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The Quality Management System


Overview of the quality management system model


When all of the laboratory procedures and processes are organized into an understandable and workable structure, the opportunity to ensure that all are appropriately managed is increased.  The quality model used here organizes all of the laboratory activities into twelve quality system essentials.  These quality system essentials are a set of coordinated activities that serve as building blocks for quality management.  Each must be addressed if overall laboratory quality improvement is to be achieved.  This quality management system model was developed by CLSI[1], and is fully compatible with ISO standards.[2],[3]

Assuring accuracy and reliability throughout the Path of Workflow depends on good management of all of the quality essentials. 


In order to have a functioning quality management system, the structure and management of the laboratory must be organized so that quality policies can be established and implemented.  There must be a strong, supporting organizational structuremanagement commitment is crucial; and there must be a mechanism for implementation and monitoring.


The most important laboratory resource is a competent, motivated staff. The quality management system addresses many elements of personnel management and oversight, and reminds us of the importance of encouragement and motivation.


Many kinds of equipment are used in the laboratory, and each piece of equipment must be functioning properly. Choosing the right equipment, installing it correctly, assuring that new equipment works properly, and having a system for maintenance are all part of the equipment management program in a quality management system.



Purchasing and Inventory


The management of reagents and supplies in the laboratory is often a challenging task.  However, proper management of purchasing and inventory can produce cost savings in addition to assuring supplies and reagents are available when needed.  The procedures that are a part of management of purchasing and inventory are designed to assure that all reagents and supplies are of good quality, and that they are used and stored in a manner that preserves integrity and reliability.


Process Control

Process Control is comprised of several factors that are important in assuring the quality of the laboratory testing processes. These factors include quality control for testing, appropriate management of the sample, including collection and handling, and method verification and validation.  

The elements of process control are very familiar to laboratorians; quality control was one of the first quality practices to be used in the laboratory and continues to play a vital role in assuring accuracy of testing.


Information Management

The product of the laboratory is information, primarily in the form of test reporting.  Information (data) needs to be carefully managed to assure accuracy and confidentiality, as well as accessibility to the laboratory staff and to the health care providers.  Information may be managed and conveyed with either paper systems or with computers; both will be discussed in the section on Information Management.


Documents and Records

Many of the twelve quality system essentials overlap each other.  A good example is the close relationship between Documents and Records, and Information Management. Documents are needed in the laboratory to inform how to do things, and laboratories always have many documents.  Records must be meticulously maintained, so as to be accurate and accessible.


Occurrence Management

An “occurrence” is an error or an event that should not have happened.  A system is needed to detect these problems or occurrences, to handle them properly, and to learn from mistakes and take action so that they do not happen again.



The process of assessment is a tool for examining laboratory performance and comparing it to standards or benchmarks, or the performance of other laboratories. Assessment may be internal, or performed within the laboratory using its own staff, or it may be external, conducted by a group or agency outside the laboratory. 
Laboratory quality standards are an important part of the assessment process, serving as benchmarks for the laboratory.




Process Improvement

The primary goal in a quality management system is continuous improvement of the laboratory processes, and this must be done in a systematic manner.  There are a number of tools that are useful for process improvement.


Customer Service

The concept of customer service has often been overlooked in laboratory practice.  However, it is important to note that the laboratory is a service organization; therefore, it is essential that clients of the laboratory receive what they need.  The laboratory should understand who the customers are, and should assess their needs and use customer feedback for making improvements.


Facilities and Safety

Many factors must be a part of the quality management of facilities and safety. These include:

  • Securitywhich is the process of preventing unwanted risks and hazards from entering the laboratory space.
  • Containmentwhich seeks to minimize risks and prevent hazards from leaving the laboratory space and causing harm to the community.
  • Safetywhich includes policies and procedures to prevent harm to workers, visitors, and the community.
  • Ergonomicswhich addresses facility and equipment adaptation to allow safe and healthy working conditions at the laboratory site.


Quality management system model

In the quality management system model all twelve QSEs must be addressed to assure accurate, reliable, and timely laboratory results, and to have quality throughout the laboratory operations.  It is important to note that the 12 QSEs may be implemented in the order that best suits the laboratory. Approaches to implementation will vary with the local situation.

Laboratories not implementing a good quality management system are guaranteed that there will be many errors and problems occurring that may go undetected. Implementing such a quality management system may not guarantee an error-free laboratory, but it does yield a high quality laboratory that detects errors and prevents them from recurring.




  International Laboratory Standards


Need for international laboratory standards

A part of quality management is assessment, measuring performance against a standard or benchmark. The new concept of quality management required that standards be set, and again industry has been in the lead.   


Important laboratory standards organizations








Using a set of standards established by the U.S. military for the manufacture and production of equipment, the International Organization for Standardization established standards for industrial manufacturing; we know these standards as ISO.

The ISO 9000 documents provide guidance for quality in manufacturing and service industries, and can be broadly applied to many other kinds of organizations. ISO 9001:2000 addresses general quality management system requirements and apply to laboratories. There are two ISO standards that are specific to laboratories:

  • ISO 15189:2007. Medical laboratories–Particular requirements for quality and competence. Geneva: International Organization for Standardization.
  • ISO/IEC 17025:2005. General requirements for the competence of testing and calibration laboratories. Geneva: International Organization for Standardization.

Another important international standards organization for laboratories is the Clinical and Laboratory Standards Institute, or CLSI, formerly known as the National Committee for Clinical Laboratory Standards (NCCLS). CLSI uses a consensus process involving many stakeholders for developing standards. CLSI developed the quality management system model used in these training materials.  This model is based on twelve quality system essentials (QSE), and is fully compatible with ISO laboratory standards.

CLSI has two documents that are very important in the clinical laboratory.

  • CLSI/NCCLS. A Quality Management System Model for Health Care; Approved Guideline—Second Edition. CLSI/NCCLS document HS1-A2. Wayne, PA: NCCLS; 2004.
  • CLSI/NCCLS. Application of a Quality Management System Model for Laboratory Services; Approved Guideline—Third Edition. CLSI/NCCLS document GP26-A3. Wayne, PA: NCCLS; 2004.



[1] CLSI/NCCLS. A Quality Management System Model for Health Care; Approved Guideline—Second Edition. CLSI/NCCLS document HS1-A2. Wayne, PA: NCCLS; 2004.

[2] ISO 15189:2007. Medical laboratories–Particular requirements for quality and competence. Geneva: International Organization for Standardization.

[3] ISO 9001:2000. Quality management systems–requirements. Geneva: International Organization for Standardization.

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