copy the linklink copied!2. Conformity assessment in Mexico

Abstract

This chapter provides an overview of the conformity assessment and accreditation frameworks applicable in the country and the actors involved in these activities. It also presents specific illustrations of conformity assessment techniques used by sectoral regulators in the health and agricultural markets.

    

In order to reap the full benefits of technical regulations and voluntary standards, and ensure that the specifications set out within them are met, countries require a well-functioning national quality infrastructure (NQI) framework. Quality infrastructure is the “the system comprising the organisations (public and private) together with the policies, relevant legal and regulatory framework, and practices needed to support and enhance the quality, safety and environmental soundness of goods, services and processes, relying on metrology, standardisation, accreditation, conformity assessment, and market surveillance”.1 A sound NQI relies on metrology, standardisation, accreditation, conformity assessment, and market surveillance.

Conformity assessment and accreditation are key building blocks of a country’s quality infrastructure. Conformity assessment connects the requirements set in technical regulations with the products and services available to the public. ISO/IEC 17000:2004 defines conformity assessment as the demonstration that the specific requirements applicable to a product, process, system, person or body are met before they enter the market. Accreditation provides an additional layer of assurance by verifying and attesting that conformity assessment bodies (CABs) have the competences and impartiality to perform their functions.

A well-designed NQI system is key for the effective operation of domestic and international markets. Strong conformity assessment and accreditation frameworks allow countries to reap the benefits from technical regulations and voluntary standards, and have a range of positive spillovers. They enable governments to effectively implement policies to promote public health and safety, as well as environmental and consumer protection, inter alia. NQI also plays a key role in supporting global trade. By strengthening the quality and effectiveness of technical regulations and conformity assessment procedures, countries can strengthen the credibility of their quality infrastructure for foreign partners.

This chapter provides an overview of the conformity assessment techniques used in Mexico and the actors involved in conformity assessment and accreditation. It then discusses the implementation of conformity assessment procedures (CAPs) in specific sectors.

copy the linklink copied!Conformity assessment in Mexico

The legal framework for conformity assessment in Mexico is set out in the Federal Law on Metrology and Standardisation (Ley General sobre Metrología y Normalización, LFMN) and its regulation. These instruments provide the process for development and implementation of CAPs and rules for the organisation of conformity assessment bodies. From the range of approaches to conformity assessment (Box 2.4), Mexico’s favours a range of third-party techniques recognising four main types of activities: certification, verification, calibration, and testing. These techniques are supplemented by other assessment forms established in some sectoral regulations or NOMs. This is the case of NOM-005-SCFI-2017 on Supply and Measurement Systems for Petrol and Liquid Fuels that recognises prototype testing of fuel meters as a form of conformity assessment.2

In addition, certain sectoral regulations establish special CAPs that depart from the accreditation and approval framework set under the LFMN. This is for instance the case of the General Health Law that provides a separate conformity assessment regime for health-related NOMs.

In Mexico, first-party CAPs remain rather underutilised. While this approach to conformity assessment relies on the manufacturer or supplier taking on the responsibility for demonstrating compliance with the requirements set in a NOM rather than a third party, it does not necessarily mean absence of conformity assessment as they need to be accompanied by the relevant technical examinations and documentation. More recently, CAPs for some NOMs have introduced the use of forms of self-certification. For example, the conformity assessment process for NOM-199-SCFI-2017 on Alcoholic Beverages3 combines two types of approaches: a Suppliers Declaration of Conformity (SDoC) to attest the conformity of fermented alcoholic beverages and third-party certification for assessment of other types of alcoholic drinks considered to be of higher risk.

Once conformity of a product or service has been assessed in accordance with a NOM, the LFMN enables the attachment of an indication to it as a certificate or mark of conformity. However, the use of these types of statements in Mexico remains limited and little guidance is provided by regulators on how to indicate conformity with NOMs. The use of these marks can help consumers identify products that comply with technical regulations. They are common in countries with strong conformity evaluation cultures. This is for instance the case of the European Union “CE” marking that demonstrates that a product sold in the European Economic Area has been evaluated to meet the corresponding safety, health and environmental protection requirements (Box 2.1). In Chile, the electricity and fuels regulator has set in place a special labelling system for a wide range of electrical and fuel products that require certification (Box 2.2).

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Box 2.1. CE Marking in the EU

In the EU, products for which EU specifications exist require a CE (Conformité Européenne or European Conformity) marking before they can be sold in the EEA. CE marking proves that a product has been positively assessed to meet EU safety, health and environmental protection requirements. The marking is valid for products manufactured both inside and outside the EEA, that are then marketed inside the area.

In cases when there is minimal risk to the public, importers, distributors and manufacturers may often self-certify their compliance with EU directives. Nevertheless, the process requires a technical dossier to support the claims of compliance with the necessary directive that proves the product meets all EU-wide requirements.

