The term Quality Management System (QMS) refers to the management practices within organizations that support defined quality requirements for their customers. The term is frequently used in Manufacturing and Life Sciences industries to support quality standards such as ISO 9001 and applicable GxP practices (including GMP, GCP and GLP). Part 11 applies to electronic records and signatures within its scope, rather than to every quality activity.
Because a QMS is a collection of business tools and processes focused on consistently meeting customer requirements and enhancing their satisfaction, it is often supported and monitored with QMS Software.
Core Requirements of a QMS
Having clear and well-defined objectives for your quality program is the first step to building a quality culture. Common documentation includes a quality manual, procedures, work instructions and records. Choose the structure that fits the organization and applicable requirements; these are useful document types, not a universal four-tier requirement.
Quality Manual
A quality program can summarize its policies in a quality manual. A quality manual is a general overview of the policies that comprise the quality program and a highlight of the organization’s commitment to it.
A quality manual should identify approved content and how it is controlled. A controlled copy follows the organization’s distribution and update rules; an uncontrolled copy is not maintained under those rules. Printed copies can be controlled, and a draft is not authorized for operational use merely because it is electronic.
Procedures
Following the development of the quality manual (policy), organizations need to establish the procedures that each department will follow to ensure that level of quality. Managers and supervisors must be well-versed in these procedures in order to ensure adherence to the quality program and respond appropriately during an audit.
These procedures should cover the “whats and hows” of how each department will operate in order to adhere to the corporate policy (quality manual). Procedures are written by experts within the business and outline details of the quality program. Like the quality manual, both controlled and uncontrolled versions of procedures exist as procedures must be updated according to the evolution of your business – whether that is a change in IT infrastructure or the introduction of new products into the portfolio.
Work Instructions
Detailed task guidance is provided through work instructions. Work instructions consist of detailed assembly, production procedures, and test procedures.
Each department will have control over its own copies and revisions. When new versions are released, employees need to be made aware immediately and their outdated work instructions must be replaced with the up-to-date version as failure to do so may result in issues during an audit.
Quality Records
The final piece in the quality jigsaw, quality records refers to the forms, specifications, and documents filled out or referenced in procedures and work instructions to prove to external auditors that employees are following the procedures.
Why Use QMS Software?
As you’ve now seen, a Quality Management System is a resource-intensive effort requiring significant documentation, policies, procedures, as well as a systematic set of checks and balances. And as organizations continue to evolve, so should the QMS.
QMS software plays a crucial role in supporting an organization in creating the quality control program, and then keeping it under control, as well as supporting its evolution and providing traceability in the event of audits.
For a process change, define the request, affected procedures, review responsibilities and approval evidence. QMS software can support that workflow when configured for it. Verify retained information and needed reports before relying on them during an audit.
Other Considerations
Evaluate QMS software against the processes, controls and user tasks your organization needs. Cloud hosting is one delivery model; implementation effort, cost and scalability depend on the service and configuration.
Identify the functions your quality program needs, such as document control, corrective action, training and audit management. Check their scope, configuration and assurance requirements. When evaluating a templated QMS package, confirm current availability and included services with the supplier. Templates do not establish deployment time, total cost or fitness for the organization’s intended use.
As requirements change, review how service updates affect configured quality processes. Confirm the supplier’s current release and change-notification practices, and assess updates against intended use and risk.
Closing Thoughts
A quality management system combines objectives, responsibilities, processes and evidence. Manuals, procedures, work instructions and records can organize that evidence, but their structure should fit the organization. Software supports the program; budget for configuration, training and assurance rather than assuming a short return on investment.
If you’d like to learn more about QMS software solutions, we recommend taking a look at the following resources:
Frequently asked questions
How do quality procedures differ from work instructions?
Quality procedures describe how a process operates, including responsibilities and controls. Work instructions explain the detailed steps for a particular task. Organizations can combine or separate them according to complexity and user needs; the important point is that employees can find the approved instructions needed for their work.
What is the difference between a quality document and a quality record?
A quality document tells people what to do, while a quality record preserves evidence of what was done. An approved inspection procedure is a document; the completed inspection result is a record. Their control needs differ because a procedure can be revised, while the evidence of a completed activity must remain traceable.
Is buying QMS software the same as implementing a QMS?
Buying QMS software is not the same as implementing a quality management system. A QMS needs defined objectives, responsibilities, processes and improvement activities. Software can organize documents and route work, but the organization must decide how those controls operate and evaluate whether they meet its quality needs.
