What Is QMS?

QMS Ensures
Regulatory Compliance


A quality management system provides a formalized system of documenting responsibilities, processes, and procedures to develop products that meet customer requirements as well as compliance with regulatory standards.

QMS Video


Regulated companies must have a QMS in place to qualify, sell, and sustain safe and effective life-enhancing products. It provides a systematic approach to help improve quality controls, eliminate nonconformance issues, reduce audit risks, and streamline new product development processes.

Regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Commission, and International Organization for Standardization (ISO) set forth specific requirements for a quality management system to ensure companies are complying with standards such as Title 21 CFR 820, Title 21 CFR Part 11, EU MDR, EU IVDR, and ISO 13485.

European Commission Logo
ISO Standards


The type of QMS that is implemented will vary by industry and depend on a company’s unique set of products, goals, and values. Organizations typically use the following standards as the basis for establishing their own QMS.

  • ISO 9001: This is a globally recognized standard that can apply to any industry. It outlines the policies, procedures, processes, and records that are needed for an effective QMS. It also provides best practices for establishing and maintaining a QMS.
  • ISO 13485: This standard guides medical device manufacturers in developing a QMS that supports the consistent design, development, production, and delivery of safe and effective products throughout the entire lifecycle.
  • AS9100: Developed by the International Aerospace Quality Group, this standard builds on the requirements outlined in ISO 9001. It provides manufacturers in the aerospace and defense sectors the key QMS elements that are needed to consistently produce safe, high-quality products on time.
  • IATF 16949: This standard provides companies in the automotive industry the framework for implementing a QMS that emphasizes defect prevention and reduction of variation and waste


ISO 9001 outlines these seven principles to help guide organizations toward improved performance and better business outcomes:

  1. Customer Focus
    Meeting or exceeding customer expectations should be the primary focus of an organization. Understanding and meeting the needs of the customer increases loyalty which in turn increases revenue.
  2. Leadership
    The senior management team should establish clear business goals and objectives that are communicated across the entire organization. This ensures everyone has a shared sense of direction and purpose.
  3. Engagement of People
    Employees at every level should be encouraged to deliver value to customers through their day-to-day work activities. Involving employees in key business decisions and rewarding their accomplishments will empower them to take ownership of their actions and achieve the company’s quality objectives.
  4. Process Approach
    By managing business activities as interrelated processes, companies can achieve more consistent and predictable results. 
  5. Continuous Improvement
    A focus on continuous improvement enables organizations to maintain performance, adapt quickly to changing market conditions, and embrace new business opportunities.
  6. Evidence-based Decision Making
    Companies often make decisions based on the interpretation of multiple types and sources of inputs. By analyzing the facts and data, companies can make more objective decisions and reach their desired results.
  7. Relationship Management
    Effectively managing relationships with suppliers, customers, and other external partners is key to an organization’s sustained success.


Over the years, organizations have adopted different quality management tools and techniques to help with product, process, and people improvement.
Some of the more commonly used methods include:

Plan-Do-Check-Act (PDCA) Cycle

PDCA serves as the foundation for continuous improvement. Senior management sets certain goals and targets (Plan). Teams then implement changes or improvements to meet those targets (Do). The performance of the changes is measured to determine their effectiveness (Check). If the changes are successful, they are implemented as a standard practice (Act). If the changes do not work, the cycle is repeated.

Continuous Improvement IPDCA

Cause-and-Effect (Fishbone) Diagram

This visual tool helps teams troubleshoot a particular problem by exploring all the possible causes until the root cause is identified and next steps are agreed upon.

Engineering Change Management Flowchart

Six Sigma

A set of statistical methods and data analysis techniques is used to find defects and determine their cause. The intent is to reduce process variation and improve the quality of products or services which results in increased revenue and enhanced employee morale.

Continuous Improvement IPDCA

Lean Manufacturing

Many companies employ this methodology to minimize waste while maximizing productivity throughout the production process. Removing inefficiencies helps to reduce costs and deliver more value to the customer.

QMS Lean Manufacturing

Just-in-Time (JIT) Manufacturing

The just-in-time inventory management strategy involves ordering just enough materials to complete production. The goal is to minimize waste, reduce inventory cost, and increase efficiency.

Just-in-Time (JIT) Manufacturing


Organizations typically do not reap the full benefits of a QMS due to their reliance on outdated, manual processes.

Many companies have been accustomed to maintaining all the records that are tied to their quality system in file cabinets, binders, or local hard drives. With industry regulations becoming more stringent, companies are having to develop and maintain more extensive documentation to demonstrate compliance. Storing, tracking, and updating paper records becomes too costly and time-consuming as the volume continues to rise. The transition to remote work practices also makes it nearly impossible to keep paper records in a centralized location and ensure everyone is working from the latest revision.

This culminates in errors and a lack of traceability which prevent companies from meeting their quality objectives and getting products to market on time.


For organizations that are looking to move away from traditional paper-based systems, electronic quality management system solutions are an ideal fit. The ability to maintain standard operating procedures (SOPs), design history files (DHFs), and other critical documentation in a secure, electronic repository helps teams gain better control and traceability of their quality processes and records. Document changes can be clearly communicated and made accessible to remote teams. In addition, everyone can easily locate files and compile the necessary information for a regulatory audit or inspection.

Cloud-native QMS solutions that are sold under a software-as-a-service (SaaS) subscription model eliminate the need for companies to invest in extensive IT infrastructure and resources as part of the implementation. Legacy product and quality data can be easily migrated to the Cloud, enabling teams to get up and running quickly.

Who Uses QMS Software?

Quality management software serves manufacturers in regulated industries. As engineering, quality, manufacturing, and procurement teams work to develop and launch new products, modern quality management system software provides a way to keep everyone aligned at all times, regardless of where teams and suppliers are located.

Whether you’re a small startup or Fortune 500 company, QMS software addresses the common challenges facing most regulated companies today:

  • Collaborating with dispersed teams, suppliers, and contract manufacturers
  • Disconnected systems limiting visibility into quality and product information
  • Developing effective design controls to comply with quality system regulations
  • Streamlining and simplifying audit processes
  • Delivering high-quality products ahead of the competition

Explore how companies are adopting quality management system software to boost productivity, reduce audit risks, and accelerate time to market (TTM).


Achieving Commercialization and Compliance Success

Pulse Biosciences

Achieving Closed-Loop Design Control Across the Organization


Driving Quality Across Supply Chain to Highest Levels


To learn even more about QMS software, check out our Ultimate QMS Guide.


To learn even more about QMS software, check out our Ultimate QMS Guide.