Source: EU (2019), EU Product Market Requirements - CE Marking, https://europa.eu/youreurope/business/product-requirements/labels-markings/ce-marking/index_en.htm (accessed October 2019).

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Box 2.2. Certification labelling by the Electricity and Fuels Superintendence of Chile

Chile’s electricity and fuels regulator, the Superintendence of Electricity and Fuels (Superintendencia de Electricidad y Combustibles, SEC) sets mandatory requirements to guarantee the safety and energy efficiency through testing and certification of a wide range of electrical products, including for instance domestic appliances, lighting, power tools, motors, and IT devices.

Since 2013, the SEC provides that products for which a certification requirement exists need to obtain an approval certificate and display a special label issued by the SEC (Sello SEC) that includes a QR Code, approval number and when applicable, energy efficiency information.

The SEC labelling system is intended to promote the purchase of products that comply with certain quality and safety standards, strengthen the market of certified products and facilitate consumer purchases. For certain types of products, the label is mandatory and any breach thereof is subject to sanctions.

Source: SEC, Exempt Resolution No. 2142/2012.

Conformity assessment bodies (CABs)

CABs are independent and impartial persons or entities responsible for performing conformity assessment activities. The organisation of CABs varies across countries; they can be public agencies, industry bodies or private organisations or companies. In many countries, a diversity of actors intervene in conformity assessment. While at times these bodies are organised as non-profit entities, they generally charge a fee for their services creating competitive markets. The services of CABs may be localised in a specific country or cover a sector or region. A number of international standards guide the operation of conformity assessment bodies involved in certification, testing and inspection.

In Mexico, CAPs can be carried out by the sectoral regulator responsible for a NOM or by CABs that act as third-party providers of assessment techniques. CABs are entities accredited by EMA and approved by the relevant sectoral regulator. These entities are subject to certain structural requirements to secure their impartiality and independence and the confidentiality of their operations. The LFMN also allows PROFECO and CENAM to perform specific conformity assessment activities as required under specific NOMs.

The activities of CABs are overseen by the DGN, as co-ordinator of technical regulations and standardisation system, and the EMA, responsible for surveilling compliance with the conditions under which CABs were accredited. The EMA is allowed sanction CABs with the total or partial suspension or cancellation of their accreditation. Finally, the CENAM oversees specific operations of CABs related to calibration.

The landscape of CABs in Mexico has increased in number and in the range of sectors covered. Yet, in certain regulated sectors, access to some conformity assessment activities prescribed under NOMs is hindered due to the inexistence or insufficiency of CABs or lack of technical capabilities to perform certain procedures. As of February 2019, only 34% of 786 NOMs in force requiring conformity assessment by an accredited body had an accredited CAB competent for evaluating their implementation.

In addition to their conformity assessment functions, CABs are occasionally invited to participate in certain sessions of CCNNs discussing the drafting of a proposed NOM or NMX.

Conformity assessment procedures in the LFMN

The LFMN defines conformity assessment procedures as the “Determination of degree of compliance with NOMs or conformity with NMXs, international standards or other specifications, dispositions or characteristics. It includes, among others, the procedures of sampling, testing, calibration, certification and verification.”

In Mexico, the relationship between NOMs and conformity assessment procedures is not linear. The LFMN recognises that not all NOMs require conformity assessment. When they do, the specific procedures required by a NOM may be designed as part of it or at a later stage after a NOM has been issued. In this case, CAPs are subject to a separate process including a 60-day public consultation period and publication in the Official Gazette. Furthermore, CAPs may cover a specific NOM or provide the assessment requirements applicable to a set of technical regulations.

As a result, a number of NOMs currently in force lack the relevant assessment techniques to evaluate that the prescribed requirements are fulfilled. Without this, these NOMs become de facto unenforceable. In practice, the absence of CAPs for a specific NOM has at times resulted in the postponement of their effects. While the DGN has taken steps to ensure that new NOMs are developed simultaneously with their corresponding CAP, looking forward Mexico could take steps to reduce the existing stock of technical regulations for which a CAP is needed but has not been developed.

When designing a technical regulation, regulators can select from a variety of approaches to conformity assessment, from self-declarations issued by the supplier (Box 2.4) to third-party evaluations such as auditing, calibration, evaluation, and testing, inter alia. Mexico favours a range of third-party conformity assessment procedures. The LFMN regulates the main techniques, including calibration, laboratory testing, certification and verification activities.

While the LFMN provides for the process for developing CAPs, it does not provide a rationale or specify the minimum requirements that a CAP needs to observe other than noting that it should be designed according to the nature of the risk addressed through a NOM. Currently, in Mexico there is no common methodology for developing CAPs or selecting procedures. As a result, the development and use of CAPs vary greatly across sectors.

