全球品管软体市场规模依部署类型、组织规模、垂直、地区和预测划分：

品管软体市场规模与预测

品管软体市场规模预计在 2024 年达到 99.5 亿美元，到 2032 年将达到 197.9 亿美元，2026 年至 2032 年的复合年增长率为 9.90%。

品管软体 (QMS) 是一个数位平台，旨在加快和改善公司内部维护和监控产品品质的流程。该软体透过自动化文件管理、合规性追踪、纠正和预防措施 (CAPA) 以及审核管理等流程，帮助公司保持高标准。它集中品质相关数据，并支援即时监控和彙报。这可以提高生产力，最大限度地减少错误，并确保产品符合法规和客户标准。

随着技术的进步，品管软体的应用范围正在不断扩大。与人工智慧和机器学习的融合将彻底改变品质资料的处理方式，提供预测性洞察和更主动的品管方法。

此外，物联网 (IoT) 设备的整合可以提供生产线的即时数据，从而提供前所未有的品质参数可视性。随着企业拥抱数位转型，品质管理系统 (QMS) 有望变得更加直观和集成，从而增强其在确保产品卓越性和业务效率方面的作用。

品管软体市场动态

影响全球品管软体市场的关键市场动态是：

关键市场驱动因素

更加重视法规合规性：法规合规性正变得越来越重要，因此需要在整个企业范围内建立强大的品管系统。美国食品药物管理局(FDA) 透露，在 2020 财年，它向未达到品质和监管标准的公司发出了 524 封警告信。监管审查力度的加强促使企业投资品管软体，以确保合规性。

更重视顾客满意度与产品品质：企业越来越意识到品管在提升顾客满意度上的价值。根据美国品质协会 (ASQ) 的民意调查，49% 的全球企业认为客户满意度是未来品质的关键因素。这种对客户满意度的关注正推动品管软体的使用，以提升产品和服务的品质。

六标准差和精益製造的日益普及：六标准差和精益製造等品质改进方法的日益普及，正在推动对品管软体的需求。根据精益企业研究所的一项调查，69.6% 运用精益理念的公司表示，在品质改进方面取得了中等至显着的进展。随着企业寻求支援这些方法的工具，这一趋势预计将提振品管软体市场。

主要挑战

与现有系统整合：品管软体 (QMS) 市场中最具挑战性的方面之一是将新的 QMS 解决方案与现有企业系统整合。许多公司同时使用旧系统和现代应用程序，这可能会引发相容性问题。确保新的 QMS 能够与现有软体（例如 ERP 或 CRM 系统）有效集成，可能需要进行大量修改并掌握必要的技术技能，这可能会导致成本增加和实施时间延长。这种复杂性可能会阻碍公司采用新的 QMS 解决方案，限制其利用高阶功能和效率提升的能力。

资料安全和隐私：随着人们对资料安全和隐私的日益关注，品管软体必须确保机密资讯免受未授权存取和洩露。这对于处理敏感资料的行业（例如医疗保健和银行业）尤其重要。为了保护您的数据，您的 QMS 提供者必须使用强大的安全措施，例如加密、安全存取控制和频繁审核。遵守 GDPR 和 HIPAA 等法规会更加困难，因为不符合这些要求可能会导致法律诉讼和声誉损害。

扩充性且灵活：随着业务扩展，您的品管要求也会随之变化，您需要一个能够随之扩展和调整的品质管理系统 (QMS)。找到一个不仅能满足当前需求，还能适应未来变化（例如新的监管标准或产量增加）的品质管理系统是一项关键挑战。过于僵化或需要进行大规模调整才能实现规模化的品质管理体係可能会成为瓶颈。企业需要一个能够适应新流程和市场需求并不断发展，且不会产生大量额外成本的系统。

