Software Connect logo Software Connect logo
Best-in-Class Software Reviews Research
8.9
Editor’s Rating:
Best Overall
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
  • Standalone solution or part of IQMS ERP
  • Detailed inventory tracking
  • Proprietary data sharing tools
9.5
Editor’s Rating:
Best for Collaboration
Unifize
  • Built for mid-size to enterprise level companies
  • Drag and drop interface
  • Integrations with existing ERP

1 Intellect QMS - Best Overall

Intellect is a highly configurable QMS system that allows you to customize the platform without any coding required. With a fast implementation you can easily modify and build apps, and meet global regulations and standards. Your team will have access to high quality data, documents, analytics, and reports in real time and on any device.

Best Overall:
Intellect QMS

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

2 DELMIAworks - Best End-to-End Solution

DELMIAworks (formerly IQMS MES) is "shop floor first", fully scalable, and comprehensive ERP solution that works for companies of various sizes. Real-time data helps manufacturing businesses scale for growth without adding additional labor to the workforce all while eliminating waste and improving efficiency.

Best End-to-End Solution:
DELMIAWorks

Plant Floor RealTime Dashboard
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

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)

Data Dashboard
Track Conversations
Internal Messages
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: Mac, Web, Windows, iOS, Android

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.

Note: 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.

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.

Benefits of Quality Management Software

Quality management systems assist all types of manufacturers in meeting some of their most critical business challenges:

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.

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.

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?

Pricing of quality management systems depends on several factors: number of users, required functionality, and 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.

With all these factors taken into consideration, costs range from $50 to $2,000 per user per month.

Integrating QMS With Other Business Software

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

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

No products found
uniPoint Screenshot

uniPoint

★★★★★
★★★★★
(2)
The configure-to-order Quality Management Software solution is designed to help your company automate its journey toward excellence. With twenty-five integrated software modules for quality and compliance management, uniPoint has transformed the quality…
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$225/user/month
Client OS
Web, Windows
Deployment
Cloud or On-Premises
TRACKMEDIUM Screenshot

TRACKMEDIUM

★★★★★
★★★★★
(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…
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$299/month
Client OS
Web, iOS, Android
Deployment
Cloud Hosted
MasterControl Qx Screenshot

MasterControl Qx

★★★★★
★★★★★
(1)
MasterControl’s software platform improves quality management processes through employee training management, document and change control, risk assessment, audits and preventative action, and more. Control quality throughout the product lifecycle from…
Client OS
Web
Deployment
Cloud Hosted
Waypoint Global Suite Screenshot
Between the four Series that are at the heart of our Document Management Suite, you can bring order to the chaos that is interfering with productivity, customer satisfaction, compliance and competitive advantages. Waypoint Global gives everyone across…
Client OS
Windows
Deployment
On-Premises
QT9 QMS Screenshot

QT9 QMS

★★★★★
★★★★★
(1)
QT9 QMS is a cloud-based quality management system that helps teams integrate data from multiple systems into one flexible and intuitive platform. With QT9, you can automate repetitive work in seconds, such as scheduling email reminders and checking…
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$1,500/user
Client OS
Mac, Web, Windows, Linux, iOS, Android
Deployment
Cloud or On-Premises
HQMS Screenshot

HQMS

★★★★★
★★★★★
(3)
Harrington Quality Management Software (HQMS) is the flagship world-class software for process improvement, compliance and EQMS Online Quality Management Software System. It addresses the needs of manufacturing, aerospace, medical device, pharmaceutical…
Client OS
Web, Windows
Deployment
Cloud or On-Premises
Qualcy eQMS Screenshot

Qualcy eQMS

★★★★★
★★★★★
(1)
Qualcy eQMS software has been designed for use in Medical Device, Pharma and Biotech applications. The quality management software system complies with 21 CFR Part11 requirements. The software helps companies comply with 21 CFR820, 21 CFR 210 and 211…
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$799/month
Client OS
Web
Deployment
Cloud or On-Premises
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…
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Client OS
Android, Web
Deployment
Cloud or On-Premises
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…
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$2,000/user/month
Client OS
Web
Deployment
Cloud Hosted
Quality Essentials Suite Screenshot
The Quality Essentials Suite from Horizons International is designed to support manufacturers in collecting and measuring their quality performance data throughout their manufacturing operations so that it is accessible for analysis and reporting in a…
Client OS
Windows
Deployment
Cloud Hosted
QMSC Screenshot
QMSC is a SaaS based supplier management solution for corporations who find that Excel and access databases and spreadsheets are no longer tenable to managing their portfolio of suppliers. Supplier performance is at the core of the QMSC solution…
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Client OS
Web
Deployment
Cloud Hosted
Qualio Screenshot

Qualio

★★★★★
★★★★★
(10)
Qualio is an eQMS tailored for the life-sciences industry. With a ready-to-use, flexible quality management system that unites teams, processes and data in one place - Qualio helps organizations get to market quickly and scale successfully. Trusted by…
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$12,000
Client OS
Web
Deployment
Cloud Hosted
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…
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$80/user/month
Client OS
Web, Windows
Deployment
Cloud or On-Premises
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…
Client OS
iOS, Android, Web
Deployment
Cloud or On-Premises
Greenlight Guru Screenshot
Greenlight Guru is the only quality management platform designed specifically for medical device companies. The platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of…
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$600/user/month
Client OS
Web
Deployment
Cloud Hosted
Ease Screenshot

Ease

Ease is a benefits administration and HR management software. With Ease, your company can say goodbye to paper enrollment forms and enjoy a faster way to get your clients online. This software allows employees to make better healthcare decisions and…
Client OS
Web
Deployment
Cloud Hosted
EtQ Reliance Screenshot

EtQ Reliance

★★★★★
★★★★★
(1)
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…
Client OS
Web
Deployment
Cloud Hosted
TrackWise Screenshot

TrackWise

★★★★★
★★★★★
(1)
TrackWise software by Sparta Systems is an enterprise quality management solution (EQMS) that optimizes quality, ensures compliance, reduces risk, and lowers costs for world-class clients across a range of industries. Commonly known as QMS software…
Client OS
Deployment
Cloud Hosted
DELMIAWorks Screenshot
Quality Management Software from DELMIAWorks (formerly IQMS) provides a powerful and flexible system to help manufacturing companies control and comply with the most stringent quality standards. The solution aids with audits, parts specifications…
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Client OS
Windows
Deployment
Cloud or On-Premises
Unifize Screenshot

Unifize

★★★★★
★★★★★
(4)
Unifize is a collaborative eQMS that enables real-time conversations around quality objectives, including NCs, CAPAs, Inspections, Audits, Vendor Onboarding etc etc. Built for mid-size to enterprise level companies, the Unifize platform integrates with…
Price Range
   $     $     $     $     $   
   $     $     $     $     $   
Starting Price
$50/user/month
Client OS
Mac, Web, Windows, iOS, Android
Deployment
Cloud Hosted

We searched and searched, but we couldn’t find any products in our database that match your criteria. Perhaps our team of software experts can help? They’d be happy to provide a list of free quality management (QMS) software recommendations that meet your exact requirements.

Sort by 
Filter by User Rating
Filter by Price Range
Filter by Deployment
Filter by Client OS