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ISO 9001

Achieve excellence and compliance with the ISO 9001 standard. Manage documents, optimize processes with AI, and enhance customer satisfaction with agility and efficiency.

Accelerate the ISO 9001 certification journey
Difficulty in controlling essential documents, compromising compliance and organization.
Inefficient identification and handling of nonconformities, increasing risks and making compliance maintenance more challenging.
Lack of process standardization leading to inconsistencies, rework, and difficulty in continuous quality improvement.

Find out how to implement an effective quality management system with our software

Achieve Excellence in Quality

  • Avoid errors and rework by automatically managing all versions of documents in your ISO 9001 management system.
  • Ensure full traceability of changes, keeping your team updated with accurate information.
  • Protect sensitive documents with secure cloud-based access control and sharing.
  • Keep your team aligned with automatic update notifications.
  • Guarantee the use of only valid and updated documents by setting review and update deadlines.
  • Create, review, and enhance action plans with our AI.

 

 Discover our solution with Copilot AI →

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Resolve Nonconformities Before They Become Problems

  • Respond quickly to nonconformities, minimizing quality impacts.
  • Identify the root cause of failures with efficient approaches, enabling structured problem analysis and resolution.
  • Drive continuous improvement by implementing effective preventive actions based on lessons learned.
  • Ensure corrective and preventive actions are effective, eliminating failures before they become critical.

 

Discover SoftExpert Nonconformity Management → 

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Improve Efficiency and Standardize Your Processes

  • Visualize and optimize workflows for more agile and efficient processes.
  • Structure processes clearly, defining activities, responsibilities, and interactions.
  • Reduce errors and boost productivity by automating repetitive tasks.
  • Facilitate audits and certifications by keeping records organized and accessible.
  • Maintain full control over process changes, ensuring traceability and continuous improvement of your ISO 9001 program.

 

 Discover SoftExpert Process →

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Use cases

Discover how SoftExpert helps companies achieve compliance with ISO 9001

Audit Management
Document Management
Incident Management (CAPA)
Risk Management
Performance Management
Process Management
Supplier Management

Simplify your audit management

Ensure compliance with ISO 9001:
9.2 - Internal Audit

Imagem ilustrativa
  • Automation of internal audits
  • Document control with restricted access
  • Change traceability in documents
  • Compliance and performance assessment                                                                                                          

 

Take a tour of the software. Click here →

Complete control over your documents with security and compliance

Ensure compliance with ISO 9001:
7.5 - Documented Information

Imagem ilustrativa
  • Automated document version management
  • Full traceability of modifications
  • Secure access and editing control
  • Guaranteed access to valid and secure information                                                                                          

 

Take a tour of the software. Click here →

Resolve nonconformities and drive continuous improvement

Ensure compliance with ISO 9001:
10 - Improvement
10.1 - Continuous Improvement
10.2 - Nonconformity and Corrective Action

Imagem ilustrativa
  • Registration and monitoring of nonconformities
  • Corrective and preventive actions based on analyses
  • Promotion of continuous improvement
  • Evaluation of the effectiveness of implemented actions

 

Take a tour of the software. Click here →

Anticipate and minimize risks and opportunities for a more robust management system

Ensure compliance with ISO 9001:
9 - Performance Evaluation
9.1 - Monitoring, Measurement, Analysis, and Evaluation
9.1.3 - Analysis and Evaluation

Imagem ilustrativa
  • Identification and prioritization of risks and opportunities in processes
  • SWOT Matrix
  • Development of risk mitigation actions
  • Risk assessment considering probability and impact                                                                                                 

 

Take a tour of the software. Click here →

Monitor and optimize organizational performance with precision

Ensure compliance with ISO 9001:
4.4 - Quality Management System and Its Processes

Imagem ilustrativa
  • Performance indicator tracking
  • Trend analysis and result variations
  • Comparison of indicators over time
  • Strategy adjustments based on data                                                                                                                      

 

Take a tour of the software. Click here →

Standardize, automate, and continuously improve your processes

Ensure compliance with ISO 9001:
6.1 - Actions to Address Risks and Opportunities

Imagem ilustrativa
  • Creation and visualization of workflows (SIPOC, Turtle Diagram, and Flowcharts)
  • Automation of manual and repetitive tasks
  • Process documentation and traceability
  • Implementation of continuous improvements

 

Take a tour of the software. Click here →

Evaluate, qualify, and monitor suppliers efficiently

Ensure compliance with ISO 9001:
8.4 - Control of Externally Provided Processes, Products, and Services

Imagem ilustrativa
  • Evaluation, approval, and selection of suppliers
  • Traceability of the approval process
  • Standardization of supplier qualification questionnaires                                                                                                                        
  • Generation of supplier performance reports

