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Lexi Sharkov11/14/233 min read

eQMS 101: Creating a Quality Management System foundation

In the life sciences industry, “quality” isn’t just a buzzword, it’s the backbone of compliance and safety. From pharmaceutical giants to nimble biotech startups, quality – and therefore, an efficient, effective quality management system – isn’t optional. 

But what does an effective quality management system look like? Let’s start with the basics. 

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What is a Quality Management System?

At its core, a quality management system, or QMS, is any formalized system that documents the processes and procedures for meeting quality goals and regulations. A quality management system can be organized manually with paper files, digitized with spreadsheets like Excel, or streamlined with dedicated platforms like an eQMS. No matter what form it takes, it needs to allow you to set, measure, and document quality practices that meet both customer safety and general regulatory requirements.

What are the key components of a Quality Management System?

The processes and policies within a QMS will look different for everyone, but the most effective quality management systems all have a few key elements in common:

  • Vision: These are the policies and goals. The "why" of quality at your organization. What do you hope to achieve in terms of quality? What standards do you want to set? Focus on clear, concise policies and actionable objectives.
  • Roadmap: Once goals are set, your "roadmap", or your quality manual, will be your foundational guide. It should translate your objectives into clear steps and ensure that every department knows its part.
  • Process and Procedure Management: At its core, a QMS is a set of established, controlled procedures that mitigate risk and prioritize quality. Once they're created, you need processes to implement, monitor, and document them.
  • Performance Metrics: Tracking the performance of your procedures and policies gives you a clear view of how well the system is working. A QMS should also have a feedback loop to drive continuous improvement for quality across the organization.
  • Training & Competency: A QMS is only as effective as the people functioning within it. Training programs are required to keep staff updated, trained, and competent on all procedures and policies.

How Do You Start Building a Quality Management System?

Whether you're starting from scratch or refining an existing quality process, these are the first steps to take to make sure your quality management system is set up for success:

  1. Conduct a gap assessment: Start by analyzing your current processes and uncover where quality is falling short. Where are you now vs. where do you need to be in terms of quality? Create a plan to fill in the missing pieces.
  2. Get stakeholder buy-in: A QMS can't be siloed in one department. Creating a culture of quality starts by getting leaders across the organization on board with the plan from day one. Make them champions of quality.
  3. Define policies & objectives: Draft a quality policy that resonates with the company's vision. Set measurable and actionable objectives and establish corrective and preventive action processes. 
  4. Choose a tool: Quality management tools can be as basic as pen and paper or as comprehensive as an electronic quality management system. It's important to pick a tool that can grow with your team and adapt with minimal headache as your processes change. (Spoiler alert: An eQMS will likely be the best choice. We explain why here.)
  5. Train your team: Regular training sessions, workshops, and certifications should be a standard part of a quality management system.
  6. Implement, Monitor, Refine: Roll out your QMS, but don't set it in stone. Regularly monitor its effectiveness, gather feedback, and make improvements. Establishing a cadence for conducting regular internal audits is a key part of any QMS. 

The larger your organization grows and/or the more complex your quality requirements, the more difficult it is to keep your quality management system organized, functional, and effective – which is exactly why many companies are undergoing a digital transformation within their quality departments. 

To learn more about what this shift can mean for you and your quality team, download our newest eBook, eQMS 101, and brush up on best practices shared by quality leaders in the life sciences space.