Quality Systems

We build the bridge to quality management systems.

Look at your organization. Where are the gaps that cause interruptions, delays, downtime, and frustration—for you, your team, your vendors, and your customers?

 

 

 

 

Qualitas brings quality to you.

  • ISO 9001
  • ISO 13485
  • CFR
  • MDR
  • MDSAP

 

Objectivity.

When you engage Qualitas, you gain the services of professionals who can untangle a system that is overly cumbersome. We bring an objective viewpoint that isn’t tainted by “the way we’ve always done it.”

We conduct a careful assessment of key processes and participants to determine obstacles to developing and maintaining a quality management system. Then we apply a risk-based approach to get a clear picture of our starting point.

What is the desired result?

  • Quality certification
  • Sustainable processes that lead to consistent quality
  • Shared vision and goals
  • Streamlined training

Where is the possibility for something to go wrong?

  • Misinterpretation of a compliance standard, rule, process, or goal
  • Lack of communication between stakeholders
  • Insufficient quality data
  • Inconsistency
  • Assumptions

What creates this gap?

  • Leadership
  • Team members
  • Processes

 

Strategic Thinking.

Once we’ve dissected your processes, we restructure the systems, one at a time. We work through each step of each process, asking ourselves, “Is there room for error if we do it this way?”

You need to create quality before you can manage it.

From the process for properly handling, sterilizing, or processing a component to managing a customer inquiry, we dissect, examine, and explore the most efficient, effective path from Point A to Point B.

Qualitas associates are skilled problem-solvers. We find gaps that others miss. We know what works and what doesn’t. We apply our experience, but realize that your business is unique, so it deserves an individual approach.

Structure.

When the processes are designed and tested, we have a framework. Your Qualitas team uses this blueprint to develop the documentation that will drive the Quality Management System for your company. We work with you to establish key performance indicators to measure the success of each process.

Every process is detailed, every step clearly defined.

Then, we test again, making sure everyone in your organization can follow the direction as outlined. Our goal is flawless execution.

 

Training and Support

Total quality only occurs with total buy-in. From the leadership to the person who answers the phone, every person must embrace this commitment.

Your Qualitas team trains everyone in your organization on the purpose of the Quality Management System and the processes they need to carry out the company-wide initiative.

Where do we start?

A Quality Management System touches every corner of your business. It doesn’t happen overnight, but with our knowledge, insight, and guidance, you will achieve excellence. We can target specific projects, get you up and running in one area and then move to another. You decide how you want to engage us.

But it starts here.

Contact Qualitas.