International examples on guidance for designing and issuing CAPs may serve as inspiration to advance towards a more coherent and consistent use of this tool. For instance, the EU framework lays down a system for selecting a CAP based on modules from which legislators can select, similarly in the United States the National Institute of Standards and Technology (NIST) provides Federal Agencies with considerations on conformity assessment options (Box 2.3). The ISO/CASCO toolbox includes guidance on the steps that may be followed for using conformity assessment in regulations including considerations on risk and availability of resources, among others. Finally, APEC’s Information Notes on Good Regulatory Practice guide regulators to select conformity assessment approaches based on risk considerations while also balancing the regulatory burden that these procedures may represent (APEC, 2000[1]).

The LFMN defines certification as the “procedure through which it is ensured that a product, process, system or service adjusts to the rules, guidelines or recommendations or national or international standardisation bodies”. In Mexico, certification activities include the following: an evaluation of the object of conformity through inspection, sampling, testing, field review or evaluation of quality programmes; and a follow-up review of compliance. Additional requirements for certification can be established by the relevant sectoral authority, the NOM or international standards. Certification bodies must have national coverage and need to be accredited by the EMA and approved by the relevant sectoral regulator. As of April 2019, there were 120 certification bodies accredited in Mexico.

The LFMN recognises conformity assessment through testing and calibration performed by laboratories accredited by EMA and authorised by sectoral regulators. As of April 2019, 1,609 laboratories had been accredited in Mexico. In addition to laboratories, CENAM and PROFECO are also allowed by law to perform specific calibration activities.

Verification activities are defined in the LFMN as “Eye inspection or verification via sampling, measurement, laboratory testing or examination of documents performed for conformity assessment at a given time”. Verification units need to be accredited by the EMA and approved by the relevant sectoral regulator to undertake these activities. However, certain NOMs allow regulators to directly authorise verification units without the need for accreditation. The statement of conformity issued by a verification unit is an opinion (dictamen). As of April 2019, there were 631 verification units accredited in Mexico.

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Box 2.3. International examples of guidance on conformity assessment approaches

The modular structure of conformity assessment in the EU New Legislative Framework

The EU’s “New Legislative Framework” (NLF) adopted in 2008, consists of a set of legal documents that complete the overall EU product-related legislative framework, including conformity assessment, accreditation and market surveillance, and the control of products from outside the EU.

Conformity assessment is a key element of the NLF. It is defined as “[T]he process carried out by the manufacturer of demonstrating whether specified requirements relating to a product have been fulfilled.” Under this framework, a product can be subject to conformity assessment both during the design and production phase.

The framework consolidates conformity assessment procedures and the rules for their selection through modules/procedures laid down under Decision No. 768/2008/EC. Conformity assessment processes are composed of one or two modules, some modules cover both the design and production phases. In other cases, distinct modules are used for each phase.

The EU approach provides a rationale for selecting from the menu of conformity assessment modules/procedures the most appropriate ones for the concerned sector, avoiding options that are too onerous. The modules are designed to favour their selection from the lightest for simple products or products that present only limited risks, to the most comprehensive, for those which are more complex or hazardous. Annex B provides an overview of the modules.

Considerations for U.S. Federal Agencies to support the use of conformity assessment

In the United States, an Office of Management and Budget (OMB) guidance document sets the elements that Federal Agencies should consider when assessing the effectiveness of conformity assessment approaches and selecting conformity assessment options. These elements are listed in Circular A-119 (Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities).

The National Institute of Standards and Technology (NIST) gives additional non-binding guidance to Federal Agencies in using conformity assessment in an efficient and cost-effective manner for both the agency and stakeholders. This publication includes elements to approach and manage conformity assessment schemes balancing the risk of non-conformity and the resources necessary to demonstrate conformity. There are four major elements to a government conformity assessment program: 1) objectives and goals; 2) conformity assessment scheme and oversight; 3) requirements for object of conformity; and 4) programme management. This guidance provides a framework for defining a conformity assessment scheme building on the elements set forth in OMB Circular A-119. These elements include:

  • Defining the conformity assessment programme goal;

  • Defining clear and unambiguous technical requirements and specifications or other requirements and standards for the object of conformity;

  • Defining a clear and unambiguous method for determining conformity;

  • Understanding the confidence point and the information derived from its analysis;

  • Selecting conformity assessment activities based on the requirements and confidence point. These activities include testing, inspection, audit, attestation, and surveillance.

  • Determining the role of the agency as the programme manager and programme oversight authority, and approval authority if needed;

  • Determining whether first-, second- or third-party organisations perform the respective conformity assessment activities;

  • Determining whether existing conformity assessment programs or activities, in both the private sector and public sector, can be leveraged to achieve conformity assessment goals, meet requirements and satisfy the confidence point;

  • Determining the mechanism for indicating conformity or approval; and

  • Developing the conformity assessment scheme and determining that when implemented, it helps to manage the risk of non-conformity, meets agency objectives, and contributes to the confidence of purchasers and users that requirements have been fulfilled.

