8.9
Editor’s Rating:
Best Overall
Intellect QMS: Dashboard
Intellect QMS
  • Easy to implement
  • Support for ISO standards and FDA regulations
  • On-premise and Cloud
7.7
Editor’s Rating:
Best End-to-End Solution
DELMIAWorks: Plant Floor RealTime Dashboard
DELMIAWorks
  • Standalone solution or part of IQMS ERP
  • Detailed inventory tracking
  • Proprietary data sharing tools
9.5
Editor’s Rating:
Best for Collaboration
Unifize: Data Dashboard
Unifize
  • Built for mid-size to enterprise level companies
  • Drag and drop interface
  • Integrations with existing ERP

The best quality management software includes:

  • Intellect QMS
  • DELMIAworks
  • Unifize

But which is the right choice for your business? The best quality management software will assess, maintain, and enhance the quality of your products and services in compliance with industry standards and regulations.

We’ve reviewed 20+ providers across 7 metrics to rank the best QMS software. We tested capabilities that optimize production processes, minimize defects, and ultimately increase customer satisfaction.

1 Intellect QMS - Best Overall

Intellect QMS stands out in the crowded market primarily because of its adaptability. Businesses across various sectors will appreciate its out-of-the-box solutions that not only align with industry best practices but are also fully customizable. This ensures that the software can be tailored to fit seamlessly into any existing workflow.

However, default workflows might not always align with specific industry standards, necessitating user configuration. Additionally, while the software’s customization is a strength, it can sometimes require a deeper understanding than some users might expect.

A highlight of Intellect is its no-code compliance platform. This feature allows users, even those without a technical background, to modify or create apps, workflows, and reports. It’s a testament to Intellect’s commitment to user-friendly design and functionality.

The software’s comprehensive suite, ranging from document management to ISO and FDA compliance, is impressive. Moreover, the claim that Intellect can reduce audit times by over 50% is a significant indicator of its efficiency. This efficiency, combined with its focus on transparency and communication, makes it a top choice for businesses aiming to streamline their quality management processes.

Best Overall:
Intellect QMS

Intellect QMS: Dashboard
Intellect QMS: Audit Management
Intellect QMS: Console
Intellect QMS: CAPA
Intellect QMS: Change Management
Intellect QMS: Complaint Management
Intellect QMS: Deviation Management
Intellect QMS: Document Control
Intellect QMS: Employee Training
Intellect QMS: Feedback Management
Intellect QMS: Nonconformance
Intellect QMS: Risk Management
Intellect QMS: Supplier Management
Intellect QMS: Validations
What We Like
Easy to implement
Support for ISO standards and FDA regulations
On-premise and Cloud
Overview

2 DELMIAworks - Best End-to-End Solution

DELMIAworks is an advanced Enterprise Resource Planning (ERP) system designed to amplify your quality management operations. It bolsters defect prevention and continuous improvement efforts, integrating effortlessly with methodologies like Six Sigma DMAIC. This synergy allows for a precise, scalable quality management system that ensures reliability and consistency.

The system is instrumental in the execution, planning, and evaluation of all customer interactions, from the initial order through to product delivery. Moreover, DELMIAWorks is pivotal in helping companies maintain compliance with a wide range of quality and regulatory standards, including ISO 9001, ISO 13485, and FDA medical device registration.

It supports advanced manufacturing capabilities, such as low-particulate production, statistical process control, and cutting-edge vision inspection. By leveraging the power of DELMIAWorks, organizations can set and surpass ambitious corporate-wide quality goals.

Best End-to-End Solution:
DELMIAWorks

DELMIAWorks: Plant Floor RealTime Dashboard
DELMIAWorks: Overall Equipment Efficiency
What We Like
Standalone solution or part of IQMS ERP
Detailed inventory tracking
Proprietary data sharing tools
Overview
Price Range: $$$$$
Client OS: Windows
Deployment: Cloud or On-Premises

3 Unifize - Best for Collaboration

Unifize is an eQMS software that is built for easy collaboration from the shop floor to all departments of a manufacturing business. Integrations with email and existing ERP and PLM systems make Unifize an excellent add-on software for quality management. Enterprise-grade security and management of roles will meet your company’s compliance needs.

