Implementing a quality management system (QMS) is a complex process with many integrated parts. Document control is one of the major challenges of any quality management system. Manual systems are time consuming and labor intensive. Quality management software can play an important role by automating the system to make it more accessible and user-friendly.

Design and Formatting

QMS software can guide a company through the process of designing and implementing a quality management system to achieve ISO 9001:2008 certification or any of the industry-specific quality management systems. Industry standards, regulations and best practices are integrated into the software to guide the user through the process to ensure compliance with requirements for certification. QMS software can connect the many processes within a system and provide a clear audit trail.

Communicate and Connect

Quality system software uses an integrated system to automate, store and give access to written documentation and interactive processes such as CAPA and internal audits. It connects every department through the company’s computer system or a web-based system. This makes communication fast and easy, eliminates the need for paper documents and cuts down the time to deliver, review and approve documents.

Single Site Storage

QMS software provides storage of all quality management system documentation in a single server location. Users can access documents and complete processes without paging through manuals, binders or paper files in multiple locations. Everything is accessible with a secure login and password.

Corrective and Preventive Action

QMS software can enable teams to share, store and access information for the Corrective and Preventive Action (CAPA) process from the initial investigation phase to the final corrective action. Team members in remote locations can access documents, enter data and make changes from any location. Some software systems have the ability to auto-populate related forms with data, eliminating the need for repetitive data entry, reducing errors and speeding up the process.

Change Control

No business stays the same. A quality management system has to be able to handle changes due to product or service revisions, quality process improvements, reaction to customer feedback and changes in regulations or compliance. QMS software systems streamline the whole change process to implement changes for a fast turnaround. Operators can access revised documents through the software system to ensure work is done with the latest information.

Training Management

QMS software can track employee quality and process training, schedule classes, record exam scores and produce training report documentation. The software can be used for course registration, sign-off verification of course attendance, and reschedule classes for employees who miss required training. It can send automatic reminders to participants and collect feedback after course completion. Some QMS software can be used for online on-demand training to meet the needs of employees on different shifts at work or after work hours.

Quality System Audits

The QMS software can be used to store audit check sheets and audit results. It can produce reports, document non-conformances and produce corrective and preventive action documentation. Teams can use the audit software to input audit data and review reports.

There are many types of QMS software packages available, and some can be customized to company specifications. They can automate as much or as little of the QMS system as needed.