Source: European Commission (2016), The ‘Blue Guide’ on the implementation of EU products rules 2016 (2016/C 272/01), https://eur-lex.europa.eu/legal-content/en/txt/pdf/?uri=celex:52016xc0726(02)&from=bg, United States (2016), OMB Circular A-119, Revised: Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities, Washington, D.C., Executive Office of the President, Office of Management and Budget, https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A119/revised_circular_a-119_as_of_1_22.pdf, and Carnahan, L. and A. Phelps (2018), Conformity Assessment Considerations for Federal Agencies, National Institute of Standards and Technology (NIST), Washington, http://dx.doi.org/doi.org/10.6028/NIST.SP.2000-02.

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Box 2.4. The variety of approaches to conformity assessment

There are three main approaches to conformity assessment depending on who performs the evaluation:

  • First-party assessment: when evaluations activities are performed by manufacturers or suppliers themselves using their own staff and equipment. This is typically the case of self-declarations such as Supplier’s or Manufacturer’s Declaration of Conformity.

  • Second-party assessment: when the evaluation is carried out by the purchaser that will use the product or service; and

  • Third-party assessment: when the evaluation of conformity is performed by a person or entity that is independent from the manufacturer or supplier of the object of conformity assessment and from its end users. This is the case of CAPs performed by certification bodies, testing laboratories, or inspection bodies. Certification is the result from a third-party assessment.

Technical regulations can target products, processes, services, management systems, persons or organisation: this is deemed the “object of conformity assessment”. The selection of approaches for conformity assessment should be based on the level of risks involved in the object of conformity assessment (Figure 2.1). When a failure of the object of conformity assessment involves a low risks of negative effects, the most appropriate approach may be a self-declarations by the supplier or manufacturer. On the contrary, when there is a high risk of harmful effects following failure of the product or service subject to conformity assessment the preferred approach may involve action by a third party to independently evaluate that the specifications set in a technical standard are met. In these cases, accreditation can provide an additional guarantee for the quality of the products or services.

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Figure 2.1. Conformity assessment approaches and levels of risk
Figure 2.1. Conformity assessment approaches and levels of risk

Source: Guasch, J. et al. (2007), Quality Systems and Standards for a Competitive Edge, The International Bank for Reconstruction and Development/The World Bank, http://dx.doi.org/10.1596/978-0-8213-6894-7; and Using ISO/CASCO standards in regulation, ISO, https://www.iso.org/sites/cascoregulators/documents/casco-regulators-fulltext.pdf.

copy the linklink copied!The Mexican accreditation system

Accreditation is the main approach used to verify the impartiality of CABs and their capabilities to perform their functions. It enables the attestation that a CAB has the competences to evaluate the conformity of a specific product or service according to a mandatory technical regulation or a voluntary standard. The key value of accreditation lies in the fact that it provides an authoritative third-party statement of the technical competences of CABs. The International Organization for Standardization (ISO) together with the International Electrotechnical Commission (IEC) have developed standards dealing with accreditation bodies and their activities (Box 2.5).

Accreditation is a key pillar of the Technical Regulations, Standardisation and Metrology System set up in the LFMN. Article 3 defines accreditation as the “Act through which an accreditation entity recognises the technical competence and reliability of certification bodies, testing laboratories, calibration laboratories and verification units for the purposes of conformity assessment.” The LFMN and its regulation set forth a number of requirements for the governance and operations of accreditation entities. While the law formally allows any private entity authorised by the Ministry of Economy to provide a statement over the competences of conformity assessment bodies, to date the Mexican Accreditation Entity (Entidad Mexicana de Acreditación, EMA) is the only accreditation body authorised to operate in the country. As such, Mexico is part of a majority of countries where a single national body performs accreditation activities (Box 2.6).

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Box 2.5. The requirements of ISO and the IEC for accreditation entities and the accreditation process

ISO has a number of standards related to conformity assessment and accreditation that are developed and published by its Committee on Conformity Assessment (CASCO) (OECD/ISO, 2016[2]). In the development of these standards, ISO works closely with a number of international organisations including the International Electrotechnical Commission (IEC), the International Accreditation Forum (IAF) and the International Laboratory Accreditation Co-operation (ILAC).

According to the ISO/IEC Standard 17000:2004 on Conformity Assessment – vocabulary and general principles, accreditation is a “third party attestation related to a conformity assessment body conveying formal demonstration of its competence to carry out a specific conformity assessment task”.

The ISO/IEC Standard 17011:2017 sets out a range of requirements for accreditation entities and the process of accreditation. These include:

  • Governance requirements – including legal responsibility, structure of the accreditation entity, impartiality, confidentiality, liability and financing and accreditation activity.

