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Description

Create a simple, efficient Quality Management System (QMS). You can install on your local server, or use our Cloud QMS solution. ISO 9001:2015 requires risk-based thinking. Risk Assessment: Failure Modes Analysis (FMEA) Implement risk-based strategies for ISO 9001, ISO 14971. Identify failure modes for each item or process. Identify the effects and severity. Identify the causes and frequency. Identify current controls and detection levels. Multiple actions should be taken in response to this failure mode. Assign owners and due dates. Establish verification and validation criteria. Management approval can be obtained by electronic signature. User login: Define passwords and privileges. Rich set of reports. Track open actions and delinquent due date. Microsoft Access is free to download. To further analyze the data, export it to Excel. Common, easy-to-use software platform

Description

Streamline your journey to ISO 9001 certification with a customized monday.com solution designed just for you! While achieving ISO 9001 certification can often feel overwhelming, our tailored approach simplifies the experience, integrating ISO template documents from Advisera into a cohesive monday.com workflow. Easily arrange your documentation, set up essential processes, and maintain adherence to the ISO 9001 standard with minimal hassle. You can conveniently oversee and document your organizational procedures, paving the way for a seamless certification process. Key features include: - Tracking the implementation of the ISO 9001 standard - Managing the improvement processes required by ISO - Organizing all documentation necessary for certification - Facilitating collaboration across multiple departments - Monitoring client feedback and measuring customer satisfaction - Utilizing performance dashboards for metric reporting Our services encompass: - Customized onboarding and implementation support - Workflow automation solutions - Integrations with existing tools - Comprehensive training and ongoing support for your team With our solution, you can transform the certification process into an organized, manageable, and efficient endeavor.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

No images available

Integrations

Azure SQL Database Yes 
Microsoft 365 Yes 
Sunday Business Systems Yes 
monday AI work platform No 

Integrations

Azure SQL Database No 
Microsoft 365 No 
Sunday Business Systems No 
monday AI work platform Yes 

Pricing Details

$135.00/one-time
Multiple user licenses are available. Licensing based on concurrent users.
Free Trial Yes 
Free Version Yes 

Pricing Details

$3500
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support No 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

Sunday Business Systems

Founded

2004

Country

United States

Website

sundaybizsys.com/fmea-database/

Vendor Details

Company Name

Simpleday Solutions

Founded

2021

Country

Israel

Website

simpledaysolutions.com/iso-9001-solution/

Product Features

Risk Management

Alerts/Notifications No 
Auditing No 
Business Process Control No 
Compliance Management Yes 
Corrective Actions (CAPA) Yes 
Dashboard No 
Exceptions Management No 
IT Risk Management No 
Internal Controls Management Yes 
Legal Risk Management Yes 
Mobile Access No 
Operational Risk Management Yes 
Predictive Analytics No 
Reputation Risk Management Yes 
Response Management Yes 
Risk Assessment Yes 

Product Features

Compliance

Archiving & Retention No 
Artificial Intelligence (AI) No 
Audit Management No 
Compliance Tracking No 
Controls Testing No 
Environmental Compliance No 
FDA Compliance No 
HIPAA Compliance No 
ISO Compliance No 
Incident Management No 
OSHA Compliance No 
Risk Management No 
Sarbanes-Oxley Compliance No 
Surveys & Feedback No 
Version Control No 
Workflow / Process Automation No 

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