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Quality Management System

Quality Management System is a general term for a structured, systematic approach to a business and production processes with an emphasis on the customer, quality and safety.

In a quality management system, all aspects of the laboratory operation, including the organizational structure, processes, and procedures, need to be addressed to assure quality. There are many procedures and processes that are performed in the laboratory and each of these must be carried out correctly in order to assure accuracy and reliability of testing.An error in any part of the cycle can produce a poor laboratory result.A method of detecting errors at each phase of testing is needed if quality is to be assured.

ISO standards group laboratory processes into pre-examination, examination, and post-examination categories.Comparable terms in current laboratory use include: pre-analytic, analytic, and post-analytic processes; or pre-test, test, and post-test processes.

The entire set of operations that occur in testing is called the Path of Workflow.The Path of Workflow begins with the patient and ends in reporting and results interpretation.

The concept of the Path of Workflow is a key to the quality model or the quality management system, and must be considered when developing quality practices.For example, a sample that is damaged or altered as a result of improper collection or transport cannot provide a reliable result. A medical report that is delayed or lost, or poorly written, can negate all the effort of performing the test well.

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, and is fully compatible with ISO standards.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.


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 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.


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.


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.


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.


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.


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.


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.

· Environmental conditions- Control of environmental temperature and humidity.

· Containmentwhichseeks 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.


As the laboratory moves from intent to action in the development of a quality management system, the major organizational steps will be to assign responsibility for implementation, allocate resources, develop and distribute a quality manual, begin implementation, and monitor compliance with the quality policy and the quality management system requirements.

Successful implementation of a quality management system requires planning, management commitment, an understanding of the benefits, engaging staff at all levels, setting realistic time frames, and looking for ways to continually improve.

·Quality is not a science; it is a way of thinking.

·Time invested today will help gain quality results, professional and personal satisfaction, and peer recognition.

·Everyone in the laboratory is responsible for quality performance.

·Laboratory Leaders and managers must commit to meeting quality needs.

Laboratory personnel must follow all quality assurance procedures and adhere to requirements and standards.

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