主要趋势

人工智慧和机器学习的融合：人工智慧和机器学习正在融入品管软体中，改善预测分析和自动化决策，从而实现更主动的品管和问题解决。

云端基础的解决方案：云端基础的QMS 解决方案因其灵活性、扩充性和成本效益而变得越来越流行，它允许公司从任何地方存取其品质资料和工具。

物联网和即时监控：利用物联网 (IoT) 技术可以即时监控工业流程，透过持续回馈提高数据准确性和品管。

行动可访问性：行动友善的 QMS 平台提供对品管工具和数据的随时随地访问，使用户能够透过行动装置管理和追踪品质问题，从而提高效率和响应能力。

目录

第一章 引言

• 市场概览
• 研究范围
• 先决条件

第二章执行摘要

第三章：已验证的市场研究调查方法

• 资料探勘
• 验证
• 第一手资料
• 资料来源列表

第四章 市场概述

• 概述
• 市场动态
  • 驱动程式
  • 限制因素
  • 机会
• 波特五力模型
• 价值链分析

第五章品管软体市场（依部署类型）

• 概述
• 本地
• 云端基础

第六章品管软体市场（依组织规模）

• 概述
• 中小型企业
• 大公司

第七章品管软体市场（依产业垂直划分）

• 概述
• 卫生保健
• 製造业
• 资讯科技/通讯
• 航太/国防
• 饮食
• 政府
• 公共产业

第八章品管软体市场（按地区）

• 概述
• 北美洲
  • 美国
  • 加拿大
  • 墨西哥
• 欧洲
  • 德国
  • 英国
  • 法国
  • 其他欧洲国家
• 亚太地区
  • 中国
  • 日本
  • 印度
  • 其他亚太地区
• 世界其他地区
  • 拉丁美洲
  • 中东和非洲

第九章 竞争态势

• 概述
• 各公司市场排名
• 主要发展策略

第十章 公司简介

• Arena Solutions, Inc.
• Cority Software Inc.
• Dassault Systemes SE
• EtQ Management Consultants, Inc.
• Ideagen Plc.
• Intelex Technologies
• MasterControl, Inc.
• MetricStream, Inc.
• Microsoft Corporation
• Oracle Corporation

第十一章 附录

• 相关报告

Quality Management Software Market Size And Forecast

Quality Management Software Market size was valued at USD 9.95 Billion in 2024 and is projected to reach USD 19.79 Billion by 2032, growing at a CAGR of 9.90% from 2026 to 2032.

Quality Management Software (QMS) is a digital platform designed to expedite and improve the procedures involved in maintaining and monitoring product quality within a business. This software helps firms maintain high standards by automating processes including document control, compliance tracking, corrective and preventative actions (CAPA), and audit management. It centralizes quality-related data, allowing for real-time monitoring and reporting. This increases productivity, minimizes errors, and ensures that goods fulfill regulatory and customer standards.

The scope of Quality Management Software is expanding as technology advances. Integrations with artificial intelligence and machine learning are poised to transform how quality data is processed, resulting in predicted insights and more proactive quality management approaches.

Furthermore, the integration of Internet of Things (IoT) devices can provide real-time data from manufacturing lines, providing unprecedented visibility into quality parameters. As companies embrace digital transformation, QMS is anticipated to become more intuitive and integrated, enhancing its role in ensuring product excellence and operational efficiency.

Global Quality Management Software Market Dynamics

The key market dynamics that are shaping the global Quality Management Software Market include:

Key Market Drivers:

Growing Emphasis on Regulatory Compliance: Regulatory compliance is becoming increasingly important, necessitating strong quality management systems across businesses. The United States Food and Drug Administration (FDA) revealed that in fiscal year 2020, it issued 524 warning letters to corporations for failing to meet quality and regulatory criteria. This increased regulatory scrutiny is driving firms to invest in quality management software to assure compliance.

Rising Focus on Customer Satisfaction and Product Quality: Companies are increasingly understanding the value of quality management in boosting customer satisfaction. According to an American Society for Quality (ASQ) poll, 49% of worldwide firms view customer satisfaction as a significant problem for the future of quality. This emphasis on customer happiness is propelling the use of quality management software to enhance product and service quality.

Increasing Implementation of Six Sigma and Lean Manufacturing Principles: The increase in adoption of quality improvement approaches such as Six Sigma and lean manufacturing is driving up demand for quality management software. According to Lean Enterprise Institute research, 69.6% of firms applying lean concepts reported making moderate to significant progress in quality improvement. This trend is expected to enhance the Quality Management Software Market as businesses look for tools to support these techniques.

