We understand that in today’s challenging healthcare environment, our customers need solutions that improve quality, efficiency, safety and patient outcomes. These needs are creating opportunities for us, together with our customers, to make healthcare better.
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.
Aligning closely with our mission and values, we define quality at our organization through this policy. 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 program 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 management systems
A QMS that enables collaboration and global agility, maximizes efficiency and ensures compliance to make healthcare better
Enabling market access through efficient best-in-class processes and advocacy with global regulatory authorities
Effective regulatory affairs, quality assurance and clinical affairs (RAQAC) acquisition integration
Integration of new businesses quickly and efficiently, instilling confidence and trust with customers and regulatory authorities
Sustaining an ecosystem where clinical evidence powers the business and drives better healthcare
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 experiences that command confidence and evoke an emotional connection to safety, reliability, durability and effectiveness
Our strategic planning initiatives are tied to our quality planning program. 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.
From our senior leaders to our team members who manufacture our devices, we line up every day to deliver high-quality products to our customers. This starts with designing quality into our processes and products.
+120 ISO13485:2016 certificates
+100 independent audits each year by Notified Bodies and global health authorities
In pursuit to be world-class in supply chain, Stryker places high emphasis on supply chain resiliency. As a result, we can ensure our business continuity plans are well developed to avoid any impact on supply. With a keen focus on supply chain resiliency, and maintenance of strong partnerships with our suppliers, we can successfully deliver on our mission – to make healthcare better, together with our customers.
To ensure we are optimally prepared at all times, we take the following steps:
Product testing standards: As we build processes and systems, we utilize over 150 accredited standards from organizations such as ASTM International, International Organization for Standardization (ISO) and British Standards Institution (BSI) to ensure compliance when designing, manufacturing and distributing our products. We use both internal and external accredited testing labs to support this activity.
Incoming, in-process and final inspection: Across all our manufacturing, logistics and distribution sites, we use acceptance activities that comply with the Food and Drug Administration (FDA) QSR 820.80 and ISO 13485 and all applicable quality and regulatory standards.
Process monitoring: We control and monitor our manufacturing and distribution sites utilizing preventative maintenance programs. These include integrated process monitoring systems, such as MES and environmental monitoring in our cleanrooms that comply with all relevant standards to ensure that products meet or exceed specifications.
Training is at the core of our quality culture, permeating through all levels of the organization. This begins 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. Each employee is aware of the relevance and importance of their activities and how they contribute to the achievement of our quality objectives.
Every employee is trained to execute their role. Our employees complete over three million formal training events each year.1 Training areas include but are not limited to Quality Management Systems, Compliance, Product, Process, Sales and Marketing and labeling training.
Our job-specific training curriculum is designed by role, function and location and tailored to support compliant execution of daily tasks to ensure we continually follow our processes and procedures.
At Stryker, we utilize the most appropriate training delivery methods to ensure efficacy, including self-paced reading, interactive web-based training and live in-person training.
Our global manufacturing sites are accredited to appropriate regulatory certifications.
We maintain a continual monitoring program to ensure Stryker sites implement the latest certifications.
Stryker supports all external audits.
Our Supplier Quality Guidebook is intended to serve as a helpful resource providing our supplier partners with an overview of our quality requirements and expectations.
All of our suppliers are assessed and qualified before they are added to our list of approved suppliers. Part of this assessment includes evaluating the category and risk of the supplier based on the products and services they will provide. Approval requirements are risk-based and may include assessment of supplier capabilities, initial audit, regulatory certifications and supplier agreements, as required.
Supplier quality agreements
We have formalized quality agreements with supplier partners based on risk level. Agreements may include –
Change control agreements and management:
We set expectations with all product and service suppliers on communication and implementation requirements on quality-impacting changes.
Change control communication tools:
We provide our suppliers with the tools necessary to ensure proper and timely communication to Stryker regarding any quality-impacting changes that the supplier may propose.
Change review board approval and prioritization:
Stryker assesses the risk and priority of supplier-proposed changes to ensure proper resources are allocated to execute the change.
Project planning and execution:
We assess the requirements and execution needs of the change request based on the appropriate risk and level of qualification needed to ensure no unintended effects occur as a result of the change.
Process capability analysis:
Together with our suppliers, we define criticality and qualify the manufacturing process by performing a process capability analysis.
Process risk management:
We expect our suppliers to maintain risk management documents and controls that predict and prevent quality issues.
We monitor our suppliers with qualified inspections to ensure they meet our requirements to protect Stryker and our customers from non-conforming product.
Supplier performance review:
We monitor the performance of our suppliers through data analytics and key performance indicators. The analysis informs our assessment and determines whether action is needed.
Supplier monitoring audits:
We perform process and quality system-based audits on high-risk suppliers with a regular cadence to drive improvements while also ensuring compliance, quality expectations and sub-tier supplier management. We also perform for-cause audits on suppliers identified through the supplier performance review.
Supplier quality improvement program:
We partner with suppliers who have been identified as needing additional focus to create quality improvement projects that aim to improve the supplier’s quality culture, processes and metrics.
ISO13485 lead auditor training
Internal subject matter experts
Foundational to our quality management system is our continuous improvement program. 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 organization.
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.
In our code of conduct, we explicitly state our commitment to accurately represent our products and services and comply with applicable regulatory and legal requirements governing our products and services marketing and sale. It is the first of our 13 corporate policies, available in 23 languages.
Our Corporate Policy 5: On-Label Product Promotion provides further guidance and direction on our commitment by making it clear that Stryker employees, contractors, consultants and other third parties acting on Stryker’s behalf may only promote Stryker products for uses consistent with the label.
Multi-layered training focused on the code of conduct, including what’s expected of employees, business partners and the company, is the subject of a broad company-wide compliance program, communications and engagement campaigns.
Stryker employees certify to the code of conduct on an annual basis and undertake yearly compliance training.
Corporate Policy #5 On Label Product Promotion is also part of the training curriculum for our Sales and Marketing job groups, as well as the below groups within Stryker:
1. Pulled from company-wide learning management system October 2021.
2. Eligible locations as of October 2021.