Commitment to Regulatory, Quality and Safety Compliance

At STERIS, we take our responsibility for public health and the safety of patients and providers very seriously. We strive for excellence in everything that we do – and, we are committed to compliance with established legal and ethical standards.

STERIS Healthcare Products manufactures a diverse array of medical device, pharmaceutical, cosmetic and chemical products to healthcare providers globally and provides related installation, maintenance and repair services. STERIS Applied Sterilization Technologies is a leading global provider of contract sterilization services to healthcare product manufacturers and the life science industry. STERIS Healthcare Specialty Services provides a range of specialty services for healthcare providers including hospital sterilization services, instrument and endoscope repairs, and linen management. STERIS Life Sciences manufactures capital equipment and consumable products, and provides equipment installation, maintenance, repair and specialty services, for pharmaceutical manufacturers and research institutions worldwide.

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 and service quality, safety, performance and regulatory compliance.

Regulatory Compliance

STERIS follows strict regulatory compliance and quality standards to ensure the safety and supply of our products and services. Our regulatory, quality and safety processes and procedures are broad in scope and apply stringent standards – from the quality of incoming materials through the design, development, manufacture, storage, handling and distribution of our products and delivery of services.

STERIS operates under many U.S. and international governing standards including but not limited to the following:

United States

  • FDA 21 CFR 820 – U.S. Quality System Regulation Good Manufacturing Practice for Medical Devices (QSR)
  • FDA 21 CFR 211: U.S. Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP)
  • FDA 21 CFR 1271.150-320: Current Good Tissue Practice Requirements (cGTP)
  • U.S. Environmental Protection Agency – 40 CFR 150-189: Pesticide Programs
  • OSHA – U.S. Occupational Safety and Health Administration
  • NRC – U.S. Nuclear Regulatory Commission

International

  • ISO 13485 – Medical Devices Quality Management System Requirements
  • ISO 9001 – Quality Management Systems – Requirements
  • ISO 11135-1 – Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • ISO 11137-1 – Sterilization of health care products – Radiation- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • ISO/IEC 17025 – General requirements for the competence of testing and calibration laboratories
  • BS EN 14065 – Textiles – Laundry processed textiles – Biodecontamination control system
  • ISO 19011 – Guidelines for Auditing Management Systems
  • EU Medical Device Directive (MDD)
  • European Chemicals Agency (EChA)
  • EU Biocidal Products Regulation
  • U.K. Medicine and Healthcare Products Regulatory Agency (MHRA)
  • Health Canada – Canadian Medical Device Regulations (CMDR)
  • Health Canada – Good Manufacturing Practices Guidelines – Pharmaceuticals (cGMPs)
  • Australian Therapeutic Goods Administration (TGA)
  • Japan Pharmaceutical and Medical Devices Agency (PMDA) – Pharmaceutical Affairs Law

To monitor compliance with these standards, internal and third-party assessments of our quality and regulatory systems are conducted. FDA conducts inspections of our manufacturing and contract sterilization facilities on a periodic basis to confirm compliance to device QSRs, drug cGMPs and human tissue cGTPs. Similar governmental inspections are conducted in our manufacturing locations outside the U.S.

Our EU Notified Body and Quality System Registrars conduct annual independent assessments of our ISO certified manufacturing, contract sterilization and healthcare specialty facilities to audit compliance with ISO 13485, ISO 9001, BS EN 14065, ISO/IEC 17025 and EU CE marking requirements under the EU MDD as applicable. Each year STERIS hosts numerous Notified Body assessments at our various facilities, as well as additional audits by many of our Customers who are themselves manufacturers.

The STERIS 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 and service regulations worldwide, including design controls, review of product changes, labeling and advertising, marketing approvals, good manufacturing practices, and adverse event reporting requirements.

Quality Policy

STERIS 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, Senior Vice President & Chief Compliance Officer, leads Corporate Internal Audit, Security and Regulatory Affairs for STERIS Healthcare, and Quality and Regulatory Affairs for the STERIS Applied Sterilization Technologies business unit.

Regulatory and Compliance inquiries 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.

Go here to view our “We Process Quality” flyer.

Visit our library to download Quality Certificates

Contact our team of experts to find out more about our Global Contract Sterilization Services