  • Management requirements – including requirements for the management system of the accreditation body, document control, records, nonconformities and corrective actions, preventive actions, internal audits, management reviews and complaints.

  • Human resource requirements – dealing with the staff associated with the accreditation body, staff involved in the accreditation process, monitoring and personnel records.

  • Accreditation process requirements – addressing accreditation criteria and information, application for accreditation, resource review, subcontracting the assessment, preparation for assessment, document and record review, on-site assessment, analysis of findings and assessment report, decision-making and granting accreditation, appeals, reassessment and surveillance, extending accreditation, suspending, withdrawing or reducing accreditation, records on CABs, and proficiency testing and other comparisons for laboratories.

  • Requirements on the responsibilities of accreditation entity and conformity assessment bodies. Dealing with the obligations of CAB and accreditation bodies as well as the reference to accreditation and use of symbols.

The activities covered under this standard include testing, calibration, inspection, certification of management systems, persons, products, processes and services, provision of proficiency testing, production of reference materials, validation and verification.

Source: Using ISO/CASCO standards in regulation, ISO, https://www.iso.org/sites/cascoregulators/documents/casco-regulators-fulltext.pdf.

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Box 2.6. The organisation of accreditation across countries

The institutional set up and legal status of accreditation entities varies across countries, although a majority of them have a single national accreditation body (Table 2.1 and Table 2.2). This is the case of EU Member countries as they are required under EU Regulation (EC) 765/2008 to maintain a single national accreditation entity that provides authoritative statements of the competence bodies to perform conformity assessment activities (European Parliament and European Council, 2008[16]). In Latin America, all signatories of the ILAC/IAF MLAs have a single accreditation body organised as either a private or public entity (IAF, 2019[3]) (ILAC, 2019[4]).

In a few countries, a number of accreditation entities coexist performing accreditations in different sectors. This is the case for instance in Korea, where three separate accreditation entities are responsible for assessing the competences of laboratories and certification institutions: the Korea Accreditation Board (KAB), the Korea Accreditation System (KAS), and the National Institute of Environmental Research (NIER). In the United States, five private bodies operate simultaneously across sectors of the accreditation market.

In addition, some countries have established common accreditation systems that allow them to share accreditation institutions. This is for instance the case of the Joint Accreditation System of Australia and New Zealand (JAS-ANZ), an independent accreditation body established in 1991 through an agreement that creates a bilateral governing board responsible for overseeing accreditation activities. Following this example, in 2013 Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, the United Arab Emirates, and Yemen created a similar system named the Gulf Accreditation Centre (GAC).

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Table 2.1. Number of accreditation bodies per economy of ILAC Full Members (MRA Signatories)

Number of ILAC Full Member (MRA Signatory) accreditation bodies per economy

Number of economies

1

78

2

4 (Australia, India, Russia and United Arab Emirates)

3

3 (Canada, Japan and Thailand)

5

1 (United States)

Notes: ILAC is the international organisation for accreditation entities involved in the accreditation of laboratories and inspections. Figures relate to ILAC’s current 101 Full Members (signatories to the ILAC MRA). The ILAC MRA currently covers five separate scopes of activity for accreditation bodies, namely: testing, calibration, medical testing, inspection, and proficiency testing providers.

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Table 2.2. Number of national accreditation bodies in IAF member’s economies

Number of accreditation entities

IAF member’s economies

1

85

2

3 (India, Russia and United Arab Emirates )

3

2 (Japan and Korea)

5

1 (United States)

Notes: IAF is the international organisation for accreditation entities involved in the accreditation of management systems, products, services, personnel and other similar programmes of conformity assessment.

Source: IAF and ILAC.

The organisation of accreditation in Mexico

The current Mexican set up for accreditation was established in 1992 with the LFMN. It allows private non-profit organisations especially created for these effects to operate as accreditation entities. Before a 1997 reform, the DGN was responsible for accreditation in Mexico.

Accreditation bodies are authorised by the Ministry of Economy with the previous approval of a majority of relevant Ministries. To obtain this authorisation, interested third parties must certify their legal, technical, administrative and financial suitability to act as accreditation entities. The request for authorisation to the Ministry of Economy also needs to indicate the maximum fees that the accreditation body will charge for their operations. The Ministry of Economy may revoke or suspend an authorisation of an accreditation entity if the requirements set in the LFMN are breached (LFMN, article 103 and 104). In these cases, the Ministry is allowed to take over the accreditation activities for a specific sector or market.

