What is a Quality Management System (QMS)?

Quality Management System Definition

A quality management system (QMS) is a formal system used to document, track, approve, and adhere to policies, procedures, regulations, and processes. The international standard ISO 9001:2015 specifies requirements for a quality management system. “QMS” is often used to describe the ISO 9001 standard, but it actually refers to the entirety of the system. Having comprehensive QMS systems in place enables companies to design, produce, and deliver safe and effective products and medical devices by complying with a variety of regulations (e.g., FDA, ISO, EU MDR). This ultimately helps manufacturing companies prevent quality mistakes, cost overruns, and nonconformances by using a single, secure system for all internal teams and their supply chain partners.


Quality management was first introduced in medieval Europe when craftsmen guilds developed strict guidelines for inspecting products.

In the late 19th century, mechanical engineer Frederick Winslow Taylor broke away from the traditional European craftsmanship model and quality practices to develop a new approach which focused on increasing productivity without increasing strain on workers. This led to his publication of “The Principles of Scientific Management” in 1910.1

In the 1920s, engineer Walter Shewhart developed statistical quality control methods to help businesses reduce variation and streamline production. His methods (also known as the Shewhart Cycle) were applied to the production of military goods during World War II, enabling armed forces to enhance product safety and quality. The Shewhart Cycle also served as the basis for the Plan-Do-Check-Act (PDCA) cycle, which is a key component of many of today’s quality management systems.2

Throughout the 1950s and 1960s, Japan focused on quality in an effort to rebuild its economy after the devastation of World War II. Japanese manufacturers soon adopted a total quality strategy which held all workers accountable for improving operational processes. This total quality approach enabled Japan to produce increasingly higher quality products at lower prices and resulted in an economic boom in the decades that followed.3,4

Around the same period, Japanese car manufacturer Toyota introduced the Toyota Production System (TPS). It was the precursor to Lean manufacturing which focuses on increasing productivity while minimizing waste.5

In the 1980s, American business leaders started to embrace the total quality management (TQM) movement in an effort to compete with Japan. TQM provided them a framework for implementing effective quality and production processes across their organization.

As the fundamentals of TQM started to fade, new quality management initiatives started to emerge. And in 1986 Motorola introduced a quality control method called Six Sigma.6 Since then, many organizations have adopted Six Sigma to increase profitability.

A year later, the International Organization for Standardization published the ISO 9000 series of quality management standards. These standards were designed to help companies document and manage the various elements of a quality management system so that they could increase customer satisfaction, meet regulatory requirements, and drive continuous improvement.

Today, companies are moving away from folders, binders, and other manual systems and embracing enterprise quality management system (eQMS) software to better manage and track all the processes and records that are tied to their quality system.


When implementing a QMS, organizations should keep these key elements in mind:

Quality policy and objectives
The quality policy outlines an organization’s purpose and mission and supports the business strategy. It also highlights the company’s commitment to continuous improvement and meeting regulatory and customer requirements. Quality objectives are measurable goals that stem from the quality policy. Examples include product performance, efficiency, safety, and delivery.

Quality manual
The quality manual outlines the scope of the QMS and includes information such as organizational objectives, expectations, and policies. The quality manual also specifies requirements for achieving compliance with regulatory standards like ISO, FDA, EU MDR, and EU IVDR.

Organizational structure and responsibilities
The QMS should include the roles and responsibilities of key stakeholders, resources, and infrastructure that contribute to an organization’s quality objectives. Flow charts or similar diagrams can be used to clearly illustrate how the organization is structured.

Internal processes
Organizations should define processes that require employees, machines, technology, or other resources to turn inputs into outputs. Standards and metrics for measuring the performance of these processes should also be documented to ensure that quality outputs are always the end result.

Customer satisfaction
Organizations must utilize surveys, complaint reports, review websites, or other tools to monitor customer satisfaction and ensure that their quality objectives are being met.

Continuous improvement
The proper processes must be in place to ensure ongoing improvement of products and services over time. Six Sigma and Lean are commonly used tools to ensure continuous improvement.

