In the early 1900s, the market was flooded with quality systems traced back to medieval Europe, when craftsmen guilds established stringent procedures for inspecting products for defects. And the necessity for them to be implemented has only risen since then!
It is not merely a market requirement to constantly enhance operations, save costs, and give the best product or service. It is essential to the company's survival.
There are an estimated 2.1 million ISO 9001-certified businesses around the world. This figure comprises firms from over 170 countries and is continually updated to reflect the most recent best practices in quality management.
Having said that, this post aims to highlight everything there is to free quality management system software, and ISO 9001 role in it.
Let's get started.
The best ISO 9001 QMS software ensures that the final versions are error-free, although it might result in a slight deviation from business objectives.
Businesses must also fulfill the customer's specific demands without flaws or compromise.
Furthermore, they must follow industry-bound product quality requirements as well as other restrictions.
10 Best ISO 9001 QMS Software In 2024
Here's a quick run down on the best ISO QMS System software for you to choose from.
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1. Xenia - Overall No. 1 QMS 9001 Compliant Software
Xenia's ISO 9001 QMS software is particularly intended for frontline worker efficiency, with a straightforward interface that teams can master in less than a day.
Best for small- to mid-sized businesses with ambitious expansion plans looking for a low-cost eQMS solution for full-quality management and compliance.
Streamline communication with in-task chat for collaboration and accountability. Xenias’ free quality management system software gives the capabilities to enhance quality management with a software platform intended to connect facility management and frontline operations.
Key Features
- Inspection and Audits: Use the audit checklist to evaluate each process and determine compliance with the ISO 9001 standard. Take detailed notes and document any findings.
- Checklists and Logs: Systematically assign tasks equipped with accountability tools such as checklists and logs to ensure transparency, efficiency, and the highest standards of quality.
- Chats: Communicate with employees at all levels of your organization in real-time with one-on-one messages, group chats, and public announcements.
- Team Performance Reporting: Use Xenia's analytics dashboards to view staff work reports. Filter by asset, location, category, or due date and export the report in PDF or Excel
- Analytics and Reports: View real-time dashboard summary of tasks, staff performance, template submissions, and other data. To make quality management easier, filter, organize, and export compliance reports.
- AI-powered SOP writing tool: Create standard procedures for each team and process to change how your company's quality management procedures are managed, documented, and shared.
Pricing
- Starter Plan: Starting at $99/month for the first 15 users, includes a work calendar view, work reports, template reports, sub-assets, and sub-locations.
- Premium Plan: Starting at $199/month for the first 15 users, includes reporting dashboards, time and cost tracking, template branding, public form submissions, automated templates, and more.
- Custom Plan: You get unlimited users, a dedicated account manager, onboarding and implementation, and integrations.
Feel Free To Book a Demo
Available for up to 5 users
Premium for $99/month for the first 20 users (with free trial period)
Available on iOS, Android and Web
2. Qualityze
Qualityze provides a range of next-generation ISO 9001 QMS software solutions to assist organizations in managing end-to-end quality management from anywhere. It is developed on Salesforce.com, the most powerful and secure cloud platform.
It delivers the necessary flexibility, scalability, and security to handle business-critical data and operations effectively. It has incredible built-in features for reducing total process cycle time. In addition, the solution supplier provides data migration and validation services.
Furthermore, the solutions are specially built to comply with FDA, ISO, and GxP laws.
Key Features
- Configurability: One size does not fit all. Their solutions are configurable and personalized to meet your unique needs.
- Al Powered Next-Gen Solutions: An easy-to-use interface with a slew of outstanding built-in features such as audit trails, digital signatures, customizable dashboards, and much more.
- Built on Sales Force: It delivers the necessary flexibility, scalability, and security to handle business-critical data and operations.
Pricing
- Ask the vendor for pricing
3. DELMIA Works
DELMIAworks is a modern Enterprise Resource Planning (ERP) solution that can help you improve your quality management operations.
The QMS 9001 software supports fault avoidance and continuous improvement initiatives by seamlessly integrating with approaches such as Six Sigma DMAIC.
This sense of collaboration enables a precise, scalable quality management system that provides dependability and consistency.
From the first purchase to product delivery, the system is critical in the execution, planning, and assessment of all customer interactions.
Furthermore, DELMIAWorks is critical in assisting businesses in maintaining compliance with a variety of quality and regulatory standards, including ISO 9001, ISO 13485, and FDA medical device registration.
Key Features
- QMS: Providing an organized and consistent process for identifying and developing the actions required to guarantee products satisfy the specific needs of your customers
- Corrective Actions: Manage corrective actions and facilitate communication between dependent departments
- Audit Trail: Maintain tighter cost control while delivering higher-quality products. Every product should have an audit trail life cycle.
Pricing
- Ask the vendor for pricing
4. AssurX
AssurX Enterprise Quality and Compliance Management is the best ISO 9001 QMS software intended to assist enterprises in managing their quality and compliance procedures more efficiently and effectively.
The platform offers a complete range of tools and capabilities that allow businesses to automate and expedite their quality management procedures while also assuring compliance with applicable rules and standards.
The QMS system enables rapid CAPA compliance for processes, resulting in higher standard conformity and customer satisfaction with quality elements.
Key Features
- Customized Workflows: Workflows that can be customized to your individual business requirements. Document management that is robust includes version control and electronic signatures.
- Inspection Management: Records the outcome of independent inspection of every product to ensure no quality defects.
- Process Automation: Increase accountability and efficiency through automated facilitation of all QMR tasks.
Pricing
- Ask the vendor for pricing
5. ETQ Reliance
ETQ, an international leader in quality, compliance, and health and safety software, is trusted by major brands in areas such as manufacturing and life sciences, food and beverage, and electronics.
It includes capabilities such as document control, supplier quality, audit management, risk management, sophisticated analytics, and non-compliance/corrective actions to promote business excellence.
The program is appropriate for quality-focused businesses of all sizes and across a wide range of sectors, including manufacturing, life sciences, food and beverage, electronics, automotive, chemicals, and consumer products.
Key Features
- Quick and Optimal: ETQ is your partner for a quick and easy QMS deployment that meets your company's requirements and operations.
- On-demand Training: The only quality management system software that allows you to learn at your own pace—and from other quality champions like you.
- ETQ Reliance: A cloud-native quality management software driven by an agile platform that powers 40+ best-in-class apps
Pricing
- The cost of ETQ Reliance is based on the number of concurrent users
6. MasterControl
MasterControl is a well-known digital quality management system program that controls end-to-end business solutions.
It is a platform-independent cloud-hosted solution. The ISO 9001 QMS software has several connectors to improve the product's functionality.
Users are also assured of industry-accepted compliance by the quality control software. MasterControl, as one of the most prominent systematic quality management systems, enables users to strategize and plan supply chain management efficiently while fostering operational excellence.
Key Features
- Defect Tracking: Manages reporting on all procedures that effectively resolve problems and track defects.
- Audit Management: This allows you to plan and schedule audits while also automating the whole audit process.
- Document Control: Helps to manage and retain access to sensitive documents effectively, communicate data depending on approvals and user access, and monitor changes.
Pricing
- Ask the vendor for pricing
7. Qualio
Qualio is an ISO 9001 QMS software designed specifically for the life sciences industry, making it a suitable option for medical device businesses, biotech/therapeutic enterprises, and pharmaceutical contractors.
One standout feature is its ability to simplify complicated procedures and assist firms in meeting industry standards such as ISO 14971 and ICH Q9.
It is specially developed to fulfill regulatory standards with a flexible pricing strategy. It can handle the business's expanding demands.
Key Features
- Intuitive Cloud Platform: Added security, powerful administration, and metrics with a cloud-based platform. Integration challenges with third-party systems like ERP and CRM.
- Integration Options: Integration issues with third-party systems such as ERP and CRM.
- Corrective and Preventive Action: A method of quality management comprised of activities designed to repair and avoid well-known problems, such as nonconformities.
Pricing
- Ask the vendor for pricing
8. Intelex
The Intelex ISO 9001 software provides a means to integrate people, processes, and tools to help organizations identify quality issues earlier, prevent them from occurring altogether, and deliver better customer satisfaction.
