What is a Quality Management System (QMS)?

Looking to learn how a modern QMS platform can help you streamline your QMS processes? Book a free demo or learn more about how a Quality Management System (QMS) can improve quality and compliance across your organization.

Quality Management System (QMS) Definition

Quality Management System (QMS) is a formalized system that documents processes, procedures, and responsibilities for continuously delivering high-quality products and services that meet regulatory and customer requirements.

The objective of a quality management system is to provide a framework that improves communication, collaboration, and consistency across your organization while also reducing waste, and promoting continuous improvement.

As the name suggests, QMS software is a quality management platform that helps you to streamline and automate quality management processes across your organization.

The adoption of such QMS tools can help you to improve quality and compliance while also reducing operational costs. They can be used across an entire organization or within specific departments such as quality, regulatory, product development, and others.

Illustration of Quality Management System and Sub-Systems

Why is Quality Management System (QMS) Important?

The importance of a quality management system is often underestimated.

Many companies think that a quality management system is only for big businesses, but this is not the case. A quality management system can benefit any size of business in any industry.

A quality management system helps organizations drive continuous improvement, helps establish compliance with regulatory authorities, and ensures that quality is built into every aspect of the product or service. This, in turn, leads to increased customer satisfaction, loyalty, and repeat business.

Benefits of Quality Management Systems

Compliance with quality standards: A quality management system helps you ensure compliance with quality standards and regulations applicable to your organization.

Improved quality: By streamlining quality processes and promoting continuous improvement, a QMS can help you improve the overall quality of your products or services.

Increased customer satisfaction: When customers are happy with the quality of your products or services, they are more likely to continue doing business with you.

Improved efficiency: A quality management system can help you eliminate waste and streamline quality processes, leading to increased efficiency and productivity.

Reduced costs: By improving quality and compliance, a quality management system can help you to reduce costs associated with rework, scrap, and customer complaints.

Improved communication and collaboration: A quality management system can help to improve communication between departments and across the organization, as well as collaboration between team members.

Different Types of Quality Management Systems

There are different types of quality management systems. The right one for your organization will depend on your industry, quality requirements, and other factors.

Some common types of quality management system requirements in the context of life science industries include:

  • ISO 9001:2015
  • ISO 13485:2016
  • FDA 21 CFR Part 820
  • ISO 17025:2017
  • ICH Q10
  • GxP
  • EU MDR & EU IVDR

Here is an illustration of the main regulatory requirements that could be applicable to medical device pharmaceutical companies.

Illustration of QMS requirements in Life Sciences

There are many other quality management standards applicable to organizations in other industries such as aviation, automotive, construction, etc.

To learn more about quality management systems and their requirements in different life science industries, explore the following articles:

Furthermore, non-standardized approaches to quality management may also be appropriate for certain types of organizations. These quality management approaches include:

  • Continuous Quality Improvement (CQI): Quality management approach that focuses on the continuous improvement of quality.
  • Total Quality Management (TQM): Quality management approach that focuses on quality throughout the organization, from design to customer satisfaction.
  • Six Sigma: Quality management approach that focuses on quality improvement by minimizing defects.

Core Elements of a Quality Management System (QMS)

Although quality management systems can vary depending on the type of organization, there are some core elements that are common to all quality management systems.

The nine core elements of a quality management system are:

  • Quality Policy and Objectives: The quality policy is a high-level statement from management that provides direction for the quality management system. The quality objectives are specific, measurable goals that support the quality policy.
  • Quality Manual: The quality manual is a document that provides an overview of the quality management system. It includes the quality policy, quality objectives, and other information about the quality management system.
  • Organizational Structure and Responsibilities: The organizational structure provides a framework for the quality management system. It defines the roles and responsibilities of individuals within the organization.
  • Data Management: This is the process of collecting, storing, and analyzing data. Data can be used to support quality improvement efforts.
  • Processes – Including Purchasing: Processes are the activities that are performed to achieve quality objectives. Purchasing is the process of procuring materials, supplies, and services.
  • Product Quality Leading Customer Satisfaction: Product quality is the degree to which a product meets its quality objectives. Customer satisfaction is the degree to which customers are satisfied with the quality of a product.
  • Continuous Improvement Including CAPA: Continuous improvement is the process of continually improving quality by making small, incremental changes. Corrective and preventive action (CAPA) is a process for addressing quality issues and preventing quality problems from occurring in the future.
  • Quality Instruments: Quality instruments are tools that are used to measure quality, this includes calibration and testing equipment which must be maintained to a high degree of quality to ensure accuracy.
  • Document Control: Document control is the process of creating, reviewing, and approving documents. Documents must be controlled to ensure that they are accurate and up-to-date.