Best for Collaboration:
Unifize
★★★★★
★★★★★
(4)

Unifize: Data Dashboard
Unifize: Track Conversations
Unifize: Internal Messages
Unifize: Traceability Details
What We Like
Built for mid-size to enterprise level companies
Drag and drop interface
Integrations with existing ERP
Overview
Price Range: $$
Starting Price: $50/user/month
Client OS: Windows, macOS, iOS, Android, Web
Deployment: Cloud Hosted

What is Quality Management System (QMS) Software?

Quality management software, also known as QMS, offers a comprehensive tool kit to analyze business risks, set quality objectives on product development, implement workflows to achieve these standards, and audit the product lifecycle for optimal performance. This integrated approach allows your company to craft standard operating procedures (SOPs) to optimize your business processes.

In particular, QMS helps businesses meet the regulatory requirements of ISO and FDA, in addition to compliance standards set by other government and industry-specific agencies.

Read more: What is a Quality Management System (QMS)? - ISO 9001 Processes

What is EQMS?

Enterprise quality management systems (EQMS) have a greater scope than generic QMS solutions. EQMS automates globalization by enhancing quality management practices across the supply chain. Many of these QMS products use the two terms interchangeably.

Read more: What is EQMS?

uniPoint Key Indicators Dashboard
Key indicators on the uniPoint dashboard.

Features of Quality Management Software (QMS)

Quality management systems offer a wide variety of functionality. Modules often include the following core functions:

  • Quality Control: Set objectives on quality processes related to cycle times, scrap/waste percentages, defect rates, measurement deviations, durability metrics, and more.
  • Risk Management and Analysis: Create what-if scenarios to reliably analyze potential costs related to quality exceptions. Predict failure and service rates, as well as their financial implications.
  • Workflow Management: Define all processes involved in manufacturing an end-product. Includes reminders, timers, and alerts. Determine corrective action assignments.
  • Corrective Action/Preventative Action (CAPA): Includes task assignments, reporting, and monitoring to ensure that the right response has been implemented when quality has deviated outside of pre-identified standards.
  • Parts Non-conformance: Define the dimension your parts are measured upon for non-conformance. Track a database of standardized parts metrics. May include more sophisticated monitoring controls that integrate with operational equipment.
  • Customer Complaint Management: Assist service personnel in quickly resolving customer issues.
  • Audits and Inspections: Define, schedule, and execute regular audits and inspections to ensure continuous improvement of business processes.
  • Document Management: Coordinate the data management challenge, facilitate collaboration, and ensure easy access to important quality management documentation.
  • Training Management: Ensure your employees are all properly trained and certified in key areas to meet compliance standards.
  • Reporting and Business Intelligence: Reference key performance indicators and performance dashboards to turn quality management data into actionable business intelligence.
Corrective Action Charts TRACKMEDIUM QMS Software
A corrective actions chart in TRACKMEDIUM.

Benefit #1: Ensure Regulatory Compliance

Managing the product lifecycle for regulatory compliance is complex work. To start, manufacturers are often subject to an alphabet soup of regulatory standards (FDA, ISO 9001, Title 21 CFR Part 11, NERC, SSOP, HAACP, and more). Compliance can be required for permitting, an eligibility condition for bid consideration, or a business necessity to avoid penalties or other legal action. A quality system provides the monitoring and reporting tools you need to simplify the complexity.

Different types of manufacturers need to comply with different regulations. For instance, manufacturers of medical devices, food, cosmetics, and chemicals all have unique, strict regulations to abide by. Selecting an industry-specific QMS system can help you control compliance for your industry.

Waypoint Global Suite Reports QMS Systems
Create quality management reports in Waypoint Global Suite.

Benefit #2: Analyze and Reduce Risk

Every business faces risk: production errors, product defects, unexpected service work, and more pose a threat to the financial health of your company. Improved quality management offers a chance to mitigate these business risks and smooth out the variance in your financial projections. QMS with quality standards and audit management tools provide an effective way to identify the root cause of any issues, allowing you to provide corrective action and enjoy higher quality results.

Analysis tools can quantify the financial risks related to quality exceptions. Identifying the cost of quality management improvements versus the likely impact of reduced financial liability is one of the more challenging business issues facing manufacturers.

QT9 QMS Document Control QMS Solutions
Manage documents in QT9 QMS.

