5 Essential Elements of a QMS for Medical Devices

Are you planning on investing in a Quality Management System (eQMS) for your medical device company?

Without careful consideration and planning, a lot can go wrong. You might even end up overspending on software that doesn’t meet the unique requirements of your business or industry.

During early-stage growth, investing in ineffective software solutions is a major waste of time, energy, and capital. That's why you need to find an eQMS that scales with your organization as it grows.

As an industry-leading eQMS provider, we’ve helped hundreds of medical device organizations to find the right eQMS. As you begin your search for the growth-oriented QMS solution that works best for your medical device organization, here are some elements you'll need to prioritize.

5 Elements of a Great QMS for Medical Devices

An eQMS is a category of enterprise technology designed to support the implementation of a formal system for quality management by managing documents and processes throughout the entire enterprise.

Organizations in highly regulated industries must adopt eQMS solutions to simplify compliance, risk management, and data handling. In recent years, organizations have deployed cloud-based quality management systems, which consist of integrated modules designed to work harmoniously with existing enterprise technology stacks. Here are the top elements of a QMS for medical devices that your organization should search for in a solutions partner.

1. Quality Objectives

The best core elements of quality management systems are built around quality objectives. Your eQMS needs to be able to fulfill your quality goals.

Good quality objectives for your organization could include:

• Onboarding staff and improving quality culture by 85%
• Achieving regulatory compliance in less than three months
• Completing your software validation in less than one month

When looking to invest in eQMS, an organization should decide what its quality objectives are. These objectives will provide a benchmark for potential software solutions that will fit your quality requirements.

2. Quality Manual

An employee manual is crucial to providing staff instruction on what a company expects of them. When you outline your quality standards, you set the expectation for your employees. They are then able to hold themselves accountable to your company’s high quality standards.

Many organizations are switching to computerized training systems and manuals to onboard their new employees. It saves time and money when it comes to training dozens of employees at once.

The software you choose to assist you in training employees should come with instructions, guidance, and supporting documents to orient everyone in the organization. Our support teams are always available to help your organization through the implementation, validation, and adoption of your new eQMS system.

3. Data Management

A successful eQMS framework must have data quality and availability. These two details are what drive preventative quality control activities and continuous improvements to a corporation.

Your organization will need to continually make corrections and improvements to create a meaningful data management system. The types of data they collect from themselves, and outside parties need to be defined.

Your data management policy should address:

• The source the data was collected from
• Which department will be responsible for the data
• The type of data
• How the data was gathered
• What kind of analysis will be conducted with the data
• Where the data will be stored
• How the organization will dispose of the data when it is no longer needed

With the data management policy also comes everything required for an effective QMS. Different organizations need different things. However, there are a few sources of data all companies need for an agile QMS:

• Product and Process Monitoring
• Supplier Performance
• Non-Conformance
• Customer Satisfaction
• Trends
• Preventive or Corrective Action

4. Organizational Structure and Processes

Hiring new personnel is a stressful process for both an organization and the new employee. A QMS details the exact expectations the organization has for new hires, making the onboarding process smoother.

A clear, visual guide helps outline the job's structure and the new hire's responsibilities. Clear documentation that describes the employee's job or a flowchart showing a workflow path will give a clearer picture of what an organization expects from the new employee. The guide should include everything a new employee will be using in their workspace or department.

Let’s look at a few examples:

Employee A: Working with Chemicals

Someone working with chemicals will have to know about the guidelines for personal protective equipment use. They need an information system to document who they shipped to or record how many chemicals they disposed of in a shift.

This same employee will need an outline of the process controls to properly handle the mixing systems and assess whether the batch of chemicals is up to standard. The company needs to provide a chart with acceptable ranges for testing chemicals to keep quality up to their standards.

Employee B: Purchasing Supplies

An employee working in the same department may not handle the chemicals but instead is in charge of purchasing supplies. You don’t want to have too many supplies expire and go to waste due to over-ordering.

You’ll need an inventory system that keeps up with how many supplies you have on hand and how much will be required to cover future orders. The person tracking the supplies will see how much they need to order in real-time to keep company production uninterrupted by supply shortages.

Signage to Direct Both Employees

Both of these employees are working in the same facility and will need clear boundaries of where they can and cannot go. The employee working directly with the finished chemicals needs certifications for the job while the inventory clerk doesn't need any.

Many states have guidelines on where uncertified employees are allowed to go. A visual map or signs on doors and windows as reminders can be useful and may even be mandatory.

5. Continuous Improvement

Everyone is responsible for continuous improvement in quality management. But those in leadership positions have a vital role. They set themselves as the standard, and when they take quality management seriously, it helps everyone see that accountability leads to maximum effectiveness in a quality-driven culture.

There is always room for improvement in any organization. An eQMS should push updates regularly to everyone in the enterprise so that everyone is always on the same page.

Learning new policies and adapting to them is crucial to an organization's quality management success. You need a system to document these improvements and make sure things are progressing as they should.

Good Documentation Addresses:

• Does the individual follow risk-based thinking?
• Is the individual innovative when it comes to keeping up with the quality standards set by the company?
• Are the safety measures in place good enough, or do they need to be updated?
• Does the employee follow the rules and policies to remain in compliance?
• At what pace is the employee improving? Are they slowly picking up on the new updates and need help? Is the individual developing at a faster pace than others?

This type of quality planning procedure will assess the person for corrective action in areas they need improvement.

When you track the areas where the employee is having trouble, you can determine if a retraining program could help. This process is more favorable than having the individual waste time going through the whole program again if there are only two or three things they don’t quite understand.

Finding the Right QMS for Your Organization

When it comes to finding the right QMS for your organization, you need to choose a system that meets the unique demands of your enterprise and industry.

With Qualio, you’ll have everything you need to ensure proper documentation of your medical devices’ lifecycle. That way, your company can ensure compliance with federal and national guidelines and raise the bar on quality standards.

Raising the bar on quality gives your company a competitive edge. When you download your free copy of our guide, 7 Things You Can Do Now to Leverage Medical Device Quality as a Competitive Advantage, you’ll learn:

• How you can improve review processes;
• How you can establish and use feedback loops successfully;
• How to guarantee that your team is appropriately trained;
• How to identify where quality standards are not being met; and
• How you can ensure your documents are in order.

Get your free guide now, and gain a quality advantage over your competitors.