The LFMN and RLFMN include a set of provisions dealing with the governance structure of accreditation bodies. They must be established as single purpose entities and secure a balanced representation of different stakeholders4 in their governing bodies, including business and academic representatives. Individuals who participate in an accreditation body are banned from joining other similar entities. There are no express rules promoting the independent operation of accreditation bodies from commercial conformity assessment activities, such as separating the ownership of accreditation bodies from CABs or other participants in the standardisation system for example. However, the Ministry of Economy can establish specific obligations on the fees and service conditions of accreditation entities or conformity assessment bodies with relevant market power (LFMN, article 70-C).5

Mexican accreditation entities must meet the requirements set in the LFMN and RLFMN to safeguard the integrity, impartiality and confidentiality of their functions. These include, inter alia, allowing public officials to oversee their activities, maintaining an updated public record of accredited entities, and addressing complains submitted by stakeholders. Accreditation entities are also required to periodically review that CABs continue to meet the conditions under which they were accredited. Finally, accreditation entities are encouraged to participate in regional or international accreditation organisms to agree on common guidelines and mutual recognition of accreditations.

The Mexican Accreditation Entity

The EMA is a private non-profit organisation established in 1999, authorised by the Ministry of Economy and approved by the CNN to grant formal recognition to CABs in Mexico through accreditation. To date, the EMA remains the only accreditation entity for conformity assessment bodies in Mexico, which comprise testing laboratories, calibration laboratories, medical laboratories, inspection bodies and certification bodies, proficiency testing providers, greenhouse gas emissions verification/validation bodies, and reference materials producers.

The Ministry of Economy, through DGN, leads the relationship between the Mexican administration and the EMA. While the LFMN and other instruments lay down the obligations of the EMA towards the Ministry of Economy, anecdotal evidence from interviews shows opportunities to enhance the strategic relationship between the two entities to strengthen Mexico’s quality infrastructure around accredited bodies. The model of the United Kingdom Accreditation Service (UKAS) engagement with the UK Government based on a Memorandum of Understanding (MoU) may provide a useful reference in this regard (Box 2.7).

The governance structure of the EMA includes a number of bodies formed by public and private sector representatives. The General Associates Assembly (Asamblea General de Asociados) is the uppermost body of the EMA and gathers 165 associates (including some accredited conformity assessment bodies). The Board of Directors (Consejo Directivo) is responsible for management and is formed by 36 members that represent the federal government holding 9 votes; business sectors holding 9 votes; participants of the accreditation market (including conformity assessment bodies) holding 9 votes; and representatives from academia holding 9 votes. Business sector representatives are appointed by the chambers of industry and commerce, while conformity assessment bodies are appointed by laboratories, inspection bodies, calibration laboratories, and certification entities.

EMA bases its accreditation requirements on international standards and is recognised by the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC), the main international organisations of accreditation bodies. EMA is also a member of the regional pillars of the international accreditation system and its accreditation services have received recognition from a number of bodies: the Inter-american Accreditation Cooperation (Cooperación Interamericana de Acreditación, IAAC); and the Asia Pacific Accreditation Cooperation (APAC). Additionally, it participates in specific fora, including those related to the OECD Good Laboratory Practices and the Mutual Acceptance of Data as well as the Joint ILAC/World Anti-doping Agency (WADA).

EMA operates at the national level and is involved in a range of activities related to the Mexican Technical Regulation and Standardisation System. However, its core responsibility is accrediting conformity assessment bodies against technical regulations and voluntary standards (Table 2.3). Accreditations are voluntary and led by evaluation committees that are formed and operate according to General Guidelines issued by the Ministry of Economy.6 These evaluation committees are formed by up to 6 technical experts, a representative of producers, a representative of consumers, a technician from EMA, a public sector official and up to two representatives from academia or research centres. The work of these evaluations committees follows the procedures established by the EMA and the monthly and annual programmes of work of the entity.

Once a CAB issues an accreditation request, the evaluation committee sets up a special team to assess the accreditation according to procedures established per sector. To date, the EMA has 10 evaluation committees that assess 29 accreditation procedures. On average, the accreditation process takes 4 months.

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Table 2.3. Activities performed by the EMA

Participation in the development of technical regulations and standards

Occasionally

Accreditation against technical regulations (NOMs)

Yes

Accreditation against voluntary standards (NMXs)

Yes

Metrology functions

No

Conformity Assessment Procedures

No

Regulatory Inspection and/or market surveillance

Yes

Source: Author’s own elaboration.

In addition, EMA is occasionally invited to participate in certain sessions of CCNNs discussing the drafting of a proposed NOM or NMX. EMA is also responsible for surveilling CABs compliance with the requirements under which their accreditation was issued and maintains a list of CABs with suspended or cancelled accreditations.

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Box 2.7. The Memorandum of Understanding between UKAS and BEIS

The United Kingdom Accreditation Service (UKAS) was established in 1995 and is the single national body responsible for the accreditation of conformity assessment bodies in the United Kingdom.

In March 2019, the Secretary of State for Business, Energy and Industrial Strategy (BEIS) and UKAS entered into a Memorandum of Understanding (MoU) that provides the way in which both entities work together to maintain and promote a strong national accreditation service and clarifies the roles and responsibilities of each institution.

