While some use the terms quality assurance software and quality management software interchangeably, they are, in fact, different things with their own distinct set of tools and methodologies. Let’s explore the differences between the two software types, how each impacts your business, and whether you need QA or a QMS.
What is quality assurance?
Quality assurance (QA) is a systematic process that ensures products and services meet specific standards and requirements. This process shouldn’t be confused with either quality management or quality control. QA is about maintaining a desired level of quality in a service or product by regularly monitoring all stages of the delivery or production processes.
In a medical device manufacturing scenario, quality assurance ensures each device meets specific quality standards and regulatory requirements. For example, a QA team might develop a set of Standard Operating Procedures (SOPs) for producing a cardiac pacemaker. These SOPs detail exact materials, assembly processes, and testing protocols.
The team would use regular inspections and audits to verify adherence to these standards. Any deviation would trigger an investigation to find and correct the root cause.
Ultimately, in this scenario, QA ensures consistent quality, industry compliance, and patient safety.
What does quality assurance software do?
Quality assurance software (QAS) automates the QA process, maximizing efficiency and effectiveness and reducing the likelihood of human error. Businesses use quality assurance software to help identify faults, defects, and inefficiencies in the production or delivery processes. It also tracks the issues to ensure that fixes roll out.
What is quality management?
Quality management is a broader concept that encompasses all the activities and tasks needed to maintain the specified level of excellence from end to end. Quality management includes quality assurance, quality control, and quality improvement.
In the same cardiac pacemaker manufacturing process, a quality management system encompasses a broader approach to quality. It would include not only the specific SOPs of the QA system but also guidelines for design, supply chain quality and selection, regulatory compliance, employee training, customer feedback, and post-market surveillance. In this way, an integrated QMS covers quality assurance, quality control, and continuous improvement.
What does quality management software do?
Quality management software (QMS) is a tool that helps organizations manage and maintain quality across all aspects of their business. An integrated QMS solution includes document control, compliance management, audit management, employee training, audit trails, and more.
Quality management software is a comprehensive solution that ensures teams maintain quality at every level of the organization. It impacts supplier quality, time to market, decision velocity, and business-wide compliance.
Quality assurance vs quality management
Quality assurance is one part of the overarching quality management solution. See how quality management vs quality assurance two compares.
ASPECT |
QUALITY ASSURANCE |
QUALITY MANAGEMENT |
Focus |
Process-oriented |
System-wide |
Tool |
QAS (specific to QA) |
QMS (covers the whole quality setup) |
Objective |
Consistency |
Overall excellence and compliance |
Implementation |
Specific areas |
Organization-wide |
Do you need QA or a QMS?
The choice between QA and QMS depends on your organization’s specific needs. QA might be the right choice if you are looking for a targeted approach to maintaining quality in a particular area. On the other hand, if you want a comprehensive solution that covers all aspects of quality, a QMS is the way to go.
However, the decision is not always straightforward. It’s wise to consult quality experts (like us) to understand your unique needs and determine the best course of action. We can help you make an informed decision that aligns with your business goals.
Start your journey to quality excellence
Ensuring top quality is not just a business strategy; it’s a commitment to excellence that reflects every aspect of your organization. Whether it’s QA or QMS, the path to quality excellence is a journey that requires careful planning and execution.
You might be considering our QMS solution or seeking expert quality help at this stage. We’re here to assist you in taking the next step in your quality journey.
Consult with an expert who can help get you started on your quality journey today.
