What are the differences between quality management, quality control and quality assurance?

In regulated industries like life science, terms like quality management, quality assurance and quality control are often used interchangeably. But while sitting under the same umbrella, the terms refer to distinct processes and outcomes.

Understanding the operational distinction of quality assurance vs quality management, and quality control vs quality management, is crucial for ensuring your organization has effectively ticked off and applied all three areas.

In fact, quality assurance vs quality control vs quality management isn't a choice so much as a 'to do' list of three interacting ingredients - you'll need to embed all for maximum quality strength at your company.

Understanding quality management in life science

Let's start with the biggest, overarching element of the three quality terms: quality management.

Quality management is the comprehensive approach that encompasses all the organizational quality processes aimed at ensuring your products and services meet consistent standards. 

That means it encompasses both quality assurance and quality control, which are themselves 'part' of quality management.

Let's look at this in more detail.

Core principles of quality management

Quality management is built on several core principles mapped out in ISO 9001, the international quality management standard:

1. Customer focus: Understanding and meeting the needs of patients and healthcare providers.
   
   
2. Leadership: Establishing a vision and direction for quality that is communicated throughout the organization.
   
   
3. Engagement of people: Involving all employees in quality processes and decision-making.
   
   
4. Process approach: Managing activities as processes to improve efficiency and effectiveness.
   
   
   
   
   
   
5. Improvement: Continuously enhancing processes and systems.
   
   
6. Evidence-based decision-making: Using data and information to guide decisions.
   
   
7. Relationship management: Building and maintaining relationships with suppliers and partners that impact quality.

You'll see that these principles are broad, systemic and business-focused - they're the guiding elements which flow 'down' to guide how your quality assurance and quality control processes operate and get results.

Because of this, quality management is also known as the quality management system, or QMS.

It's the system and engine that gets quality done, from assurance to control.

FURTHER READING: What is a quality management system?

Quality management vs quality assurance vs quality control

The quality management vs quality assurance relationship, and the quality control vs quality management relationship, can both be explained as a kind of Russian doll set-up:

• Quality Management (QM): The overarching system that coordinates all activities and functions in your organization to achieve quality.
  
  
• Quality Assurance (QA): Part of QM, focused on assuring that the requirements of the quality management system are executed through planned, systematic activities and processes.
  
  
• Quality Control (QC): Part of QM and QA, focused on controlling quality requirements at the product level through checks, tests and inspections.

This diagram from ASQ is a helpful way of visualizing the quality assurance vs quality control vs quality management relationship.

In this context, as we've just seen above, the QMS or quality 'system' is synonymous with quality 'management'.

Quality control provides the on-the-ground tests and checks to ensure that quality assurance plans and processes are working properly.

And the quality management system sits above both as the housing structure of documentation, training, information and processes binding it all together.

So if quality control sits within both QA and QM, why aren't quality assurance and quality management treated as the same thing?

Let's go a little deeper.

FURTHER READING: The ultimate guide to pharmaceutical quality assurance

Quality management vs quality assurance

Quality management vs quality assurance isn't exactly the same thing because quality management encompasses additional activities beyond just quality assurance (and quality control within it).

To understand this, let's look at the scope of what QA activities entail.

Quality assurance definition and scope

Quality assurance is a systematic process designed to determine if the products or services meet specific requirements before they reach the customer.

It's proactive, focusing on preventing defects through the implementation of robust processes, and this sets it apart from the reactive check-and-test activity of quality control.

FURTHER READING: Quality assurance vs quality control: 5 key differences

Quality assurance in practice

In practice, then, QA means things like developing standard operating procedures (SOPs), conducting audits, verifying and validating processes, and training staff.

The word 'assurance' itself is key here - implying the setting of an agreed quality benchmark, then making sure the company continually hits it.

Remember those guiding principles of quality management we looked at, above? QA ticks some of those off, like the process approach, customer focus, and evidence-based decision-making.

But modern quality management system development, guided by ISO 9001 best practice, also involves critical elements like leadership, engagement of people and teams, and - perhaps most importantly of all - continuous improvement.

And it's here that the quality management vs quality assurance distinction is best understood.

Key differences between quality management and quality assurance

Simply put, quality management is more than simply assuring the quality and integrity of your products and services.

How do your senior leaders promote and engage with quality?

How is quality weaved into departmental objectives?

How will your quality be continuously pushed and improved?

These are questions for your quality management system to deal with - not quality assurance.

When we published our 2024 life science quality trends report, we showed how much time life science quality professionals were spending in four key areas.

We broke down the time spent on quality control and assurance, but also on admin and on continuous improvement tasks, too.

This is a helpful way to understand the quality assurance vs quality management breakdown.