The MoU is an operational and voluntary document that establishes the details of the scope of activities, governance and accountability of UKAS and the forms of support across institutions. An Appendix sets out the basis for this BEIS monitoring of UKAS through delivery of documentation on a periodic basis and upon request, regular meetings, participation of BEIS as a member in certain UKAS activities and sharing of independent reviews.

Source: (BEIS/UKAS, 2019[5]).

copy the linklink copied!CAPs in Mexico: Experience from specific sectors

In Mexico, certain laws governing specific sectors establish special conformity assessment procedures that diverge from the regime set under the LFMN. This section presents specific conformity assessment techniques, taking place in the health and agricultural sector.

COFEPRIS

The Federal Commission for the Protection of Sanitary Risks (Comisión Federal para la Protección Contra Riesgos Sanitarios, COFEPRIS) is Mexico’s health authority. COFEPRIS is a decentralised and autonomous body that oversees the enforcement of four regulations on medical devices, health control of products and services, environmental health and pesticides. In total, COFEPRIS has 81 NOMs under its authority.

The LFMN recognises that the procedures for verification and testing of products, activities and services regulated in the General Health Law (Ley General de Salud, LGS) part from the default regulatory delivery regime and are specially governed by this sectoral law.7 This regime differs from the framework set under the LFMN on a number of fronts. Certain health-related NOMs, for example, do not embed a specific CAP since their assessment is carried out by sanitary inspection and testing activities set forth in the LGS. In addition, the organisation of CABs in this sector is led by COFEPRIS and does not rely on Mexico’s accreditation infrastructure. Finally, the LGS also provides for specific pre-market and post-market regulatory delivery mechanisms as well as sanctions for non-compliance. In fact, NOMs are only used in health for medical labelling (NOM137 – Labelling of medical devices) and the post-market surveillance (NOM240 – Installation and Operation of Technosurveillance).

As part of its activities, COFEPRIS supervises health facilities, control of advertising activities, and monitors the manufacturing, import and export of health products. Although it does not follow the CAP process under the LFMN, COFEPRIS requires that most medical devices, pharmaceuticals and other health products are registered before they are placed on the market, after they have been demonstrated to be safe through a combination of testing, inspection and certification.

Authorised Third Parties

In Mexico’s health sector, conformity assessment activities are carried out directly by COFEPRIS or by specially authorised third parties (Terceros Autorizados, ATPs). Authorised third parties support health control and inspection activities through testing, verification or by performing bioequivalence and/or bio comparability studies. The authorisation can fall on four types of bodies: testing laboratories; verification units; biocomparability and interchangeability testing units. As of June 2019, there were 212 third parties authorised by COFEPRIS (115 testing laboratories, 28 verifications units, and 69 biocomparability and interchangeability testing units) (COFEPRIS, 2019[6]). The statement of conformity issued by an ATP is an opinion (dictamen).

ATPs must meet the requirements set in the LGS and Regulation of Health Supplies (Reglamento para Insumos de la Salud) to secure their technical competences and the integrity, impartiality and confidentiality of their activities. Authorisations are voluntary and once a request is submitted a technical evaluation committee assesses the application. These evaluations are carried out according to guidelines issued by COFEPRIS for each type of authorised body. COFEPRIS periodically publishes calls for expressions of interest to be authorised to act as an ATP for a specific regulation or NOMs.

COFEPRIS is responsible for overseeing the activities of ATPs, including through inspections aiming to ensure that they continue to meet the conditions under which they were authorised. The authorisation may be revoked or suspended if an ATP fails to meet the requirements set in the LGS or regulations. COFEPRIS publishes a record of authorised ATPs as well as revoked or cancelled authorisations.

Registration of Medical Devices

Distributors or manufacturers are required to prove the device’s safety and efficacy before sale. There are two paths to this registration of compliance with Mexican requirements for medical devices. Through the standard path, the distributor shows approval of the device in the manufacturer’s home market and proof of a certified quality management system (e.g. ISO 13485 certificate). A second path involves the use of a Third Party Reviewer. TPRs are public or private entities authorised by COFEPRIS to provide a technical report on the medical device’s efficacy, based on the dossier sent by the manufacturer or Mexican distributor for the medical device. Once reviewed by a TPR, the information is submitted to COFEPRIS for a final registration certificate. If necessary, COFEPRIS may request additional information. However, the use of a TFR normally speeds up the registration certificate process.

