Mexico’s National QI Programme 2023

Mexico

The Mexican Ministry of Economy is reviewing technical regulations and standards presented in the National Quality Infrastructure Programme (PNIC) 2023. These refer to circular economy, cybersecurity, electronic medical devices, information security management systems, railway transport and machinery safety, among other topics.

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On 28 February, the National Quality Infrastructure Programme (Programa Nacional de Infraestructura de la Calidad - PNIC) 2023 was published in the Official Gazette of the Federation (Diario Oficial de la Federación – DOF). Each year, the programme contains the new initiatives, modifications and eliminations of technical regulations and standards as proposed by the Mexican regulatory authorities, standardisation bodies and business associations. Here is a summary of some relevant new developments covered by PNIC.

 

PNIC 2023 includes the following changes among others:

 

  • Changes to technical regulations for railway transport and machinery, aiming to improve product and process safety.
  • The development of a new technical regulation for electronic and electric equipment, as well as electric vehicle (EV) batteries - a further step in defining the technical basis for Mexico's transition to a circular economy.
  • Modifications to standards concerning electronic medical devices, information security management systems (ISMS) and cybersecurity.

 

Increasing safety in the railway sector

 

The modification to the Mexican technical regulation NOM-003-ARTF-2019 defines the classification and minimum requirements that each class of railway track must comply with to ensure the safety of train traffic. In addition, it incorporates improvements to the track in accordance with technological advances.

 

In a similar vein, the modification to NOM-004-ARTF-2020 seeks to establish the methodology for reporting accidents in the operation of railway services to the Regulatory Agency for Rail Transport (Agencia Reguladora del Transporte Ferroviario – ARTF). NOM-050-SCT2/2017 defines the signaling and devices to be installed at level crossings of roads, streets and highways with railroads. It will also be modified.

 

Improving safety of machinery and introducing «safety by design»

 

NOM-020-STPS-2011 on safety conditions for operating pressure machinery will be updated regarding the safety and health conditions that must exist for the operation of pressure vessels and steam generators or boilers in workplaces. This NOM establishes provisions on occupational safety and health to avoid risks for workers.

 

A novelty in the PNIC 2023 is the inclusion of safety by design as a topic for a new regulation. This new NOM proposal focuses on specifications concerning safety by design and during construction, as well as commercial information of machine tools. The regulation will establish minimum design considerations and information to be provided to users in order to reduce accidents in the use of machine tools. It refers to the ISO 9001:2015 standard on quality management systems, and the ISO 16092-1 on general safety requirements for machine tools safety. This NOM proposal is also a modification based on the European Directive 2006/42/EC on machinery.

 

Safety requirements for electronic medical equipment

 

The draft of the Mexican standard PROY-NMX-J-866-2-30-ANCE-2022 specifies requirements for the basic safety and essential performance of automated sphygmomanometers, which are used for indirect blood pressure measurement. The proposal refers to the international standard IEC 80601-2-30 ed2.0 (2018-03).

 

Cybersecurity standards updated

 

The Mexican standard NMX-I-27001-NYCE-2015, will be updated to align with the latest version of standard ISO/IEC 27001 for ISMS, published in 2022. NMX-I-27001-NYCE-2015 specifies the requirements for establishing, implementing, maintaining and continuously improving an information security management system in organisations.

 

Furthermore, the Mexican standard draft PROY-NMX-I-27006-NYCE-2021 specifies requirements and provides guidance for bodies which audit and certify ISMS. It is mainly intended to support the accreditation of conformity assessment bodies in this field. It is based on ISO/IEC 27006:2015/Amd 1:2020.

 

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Underpinning the transformation towards circular economy

 

The draft of the new technical regulation «Circular Economy - Safety specifications for electrical and electronic equipment and electric vehicle batteries» is currently being developed. It promotes the transition to circular economy in key sectors. The regulation will establish specifications to be met by electric and electronic devices and batteries for electric and hybrid vehicles, in order to extend their lifespan. It will complement the pillars of recycling, remanufacturing and reusing within the circular economy framework with specifications of a design for durability. Here, the United Nations Global Technical Regulation No. 22. on in-vehicle battery durability for EV is used as a reference. The publication of the draft regulation for public consultation is scheduled for June and July 2023.

 

Related to the treatment of EV batteries at the end of their life cycle, NOM-052-SEMARNAT-2005 establishes the characteristics, identification procedure, classification and lists of hazardous waste. The modification of this NOM aims to update the lists of hazardous waste by specific and non-specific source. The Working Group for the Electrification of Transport of the Mexican Ministry of Foreign Affairs (Secretaría de Relaciones Exteriores – SRE) proposed in a study –published in January 2023, in Spanish– to include EV batteries in the definition of hazardous waste. In this case, EV batteries would fall under the scope of the draft regulation PROY-NOM-160-SEMARNAT-2011 that details the requirements for the design and implementation of hazardous waste treatment plans. PROY-NOM-160-SEMARNAT-2011 is also included in the PNIC 2023.

 

On 09 March, the Mexican Ministry of Economy announced that it is currently undertaking an in-depth revision of PNIC 2023. It will align the technical regulations and standards included with the goals and priorities of the Ministry’s present administration. It also aims to promote competition and a level playing field. Finally, this can reduce production costs and allow technological advances and market access for small and medium enterprises. This revision of the QI Programme will be reflected in the supplement of PNIC 2023, which will be published in April.

 

The National Quality Infrastructure Program (PNIC) 2023 can be found in the DOF here (in Spanish).

 

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