Proven to be one of the top ISO 9001 software in the industry with an intuitive cloud-based software suite, Intelex QMS software solutions contain a vast amount of tools and applications for environmental, health and safety, quality, and business performance management.
The software allows you to report, measure, and manage your corporate health and safety data with a few vows and clicks.
The Intelex solution also offers a broad range of health and safety functionality to efficiently manage occupational injuries, illnesses, audits, inspections, and document control processes all geared toward meeting workplace safety standards.
With environmental, health, and safety functionality the Intelex QMS solution also offers a range of quality management tools, helps support regulatory compliance requirements, and helps manage operational risks ensuring holistic management processes and associated performance metrics.
Replace complicated processes made up of a bunch of tasks, emails, and documents with a powerful business workflow.
Add a document or form to any task and forward the information to others for completion.
Integrated document management controls all your important record templates while advanced quality toolsets for tasks like FMEA, APQP, and PPAP make sure you are using the best methodologies to produce high-quality plans that reduce your risk.
The software’s adaptability makes it a good fit for a wide number of industries and firms such as accounting, automotive, healthcare, education, engineering, and manufacturing.
Key Features
- Configurable ISO 9001 Project Plan: To speed up the certification process, Intelex ISO 9001 Implementation Module creates a customized project plan based on the start and completion dates specified by the company.
- Comprehensive Tracking: Ensuring transparency and accountability throughout the implementation process, the program enables thorough recording and reporting of expenses, activity descriptions, accountable persons for accomplished activities, and intended completion dates.
- Daily Status Reports: Organizations can make well-informed choices and necessary changes based on the most recent information about their implementation status that is provided via real-time reporting features.
Pricing
- Small and Medium businesses – Contact vendor
- Enterprise -Contact Vendor
9. Mango QHSE Software
Mango has grown out of the drive for simplicity and clarity in all aspects of a QHSE management system.
A key strength of Mango is that it gives you full control of every aspect of your quality system. With Mango you can define your workflows, risk templates, and training requirements, meaning that you can have quality software that works exactly the way your business does. In addition to this, Mango goes a long way to automating many tasks and therefore helps you reduce the amount of work spent on quality management and also helps ensure a consistent approach to quality.
Mango ensures that important documents are available, whoever and wherever they are.
Updates made by the right people are instantly synced throughout the company, ensuring that the correct version of a document is always being used, no more uncontrolled copies, aligned with all the latest standards and procedures, and globally visible or just in a folder.
The Improvement Module supports the systematic recording and management of non-conforming products, processes, and customer complaints for example; providing an assigned investigation task for all relevant stakeholders while Mango captures and time-stamps every piece of evidence added to the system.
All this equates to complete control of your workflow, involvement levels, and timeliness.
Key Features
- Document Management: Mango simplifies the process of organizing, evaluating, updating, and revising documents, assisting businesses in staying by internal guidelines and ISO standards.
- Risk management: Organizations may proactively reduce risks and improve operational resilience by using the risk management module, which gives users the ability to recognize, evaluate, and control aspects and repercussions.
- Legal Compliance: The platform gives enterprises a comprehensive picture of their regulatory responsibilities and makes it easier for them to comply with the law by formalizing legal requirements inside a centralized document repository.
- Communication: Mango's documents module makes all employees aware of the organization's goals and objectives, which promotes alignment and keeps everyone informed and motivated to work toward them.
- Improvement Tracking: Mango's Improvement Module makes it simple to record and manage all quality opportunities, allowing companies to monitor their progress and improve overall quality performance through continuous improvement.
Pricing
- Starting from $7200/year
10. ComplianceQuest
ComplianceQuest is one of the top ISO QMS software solutions providing next-generation quality and safety management solutions through a combination of advanced software, domain knowledge, and expert services.
It enables manufacturers to identify, mitigate, and prevent risks, assure the safety and quality of their products and thereby, protect their customers and safeguard their brand equity.
