**3.2. ISO 15189: competence of clinical laboratories**

ISO 15189 includes all the requirements that medical laboratories in charge of human biological sample analysis must comply to guarantee that:


In the same way that ISO 17025, this standard does not certify but accredits specific testing techniques in function of the laboratory needs. Achieving ISO 15189, clinical laboratories 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 services [7].

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

As it was mentioned before, unlike ISO 9001 certification, the following standards accredit

ISO 17025 establishes a set of requirements that must be met by entities performing tests and/or calibrations, including sampling. This standard is used by laboratories that want to develop and implement a quality management system for their services and to achieve laboratory accreditation. It establishes a model for the evaluation of the technical competence of

ISO 17025 applies to all laboratories, regardless of the number of employees or the extent of the scope of testing or calibration activities and either for other organizations or individuals or their own organization. It covers tests based on standardized, non-standardized, or

• Management requirements: very similar to ISO 9001, they are related with the quality man-

• Technical requirements: aspects that influence directly on the results of laboratory testing

Benefits of operating within a QMS like this are recognized by analysts thanks to the revenue

ISO 15189 includes all the requirements that medical laboratories in charge of human biologi-

In the same way that ISO 17025, this standard does not certify but accredits specific testing techniques in function of the laboratory needs. Achieving ISO 15189, clinical laboratories

and are more often used by laboratories that wish or need to prove their proficiency.

**3.1. ISO/IEC 17025: competence of testing and calibration laboratories**

standards for laboratories that are not the scope of this review.

**3. ISO standards applicable to laboratories**

the laboratory through a third-party audit.

ISO 17025 is formed by two groups of requirements:

**3.2. ISO 15189: competence of clinical laboratories**

cal sample analysis must comply to guarantee that:

• They have the capacity to produce technically valid results.

• They have a quality management system.

• They are technically competent.

laboratory-developed methods.

24 Quality Control in Laboratory

agement of the laboratory.

and calibration activities.

increasing of laboratory business [5].

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 sensitivity.


ISO 15189 extends also its scope to analytical, pre-analytical, and post-analytical phases to establish interaction mechanisms between patients, medical staff, and the laboratory.


On the other hand, the choice between certification (ISO 9001) and accreditation (ISO 17025 standard applicable to testing or calibration laboratories or ISO 15189 when it is a clinical laboratory) will depend on the requirements from current or potential customers, regulatory boards, or the expected growth and development of the laboratory [8]. **Figure 1** shows the

Annex A Nominal cross-references

Quality Management Systems for Laboratories and External Quality Assurance Programs

Annex A Correlation with ISO 9001:2008 and ISO/IEC 17025:2005

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

27

Annex B Comparison of ISO 15189:2007 and ISO 15189:2012

to ISO 9001:2000

specific fields

Bibliography Bibliography Bibliography

**Table 1.** Structure and items from the ISO 9001, ISO/IEC 17025, and ISO 15189 standards.

Annex B Guidelines for establishing applications for

When customers need international recognition of their results or the laboratory wishes to incorporate users with international requirements, corresponding laboratory accreditation for the required tests is the best option, since it allows establishing the validity of their tests. If customers must ensure the sample traceability from the collection to result delivery, the easiest and cheapest option of quality management system is ISO 9001. At the local level, the ISO 9001 certification may be enough to provide confidence quality in the products or services offered, to be able to differentiate themselves from the competition and gain market share and

similarities and differences between certification and accreditation.

**ISO 9001 ISO/IEC 17025 ISO 15189**

8.3 Design and development of products and services 8.4 Control of externally provided processes, products, and services 8.5 Production and service provision 8.6 Release of products and service 8.7 Control of nonconforming outputs

9.1 Monitoring, measurement, analysis, and evaluation

10.2 Nonconformity and corrective

10.3 Continual improvement Annex A Clarification of new structure,

Annex B Other international standards on quality management and quality management systems developed by ISO/

9 Performance evaluation

9.2 Internal audit 9.3 Management review

10 Improvement 10.1 General

action

terminology, and concepts

TC 176

public tenders, among other objectives.