Key Challenges:

Integration with Existing Systems: One of the more difficulties in the Quality Management Software (QMS) market is integrating new QMS solutions with current enterprise systems. Many firms utilize a combination of historical systems and contemporary applications, which can lead to compatibility concerns. Ensuring that a new QMS connects effectively with existing software, such as ERP or CRM systems, necessitates substantial modification and technical skill, which sometimes leads to increased costs and longer implementation times. This complexity can dissuade firms from implementing new QMS solutions, limiting their ability to take advantage of advanced capabilities and increased efficiencies.

Data Security and Privacy: With growing worries about data security and privacy, quality management software must ensure that sensitive information is safeguarded against unauthorized access and breaches. This is especially important for industries that handle sensitive data, such as healthcare or banking. To preserve data, QMS providers must use robust security measures such as encryption, secure access controls, and frequent audits. Compliance with rules such as GDPR and HIPAA adds another layer of difficulty, as failure to achieve these requirements can result in legal ramifications and harm to reputation.

Scalability and Flexibility: As businesses expand, their quality management requirements change, needing a QMS that can scale and adapt accordingly. Finding a QMS that not only fits current requirements but is also adaptable to future changes, such as new regulatory standards or greater production quantities, is a significant task. Systems that are excessively rigid or require significant adaptation to scale might become bottlenecks. Companies require a system that can scale with them and adapt to new procedures or market demands without requiring significant additional expenses.

Key Trends:

AI and Machine Learning Integration: AI and machine learning are increasingly being integrated into Quality Management Software, which improves predictive analytics and automated decision-making, resulting in more proactive quality management and problem resolution.

Cloud-Based Solutions: Cloud-based QMS solutions are becoming increasingly popular due to their flexibility, scalability, and cost-effectiveness, allowing businesses to access quality data and tools from anywhere.

IoT and Real-Time Monitoring: The use of Internet of Things (IoT) technology enables real-time monitoring of industrial processes, boosting data accuracy and quality control through continuous feedback.

Mobile Accessibility: Mobile-friendly QMS platforms provide on-the-go access to quality management tools and data, improving efficiency and responsiveness by allowing users to manage and track quality concerns from their mobile devices.

Global Quality Management Software Market Regional Analysis

Here is a more detailed regional analysis of the global Quality Management Software Market:

North America:

North America currently reigns supreme in the quality management software (QMS) market, holding the largest market share. The Quality Management Software Market in North America is being driven by an increased focus on regulatory compliance. In fiscal year 2021, the United States Food and Drug Administration (FDA) recorded 3,706 medical device recalls, a 26.5% increase over the previous year, underlining the importance of strong quality control systems.

Furthermore, the FDA's Center for Devices and Radiological Health (CDRH) reported that 89% of inspections in 2020 either yielded no action or resulted in voluntary actions, indicating increased compliance efforts. These regulatory requirements are leading firms, particularly those in healthcare and manufacturing, to implement quality management software to ensure standard adherence and reduce compliance risk.

North America's technological supremacy is a major driver of the Quality Management Software Market. The US manufacturing sector's productivity improved by 3.8% in 2021, above the broader nonfarm business sector's growth of 2.2%, owing largely to modern technologies such as quality control systems. According to the Software & Information Industry Association (SIIA), 94% of firms in the United States employ cloud-based software, demonstrating the region's preparedness to accept new technologies such as QMS. This early adoption tendency is driving the growth of the Quality Management Software Market, as companies attempt to improve quality systems and preserve a competitive advantage.

Asia Pacific:

Rapid industrial growth in the Asia-Pacific region, notably in manufacturing powerhouses such as China and India, is driving the Quality Management Software Market. China's National Bureau of Statistics reported a 3.6% growth in industrial output year on year in 2022, whereas India's Ministry of Statistics reported a 5.2% increase in the Index of Industrial Production in January 2023.

The Asian Development Bank projects a 4.8% growth in developing Asia's economy in 2023, with industrial expansion playing a vital role. This spike in industrial activity is driving increasing demand for quality management systems, as businesses struggle to maintain high standards and remain competitive globally. According to a poll conducted by the Asian Productivity Organization, 68% of enterprises in the region regard quality management as critical to competitiveness, demonstrating the growing demand for QMS software.

