Global quality

At the heart of what we do and believe is making healthcare better. We do this by collaborating with our customers to develop innovative products and services that ultimately improve the lives of patients and we express it through our mission: Together with our customers, we are driven to make healthcare better.

Our core values of Integrity, Accountability, People and Performance guide our behaviours and actions. We do what’s right, we do what we say, we grow talent and we deliver. These values are part of our DNA and are fundamental to how we execute our mission.

We understand that in today’s challenging healthcare environment, our customers need solutions that improve quality, efficiency and the patient experience. These challenges are creating opportunities for us to make healthcare better, for our customers and the patients they serve.

Our quality policy


While our mission and values drive direction for our business, our closely aligned quality policy sets the direction for quality within our organisation. To remain a leader in the medical technology industry, a company must have a passion for product quality and reliability. We are committed to meeting and exceeding global regulatory standards. We stand behind our products and address issues if they arise. To support this, we have a robust quality data programme that includes key process indicators for different dimensions of quality. This data is used to manage the day-to-day quality activities and is also regularly reviewed with executive leadership.
 

Quality Policy

At Stryker, quality is first in everything we do. We are driven to make healthcare better for our customers by providing innovative products and services that meet regulatory requirements through our effective quality system.
 

A culture of quality

Quality is at the forefront of everything we do and is embedded into our culture. From our senior leaders to our team members who manufacture our devices, we line up every day to ensure that we are delivering high quality products to our customers. This starts with designing quality into our processes and products. 

During our new product development process, we are designing for quality and for manufacturability, serviceability and reliability. We have dedicated quality teams working throughout the new product development process who partner closely with our design engineering teams to ensure our quality culture is pushed upstream into the product life cycle. Feedback from current generation products that are actively manufactured in plants is taken back to the research and development teams so they can continually improve next generation designs.

Our focus on quality continues through our manufacturing and sourcing processes. Making a quality product starts with quality materials. We partner with our suppliers early in the development process. We measure the performance of our suppliers in both a short-term measure which focuses on the achievement of good quality parts coming into our manufacturing facilities via the supply chain, and a long-term measure that focuses around the overall capabilities of our suppliers. We believe that fostering strong partnerships with our suppliers with a shared focus on quality delivers the best results.

We have a strong focus on right-first-time performance in our manufacturing facilities. This requires our research and development teams to focus early in the development process on both design for manufacturability and the ongoing ability to control the manufacturing process. Putting the controls upstream prevents issues from progressing through the manufacturing process which also greatly reduces rework and scrap and lowers manufacturing costs.

Training is at the core of our quality culture, permeating through all levels of the organisation. Beginning in the recruiting process, where we hire talented employees based on a combination of education, training, skills and experience, through onboarding, and continual learning and development. Every employee is aware of the relevance and importance of their activities and how they contribute to the achievement of our quality objectives.

Foundational to our quality management system is our continuous improvement programme. At its core, continuous improvement is designed to empower employees to solve challenges that they encounter in their day-to-day work. Creating this type of environment with our employees enables a proactive versus reactive culture within our organisation. As it relates to feedback from customers, we have a standard complaint handling process by which complaints are received, evaluated and investigated. We also have defined processes for how our post-market information is tracked and trended once received. The output of these post-market processes is also fed into our corrective and preventive action process for continuous improvement.

Our quality strategy

Leverage our culture of quality to exceed our customer's expectations through:

Quality management systems
A QMS that enables collaboration and global agility, maximises efficiency and ensures compliance to make healthcare better

Regulatory affairs
Enabling market access through efficient best-in-class processes and advocacy with global regulatory authorities

Effective RAQAC acquisition integration
Integration of new businesses quickly and efficiently, instilling confidence and trust with customers and regulatory authorities

Clinical affairs
Sustaining an ecosystem where clinical evidence powers the business and drives better healthcare

RAQAC talent

Grow RAQAC talent and promote a culture that drives business growth, develops leadership at all levels and makes Stryker a top tier employer of choice

Product quality

Product experiences that command confidence and evoke an emotional connection to safety, reliability, durability and effectiveness

Our strategic planning initiatives are tied into our quality planning programme. In our journey of continuous improvement, we focus on strategies that will keep Stryker’s quality at the forefront of the industry, while working with our customers to make healthcare better. In support of our quality strategy, we certify all of our manufacturing and design sites to ISO 13485:2016, the international standard for medical product quality systems. 


Fast facts
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+120 ISO13485:2016 certificates

+30 MDSAP (Medical Device Single Audit Programme) certified locations

+100 independent audits each year by Notified Bodies and global health authorities

Actively engaged with FDA and MDIC in the Case for Quality programme

Active participation in FDA’s Experiential Learning programme