**Table 1.** Structure and items from the ISO 9001, ISO/IEC 17025, and ISO 15189 standards.

**ISO 9001 ISO/IEC 17025 ISO 15189**

5.3 Organizational roles,

26 Quality Control in Laboratory

6 Planning

7 Support

8 Operation

responsibilities, and authorities

6.1 Actions to address risks and

7.5 Documented information

8.1 Operational planning and control 8.2 Requirements for products and

6.2 Quality objectives and planning to

opportunities

achieve them 6.3 Planning of changes

7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication

services

5 Leadership 5 Technical requirements 5 Technical requirements 5.1 Leadership and commitment 5.1 General 5.1 Personnel

5.2 Policy 5.2 Personnel 5.2 Accommodation and

5.3 Accommodation and environmental conditions

5.8 Handling of test and calibration items

5.9 Assuring the quality of test and calibration results

5.4 Test and calibration methods and method validation

4.11 Corrective action 4.11 Prevention action

5.5 Equipment 5.5 Analytical processes 5.6 Measurement traceability 5.6 Assurance of the quality of

5.7 Sampling 5.7 Post-analytical processes

5.10 Reporting the results 5.10 Management of laboratory

4.12 Prevention action 4.12 continuous improvement 4.13 Control of records 4.13 Control of records 4.14 Internal audits 4.14 Evaluation and audits 4.15 Management reviews 4.15 Management reviews

environmental conditions

5.3 Laboratory equipment, reagents, and consumables

5.4 Pre-analytical processes

the analysis results

5.8 Notification of results

5.9 Comunicación de los resultados

information

On the other hand, the choice between certification (ISO 9001) and accreditation (ISO 17025 standard applicable to testing or calibration laboratories or ISO 15189 when it is a clinical laboratory) will depend on the requirements from current or potential customers, regulatory boards, or the expected growth and development of the laboratory [8]. **Figure 1** shows the similarities and differences between certification and accreditation.

When customers need international recognition of their results or the laboratory wishes to incorporate users with international requirements, corresponding laboratory accreditation for the required tests is the best option, since it allows establishing the validity of their tests. If customers must ensure the sample traceability from the collection to result delivery, the easiest and cheapest option of quality management system is ISO 9001. At the local level, the ISO 9001 certification may be enough to provide confidence quality in the products or services offered, to be able to differentiate themselves from the competition and gain market share and public tenders, among other objectives.

Alternatively, laboratory mission, vision, and policy can include issues related with market positioning, so that specific objectives should be defined regarding to certification and accreditation in each case.

**4. External quality assurance programs**

or accreditation [9].

ence interval [10].

participants.

methods.

Acceptance limits have been classified as [13]:

• Clinical: based on medical decisions.

"External quality assurance or assessment" (EQA) programs are a tool designed by different providers (usually medical or scientific societies) with an educational, training, and helping purpose. They allow the evaluation of the analytical performance for every variable involved (staff, equipment, reagents, and method) in comparison with the expected results. Similarly, EQA schemes are an educational tool to evaluate the competence of the laboratory in relation with specific variables. In addition to internal quality control (IQC), EQA is complementary in the quality management system. Alternatively, proficiency testing (PT) is used as external quality assurance with a regulatory purpose for laboratory licensing and/

Quality Management Systems for Laboratories and External Quality Assurance Programs

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

29

EQA programs allow comparing the laboratories' results and informing on global variation with the objective of working toward the harmonization. This goal is extremely important because medical decisions are based on comparisons of analytical results with time or a refer-

In this sense, international societies recognize the importance of EQA provision [11]. The World Health Organization has an available manual for organizing a national EQA program for health laboratories and other testing sites, providing guidance on the international standards ISO 17043:2010 Conformity assessment—general requirements for proficiency testing and ISO 13528:2015 Statistical methods for use in proficiency testing by interlaboratory comparison. Contrary to expectations, not enough evidences of quality improvement of the ana-

The EQA participation process is summarized in **Figure 2**. Samples prepared by the EQA provider are sent to the laboratories for their analysis. These samples of unknown nature are handled by the laboratory from their reception until the report emission as usual samples, although trying to participate each analyzer in the whole program [9]. EQA provider receives the analytical results from all of the laboratories and prepares a confidential report with the identified deviation regarding to an assigned value [13]. Optionally, report may establish acceptance limits for the assigned value in accordance with analytical performance specifications [14] and inform about the performance evaluation of the several methods employed by

• Regulatory: for identification of laboratories with a poor performance of the analysis.

• Statistical: an acceptable result is defined by its similarity with others derived from the same method. The disadvantage of this kind of acceptance limit is that it varies between

In case of nonregulatory EQA participation, the laboratories should decide the proper limits for the proposed objective. When the acceptance limit is defined as the "fitness for purpose",

such purpose must be specified based on external requirements [15].

lytical performance as a result of EQA participation have been reported [12].

Benefits from implementation of ISO 9001, ISO/IEC 17025, and ISO 15189 in the laboratory are shown in **Table 2** [6].

**Figure 1.** Similarities and differences between certification and accreditation.


**Table 2.** Benefits from implementation of ISO 9001, ISO/IEC 17025, and ISO 15189 in the laboratory adapted from [6].