Benefit #3: Increase Customer Satisfaction

Customer satisfaction is key to the success of every business model. Your customers are continually evaluating your products for quality, reliability, and whether or not they do what they are supposed to do. Quality assurance modules provide ways to review products for defects before they get sent to retailers or consumers, giving you the opportunity to make corrections. Fewer defective products on the market mean happier customers.

CAPA Reporting The Lean Machine Quality Management Software
CAPA Reporting in The Lean Machine.

Common Certifications, Standards, and Compliance with QMS Software

ISO standards include:

ISO Standard Meaning
ISO 9001 Sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity
ISO 13485 Similar to ISO 9001 but for medical devices. Has the specific requirement for software validation and requires validation reports to verify for the auditor that it will work as intended. Includes requirement for CFR 21 specific electronic signatures
ISO 50001 Energy management standard for addressing the energy consumption and use of an organization
ISO 27001 Information security, similar to ISO 9001 but with a change in focus to data security and integrity vs product quality
ISO 45001 Health and safety, similar to ISO 9001 but with a change in focus to employee safety vs product quality
ISO 14001 Health and safety, similar to ISO 9001 but with a change in focus to environment concerns vs product quality
ISO 17025 Laboratory testing and calibration

FDA certifications include:

FDA Meaning
FDA 21 CFR Part 11 Electronic records and electronic signatures
FDA 21 CFR Part 211 Drug and pharmaceutical manufacturing
FDA 21 CFR Part 820 Medical device manufacturing and distribution

Other common QMS standards include:

  • API Q1/Q2: Standards specific to the oil and gas industry that are similar in nature to ISO 9001. API W2 has the explicit requirement for contingency planning. Both API Q1/Q2 make the distinction between corrective and preventive action (something ISO 9001 does not)
  • ASME: Highly focused on product specifications and work instructions. Little emphasis on standard QMS requirements such as nonconformities and corrective action
  • API Design Stamps: Similar to ASME. Components have specific technical requirements to be met. Generally coupled with API Q1/Q2
  • IATF 16949: Automotive quality management standard similar to ISO 9001 with additional requirements
  • AS 9100: Aerospace quality management standard similar to ISO 9001 with additional requirements
  • HACCP: Food safety preventative maintenance
  • SQF: Food quality management

Non ISO Standards

  • Statistical Process Control (SPC): Identify product quality issues and process variations in order to take corrective action before extensive issues occur, as well as improve process performance. May pair well with a QMS but is better used to report on the output of the production process.
  • Production Design Lifecycle System (PDLC): Mainly used for showing verification and validation of a product design requirements. Focus on the interaction between suppliers, engineering, and test data. Includes production part approval processes (PPaP).
Intellect QMS Software Dashboard
The dashboard of Intellect QMS showing activities.

How Much Does QMS Software Cost?

QMS software ranges from $50 to $2,000 per user per month. Pricing of quality management systems depends on several factors:

  • Number of users
  • Required functionality
  • Additional integrations

Another variable to consider is whether you want an on-premise or cloud-based system. Generally, an on-premise software will have a one-time perpetual licensing fee while a cloud platform will be part of a monthly or annual subscription. The one-time fee and setup often results in a higher cost of entry while SaaS QMS can be more expensive over time.

Integrating QMS With ERP Software

Quality management software incorporates information from across the enterprise. Very often, QMS systems are found within larger ERP software

Because QMS systems typically operate best when they are taking a holistic approach to the enterprise challenge of optimizing quality, you may need to manage integrations with other information systems, such as:

  • Supply chain management systems manage the provisioning of goods from suppliers through to the customer. Relaying information regarding quality issues stemming from certain suppliers is an important piece of the quality management puzzle.
  • Customer relationship management software programs provide a coordinated approach to capturing customer specific information. Order histories and other customer interactions are logged to CRM programs. The ability to flow quality issue information from CRM software to QMS programs is important. It can assist in ensuring that quality issues addressed post-sale are being addressed both in terms of service work and process improvement.
  • Material resource planning and production scheduling software manages the materials required for production and the processes that go into the manufacturing operations. Importing quality related information from the QMS to the MRP system will help create more accurate manufacturing plans and forecasts.
TrackWise Events QMS Software
Create tasks and events for employees in TrackWise.