Who is Quality Management System Software For?

Quality management system software is for organizations that want to streamline and automate their quality management system, reduce quality-related costs, improve quality, and maintain compliance with quality standards.

It can be used by organizations of all sizes, in all industries, and with different quality management approaches.

QMS software enables everyone – quality control, quality assurance, regulatory affairs, product development, or any other department – to manage quality processes in a structured and consistent way.

Although not all quality management solutions are created equal. Some tools are better suited for certain types of organizations than others.

For example, at SimplerQMS, we specialize in providing quality management software for life science companies. We offer a pre-validated, all-in-one quality management solution that out-of-the-box is compliant, audit-ready, and easy to use.

SimplerQMS Document Control Interface - Procedure List

What Does an Automated QMS System Do?

An automated quality management system (QMS) solution helps organizations streamline and automate quality management activities throughout the product lifecycle, from design to manufacturing, and post-market surveillance.

Automated QMS systems start by providing a centralized repository – a single source of truth for quality data. This repository can be used to manage any kind of document or file – quality control records, audits findings, customer complaints, CAPA records, etc.

Automated workflows for document creation, review, approvals, escalation, and archiving, as well as notifications and reminders, help quality teams to stay on top of their assignments.

The system automates, streamlines, and helps manage core QMS processes including:

  • Document control
  • Change control
  • Design control
  • Supplier management
  • Training management
  • Non-conformance management
  • CAPA management
  • Complaint management
  • Audit management
  • Risk management
  • And more

Finally, QMS solutions provide quality reporting and analytics capabilities. These features help organizations track quality KPIs, identify quality trends, and make data-driven decisions to improve quality.

SimplerQMS CAPA Management Software Interface

How QMS Software Can Help Your Business Today

1. Connect Data Across the Product Lifecycle

Disconnected quality data and organizational silos are common quality management challenges. Often, quality data is spread across multiple systems – from product development to manufacturing to quality assurance and customer service.

QMS platform connects quality processes and data throughout the product lifecycle. With cloud-based QMS software employees across the organization can access needed data in real-time, from anywhere. This provides a single source of truth and helps break down silos.

2. Improve Efficiency and Save Time

Organizations that rely on paper-based or hybrid quality management processes can take hours to complete quality tasks that could be done in minutes using quality management software.

Introducing a QMS platform has been shown to produce real results – including direct improvements to quality, quality-related costs, and efficiency.

One of many examples is Cortex Technology – after implementing SimplerQMS Quality Management Software they were able to decrease time on change management by more than 50%.

By automating quality processes quality teams can eliminate manual tasks, such as finding documents, making changes to records, reviews, approvals, and other tasks, reduce errors, and free up time to focus on more value-adding activities.

3. Train Employees Quickly and Effectively

Effective employee training is critical to quality and compliance. Digital quality systems with built-in training management features can help you streamline employee training by providing a central location to store training materials, employee training records, and more.

Customizable dashboards and KPI reports help monitor employee training status and performance. Plus, notifications and reminders ensure that training assignments are completed on time.

SimplerQMS Training Management Software Interface

4. Streamline Core Quality Management Processes

A good QMS platform will offer a suite of quality management features to help you streamline quality processes. These would typically include:

  • Document control
  • Change control
  • Supplier management
  • Training management
  • Non-conformance management
  • CAPA management
  • Audit management
  • And more

By automating such processes, you can improve quality and compliance while reducing costs.

Learn more about all the QMS modules that SimplerQMS offers.

5. Reduce Human Error

When all quality data is manually entered it is susceptible to human error.

An automated quality management system helps to reduce human error by automating tasks such as:

  • Document creation and data entry
  • Document naming, numbering, and versioning
  • Document routing, review, approvals, and obsolescence
  • Tasks notifications and reminders
  • Document access and permissions
  • And others

As a result, quality teams can be confident that data is accurate, up-to-date, and compliant.

6. Ensure Regulatory Compliance

Modern QMS platforms help you standardize quality processes and ensure compliance with applicable quality regulations. By automating processes you can be sure that records are accurately and consistently created and that quality data is properly collected, stored, and reported.

This is especially important for quality-critical life science industries such as medical devices, pharmaceuticals, biotechnology, and others that are subject to stringent quality regulations.

SimplerQMS was purposefully built for life science industries, with regulatory compliance in mind. With pre-configured workflows for quality processes such as document control, change control, non-conformance management, CAPA management, and others, quality teams can be more confident that they are meeting quality requirements while using SimplerQMS.

