ENSUR QMS Software
The primary purpose of a Quality Management System (QMS) is to ensure your company is meeting customer and regulatory requirements and providing consistent products or services throughout your organization. Managing the many moving parts and pieces of your QMS using manual methods such as Word documents, spreadsheets, email, and file shares is inefficient and difficult to track for regulatory compliance.
ENSUR is an easy-to-use, electronic QMS software that automates all your quality activities and enables you to link documents from different quality processes together for game changing visibility, traceability and control. When you centralize your quality documentation in one system, you can easily track all document changes, route for approval, update key stakeholders, conduct employee training and simplify audits.
Excellence in Quality Management Solutions
CAPA: Create corrective action and preventive action requests, perform root cause analysis, and link to other quality items within the system.
Training: Deliver training packages based around your employees’ job titles, define training requirements, manage rosters, test comprehension, and track results.
Change Control: Create and track Change Requests and Change Orders, route for review and approval, and automatically notify key stakeholders at each step of the process.
Equipment Management and Calibration: Create custom calibration forms where you can set standard tolerance values, automate email reminders, capture electronic signatures, view full audit trails, and quickly generate reports for audits.
Incidents and Complaints: Track incidents and complaints and link to CAPAs, work instructions, procedures, training events, and specifications stored within the system.
Non-conformances: Record and track non-conformances to ensure that issues, mistakes, and deviations from specifications are identified and corrected.
Out of Specification (OOS): Investigate out-of-specifications, identify the root causes, and ensure appropriate follow-up on the conclusions with trackable action items.
Deviations: Create and complete customizable deviation forms to automate the processes of documenting, investigating, and resolving deviations.
Adhering to ISO 9000 Standards for Quality Management
The ISO 9000 family of standards provide a model for improving the quality of your products and services and meeting your customers’ expectations. The ISO 9001 standards set the criteria for a quality management system.
The ENSUR QMS Software automates the procedures and activities required to adhere to the ISO Quality Management standards, including:
- Managing quality documentation and their workflows
- Employee training
- Periodic review of policies and procedures
- Document linking and BOMs
- Email notifications to stakeholders and customers
- Internal audits
- Incident tracking
- Nonconformances and CAPAs
Learn more about how ENSUR helps you comply with ISO Standards here:
ISO 9001 Document Management with ENSUR
Contact us today to learn more about how ENSUR can optimize your quality and compliance processes.
- What is Quality Management System?
- A quality management system is a collection of business functions that work to continuously improve your company’s quality, guarantee customer expectations are met, and ensure compliance.
- How does a QMS increase efficiency?
- Quality management software offers your company a seamless link between processes, documents, and policies that work in tandem with an automated quality workflow. These capabilities help your company work towards improved business processes and work instructions, making it possible for your employees to speed up their day-to-day activities without compromising on quality.
- What are the 4 main components of quality management?
- Quality management can be segmented into these four main components:
1) Quality planning
2) Quality control
3) Quality assurance
4) Quality improvement
- Quality management can be segmented into these four main components:
- How will a QMS help maintain ISO 9001 compliance?
- A QMS enables you to control, track, and report on quality activities related to ISO 9001; including Document Control, CAPAs, Complaints, Training, Nonconforming Testing and/or Calibration Work, Continuous Improvement and Audits.
