Mexico enacts new Quality Infrastructure Law
Mexico
On 1 July 2020, Mexico officially published its new Quality Infrastructure Law, which abrogates the Federal Law on Metrology and Standardisation. The new Law will come into effect 60 days after publication.
The new Mexican Quality Infrastructure Law was published as part of a set of reforms and new laws, with the aim of complying with several provisions of the United States-Mexico-Canada Agreement (USMCA) that came into effect on 1 July 2020. The official publication of the Law can be found here (in Spanish).
The new law sets guidelines to strengthen the procedures of essential QI pillars, aiming to consolidate the national quality infrastructure system. The modernised regulatory framework of the national QI system aims to improve the quality and efficiency of standardisation, accreditation and conformity assessment. Incentives and sanctions are explicitly mentioned to increase compliance with technical regulations and other QI legal provisions. The new law also indicates that Mexico aims to align its QI system more effectively with international standards and best practices to promote and facilitate trade.
A new National Commission of Quality Infrastructure, which replaces the National Commission of Standardisation, will be the body in charge of directing and coordinating the national QI system. It will be presided by the Ministry of Economy (SE) and composed of the public ministries, competent national commissions and councils, the National Metrology Institute (CENAM), as well as public entities designated by it and approved by the SE, which act as so-called designated metrology institutes, selected business chambers, confederations and associations, academic institutions, accreditation entities, national regulators empowered to issue technical regulations (Norma Oficial Mexicana - NOM, in Spanish), and national standardisation organisations.
An annual National Quality Infrastructure Program will replace the National Standardisation Program and contain those NOMs and standards (previously named Norma Mexicana "NMX) that will be adapted, developed, modified, or cancelled each year. The players that can carry out standardisation activities are the national standardisation organisations, stakeholders (business chambers, academic institutions, associations, etc.), and in certain cases, national regulators.
To increase compliance with technical regulations (NOM), all NOMs must outline conformity assessment procedures (CAP) according to the level of risk or protection. NOMs will be systematically reviewed by the corresponding national regulators, at least five years after their official publication date. Standards must also include CAP, when applicable. Besides conformity assessment bodies (CABs), national regulators may also carry out conformity assessment. In case the standard lacks a CAP, the person responsible for the product or service may exhibit a self-declaration of conformity given a low level of risk.
CABs still need to be accredited by a national accreditation entity and afterwards apply for approval with the corresponding national regulator. According to the new law, CABs need to include a list of rates and prices for their services and the methodology to determine them, consisting of a transparent procedure based on costs among their regular documentation in order to receive the approval of the national regulator.
Likewise, accreditation entities must present a list of rates and prices for their services within their documentation to be authorized by the SE, following a favourable statement from the National Commission of QI. Additionally, every six months, the entities must present a report to the SE on the accreditations it issued and the acts they performed during that time.
Both, accreditation entities and CABs will be subject to regular inspections from the SE or other national regulators and accreditation entities, as applicable.
Recognizing the need to develop physical as well as digital infrastructure to carry out QI activities, the Quality Infrastructure online platform (Plataforma Tecnológica Integral de Infraestructura de la Calidad) is set to manage and publish NOM, standards, metrology data, the National Quality Infrastructure Program, accreditation entities, CABs, and standardisation organisations, among others.
The enactment of the QI Law became possible after an extraordinary session of the Senate and the Chamber of Deputies, on 29 July and 30 July 2020. These sessions were convened to address and pass a set of reforms and new laws regarded by Mexico as necessary to comply with several provisions of the USMCA.
Aside from the Quality Infrastructure Law, Mexico also enacted the following laws and reforms: