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. Cloud-based systems like Arena QMS help eliminate nonconformance issues, reduce audit risks, and improve new product development processes by improving quality controls and documenting policies, procedures, and practices.


Product-centric eQMS software provides a controlled and automated way for teams to manage product and quality processes throughout the entire lifecycle. By bringing quality records and the entire product assembly (i.e., software, mechanical, and electrical components) into one shared system, dispersed teams can collaborate on the entire design before releasing the final product to downstream enterprise systems (e.g., ERP, MES, and CRM).

Automated engineering change order (ECO) processes enable internal teams and supply chain partners to share, review, and approve design changes quickly. In addition, all tasks associated with corrective and preventive action (CAPA) quality processes are linked to the appropriate part of the product record. This enables teams to quickly identify and resolve product issues.


To introduce safe and effective products, manufacturers must maintain a tight connection between all of the product information, quality records, training plans, and audit processes. Regulations also require organizations to establish strong design controls and manage the design history file (DHF) and the device master record (DMR).

Conventional document-centric platforms address only a subset of the information that is needed to meet the requirements set forth by FDA, ISO, and other regulatory bodies. In fact, they fail to manage the complete product record which is comprised of mechanical, electrical, and software components, assembly instructions, and other items that make up the bills of materials (BOMs).

Product-centric solutions like Arena QMS on the other hand, manage linked relationships between DMRs, DHFs, BOMs, individual components, approved manufacturer/supplier lists, documentation, product history, and any changes or quality issues.

Key benefits include:

  • Ensures compliance to FDA, ISO, EU MDR, and other regulations
  • Establishes strong design controls
  • Provides closed-loop CAPA processes
  • Improves training record management
  • Controls DHFs, DMRs, SOPs, and key quality documents
  • Connects product and change processes
  • Drives faster product development and launches
  • Mitigates audit risks
  • Enhances supplier collaboration
  • Improves visibility, traceability, and business insights


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.

  • Cloud-based QMS software helps eliminate nonconformance issues, reduce audit risks, and improve new product development processes by improving quality controls and documenting policies, procedures, and practices.

  • Unlike traditional document-based platforms which only provide basic document management capabilities for SOPs and other related files—product-centric QMS platforms maintain a tight connection between all of the product information, quality records, training plans, and audit processes so that companies can streamline compliance and introduce safe and effective products.


  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/

The Cost

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