By Sarah B. Cruz CSPDT, CRCST, CHL, CIS
“Quality” appears to be the healthcare industry’s new buzzword. Sitting high amongst other phrases like “let’s take that offline” and “state-of-the-art,” a variety of professions use the word in their own ways. Originating from the craftsmen of the medieval era, guilds would compose strict guidelines that required their products to be inspected for defects. These practices remained present, surviving through the Industrial Revolution,¹ and have evolved into the quality management systems seen in the 21st century. From medieval craftsmen that created the first quality control program to the first quality assurance program in the 1920s, quality control has been present throughout history.¹ Over time, quality programs began to emerge in industries not necessarily specific to the factory setting. As the healthcare industry incorporates quality systems into daily operations and patient care, professionals face the challenge of defining what it means to provide “quality care” within an organization that serves patients. There is an even greater challenge to professions like Sterile Processing (SP), whose quality management systems are directly linked to an entirely separate profession’s ability to perform their quality of care.
Learning Objectives
- Define quality in the context of the healthcare industry, particularly in Sterile Processing.
- Understand the purpose of a Quality Management System and key factors to consider when developing one.
- Be able to differentiate between Quality Assurance, Quality Control, and Quality Culture, and explain how they contribute to better outcomes in the Sterile Processing department.
About the Author

Sarah B. Cruz, CSPDT, CRCST, CHL, CIS is president and founder of PRETREAT CSS, where she and Sterile Processing professionals work together to create objective-driven goals to advance their professional development. She is an industry speaker, published writer, social media enthusiast, mentor, and CTSPA Chapter President and HSPA Director. Sarah is a Sterile Processing instructor at her local community college and a CS Quality Education Program Development Coordinator in her full-time role.
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Sterilization Quality Control: Your Path to Protecting Your Patients
Ensuring Success: Become a Preceptor for Robotic Assisted Surgery Instruments in the Sterile Processing Department
Lost in Translation: Ethical Dilemmas in Medical Manufacturing Instructions
What Sterile Processing Should Know About Multidrug-Resistant Organisms (MDRO)
Making the Right Choice for Sterile Processing Consumable Stock Outages
UV-C Disinfection Technologies: How it works and what are the current applications for health care settings
The Differences Between Peracetic Acid High-level Disinfectants and Sterilants
The Mystery of Bowie & Dick: Alterations in the Vacuum on Your Sterilizer Throughout the Year
Meeting the Challenges of Endoscope Reprocessing and Documentation
Education Nation: Sterile Processing Quality Management Systems
Product testing: The overlooked 4th pillar of a robust sterilization process monitoring program
Importance of Water Quality for Medical Device Reprocessing
Mechanical Cleaning Safety: A Tale of Two Sides
Sterilization Choices for the SPD
When Is Disposable the Right Choice for SPD?
Education Nation: Sterile Processing Leadership Planning Sessions
How Safe Is Your Sink?
Sterile Processing Education – The balancing act between documentation and application
Moisture Absorption Devices….No This Is Not a Wet Pack Article
Positive Biological Indicators
Washer disinfector release for use after maintenance
Beyond the visual: The importance of quality cleaning verification programs
Education nation: Creating Sterile Processing Department SOPs
Cross out cross contamination in endoscope processing
What’s new in AAMI ST79:2017? A review
Healthcare soils 101: Identifying and removing them
Expiration dating in the SPD
The Science of Speed
The fantastic four: Sterile processing, operating room, quality and education
Ugh! Another wet pack. What’s a technician to do?
Sterilization quality control: Validation, routine monitoring go hand in hand
Manual cleaning – The critical human element
Water for cleaning medical devices
Can you afford to ignore obsolescence?
Automatic Equipment and Productivity in a Sterile Processing Department
External Transport of Medical Devices
Troubleshooting Washer-Disinfector Performance

