Roadmap for Selecting a New QMS

Moving to a new Quality Management System (QMS) can significantly impact your company’s ability to maintain high standards of quality, ensure compliance, and drive continuous improvement. Whether you are upgrading your existing system or looking for something completely new, choosing the right QMS involves careful consideration of various factors to ensure it meets your specific needs.

Here are the key steps and considerations to guide you through the selection process:

Ensure you have full support from leadership to start this project.
Identify all stakeholders and their needs from the system.
Identify a small team of QA and IT personnel to lead the QMS search and comparison effort.
Search the web and talk with QA and SQA colleagues about what systems they use and whether they are satisfied.
Create a matrix so you can compare pricing, features, and functions across all systems in consideration.
If you are considering an Electronic QMS (eQMS), contact vendors to set-up demos and obtain pricing:

a. Prepare questions ahead of time based on your research and colleague feedback: i. Modules available, modules included, audit trails, system roles

ii. Integration options/API

iii. Features to fix current issues or sufficient configurability to change workflows

iv. Pricing of modules, licenses, data migration, and implementation

v. Typical implementation timing

vi. Customer service model

vii. Validation options

b. Record the demos, when allowed

c. Take notes

d. Request a “sand-box” version so you can try the QMS outside of the demo

e. Speak with references.

7. Share the team’s findings and recommendations with leadership and stakeholders to ensure all of their concerns have been addressed. If needed, schedule follow-up demos to answer specific questions.

Selecting a new QMS is a strategic decision that requires careful planning and consideration. A well-chosen QMS not only ensures compliance and product quality but also supports your organization’s long-term success