The Quality Management Software Market in Asia-Pacific is being driven by an increasing realization of the long-term benefits of quality management. According to a survey conducted by the Asian productivity organization, 78% of regional enterprises have implemented quality management systems, with 62% identifying increased product quality as a key advantage. Between 2018 and 2022, the China association for quality reported a 15% improvement in customer satisfaction for enterprises that implemented complete quality management systems. In Japan, the Ministry of Economy, Trade, and Industry discovered that enterprises with advanced quality processes experienced 23% higher export growth.

Furthermore, the Indian Ministry of Micro, Small, and Medium Enterprises reported a 31% decrease in defect rates and a 27% increase in productivity among SMEs who use quality management systems. These findings demonstrate a growing understanding of the benefits of quality management, which is driving higher adoption of QMS software throughout the area.

Global Quality Management Software Market: Segmentation Analysis

The Global Quality Management Software Market is Segmented on the basis of Deployment Type, Organization Size, Verticals, And Geography.

Quality Management Software Market, By Deployment Type

• On-Premises
• Cloud-Based

Based on Deployment Type, the market is bifurcated into On-Premises, and Cloud-Based. The on-premise category dominates the QMS market, accounting for the vast bulk of revenue. However, the cloud-based market is growing the fastest due to benefits such as cost, scalability, and ease. While on-premise solutions provide more control, cloud solutions are becoming more appealing with advantages such as remote access and automatic updates. This pattern shows that cloud computing may become dominant in the future.

Quality Management Software Market, By Organization Size

• Small and Medium Enterprises (SMEs)
• Large Enterprises

Based on Organization Size, the market is segmented into Small and Medium Enterprises (SMEs), and Large Enterprises. Large organizations presently retain the majority of the QMS market due to their complicated workflows and stringent regulatory requirements, while SMEs are the fastest-growing group. Cloud-based QMS solutions, noted for their low cost and ease of use, are especially appealing to SMEs. As these businesses become more aware of the benefits of quality management, and cloud technology becomes more accessible, the SME category is expected to expand significantly in the coming years.

Quality Management Software Market, By Verticals

• Healthcare
• Manufacturing
• IT & Telecom
• Aerospace & Defense
• Food & Beverage
• Government
• Utilities

Based on Verticals, the market is segmented into Healthcare, Manufacturing, IT & Telecom, Aerospace & Defense, Food & Beverage, Government, and Utilities. The manufacturing industry now dominates the quality management system market. This is owing to the established emphasis on quality control in manufacturing and the requirement to follow tight rules. However, the healthcare industry is growing the fastest. This is being pushed by an increased emphasis on patient safety and quality of care, as well as new rules such as the PPACA (US), which require quality management methods in healthcare. As healthcare organizations strive for better patient outcomes, they are turning to QMS solutions to increase efficiency and compliance.

Key Players

The "Global Quality Management Software Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are Arena Solutions, Inc., Cority Software Inc., Dassault Systemes SE, EtQ Management Consultants, Inc., Ideagen Plc., Intelex Technologies, MasterControl, Inc., MetricStream, Inc., Microsoft Corporation, Oracle Corporation, Pilgrim Quality Solution, Plex Systems, Inc., SAP SE, Siemens AG, Sparta Systems Inc., uniPoint Software, Inc., and Veeva Systems. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

• Quality Management Software Market Recent Developments
• In January 2024, Master Control, a provider of quality management and sophisticated manufacturing execution software, officially introduced its cutting-edge Quality Event Management (QEM) product. This revolutionary tool provides customers with unrivaled flexibility in configuring procedures, creating forms, and capturing data linked to quality events.
• In April 2023, Greenlight Guru, a creator of cloud-based software solutions for MedTech enterprises, will debut its Export API. The new functionality allowed clients to export data from the QMS platform to third-party software such as CRM, ERP, and business intelligence solutions. Furthermore, the new API feature allowed users to increase productivity.
• In April 2023, Qualityze, a developer of quality management software, will launch Qualityze EQMS, a cloud-based quality management solution for the telecoms industry. The program was developed on Salesforce, Inc.'s cloud platform to assist telecommunications organizations in meeting multiple quality objectives with increased security, dependability, and flexibility.