ComplianceQuest’s software suite offers solutions specifically designed to capture, track, and assess the issues relevant to organizational performance while also providing additional solutions that allow the same detailed tracking of external issues such as supplier and Customer Performance Reports (CPR) and Supplier Evaluation (SE) solutions to manage the comprehensive supplier rating scorecard.
ComplianceQuest is an end-to-end solution that connects all quality processes on a single platform. From product conception to customer satisfaction the platform helps increase quality and compliance for you and your entire value chain. The result is higher quality, improved safety, reduced cost, and regulatory compliance allowing you to drive quality while driving value.
In addition, it is considered to be pre-validated and user-friendly which allows for easy setup, and implementation, along with ease of use and maintenance.
Key Features
- Quality Management Oversight: The CQ EQMS Platform enables executives to oversee the quality management system and embedded processes throughout the organization. This includes monitoring internal and supplier audit results, assessing staff training competency, identifying gaps, and applying CAPA techniques for continuous improvement.
- Customer Feedback Analysis: Analyzing trends in customer complaints gives businesses valuable information about product flaws and customer satisfaction levels, allowing them to resolve problems early on and enhance overall product quality.
- Collaboration Technologies: ComplianceQuest integrates collaboration and communication technologies like as Chatter and Social Media across the organization, allowing stakeholders to participate and exchange information more effortlessly. Dashboards and reports provide actionable data, hence improving decision-making processes.
Pricing
- Starting from $30/user/month
What Is ISO 9001:2015?
ISO 9001 is a global standard that sets the standards for a quality management system (QMS).
Organizations use the standard to show their capacity to consistently provide goods and services that fulfill consumer and regulatory requirements. It is the most widely used standard in the ISO 9000 series and the only one to which enterprises can certify.
The International Organization for Standardization (ISO), an international organization comprising national standards organizations from more than 160 countries, initially released ISO 9001 in 1987. The most recent ISO 9001 version was issued in September 2015.
What Kind of Businesses is the ISO 9001 Applicable To?
ISO 9001:2015 applies to all organizations, no matter their size or sector. More than a million enterprises from over 160 countries have used the ISO 9001 standard criteria to improve their quality management systems.
Here are some of those industries and their identification codes:
- Medical device manufacturing (ISO:13485)
- Circuit board manufacturing (ISO:9001)
- Aerospace and defense manufacturing (AS9100 revC, AS9100 revD)
- Automotive Manufacturing (TS-16949)
- Nuclear power (Nuclear Regulatory Commission standards)
The ISO 9001 requirements are divided into eight sections (referred to as ISO 9001 clauses), five of which contain mandatory QMS requirements: general Quality Management System requirements (clause 4), Management Responsibility (clause 5), Resource Management (clause 6), and Product Realization (clause 7).
Businesses that now utilize ISO 9001 are recommended to upgrade to ISO 9001:2015 as soon as possible. This covers not just ISO 9001:2008-certified firms but also any organizations engaged in teaching or certifying others.
QMS Meaning - What Is It?
An enterprise-wide Quality Management System (QMS) is a collection of rules, procedures, and practices that have been created. This system manages and directs important business operations. The ISO 9001 QMS software seeks to deliver optimum performance at all times, in addition to ongoing improvements in effectiveness and efficiency.
A quality management system assists firms in lowering expenses, improving performance, reducing waste, and establishing a training foundation for new and current staff members.
Quality management is defined by ISO 9000 as the documentation of all business operations that are carefully monitored by personnel. This is the foundation for many different kinds of quality management systems.
You can ensure compliance with the most recent standards and regulations in either situation without outsourcing all of your procedures.
By applying Total Quality Management (TQM), your organization can improve efficiency and decrease waste with an ISO certification. TQM may improve all elements of your organization, from the front desk to the manufacturing line.
Choosing Quality Management Software?
The best ISO 9001 QMS software is tailored to a certain company type, size, or form. Some are beneficial to life science firms, while others are beneficial to food and manufacturing enterprises.
Choosing software that is particularly intended for enterprises like yours will result in faster deployment, better acceptance, and a shorter time to value. Choosing an ISO 9001 QMS software for highly regulated organizations in industries involves a number of functional concerns. Typical eQMS features include:
- Management of Documents
- Controls over Design (for medical device manufacturers)
- Management of Risks
- Management of Training
- Audit Administration
- Management of Corrective and Preventative Action (CAPA)
- Supplier Administration
On That Note
Quality management software is a must-have for every organization that intends to attain and maintain high-quality standards and pursue certification.