 

Take a tour of the software. Click here →

  • Voltar aos tópicos
    Audit Management
    Simplify your audit management

    Ensure compliance with ISO 9001:
    9.2 - Internal Audit

    Imagem ilustrativa
    • Automation of internal audits
    • Document control with restricted access
    • Change traceability in documents
    • Compliance and performance assessment                                                                                                          

     

    Take a tour of the software. Click here →

  • Voltar aos tópicos
    Document Management
    Complete control over your documents with security and compliance

    Ensure compliance with ISO 9001:
    7.5 - Documented Information

    Imagem ilustrativa
    • Automated document version management
    • Full traceability of modifications
    • Secure access and editing control
    • Guaranteed access to valid and secure information                                                                                          

     

    Take a tour of the software. Click here →

  • Voltar aos tópicos
    Incident Management (CAPA)
    Resolve nonconformities and drive continuous improvement

    Ensure compliance with ISO 9001:
    10 - Improvement
    10.1 - Continuous Improvement
    10.2 - Nonconformity and Corrective Action

    Imagem ilustrativa
    • Registration and monitoring of nonconformities
    • Corrective and preventive actions based on analyses
    • Promotion of continuous improvement
    • Evaluation of the effectiveness of implemented actions

     

    Take a tour of the software. Click here →

  • Voltar aos tópicos
    Risk Management
    Anticipate and minimize risks and opportunities for a more robust management system

    Ensure compliance with ISO 9001:
    9 - Performance Evaluation
    9.1 - Monitoring, Measurement, Analysis, and Evaluation
    9.1.3 - Analysis and Evaluation

    Imagem ilustrativa
    • Identification and prioritization of risks and opportunities in processes
    • SWOT Matrix
    • Development of risk mitigation actions
    • Risk assessment considering probability and impact                                                                                                 

     

    Take a tour of the software. Click here →

  • Voltar aos tópicos
    Performance Management
    Monitor and optimize organizational performance with precision

    Ensure compliance with ISO 9001:
    4.4 - Quality Management System and Its Processes

    Imagem ilustrativa
    • Performance indicator tracking
    • Trend analysis and result variations
    • Comparison of indicators over time
    • Strategy adjustments based on data                                                                                                                      

     

    Take a tour of the software. Click here →

  • Voltar aos tópicos
    Process Management
    Standardize, automate, and continuously improve your processes

    Ensure compliance with ISO 9001:
    6.1 - Actions to Address Risks and Opportunities

    Imagem ilustrativa
    • Creation and visualization of workflows (SIPOC, Turtle Diagram, and Flowcharts)
    • Automation of manual and repetitive tasks
    • Process documentation and traceability
    • Implementation of continuous improvements

     

    Take a tour of the software. Click here →

  • Voltar aos tópicos
    Supplier Management
    Evaluate, qualify, and monitor suppliers efficiently

    Ensure compliance with ISO 9001:
    8.4 - Control of Externally Provided Processes, Products, and Services

    Imagem ilustrativa
    • Evaluation, approval, and selection of suppliers
    • Traceability of the approval process
    • Standardization of supplier qualification questionnaires                                                                                                                        
    • Generation of supplier performance reports

     

    Take a tour of the software. Click here →

Bring Left
Bring Right

Bring this solution to your company

Why do customers choose SoftExpert

União Química

Success Case
União Química manages more than 3,000 documents in SoftExpert Suite and increased its productivity in content management by 30%
See The Full Story

Gestamp

Success Case
Gestamp Reduces Production Printouts by 50% and Improves Document and Information Quality
See The Full Story
View all cases

Learn how SoftExpert solutions can help you achieve standards certification and regulatory compliance

Enterprise Content - ECM
Product Lifecycle - PLM
Business Process - BPM
Innovation and Change - ICM
Environment, Health, and Safety - EHSM
Enterprise Asset - EAM
Enterprise Risk - ERM
Quality Management - QMS
Work Management - CWM
Supplier Lifecycle - SLM
Corporate Performance - CPM
Governance, Risk and Compliance - GRC
Human Development - HDM
Project and Portfolio - PPM

Enterprise Content - ECM

SoftExpert ECM is a comprehensive enterprise content management software solution that centralizes all organizational content. It allows you to create, capture, manage, store, preserve and share documents and records, reducing paperwork and related deviations. The ECM solution ensures security, integrity, reliability, and compliance with international standards such as ISO 9001 and FDA 21 CFR Part 11.