Further Reading

All Products

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uniPoint Screenshot

uniPoint

★★★★★
★★★★★
(3)
uniPoint is a configure-to-order QMS solution designed to help your company automate its journey toward excellence.
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TRACKMEDIUM Screenshot

TRACKMEDIUM

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★★★★★
(2)
TRACKMEDIUM is a cloud-based quality management system (QMS) with a subscription-based service which can be accessed from any web browser making it ideal for small to medium businesses (SMEs). The platform is preloaded with all the needed quality management modules including Audit Management, CAPA, Document Control, Management of Change, Nonconformance Management (NCM), Gage Management, Training Management, and many more. Just load your users, customers, suppliers and drop-down options and you
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MasterControl Qx Screenshot

MasterControl Qx

★★★★★
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Waypoint Global Suite Screenshot
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AssurX Screenshot

AssurX

★★★★★
★★★★★
(3)
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QT9 QMS Screenshot

QT9 QMS

★★★★★
★★★★★
(1)
QT9 QMS is a cloud-based quality management system that helps business teams integrate data from multiple systems into one flexible and intuitive platform.
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HQMS Screenshot

HQMS

★★★★★
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Qualcy eQMS Screenshot

Qualcy eQMS

★★★★★
★★★★★
(2)
Qualcy is a web-based QMS software supports document, training, supplier quality, and equipment management. It also offers non-conformance, CAPA, and auditing features. Qualcy meets 21 CFR 820, 210, 211 and ISO 13485 standards.
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Effivity Pro Screenshot

Effivity Pro

★★★★★
★★★★★
(2)
Effivity is a Workflow & Business Process Automation Software with pre-configured workflows used for implementation of various internation standards like ISO 9001:2015 ,ISO 14001:2015 , ISO 22001:2018 , ISO 27001 and many other standards.It is based on the BPM framework that enables organizations to easily manage and optimize their own business processes for sustainable competitive advantage @youtube Pre-Configured modules for: Quality Management system; Health Safety and Environment; Food
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Qualityze Screenshot

Qualityze

★★★★★
★★★★★
(1)
Qualityze is a cloud-based technology solution provider for Enterprise Quality Management System (QMS). Qualityze offers clients in the life sciences and manufacturing industries a preconfigured QMS solution and custom solutions with high quality that are cost-effective. The solution is Salesforce Lightning Certified. Nonconformance Management; CAPA Management; Change Management; Document Management; Audit Management; Complaint Management; Training Management; and Supplier Management. Life
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Quality Essentials Suite Screenshot
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QMSC Screenshot
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Qualio Screenshot

Qualio

★★★★★
★★★★★
(11)
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Total Lean Management Screenshot

Total Lean Management

★★★★★
★★★★★
(7)
Total Lean Management (TLM) software is the first QMS software to recognize both user groups found in every quality system—Upstream and Downstream. Upstream users include the quality professionals in your organization who are familiar with the full scope of MMS activities—responsible for the set up, administration, and the creation of workflows.; and Downstream users are anyone else who needs access to participate, approve, read procedures, sign off on training records, complete quizzes, enter
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EPC - Enterprise Process Center Screenshot

EPC - Enterprise Process Center

★★★★★
★★★★★
(4)
Interfacing Technologies enables organizations to efficiently govern business complexity and continuous transformation through process-based quality, performance and compliance management solutions. Interfacing’s clients are noted medium to large organizations. The company partners with leading management consulting firms to provide integration, workflow, SOP, GRC and process excellence services worldwide. @youtube Integrated Management System; Quality Management Workflows - eQMS; Process
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Greenlight Guru Screenshot
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Ease Screenshot

Ease

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EtQ Reliance Screenshot

EtQ Reliance

★★★★★
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EtQ Reliance is an EHS and quality management system that is designed to manage critical business processes and improve overall quality. EtQ Reliance is easy to use and flexible to meet your unique business requirements. This solution is web-based, allowing for fast implementation and frequent updates. @youtube Document Control; Employee Training Management; Audits Management; Corrective Action/Preventive Action (CAPA); Change Management; Suppliers, Materials, and Chemicals Management; Risk
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TrackWise Screenshot

TrackWise

★★★★★
★★★★★
(1)
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DELMIAWorks Screenshot
In manufacturing, your money is made on the shop floor. That is why accurate, real-time visibility into your production and factory floor is a critical component of the modern manufacturing environment.
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