Table of Contents
    Home / Definitions / Quality Management System (QMS)
    Definitions 4 min read

    Quality Management System (QMS)

    A quality management system (QMS) is a centralized system for managing business processes. QMS systems support the goal of meeting industry expectations and standards regarding the goods and services provided by the organization. 

    Adopting QMS software offers a way for businesses to meet compliance requirements and provide quality services as well as manage quality management-based compliance documentation from a single solution. Read on to learn more about how QMS solutions work and the benefits they can offer businesses that need this kind of support.

    Portions of this definition originally appeared on CIO Insight and are excerpted here with permission.

    What Are Key Features of QMS Software?

    Some of the most important features of QMS software include:

    • Supplier/third-party management: QMS software can ensure third parties meet organizational expectations and compliance standards.
    • Risk management: QMS software may include risk management features like risk assessments to manage vulnerabilities and threats.
    • Document management: With company policies and procedures available in one place, organizations can more easily cross-check data and processes.
    • Change control: QMS software may offer change control tools to document changes and adjustments as well as share change reports with employees.
    • Audit management: A QMS allows businesses to easily track and prepare data and documentation needed for both internal and external audits.

    Quality Management System Use Cases

    Since the purpose of a QMS is to meet compliance regulations and satisfy customers, industries that can benefit the most from QMS software are those that produce goods and services or that must meet a certain regulatory standard. These industries might include:

    • Medical: FDA requirements for devices and pharmaceuticals
    • Manufacturing: Baseline product safety standards
    • Automotive: Vehicle feature expectations
    • Food and beverage: FDA requirements, ISO 22000, and food safety management audits

    There are several ways organizations can perform quality assurance in a QMS. Handling customer feedback and complaints plays an important role along with breaking down and keeping track of production steps for quality assurance purposes. Other methods include preparing for audits, organizing supplier information, and collaborating with customers to find an acceptable level of quality for goods and services.

    What Are Common Standards Covered by QMS Software?

    Companies that use QMS software typically have one or more compliance standards they must meet, such as:

    • ISO 9000 and 9001: QMS and quality assurance guidelines
    • ISO 27001: Information security standards
    • ISO 13485: Medical device and service requirements to meet regulations
    • ISO 22000: Food safety management systems standards
    • Code of Federal Regulations (CFR) FDA Title 21: Pharmaceutical products and cosmetics standards

    In addition to meeting these compliance requirements, organizations can also become certified in some regulations, such as ISO 9001 and 27001. These certifications may be required for certain industries or QMS software, but others may simply help improve customer confidence or loyalty to the vendor.

    What Are the Benefits of Using QMS Software?

    Aside from being able to manage consumer and industry quality expectations and standards, a QMS enables businesses to more easily prepare for audits. Since all procedural, regulatory, and supplier information can be found in one place, required documentation can be more efficiently prepared. This kind of preparation is typically time-consuming and messy without a QMS.

    A QMS solution can also provide alerts for compliance task completion, allowing organizations to easily manage compliance tasks and goals for employees. In addition, depending on the QMS solution, it can offer documentation that outlines quality management and assurance processes as well as training or support—such as videos, webinars, or technical support—for the platform.

    Read next: Best Quality Management System Software