Explore the solution
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enterprise-content-management-ECM-1.webp

Product Lifecycle - PLM

Manage your products’ entire lifecycle with a cloud-based solution powered by Gen AI. SoftExpert PLM accelerates time-to-market, automates repetitive tasks, and delivers intelligent insights for strategic decisions. Improve quality, reduce costs, and optimize resources with a secure, scalable, and innovative platform.

Explore the solution
product-lifecycle-management-PLM-1.webp
product-lifecycle-management-plm-2.webp

Business Process - BPM

Standardize your business processes, automate workflows, integrate applications, and accelerate digital transformation across your organization with a results-driven business process optimization software.

Explore the solution
Business-Process-BPM-2.webp
business-process-bpm-01.webp

Innovation and Change - ICM

Manage your change processes with excellence, transform innovative ideas into concrete results, and drive organizational transformation with a comprehensive platform that reduces implementation time and increases the success of your initiatives through digitization, integration between stages, traceability, and real-time monitoring of actions.

Explore the solution
Corporate-Change-and-Innovation-Management-ICM-02.webp
Corporate-Change-and-Innovation-Management-ICM-01.webp

Environment, Health, and Safety - EHSM

Drive EHS maturity with a platform that centralizes risks, permits, KPIs, and corrective actions in one place. Ensure full compliance with ISO 14001 and 45001, proactively reduce incidents, and deliver measurable results to stakeholders, customers, and investors.

Explore the solution
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environment-health-and-safety-ehsm-1.webp

Enterprise Asset - EAM

SoftExpert EAM offers physical asset management throughout the entire lifecycle. Focused on sustainable value, it supports everything from inventory to maintenance and performance analysis. Reduce costs and downtime with the support of an automated maintenance management system integrated with your operation. Increase operational efficiency and build effective strategies to optimize critical assets.

Explore the solution
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enterprise-asset-eam-1.webp

Enterprise Risk - ERM

Lower the likelihood and impact of risk events using an integrated enterprise risk management solutions that unlocks the potential of opportunities, optimizes resources, and directs strategies and decisions.

Explore the solution
Enterprise-Risk-ERM-01.webp
enterpris-risk-management-ERM-2.webp

Quality Management - QMS

Modernize your quality management system (QMS) with an all-in-one solution. Reduce the effort to stay compliant, increase process agility, and gain transparency to drive continuous improvement with more control and efficiency.

Explore the solution
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quality-management-software-EQM-1.webp

Work Management - CWM

The only all-in-one cloud platform to improve team collaboration and task efficiency.

Explore the solution
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Work-Management-CWM-02.webp

Supplier Lifecycle - SLM

Manage the full supplier lifecycle with a cloud-based solution enhanced by Gen AI. SoftExpert SLM automates processes, qualifies partners, ensures compliance, and reduces risks with real-time insights. Boost performance visibility, efficiency, and trust with a secure, intelligent, and scalable platform.

Explore the solution
supplier-lifecycle-management-SLM-1.webp
supplier-lifecycle-management-SLM-2.webp

Corporate Performance - CPM

Manage strategy effectively by mapping scorecards with objectives, indicators, action plans, and everything you need to achieve business success using corporate performance management software.

Explore the solution
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Corporate-Performance-CPM-01.webp

Governance, Risk and Compliance - GRC

Strengthen corporate governance with full visibility and control over organizational risks through a solution that enhances security, integrates business strategy and ensures regulatory compliance. All powered by AI to optimize your daily operations.

Explore the solution
Governance-Risk-and-Compliance-GRC-01.webp
governance-risk-compliance-management-grc-2.webp

Human Development - HDM

Satisfy your needs for talent management, training and development, team performance assessments and career and succession planning all in a single platform.

Explore the solution
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human-development-hdm-2.webp

Project and Portfolio - PPM

Transform your project and portfolio management with a complete, cloud-based, AI-powered solution aligned with PMBOK. Connect planning, execution, and monitoring through intelligent automation and real-time insights to ensure on-time delivery with quality and high performance.

Explore the solution
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project-and-portfolio-management-ppm-2.webp

Compliance with global privacy and security standards

Advanced data protection

SoftExpert ensures the protection of your company's data and compliance with the requirements of the latest standards.

Integrate with your ERP, CRM, Office365, and much more

Connect SoftExpert Suite to other business tools already used in your organization.

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Worldwide Office Locations

Supporting and implementing your growth and expasion everywhere! We are present locally, ready to ensure that SoftExpert solutions are working without limits.

Contact us
Meet us

Customize the solution to your needs

Add new modules to your product, customize your experience and get all the solutions you need for your company.

Glossary

ISO 9001

International standard for quality management systems.

Stars

An award-winning platform recognized by customers