Global quality

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.


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.

Aligning closely with our mission and values, we define quality at our organisation 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 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.


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 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

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


Product quality

Our strategic planning initiatives are tied to 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.

From our senior leaders to our team members who manufacture our devices, we set out every day to deliver high-quality products to our customers. This starts with designing quality into our processes and products.


Fast facts

+120 ISO13485:2016 certificates

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

Active participation in FDA’s Experiential Learning programme

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

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


Product development

Designing for quality
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 to continually improve next-generation designs.

Manufacturing, distribution and logistics quality

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 these controls in place upstream prevents issues from progressing through the manufacturing process, reducing reworks, limiting the amount of scrap and lowering manufacturing costs.

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:

  • We closely monitor global demand and have a great insight into emerging global risks.
  • We spread our manufacturing network and suppliers across the globe and leverage multiple suppliers across each commodity.
  • We use standardised machines and processes so, if a situation warrants it, we can move products across plants and to capable manufacturing locations in other regions. We have a robust set of processes and a dedicated product transfer team to enable such transfers and qualify alternative components and materials in case of shortages.
  • We are equipped to make products in multiple plants in cases where demand overshoots a manufacturing plant's capacity.

Product testing standards: As we build processes and systems, we utilise over 150 accredited standards from organisations 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 of 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 utilising preventative maintenance programmes. 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 organisation. This begins in the recruitment 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 3 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 labelling 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 utilise 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.

  • Across all of our manufacturing sites, we are accredited to ISO13485, and all eligible Stryker locations are certified as part of the Medical Device Single Audit Programme (MDSAP).2

We maintain a continual monitoring programme to ensure Stryker sites implement the latest certifications.

  • Throughout all applicable Stryker sites, we are engaged in a multi-year programme to implement and adhere to EUMDR.

Stryker supports all external audits.

  • Every year, Stryker supports over 100 external audits across our manufacturing, logistics and distribution sites to ensure adherence to all relevant standards.

Supplier quality management

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 two ways. A short-term measurement that focuses on achieving good quality parts coming into our manufacturing facilities via the supply chain. Then, a long-term measurement that focuses on 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.

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.

Download the guidebook

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.

Learn more about Supplier Diversity at Stryker

Supplier quality agreements
We have formalised quality agreements with supplier partners based on risk level. Agreements may include –

  • quality and communication expectations;
  • definition of roles and responsibilities;
  • applicable standards and regulations;
  • registration and certification requirements;
  • acceptance of announced and unannounced audits from external regulatory bodies.

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 prioritisation:
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.

Supplier inspection:
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 programme:
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.

MedAccred partnership

  • We partner with Performance Review Institute's (PRI) MedAccred, an industry-managed, consensus-driven approach to ensuring critical manufacturing process quality throughout the medical device supply chain. We leverage this accreditation as part of our supplier evaluation processes.

ISO13485 lead auditor training

  • All of our supplier lead auditors are trained and certified as ISO 13845 Lead Auditors.
  • We leverage our expertise to develop our suppliers through quality improvement projects, in addition to our supplier audits.

Internal subject matter experts

  • We leverage our internal expertise to add value to our process-based supplier audits of specialised processes.

Post-market surveillance

Improvement, complaints
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 it's received. The output of these post-market processes is also fed into our corrective and preventive action process for continuous improvement.

Ethical marketing

At Stryker, we are committed to conducting our affairs ethically and lawfully. Our policies and procedures are intended to guide employees, officers and directors in the performance of their duties and responsibilities and ensure compliance with the company's commitment to ethical and lawful conduct. Our focus on doing what's right stems directly from our mission and values and joins all employees in protecting our customers and our business.

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 programme, communications and engagement campaigns.

Stryker employees certify to the code of conduct on an annual basis and undertake yearly compliance training.

Corporate Policy No.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:

  • Clinical Affairs
  • Communications
  • Compliance
  • Executive and General Management
  • Human Resources
  • Legal Affairs
  • R&D
  • RAQA



1. Pulled from company-wide learning management system October 2021.
2. Eligible locations as of October 2021.