However, selecting the best ISO 9001 QMS software for your organization might be difficult.
With contextual in-app AI SOP writer, reinforcement training, real-time end-user assistance, and user behavioral analytics and event monitoring, Xenia helps enterprises optimize their systematic quality management systems investment and elevate quality management efforts.
Unify Team Operations, Maintenance and Safety Compliance with Xenia
Xenia unifies daily operations, maintenance management and quality assurance to help ensure teams and facilities are effective and efficient.
Our customers love Xenia's robust use cases including:
Operational Execution
✔️ Checklists & SOPs
Create checklists, SOPs, Inspections and Data Logs to power accountability, training and staff clarity on every task.
💪 Team Task Management
Assign work digitally to defeat pencil whipping and disorganized teams. Complete tasks, chat with teams on any device, track time, collect photos, and ensure high quality work.
📆 Recurring Tasks
Create recurring schedules for daily opening and closings, performance review meetings, inspections, cleanings and more.
📲 Chats & Announcements
Centralize team communications with in task chats, one-on-one chats, team messages and company wide announcements
📊 Team Performance Reporting
Use Xenia's analytics dashboards to view staff work reports. Filter by asset, location, category or due date and export the report in PDF or Excel
Maintenance Management
🛠️ Work Orders
Create work orders with associated team, asset, location, priority, category and due date. View live progress reports on each work order, chat with teams, and review resulting template submission, images and notes to improve operations.
🧰 Preventive Maintenance
Create a preventive maintenance calendar to ensure asset uptime is not compromised. Attach images, templates, videos and notes to every task and assign to a team or individual for completion.
📲 QR Codes
Generate and attach QR codes to equipment and facility locations to enable fast and accurate inspections and data logs.
⚙️ Work Order Requests
Receive, approve and assign work order requests from tenants, regular customers and vendors. Enable requesters to submit, track, and communicate with your team, without access to operations templates or unrelated work orders.
📁 Equipment Work History
View work history for every asset and sub asset in Xenia. Review performance data and enable corrective actions to improve your operation.
Safety Compliance & Quality Assurance
👍 Concrete Brand Standards
Put your brand standards in a clear and operational checklist to be attached to work assignments.
🔎 Smart Inspection Workflows
Xenia's operations template builder has built in conditional logic into each step. This allows you to trigger actions based on a form response such as creating a corrective action on a failed inspection step, sending a notification to management for out of range meter readings, and much more.
✨ Corrective Actions
Operationalize inspections with fast work order assignment arising from a failed inspection step. All corrective data is stored in the checklist submission for auditing and accountability.
📋 Analytics and Reports
View live dashboard summaries of tasks, employee performance, template submissions and more. Filter, organize and export compliance reports to PDF and Excel formats to simplify compliance management.
All Your ISO 9001 QMS Needs Met At One Place!
We understand that upholding your business to ISO 9001 QMS standards is challenging at best.
Xenia unifies daily inspection audits, QMS operations, maintenance management and quality assurance to help ensure that everyone's on the same page.
Our customers love Xenia's robust use cases including:
Achieve Process Excellence With The Best Facility Inspection App
✔️ Checklists & SOPs
Create checklists, SOPs, Inspections and Data Logs to power accountability, training and staff clarity on every task.
💪 Build Inspections, SOPs and Logs Within Minutes!
Take the lead on your church facility management activities by creating detaild templates with unlimited steps and diverse reponse times.
📆 Plan Ahead With Scheduled & Recurring Tasks
Create recurring schedules for daily opening and closings, performance review meetings, inspections, cleanings and more.
📲 Chats & Announcements
Centralize team communications with in task chats, one-on-one chats, team messages and company wide announcements
🛠️ Work Orders Management
Create work orders with associated team, asset, location, priority, category and due date. View live progress reports on each work order, chat with teams, and review resulting template submission, images and notes to improve operations.
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