**2. International standards for laboratories**

Requirements from ISO 9001 for the quality management system implementation and certification are the most widely international standards used by laboratories.

ISO 9000 documents provide guidelines for manufacturing and service industry quality and can be applied to many kinds of organizations. ISO 9001 addresses the general requirements for integration of a quality management system [1] in companies' activities from different productive sectors, including laboratories independently of its size and preserving the organization characteristics. ISO 9001 is characterized by a process-based approach, hence establishing common processes to any activity or organization, product development, or service delivery (e.g., documentation control, equipment maintenance, traceability, or staff training). Specifically, ISO 9001:2015 indicates the issues whose records must be kept:


In addition, there are two ISO standards especially focused on laboratory accreditation that will be detailed below:


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, voluntary norms can become enforced in some countries and in some productive sectors.

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 is easy to implement because of its alignment with a variety of laboratory and accreditation standards, which helps requirement compliance in laboratories [3].

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. The main objectives of GLPs are:

• Resources optimization

The QMS plans, controls, shares, and improves the elements that influence the fulfillment of

An alternative definition of a QMS is through the meaning of each word separately, according

• Quality: degree in which a set of inherent characteristics of an object (product, service, process, person, resource, etc.) meet the requirements (established need or expectation,

We can conclude from these three sentences that the business, planning, and control activities

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 nec-

Requirements from ISO 9001 for the quality management system implementation and certifi-

ISO 9000 documents provide guidelines for manufacturing and service industry quality and can be applied to many kinds of organizations. ISO 9001 addresses the general requirements for integration of a quality management system [1] in companies' activities from different productive sectors, including laboratories independently of its size and preserving the organization characteristics. ISO 9001 is characterized by a process-based approach, hence establishing common processes to any activity or organization, product development, or service delivery (e.g., documentation control, equipment maintenance, traceability, or staff training).

to the ISO 9000:2015 quality management system—fundamentals and vocabulary:

• Management: coordinated activities to direct and control an organization.

performed on a set of elements to achieve quality represent a QMS.

essary quality management system that controls, detects, and tracks them.

cation are the most widely international standards used by laboratories.

Specifically, ISO 9001:2015 indicates the issues whose records must be kept:

user requirements and satisfaction as well [2].

22 Quality Control in Laboratory

generally implicit or mandatory).

• System: a set of interrelated or interacting elements.

**2. International standards for laboratories**

• Quality management system and its processes

• Monitoring and measurement of resources

• Nonconformity and corrective actions

• Monitoring, measurement, analysis, and evaluation

• Quality objectives

• Competition

• Internal audit

• Review of management


However, GLPs is not focused on the continuous improvement.

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 appropriate to the intended use [4].

Finally, there are many other standards for laboratories that are conducted only to specific laboratory areas, analysis, or programs and zones such as the standards developed by the World Health Organization (WHO), and some countries have even provided national quality standards for laboratories that are not the scope of this review.

demonstrate in an objective way and accredit that they have the necessary quality and technical competence, with a correct functioning of the laboratory. In an ISO 15189 laboratory, their processes are controlled and satisfy the technical requirements to ensure clinical diagnosis information, establishing a confidence framework between society, patients, doctors, and the laboratory service [6]. This standard is a good option for high-quality clinical laboratories and

Quality Management Systems for Laboratories and External Quality Assurance Programs

http://dx.doi.org/10.5772/intechopen.73052

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Comparing ISO 9001, ISO/IEC 17025, and ISO 15189 (**Table 1**), ISO/IEC 17025 requires that "technical requirement" processes are documented. In other words, those factors that contribute to the accuracy, reliability, and validity of tests and calibrations, such as the staff, environmental conditions, equipment, or samples, must be recorded. These requirements related to human resource management (specifically in terms of qualification and competence or infrastructure (to guarantee test conditions) are due to test and calibration specificity and

ISO 15189 extends also its scope to analytical, pre-analytical, and post-analytical phases to

4.4 Review of requests, tenders, and contracts

calibrations

supplies

work

4.5 Subcontracting of tests and

4.6 Purchasing services and

4.9 Control of nonconforming testing and/or calibration

4.1 Organization 4.1 Organization and

4.2 Management system 4.2 Management system

4.3 Document control 4.3 Document control

4.7 Service to the customer 4.7 Advisory services 4.8 Complaints 4.8 Resolution of claims

4.10 Improvement 4.10 Corrective action

responsibility of management

4.4 Contracts for the provision

4.5 Analyses carried out by subcontractor laboratories

4.6 External services and supplies

4.9 Identification and control of nonconformities

of services

establish interaction mechanisms between patients, medical staff, and the laboratory.

2 Normative references 2 Normative references 2 Normative references 3 Terms and definitions 3 Terms and definitions 3 Terms and definitions 4 Context of the organizations 4 Management requirements 4 Management requirements

**ISO 9001 ISO/IEC 17025 ISO 15189** Foreword Foreword Foreword 0 Introduction 0 Introduction 0 Introduction 1 Scope 1 Scope 1 Scope

services [7].

sensitivity.

4.1 Understanding the organization

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the quality management system

4.4 Quality management system and

and its context

its processes