Document control
A system must be in place to ensure:

  • Review and approval of documents for adequacy prior to release
  • Review/update/re-approval of documents on an as-needed basis
  • Identification of changes and current document revision status
  • Prevention of obsolete documents from unintended use
  • Policy or procedure for the identification, storage, protection, retrieval, retention, and disposal of documents

Enterprise quality management system (eQMS) software
To gain greater traceability and control of quality processes and simplify compliance, companies are making the switch from traditional paper-based systems to eQMS solutions.


Paper-based quality management systems may work for a short period; however, as the document history grows and processes evolve, it becomes harder to manually locate and update files not to mention keep track of the latest revisions. These shortcomings are exacerbated by the COVID-19 pandemic, which has driven many businesses to adopt remote work practices. With teams now spread across different locations, they need a more efficient way to store and access information while gaining greater control and traceability.

In a highly regulated environment, companies must develop and maintain vast amounts of quality documentation to demonstrate adherence to industry standards. Getting these documents through review cycles and obtaining the necessary signoffs can take longer with manual, paper-based processes. In addition, handwritten changes are oftentimes incomplete or illegible and more prone to misinterpretation and errors. Paper-based systems also make it difficult for teams to track corrective and prevent actions (CAPAs) and demonstrate closed-loop quality processes. To make matters worse, teams are unable to quickly compile complete and accurate information for a regulatory audit or assessment. These issues create compliance risks and prevent organizations from achieving commercialization success.

In contrast, digital QMS solutions enable companies to electronically document, store, and maintain CAPAs, training documents, design history files (DHFs), and other essential records in a single location. Teams can easily access the latest changes and expedite reviews and approvals. With a complete document history readily available, organizations can gain better control and visibility over their quality processes and streamline compliance.

Key benefits of an electronic quality management system include:

  • Ensures compliance to FDA, ISO, EU MDR, and other regulations
  • Establishes strong design controls
  • Provides closed-loop CAPA processes
  • Improves training record management
  • Streamlines engineering change processes
  • Provides greater control and traceability of DHFs, DMRs, SOPs, and other quality documents
  • Improves visibility and business insights
  • Enables fast and easy accessibility
  • Reduces paper waste/environmentally friendly


What are the types of quality control?

Four commonly used quality control methods include:

  1. Control Chart – Illustrates whether sampled products or processes are meeting their intended specifications and the degree by which they vary from those specifications.
  2. Taguchi Method – Emphasizes the roles of product design and product development in reducing the occurrence of defects and failures in products. It considers design to be more important than the manufacturing process and tries to eliminate variances in production before they occur.
  3. 100% Inspection Method – Assesses all parts of a product to rule out any flaws.
  4. Six Sigma – Focuses on cycle-time improvement to reduce defects in the manufacturing process to no more than 3.4 occurrences per million units.

*Source: https://www.investopedia.com/terms/q/quality-control.asp

What are the top three benefits to companies using QMS?

The top three benefits for QMS include the ability to help companies:

  1. Drive continuous improvement and establish compliance with U.S. Food and Drug Administration (FDA), European Medical Device Regulation (EU MDR), International Organization for Standardization (ISO), and other regulations and standards
  2. Improve product performance and reduce costs
  3. Improve customer satisfaction
How does QMS enhance the final product launch?

QMS enables companies to bring safe and effective products to market faster while enabling quality controls and regulatory compliance.


  • A quality management system provides manufacturers a formalized system to document responsibilities, processes, and procedures for developing products that meet customer and regulatory requirements.
  • Today, companies are moving away from traditional paper-based systems and embracing enterprise quality management system (eQMS) software to better manage and track all the processes and records that are tied to their quality system.
  • Digital QMS solutions enable companies to gain better control and traceability over their quality processes and streamline compliance.


  1. https://www.qad.com/blog/2018/04/frederick-winslow-taylor-scientific-management
  2. https://www.leansixsigmadefinition.com/glossary/walter-shewhart/
  3. https://www.bl.uk/people/w-edwards-deming
  4. https://www.juran.com/blog/the-history-of-quality/
  5. https://www.leansixsigmadefinition.com/glossary/toyota-production-system/
  6. https://www.6sigma.us/six-sigma-articles/six-sigma-its-origin-and-meaning/

Best Practice

Read this Ultimate Guide to QMS Software to learn how it works, essential components of an enterprise system, and what to consider when implementing a QMS software solution.