Furthermore, by implementing a pre-validated QMS solution, like SimplerQMS, you will also be able to save valuable time and money on quality system validation and continuous re-validation. A requirement for quality-critical life science industries, which our quality management software already meets.

For you, the benefits of a modern eQMS solution might be obvious. But implementing it can be a big decision as it impacts a lot of people and comes with a cost, so you will need to make the case for QMS software and present it to the upper management.

Get our free eQMS business case template to uncover the real value of a QMS solution.

eQMS Business Case Template Banner

What Cloud-Based QMS Offers Your Business

Nowadays, quality teams are no longer limited by on-premise quality systems.

Organizations across the globe are moving quality management systems to the cloud to take advantage of the many benefits it offers.

Ability to Work From Anywhere

Cloud-based quality management systems offer quality teams the ability to work from anywhere, all the time.

By storing files in a centralized, cloud-based location, employees can access the same information, from any device, whether they are in the office or out in the field. This is especially beneficial for quality teams that work remotely or have a distributed workforce.

Improved Security

Cloud-based QMS systems offer improved security features to help protect quality data.

With user permissions and role-based access, you can control who has access to data. In addition, data is backed up in the cloud and can be quickly recovered if lost or corrupted.

Illustration of Secure Cloud Storage Backups

Reduced Costs

QMS platforms with a cloud deployment model are often more cost-effective than on-premise quality solutions.

A cloud-based system does not require special hardware or complicated IT infrastructure. This allows you to keep IT costs to a minimum and frees up resources that can be better used elsewhere in the organization.

Many Other Cloud-Based QMS Platform Benefits

By choosing a QMS platform with a cloud deployment you can expect many other benefits, such as:

  • Automatic software updates
  • Faster implementation
  • Scalability

SimplerQMS provides an all-in-one QMS software for life sciences. Manage quality processes from a single platform with ease – increase efficiency and ensure compliance.

When is the Right Time to Implement a QMS Software?

Before you can decide if it is the right time to implement the QMS software solution you need to first plan and build the documentation for your quality management system. Or be in the process of doing so.

Once your QMS content is sorted, you can start thinking about the software solution that will help you streamline quality processes and improve quality management.

Although to say exactly what is the right time to implement a quality management system software solution is difficult, the answer for most companies is pretty simple. While you may be able to get away without a quality management solution, adopting a QMS platform sooner rather than later will save you time, money, and headaches in the long run.

Illustration of a woman sitting next to an eQMS clock

Certain signs suggest you might be ready to implement a quality management software solution:

  • You are using multiple tools and want to consolidate quality processes into one QMS solution
  • You are still using manual QMS processes and are looking for a way to automate quality management
  • You want to improve communication and collaboration between different teams involved
  • You want to improve quality management visibility and traceability
  • You want to better ensure regulatory compliance with quality standards
  • You are looking for a QMS that is scalable and flexible to accommodate your company’s growth

If any of the above apply to you, then it might be time to start looking for a quality management software solution.

Not sure where to start? Check out our guide on choosing quality management software.

Frequently Asked Questions

Here are the common questions for people learning about QMS.

What is QMS?

A quality management system (QMS) can be referred to as a system or software that helps organizations manage and document quality processes that help ensure the products and services meet customer expectations and quality standards. The main objective is to provide processes to follow to consistently deliver quality products/services, meet regulatory requirements, and improve communication and collaboration across the organization while reducing waste and promoting continuous improvement.

What is a Digital QMS Used For?

A digital QMS system is used to manage quality processes and quality data electronically. Electronic QMS helps manage processes such as document control, quality control, audit management, supplier management, training management, CAPA management, and more.

The system streamlines and automates these QMS processes, making it easier to manage quality data and quality processes across the organization. Additionally, a digital QMS can provide real-time visibility into quality management metrics and statuses on quality processes, so you can quickly identify and resolve quality issues.

Different groups can access the system within your organization for different tasks. For example, the regulatory affairs team can use the system to track and manage regulatory processes, while the quality control team can use it to manage supplier-related activities, and more.

What Are the Benefits of a QMS Platform?

A QMS platform streamlines and automates mundane tasks, freeing up quality teams to focus on more strategic quality initiatives. Most QMS solutions nowadays offer a cloud-based platform that is accessible from anywhere, making it easy for employees to collaborate and easily access needed documents from anywhere, using any device.

A quality management platform also promotes continuous improvement by providing quality teams with the ability to track quality metrics and identify trends. This data can be used to make informed decisions about where quality improvements can be made within the organization.

Ready to learn more?

To learn how your life science organization can make the most of SimplerQMS’s QMS solution, book a tailored demo.

SimplerQMS Demo Interface