With a long list of first-to-market products and industry leading innovations, STERIS is a global leader in infection prevention, contamination control and surgical care technologies. We are committed to providing our Customers throughout the world with safe, effective, quality products and services.
When it’s a matter of life and death, patients and their families count on the expertise of caring professionals. And those professionals count on STERIS. Our goal is to help ensure that the environments in hospitals, surgical centers and pharmaceutical and research laboratories allow every patient to receive vital care without undue risk of infection or contamination.
To achieve this goal, STERIS has a broad range of programs that address product quality, safety, performance and regulatory compliance.
STERIS maintains strict quality standards regarding the safety and supply of our products. Our quality and safety processes and procedures are broad in scope and apply stringent quality and safety standards – from the quality of incoming materials through the design, development, manufacture, storage, handling and distribution of our products. STERIS’ Governing Standards include:
To monitor compliance with these standards, internal and third party assessments of our quality and regulatory systems are conducted. FDA also conducts Good Manufacturing Practice (cGMP) inspections of our manufacturing and contract sterilization facilities on a periodic basis. Similar governmental inspections are conducted in our manufacturing locations outside the U.S. In fiscal year 2011, 10 facilities were audited by the FDA.
Our notified body, BSI, conducts annual independent assessments of each manufacturing facility. In fiscal year 2011, 21 BSI audits confirmed our compliance with International Standards, including Conformity Europe (CE) marking.
Our Corporate Internal Audit Department conducts regular Quality and Regulatory audits in our manufacturing facilities. The results are reported to both the Audit Committee and the Compliance Committee of the Company’s Board of Directors. We also engage third party independent auditors to conduct Quality and Regulatory audits.
Robust processes are in place to monitor and support compliance with product regulations worldwide, including design controls, review of product changes, labeling and advertising, marketing approvals, good manufacturing practice, and adverse event reporting requirements.
STERIS Quality Policy
STERIS Corporation is committed to delivering satisfaction to our customers by anticipating their needs and offering value, quality, and reliability that exceeds their expectations.
The success of STERIS and our customers is powered by our people, a culture of teamwork, innovative solutions, and by continually improving the effectiveness of our Quality System as a foundation for business performance.
We value safety, integrity and mutual respect, supporting our employees, communities and customers, complying with all applicable laws and regulations.
This is The STERIS Way, a culture of quality.
Quality and Regulatory Leadership
Kathie Bardwell, CPA, CQA, is vice president and chief compliance officer and leads Regulatory Affairs and Internal Audit.
Regulatory and Compliance inquires should be directed to 440-392-7163.
Greg Meunier, vice president, Customer Quality, is qualified in Continuous Improvement methodology and leads STERIS’s quality system initiatives.
Product Quality inquiries should be directed to 440-392-7670.