TABLE OF CONTENTS

1 INTRODUCTION OF GLOBAL QUALITY MANAGEMENT SOFTWARE MARKET

• 1.1 Overview of the Market
• 1.2 Scope of Report
• 1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH

• 3.1 Data Mining
• 3.2 Validation
• 3.3 Primary Interviews
• 3.4 List of Data Sources

4 GLOBAL QUALITY MANAGEMENT SOFTWARE MARKET OUTLOOK

• 4.1 Overview
• 4.2 Market Dynamics
  • 4.2.1 Drivers
  • 4.2.2 Restraints
  • 4.2.3 Opportunities
• 4.3 Porters Five Force Model
• 4.4 Value Chain Analysis

5 GLOBAL QUALITY MANAGEMENT SOFTWARE MARKET, BY DEPLOYMENT TYPE

• 5.1 Overview
• 5.2 On-Premises
• 5.3 Cloud-Based

6 GLOBAL QUALITY MANAGEMENT SOFTWARE MARKET, BY ORGANIZATION SIZE

• 6.1 Overview
• 6.2 Small and Medium Enterprises (SMEs)
• 6.3 Large Enterprises

7 GLOBAL QUALITY MANAGEMENT SOFTWARE MARKET, BY VERTICALS

• 7.1 Overview
• 7.2 Healthcare
• 7.3 Manufacturing
• 7.4 IT & Telecom
• 7.5 Aerospace & Defense
• 7.6 Food & Beverage
• 7.7 Government
• 7.8 Utilities

8 GLOBAL QUALITY MANAGEMENT SOFTWARE MARKET, BY GEOGRAPHY

• 8.1 Overview
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
  • 8.2.3 Mexico
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 U.K.
  • 8.3.3 France
  • 8.3.4 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 Japan
  • 8.4.3 India
  • 8.4.4 Rest of Asia Pacific
• 8.5 Rest of the World
  • 8.5.1 Latin America
  • 8.5.2 Middle East and Africa

9 GLOBAL QUALITY MANAGEMENT SOFTWARE MARKET COMPETITIVE LANDSCAPE

• 9.1 Overview
• 9.2 Company Market Ranking
• 9.3 Key Development Strategies

10 COMPANY PROFILES

• 10.1 Arena Solutions, Inc.
  • 10.1.1 Overview
  • 10.1.2 Financial Performance
  • 10.1.3 Product Outlook
  • 10.1.4 Key Developments
• 10.2 Cority Software Inc.
  • 10.2.1 Overview
  • 10.2.2 Financial Performance
  • 10.2.3 Product Outlook
  • 10.2.4 Key Developments
• 10.3 Dassault Systemes SE
  • 10.3.1 Overview
  • 10.3.2 Financial Performance
  • 10.3.3 Product Outlook
  • 10.3.4 Key Developments
• 10.4 EtQ Management Consultants, Inc.
  • 10.4.1 Overview
  • 10.4.2 Financial Performance
  • 10.4.3 Product Outlook
  • 10.4.4 Key Developments
• 10.5 Ideagen Plc.
  • 10.5.1 Overview
  • 10.5.2 Financial Performance
  • 10.5.3 Product Outlook
  • 10.5.4 Key Developments
• 10.6 Intelex Technologies
  • 10.6.1 Overview
  • 10.6.2 Financial Performance
  • 10.6.3 Product Outlook
  • 10.6.4 Key Developments
• 10.7 MasterControl, Inc.
  • 10.7.1 Overview
  • 10.7.2 Financial Performance
  • 10.7.3 Product Outlook
  • 10.7.4 Key Developments
• 10.8 MetricStream, Inc.
  • 10.8.1 Overview
  • 10.8.2 Financial Performance
  • 10.8.3 Product Outlook
  • 10.8.4 Key Developments
• 10.9 Microsoft Corporation
  • 10.9.1 Overview
  • 10.9.2 Financial Performance
  • 10.9.3 Product Outlook
  • 10.9.4 Key Developments
• 10.10 Oracle Corporation
  • 10.10.1 Overview
  • 10.10.2 Financial Performance
  • 10.10.3 Product Outlook
  • 10.10.4 Key Developments

11 Appendix

• 11.1 Related Reports