Feb 18, 2021 Robert Fenton

The 12 Essentials of Quality Management in Laboratory Environments

The good news? Laboratory error rates have been on the decline for several decades; from 0.47% in 1977 to 0.33% in 2007.

The bad news? The error rate isn't 0.0%

While those numbers may seem small, they won't matter if your laboratory makes a potentially catastrophic mistake like mixing up a specimen and wrongly identifying a cancer patient.

Obviously, quality should be a high priority for your company. With a firm understanding of the 12 essentials of quality management in laboratory environments, you'll be able to confidently lead your medical services team to new levels of excellence and avoid potentially life-threatening mistakes.

Quality Management in Laboratory Environments: The 12 Essentials

Quality management has been around for about 800 years. The concepts first used in medieval European guilds have been solidified and refined over the centuries into what is now known as quality management systems. The quality management system (QMS) model has been adapted to the medical laboratory environment resulting in a dozen essentials that form the framework for quality. The model for the following 12 essentials is from the Clinical and Laboratory Standards Institute (CLSI) and ISO 15189.


Image by WHO via Creative Commons.

1. Organization

The laboratory needs to be organized around a formal quality management system that supports consistent procedures. The management team and quality unit play an integral role in a quality-driven culture, along with structures for monitoring ongoing quality.

2. Personnel

Capable staff members are the single most important asset to a laboratory. Training, motivation, and engagement are key parts of the quality management system.

3. Equipment

Every piece of equipment used in the laboratory must be maintained to operate safely.

4. Purchasing and Inventory

Properly managing the supply chain is critical to ensure that raw inputs and other supplies are consistently high-quality. Inventory activities should verify that materials and supplies are stored in a way that protects integrity. New call-to-action

5. Process Control

Process control encompasses QC processes for testing, including:

  • Collection
  • Handling
  • Method Verification
  • Process Validation

6. Information Management

The laboratory produces many forms of information, including QC test results, maintenance reports, and other data. This data needs to be managed in a way that ensures all information is accurate, secure, confidential, and accessible to individuals with the right privileges, such as lab managers and leadership.

7. Documents and Records

Documents are a similar concept to information management, and there’s a significant overlap between these categories. One of the most essential lab documents is standard operating procedures (SOPs) to create a standard for each process. Documents need to be available at the point of work, maintained, accurate, and secure.

8. Occurrence Management

An “occurrence” is any error or non-conformance. A QMS software can help you detect these issues and facilitate investigations to discover the root cause and prevent reoccurrence.

9. Assessment

Assessment involves comparing laboratory performance to internal standards for quality or external data sets, such as industry benchmarks. Assessments include the activities of lab or QC managers, internal auditors, or external inspectors.

10. Process Improvement

A quality management system should support continuous process improvement of laboratory processes. Components of the QMS which support improvement can include QC and CAPA (occurrence management).

RELATED READING: 12 Questions to Ask Before Buying an eQMS

11. Customer Service

Customer service is the goal of a laboratory. A laboratory’s QMS should support operations that consistently provide a positive customer experience through the production of consistently high-quality products or other missions. The laboratory needs to understand the customers and their needs and use customer feedback for improvement.

12. Facilities and Safety

Laboratories need a comprehensive set of procedures and standards to ensure a safe, secure, and clean environment. This includes physically securing the lab, containment procedures for hazards, worker safety, and ergonomics.

The Role of Software in Laboratory Quality Management

ISO and the CLSI define a quality management system as “coordinated activities to direct and control an organization with regards to quality.”

A lab QMS needs all 12 of the essentials to support consistently high-quality operations, and systems to ensure these elements are working in sync. If your QMS is missing several elements, such as document control or physical security, the entire system can easily crumble. Similarly, if your QMS hits all the basics but you can’t coordinate between the essentials by understanding the bigger picture of quality trends or root causes, you’re at risk of error.

Software isn’t strictly required by ISO standards or regulatory agencies, but it makes creating and maintaining a QMS much simpler. The right software can help you avoid having to reinvent the wheel by building a QMS from the ground up. Maintaining coordinated quality processes with paper systems can lead to poor visibility and human error.

Qualio is the first cloud-based QMS for life sciences laboratories, built specifically in accordance with ISO and FDA best practices. It includes all the essentials to help fast-growing lab startups and scale-ups create a solid quality baseline. Learn more about our solution here. New call-to-action


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Published by Robert Fenton February 18, 2021