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What is ISOQualitas.PLM?

ISOQualitas.PLM is a comprehensive Quality Management System (QMS) designed for automotive suppliers to effectively gather and manage information related to product development, design, and manufacturing. The platform allows for the creation, printing, and storage of vital quality documents, such as Control Plans, CSRs, and Work Instructions. By standardizing quality management processes, ISOQualitas.PLM enhances efficiency by up to 80% compared to traditional spreadsheets and ensures full compliance with IATF16949 standards. This software enables quality team members to collaborate on their individual tasks from both the office and remote locations, promoting flexibility in workflow. To ensure that both users and management are informed about the latest developments, tasks are organized and showcased on progress charts. The platform guarantees consistency across all documents, effectively addressing one of the most prevalent issues related to audit non-compliance. Furthermore, it assigns specific roles to each user, allowing for controlled information and document approval, which streamlines the overall quality management process. In this way, ISOQualitas.PLM not only improves efficiency but also enhances accountability within the quality team.

What is FMEA Database?

Develop a straightforward and effective Quality Management System (QMS) which can be hosted on your local server or accessed via our Cloud QMS option. Adhering to ISO 9001:2015 mandates the incorporation of risk-based thinking. Conducting a Risk Assessment through Failure Modes and Effects Analysis (FMEA) is essential for implementing risk-based strategies aligned with ISO 9001 and ISO 14971. It is crucial to identify potential failure modes for every item or process, assess their effects and severity, determine the underlying causes and their frequency, and recognize existing controls along with their detection capabilities. A series of actions must be initiated in response to each identified failure mode, with clear assignment of ownership and due dates. Additionally, it is important to set up criteria for verification and validation, which can be approved by management through electronic signatures. User login protocols should include defined passwords and privilege levels, while a comprehensive suite of reports will facilitate tracking of unresolved actions and overdue tasks. Microsoft Access can be downloaded free of charge, and for deeper data analysis, the information can be exported to Excel. This system operates on a commonly used software platform that is both accessible and user-friendly, ensuring that organizations can maintain high standards of quality management effortlessly.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

$135.00/one-time
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

ISOQualitas

Date Founded

1995

Company Location

Brazil | México | Spain | Switzerland | USA

Company Website

www.isoqualitas.com

Company Facts

Organization Name

Sunday Business Systems

Date Founded

2004

Company Location

United States

Company Website

sundaybizsys.com/fmea-database/

Categories and Features

Product Lifecycle Management

Change Management
Compliance Management
Cost Tracking
Design Management
Document Management
Product Data Management
Project Management
Requirements Management
Supplier Management

Work Instructions

Branding & Style Sheets
Content Management System
Drag and Drop
Dynamic Tags
Employee Feedback
Guide Approval Workflows
Media Editor
Multi-Brand Publishing
Rich Text Editor
SSO (SAML)
Translations
User Management
Version Control

Categories and Features

Risk Management

Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment

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