An efficient and easy-to-use Quality Management System
- Customer complaints
- Internal defects and deviations
- Assign issues to specific employees with notifications
- Manage your RMAs from beginning to end
- Safety Issues
- Business Improvement Proposals submitted by employees
- Documentation organization
- SCRUM project management
- And many more!
What makes Wismatix QMS different from many other systems? Your eQMS comes complete with all modules, no need to pick and choose which modules you want based on budget!
Wismatix QMS will help you have full control over your Quality Management by implementing a system that will be used by all of your employees. The end result – optimizing your company performance and boosting your bottom line.
Wismatix QMS supports
Quality standards and regulations,
– ISO 9001, ISO 13485, FDA 21 CFR Part 820Environmental standards,
– ISO 14001, ISO 45001IT standards.
– ISO 27001, FDA 21 CFR Part 11
What is included in the Wismatix System?
Everything!
We don’t believe that your Quality Management System should be pieced together based on cost – you’ll receive all of the modules listed below for a full Quality Management experience.
Chemicals
Safety data sheets, protective equipment and workplace descriptions [...]
Company Administration
Your company's basic setup Setup and administration of [...]
Contacts
Easy access to information about your customers and suppliers. [...]
Customer Complaints
Minimize your customer complaints. Easy registration and efficient handling [...]
Documentation Management
Document management is easily done with Wismatix QMS [...]
Employee Administration
Employees, qualifications, and affiliations, etc. Enter employees and [...]
Equipment and Tools
When function and accuracy are important factors [...]
Improvements
Optimization of your business. Make it easy [...]
Internal and External Audits
Internal and External Audits Documentation of internal and [...]
Internal Defects and Deviations
Minimize future internal defects and deviations. Detecting [...]
Management Reviews
The quality management system's quarterly, half-yearly or annual statement [...]
My Menu
Easy access to all your information in one place. [...]
Organization Management
Overview of the organization. Based on the employees' [...]
Performance and security
Built to be fast, reliable, easy to use, and [...]
Performance Dashboard
Overview of your QMS in real-time. The [...]
Process Management
Overview of processes, environmental aspects, and risks Get [...]
Product Management (PLM)
Product management, changes, revisions and BOMs Define a [...]
Project management (SCRUM)
Agile & SCRUM is flexible and efficient project management [...]
Qualification Management
Setting up basic qualifications for your company and employees. [...]
RMA Records
Effective management of your RMAs (Return Merchandise Authorizations). [...]
Role administration
Defining the roles of the company Define your [...]
Safety Issues and Records
Minimize the risk of work-related injuries. Register [...]
Service Management
Maintenance pays off. Servicing and maintenance of customers [...]
Supplier Complaints
Help your suppliers get better and minimize supplier complaints, [...]
SWOT Overview
Preparation of SWOT analysis Preparing a SWOT analysis [...]
Overview of your QMS in real-time.
The first thing you see when you log in to Wismatix QMS is your Dashboard. The dashboard gives you a full overview of the quality management system’s effectiveness through relevant key figures in real-time.
The dashboard’s key figures on the quality management system’s effectiveness include
- Customer complaints
- RMA cases
- Supplier complaints
- Improvement proposal
- Safety Issues
- Internal defects and deviations
FDA and ISO links
FDA (Food and Drug Administration) – eCFR (Electronic Code of Federal Regulations)
- CFR Title 21 Part 11 – ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
- CFR Title 21 Part 820 – QUALITY SYSTEM REGULATION
ISO (International Organization for Standardization)
- ISO 9000 family – Quality management
- ISO 13485:2016 / Medical devices – Quality management systems – Requirements for regulatory purposes
(FREE in a read-only version directly from ISO due to COVID-19) - ISO 14971:2019 / Medical devices — Application of risk management to medical devices
- ISO / IEC 62304:2006 / Medical device software — Software life cycle processes