufacturing, it always means strict regulatory compliance. We will work with you to flag and refine any issues that may ultimately affect the product specifications. But most critically, you can leverage our vast experience and expertise navigating your requirements to prevent anything — from minor technicalities to major issues — from keeping your device from the market that needs it.

Our Quality Investment

LLS Health’s Quality Processes

LLS Health develops and validates every process through statistical analysis so we know it will produce consistent results of the highest quality. Every team member is empowered to stop the production line whenever a concern arises, allowing us to quickly document and troubleshoot potential problems and restore production once we know your product quality standards will be achieved. Learn more about our quality management process.

LLS Health’s Technology

LLS Health utilizes the latest in software and equipment to support our constant drive for unsurpassed quality. Using advanced inspection equipment throughout our manufacturing processes we ensure consistent product quality. And with our enterprise wide electronic data storage system we are able to access data to drive our continuous improvement initiatives.

LLS Health’s People

From the production line through upper management, our people act on the knowledge that quality is our most important service. Our quality assurance department oversees all efforts for compliance to your manufacturing specifications. And our ongoing training programs constantly evolve, ensuring that our entire team has the knowledge, tools and support necessary to meet your needs.

LLS Health Quality Management Process

From start to finish, LLS Health cares for the life of your product.

LLS Health’s Quality Management Systems

ISO Registration

All LLS Health systems are designed to support compliance. LLS Health maintains ISO 13485 certified Quality System and is a certified supplier to many of the top medical device manufacturers in the global healthcare industry. 

CE Registration 

Our PTA balloon catheter platforms (0.035 and 0.014) are CE certified. We are an approved manufacturer for drug coated balloons in accordance with German pharmaceutical law (AMG)

Process Validation

Each step of LLS Health's process is validated. Beginning with pre-production, LLS Health validation includes reviewing design attributes, establishing process parameters, tooling validation, prototyping, testing and inspection. Our quality management system uses industry-standard population statistics, Hi / Lo grouping, pass / fail and capability methods.

Lean Six Sigma

LLS Health incorporates Lean Six Sigma quality management principles at every level of our operation to verify that quality standards are being met, and to identify areas in need of improvement. We have Six Sigma black belts — with more in training — driving Six Sigma guidelines throughout the organization. And we’re committed to helping qualified individuals obtain black belt certification. 

Analytics and Reporting

We conduct Gauge Reproducibility and Repeatability Studies. And our running validation includes a first article inspection report, qualification data collection and statistical analysis. We continually analyze the results and use them as guides for refinement of the process.

Achieving Excellence with Six Sigma

In today’s competitive and ever-changing global environment there's no room for error. You can’t afford it. Your customers can’t afford it. That’s why Lubrizol Life Science Health continuously pursues ways to improve quality and increase efficiency, supporting your Six Sigma processes. It’s important to you, so it’s important to us.

Six Sigma at LLS Health

LLS Health incorporates Six Sigma quality management principles at every level of our operation to verify that quality standards are being met, and to identify areas in need of improvement. Our Six Sigma trained resources help define goals that are consistent with your demands and enterprise strategy.

Certifications and Standards

Your products must meet the most stringent standards imaginable. So, you need a manufacturing partner that can meet those demands. Lubrizol Life Science Health is fully qualified to manufacture medical device components that comply with the applicable domestic or global standards. Our Six Sigma trained resources apply our quality management system to your product development process and ensure compliance with your Six Sigma requirements.

View our ISO 13485 and Safety and security certificates