# Management System According to ISO/IEC 17025: Method Validation
## 1 Introduction  
Seeking accreditation, synonymous with technical competence and reliability, should be a primary strategic decision for any calibration or testing laboratory. Implementing a quality management system based on the criteria of the ISO/IEC 17025:2017 [1] standard is crucial, as it acknowledges the validity and certainty of results issued by testing laboratories for conformity assessment purposes. In this context, the Mexican Accreditation Entity (EMA) requires a set of requirements to attain accreditation, in addition to those outlined in the ISO/IEC 17025:2017 [1] standard. These requirements are detailed in the document \"Application Criteria of the ISO standard 17025 (MP-FE005-13)\". Through evaluation and practical experience, the accrediting body has updated the application criteria of ISO 17025:2017 to clarify and interpret the management and technical requirements of the standard that are deemed critical. Moreover, this document aims to establish complementary requirements that form part of the evaluation criteria used in the accreditation processes of testing and calibration laboratories. These criteria are essential for laboratories, dependencies, accredited laboratories, members of the national registry of evaluators, and interest groups to adhere to, ensuring clarity and interpretation of the ISO/IEC 17025:2017 standard's management and technical requirements. The strategy for accrediting any test or calibration method, as outlined in the preceding paragraph, is subject to a dual set of criteria: the primary criteria of the ISO/IEC 17025:2017 [1]standard and an additional set of interpretation criteria provided by the EMA in the document MP-FE005-13. Within this framework, Section 7.2 of the ISO/IEC 17025:2017 standard delineates the requirements, both implicit and mandatory, for validating any test, trial, or calibration method. This section, specifically titled \"Selection, Verification, and Validation of Methods,\" is crucial for ensuring the accuracy and reliability of the methods employed. It should be understood that both references recognize two types of methods: regulated ones, which undergo verification, and non-regulated or proprietary methods, which require validation. While the ISO/IEC 17025:2017 [1] standard mandates scope validation for methods, the EMA MP-FE005-13 guide provides a more detailed description of the criteria to be addressed for these test methods. The specific items mentioned above will be further discussed in subsequent sections of this paper. Following a discussion on the validation process for non-regulated methods, it is essential to provide a clear description of the method under consideration and outline the necessary documentation to cover the validation requirements outlined previously. The method in question, colloquially known in Mexican mines as the 'anchor test', formally titled 'Strength Determination in Anchors Installed Inside the Mine', will be expounded in the following section. The method \"Resistance Determination in Anchors Installed Inside the Mine\" is not a recent innovation but rather an established process rooted in the principle of material adherence. Specifically, it focuses on the bond between certain metals and mortar. This fundamental phenomenon is crucial for the method's functionality. As highlighted by [PERSON] and [PERSON] [2], without this adherence, steel bars would lack the ability to withstand even minimal tensile stress, as the steel would simply slide along its entire length without resistance. However, due to the presence of adherence, stress is evenly distributed throughout the material, allowing the steel to bear the load. Even when cracks occur, they are distributed evenly, maintaining the bond between the materials in the cracked areas. The adhesion serves two purposes: first, it ensures anchorage, primarily provided by the length of the steel barrel; second, it transmits peripheral tangential forces arising in the main reinforcement due to variations in longitudinal stress.