**1. Introduction**

A quality management system (QMS) is formed by a series of coordinated activities that are carried out on a set of elements to achieve the quality of the products or services offered to the customer or user. In the case of a laboratory, the accuracy, reliability, and timeliness of the analytical results reported define its quality, and all aspects of analytical operations should be controlled [1].

© 2016 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. © 2018 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

The QMS plans, controls, shares, and improves the elements that influence the fulfillment of user requirements and satisfaction as well [2].

In addition, there are two ISO standards especially focused on laboratory accreditation that

Quality Management Systems for Laboratories and External Quality Assurance Programs

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• ISO/IEC 17025:2005. General requirements for the competence of testing and calibration

• ISO 15189:2012. Medical laboratories—requirements for quality and competence (Geneva:

Accreditation is an additional level in quality than certification. Anyway, ISO standards are voluntary norms at an international level and were created in order to standardize different activities to achieve high-quality products and services. However, accreditation is already a requirement in different government agencies for laboratory registration. Therefore, volun-

Other important international standards for laboratories have been developed and provided by the Clinical and Laboratory Standards Institute (CLSI) by means of a consensus process from many stakeholders including the global laboratory community. These CLSI consensus-based medical laboratory standards are addressed to continually improve the testing quality, safety, and efficacy promoting medical care excellence. The quality management system model generated by CLSI is based on 12 key elements and is fully compatible with ISO standards for laboratories [1]. The CLSI has published two prominent reference documents for the clinical laboratory:

• GP26-A4 Application of a Quality Management System Model for Laboratory Services

GP26-A4 is easy to implement because of its alignment with a variety of laboratory and

Good laboratory practices (GLPs) represent a quality management system related with organizational processes and normalized conditions, under which nonclinical health and environmental safety studies are planned, performed, controlled, recorded, archived, and informed.

On the other hand, good manufacturing practices (GMPs) specifically control the production variables that affect the final quality of medications according to the quality standards appro-

tary norms can become enforced in some countries and in some productive sectors.

• A Quality Management System Model for Health Care (Document HS1-A2)

accreditation standards, which helps requirement compliance in laboratories [3].

• People, environment, and experimentation animals' protection

• To guarantee the quality and reproducibility of study results

However, GLPs is not focused on the continuous improvement.

• Establishment of standardized operating methods

laboratories (Geneva: International Organization for Standardization)

International Organization for Standardization)

will be detailed below:

(fourth edition)

The main objectives of GLPs are:

• Resources optimization

priate to the intended use [4].

An alternative definition of a QMS is through the meaning of each word separately, according to the ISO 9000:2015 quality management system—fundamentals and vocabulary:


We can conclude from these three sentences that the business, planning, and control activities performed on a set of elements to achieve quality represent a QMS.

Many processes are performed in laboratories to guarantee the accuracy, reliability, and traceability of the results, avoiding that any error affects its users. All those processes make a necessary quality management system that controls, detects, and tracks them.