Quality management also involves moving beyond the baseline of quality assurance, continuously improving quality by refining processes, stamping out defects and deviations, and actioning stakeholder feedback.

As such, it involves activities like management reviews for looping in leadership and securing their participation, as well as softer cultural activities like incentivizing teams and setting objectives for supporting quality business-wide.

These don't have a direct quality assurance impact, but are vital for ensuring quality becomes part and parcel of how the business runs generally. They're therefore classic quality management tasks.

Unfortunately, as any quality professional knows, modern quality management can also involve administrative 'upkeep' activity which doesn't really fulfil any control, assurance or improvement role, but rather helps the company remain compliant with its relevant regulatory requirements.

Things like populating spreadsheets, chasing employees for signatures, and producing reports for auditors to check up on all fall under modern quality management work, but not quality assurance.

(Fortunately, the growing adoption of modern tools like electronic quality management system (eQMS) software is increasingly helping to eliminate and automate these non-value-add activities, freeing up time for more assurance, control and improvement work.)

In short, the quality management system vs quality assurance division isn't a clean one: the QMS incorporates quality assurance tasks, and more.

In an average company, quality assurance might occupy 65-70% of your overall QMS activity, with the rest devoted to improvement initiatives, admin and upkeep.

FURTHER READING: 8 benefits of a QMS in 2024

Quality control vs quality management

What about understanding quality control vs quality management?

As you might have guessed by now, it's a similar story.

Like quality assurance, quality control is one part of the overarching quality management system, and is really best seen as a subpart of quality assurance.

Quality control definition and scope

Quality control is the practice of identifying and correcting defects in the finished products. Unlike QA, which is preventive, QC is reactive, focusing on detecting and addressing quality issues.

Quality control in practice

QC activities include inspection and testing, checking products at various stages of production to ensure they meet quality parameters like critical quality attributes or physical dimensions.

QC can also include statistical quality control (SQC), using statistical methods to monitor and control quality.

Key differences between quality management and quality control

The quality control vs quality management distinction is sharper than the quality assurance vs quality management breakdown, because quality control is an even more specific and focused set of activities.

Quality management is ultimately about creating an operational environment where quality resides in all areas of the business - with initiatives like total quality management (TQM) pushing this focus even further.

QC, on the other hand, is focused on the specific activities that detect and correct defects, often at the proverbial coalface like the assembly or manufacturing line.

In a robust and optimized quality management system, quality control should only form a small part of your overall activity - say, 25-30%.

And with the increased automation of quality control activity in sectors like pharmaceuticals, with tools like process analytical technology (PAT) increasingly seen on drug manufacturing lines, quality control time can be largely automated and reduced even further.

FURTHER READING: 5 things your life science quality management system needs

Integrating quality management, quality assurance and quality control

As we touched on in our breakdown of quality assurance vs quality control, an optimized quality management system requires a healthy balance of interacting activity.

Your QMS needs both quality assurance and control in place, but it's important too to commit time and energy to the extra continuous improvement activities we touched on above.

Complementary roles of quality management, QA and QC

For optimal results, then, quality management, quality assurance and quality control should be integrated.

QM provides the framework and cultural elements, QA ensures high-quality processes are followed, and QC verifies that your final products meet quality parameters.

Best practices for integration

There are a few things you should do to get a healthy mixture in place.

The stronger and more supported your quality management system is, the more you'll be able to secure company-wide buy-in and consistent commitment to all the forms of quality activity you need.

For that, a culture of quality built on effective communication is vital.

Leadership should be active quality advocates who empower and support all employees to support quality collaboratively.

And a clear definition of organizational structure, hierarchy, roles and performance should be in place, underpinned by SMART objectives and goals written with quality in mind.

Perhaps most importantly, the tools and systems you put in place are critical for promoting all three elements of the quality triangle.

Tools and processes

As we saw from our global quality survey above, quality professionals often struggle to adequately balance the time they can commit to the various aspects of quality management.

QMS software is an important tool for automating and eliminating quality admin, in time maximizing your available energy and headspace for control, assurance, management and improvement tasks. 

System guardrails make quality and compliance natural and automatic, while bespoke workflows allow new processes to be built and cascaded with ease - as tasks like document control, e-signature collection and recording quality information are automated and cut from your day-to-day.

Centralizing your QMS in a single platform like Qualio's QMS software allows full visibility and control of your quality system, with analytics allowing trends and bottlenecks to be spotted for quality control, assurance and continuous improvement.

Quality assurance vs quality control vs quality management is ultimately a shopping list, not 'one or the other'. The stronger your overall quality management system is, and the tools you use to run it, the more effective the assurance and control processes within will be.