The issue of product quality is larger than a program and more than a process—it is the promise we make every day to our customers. Quality matters in everything we do, everywhere, all the time.
Keeping this promise means being the company people count on to make things right and having zero tolerance for products and services that do not meet our standards. This requires 100% engagement from Hillrom employees, from the factory floor to the executive suite.
Hillrom’s products are divided into three global business segments:
1. Patient Support Systems—Smart Beds and Surfaces, Safe Patient Handling and Mobility Solutions and Care Communications, software-based solutions for insightful communication/collaboration between caregivers and patients.
2. Front Line Care—Diagnostics and Monitoring technologies and vision and respiratory care devices for diagnosing, treating and managing a wide variety of illnesses and diseases.
3. Surgical Solutions—Workflow and Positioning solutions that improve surgical safety and efficiency in the operating room, including tables, lights, pendants, positioning devices and other surgical instruments and accessories.
Hillrom does not develop, manufacture or market any drugs, conduct clinical trials or outsource such trials to any third party, and we do not conduct animal testing or outsource animal testing to any third party.
Responsible for product quality and safety across all Hillrom operations, the Senior Vice President of Quality Assurance and Regulatory Affairs is a member of the CEO-lead Executive Leadership Team. This SVP gets direct reports from those focused on product safety (Vice President, Medical Affairs) and product quality (Vice President, Quality Operations).
Our Executive Leadership Team has established and maintains a Quality Management System that complies with the requirements of current versions of the ISO 13485 and the EN ISO 13485 standard; the ISO 9001 standard, the U.S. Food and Drug Administration Quality System Regulation (21 CFR 820), the European Union Medical Device Directive (93/42/EEC), Health Canada Medical Devices Regulations (SOR/98-282), Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), Japan Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169), Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3), China Good Manufacturing Practices (CFDA 2014 No. 64 Announcement) and Good Supply Practices (CFDA 2014 No. 58 Announcement); and/or other applicable local, state, national and international regulations where applicable (i.e. ISO 17025 - General requirements for the competence of testing and calibration laboratories; ISO 14001 – Environmental Management Systems; OIML non-automatic weighing instruments; applicable cybersecurity standards).
All of Hillrom's design and manufacturing locations maintain active quality management certifications, reflective of the type(s) of the medical devices that the locations design and/or make. All certifications are externally certified by a notified body, which requires annual audits and/or inspections.
Each Hillrom product undergoes appropriate levels of testing prior to shipment. Throughout the design and manufacturing process, our products are tested for safety, cybersecurity vulnerabilities and usability and performance. The level of testing reliability and confidence is based on each product’s risk profile using various product volumes, duration and frequency of testing. The methodology is based on statistical procedures for the medical device industry written by Dr. Wayne Taylor, a leading expert on acceptance sampling in the pharmaceutical, medical device and diagnostics industries. All procedures to control and verify minor, moderate, and major design changes are established and documented.
Every employee is assigned annual training that covers quality management principles and how they apply to the business, ensuring Hillrom maintains world-class standards in product quality and safety.
Our post-market surveillance process evaluates data from a variety of sources to ensure product adherence to published marketing, advertising and sales guidelines. This evaluation is performed annually (or sooner in the case of a safety recall or significant incident) as part of our Clinical Evaluation Reporting process for collecting, analyzing and assessing clinical data, done in order to verify the safety, performance and benefits of our medical devices. Sources of data reviewed and evaluated include the following: clinical literature databases, clinical trial databases, safety registries, adverse event databases and internal data sources (customer complaints, risk management files, trending, pre-clinical test reports and post-market clinical follow ups).
If our post-market surveillance process identifies a risk, Hillrom follows a field action process that determines if a recall action needs to be taken, identifies the steps necessary to investigate and approve such an action and defines steps required to identify if the field action needs to be reported to regulatory agencies. The field action process is governed by the Corporate Field Action Committee that is chaired by the Senior Vice President of Quality Assurance and Regulatory Affairs and consists of representatives from Legal, Finance, Marketing and Service.
Medical device, medical device accessory and other critical suppliers are expected to acknowledge our quality standards through signing of a Quality Agreement.
We monitor direct and indirect approved suppliers for quality performance by routinely auditing and monitoring delivery performance data. Requests for corrective action are issued to suppliers with product quality issues and tracked until the issue is adequately resolved. If the issue pertains to a sub-tier supplier affecting final product quality, Hillrom requires our first-tier supplier to resolve at the sub-tier supplier. As needed, we engage with our suppliers at all tiers to help solve problems.
Hillrom's Sourcing team has regular business reviews with suppliers, emphasizing our quality and safety standards in order to achieve excellence in supplier performance metrics, including on-time delivery and reduction in supplied defective parts per million.
We are an active member of the Advanced Medical Technology Association (AdvaMed), a trade association that leads the advancement of medical technology to achieve healthier lives and economies around the world. AdvaMed is influential in shaping legislative direction to promote better quality and safety in the supply chain. Recent examples of its activities include providing feedback to the FDA on the Quality, Safety and Effectiveness of Servicing of Medical Devices in Accordance with Section 710 of the Food and Drug Administration Reauthorization Act, Availability of Masked and De-Identified Non-Summary Safety and Efficacy Data and Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health.