In addition, COFEPRIS recognises the certificates of a number of other jurisdictions, often unilaterally. Medical devices approved by the US FDA and Health Canada can apply for registration without an extensive technical review. Additionally, the USMCA further strengthens the mutual recognition of pre-market health product approval processes. The Pharmaceutical Annex of the USMCA states that:

Each Party shall ensure that for a measure it applies to ensure the safety, effectiveness, or quality of pharmaceutical products, including marketing authorizations, notification procedures, and elements of either, products imported from the territory of another Party be accorded treatment no less favorable than that accorded to like products of national origin and to like products originating in any other country, in a comparable situation. (Article 12.F.5 of the Annex to the USMCA)

The Annex further states that the three countries will share information on pharmaceuticals upon certification by a competent authority.

SENASICA Federal Inspections Type (TIF) Certification

The National Service of Health, Food Safety and Agri-food Quality (Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria, SENASICA) is a deconcentrated body of the Ministry of Agriculture and Rural Development (Secretaría de Agricultura y Desarrollo Rural, SADER). SENASICA is responsible for the prevention of epidemics and diseases that affect agriculture, aquaculture and animal husbandry. In addition, it regulates and promotes the application of mechanisms to reduce the risk of food contamination.

In 2014, SENASICA published the requirements and specifications for the authorisation of third parties that carry out conformity assessment procedures in the sector. These third parties (órganos coadyuvantes) are private entities or individuals authorised to verify, certify, diagnose and confirm that regulated subjects comply with their regulatory requirements—particularly NOMs. Although third parties perform most of the conformity assessment procedures, if deemed necessary SENASICA can inspect and audit its regulated subjects directly.

For NOMs and regulations related to meat products and by-products, SENASICA created the Federal Inspections Type Certification (Tipo Inspección Federal, TIF). A TIF certified establishment is a slaughter facility for animals, refrigerators and industries of beef, poultry, eggs, dairy, honey, sausages and cold meats that is subject to permanent sanitary inspections to verify that the place and the processes comply with the regulations indicated by the SADER.

Establishments that wish to receive the TIF certification are required to have an authorised veterinarian—who is in charge of carrying out the conformity assessment procedures—on the premises. Furthermore, in export-oriented establishments the authority appoints an additional independent veterinarian. SENASICA determines the requirements and criteria that the veterinarians must follow for assessing regulatory compliance in the slaughter facilities. It also provides online guides and manuals—including instructions for animal welfare, inspections, and maintaining sanitary conditions—to meet the stringent criteria. According to information from SENASICA, by August 2019 there were two accreditation bodies of TIF establishments in Mexico and 471 certified premises, which produce more than 60% of the beef available in the market.

Anecdotal evidence shows that compliance with NOMs is generally better in industries that are strongly export-oriented. As TIF establishments are the only ones eligible to export, this certification has helped reduce the risk of diseases, improved national supply of meat and its by-products, and benefited the national economy. Moreover, as discussed in greater detail in Chapter 3, SENASICA appears to have developed a more robust risk-based approach to enforcement that helps to maintain the integrity of this sector.

References

[1] APEC (2000), APEC Information Notes on Good Practice for Technical Regulation, APEC, https://www.apec.org/~/media/Files/MinisterialStatements/Annual/2000/00_scsc3_017.doc.

[5] BEIS/UKAS (2019), Memorandum of Understanding between the the Secretary of State for Business, Energy and Industrial Strategy (BEIS) and the United Kingdom Accreditation Service (UKAS), https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/816809/MoU-BEIS-UK-Accreditation-service.pdf.

[6] COFEPRIS (2019), Relación de Terceros Autorizados, https://www.gob.mx/cofepris/documentos/relacion-de-terceros-autorizados (accessed on 4 September 2019).

[3] IAF (2019), IAF Members & Signatories, https://www.iaf.nu//articles/IAF_MEMBERS_SIGNATORIES/4 (accessed on 16 September 2019).

[4] ILAC (2019), ILAC MRA and Signatories, https://ilac.org/ilac-mra-and-signatories/ (accessed on 16 September 2019).

[2] OECD/ISO (2016), International Regulatory Co-operation and International Organisations: The Case of the International Organization for Standardization (ISO), OECD/ISO, https://www.oecd.org/gov/regulatory-policy/ISO_Full-Report.pdf.

Notes

← 1. International Network on Quality Infrastructure https://www.bipm.org/en/news/full-stories/2018-12-inetqi.html.

← 2. NOM-005-SCFI-2017 on Supply and Measurement Systems and Instruments for Petrol and Liquid Fuels – Specifications, and testing and verification methods (NOM-005-SCFI-2017 Instrumentos de medición-Sistema para medición y despacho de gasolina y otros combustibles líquidos-Especificaciones, métodos de prueba y de verificación").

← 3. Conformity Assessment Procedure for NOM-199-SCFI-2017 on Alcoholic Beverages – Denomination, Physico-chemical Specifications, Comercial Information and Testing Methods (Proyecto de Procedimiento para la Evaluación de la Conformidad de la Norma Oficial Mexicana NOM-199-SCFI-2017, Bebidas Alcohólicas- Denominación, Especificaciones Fisicoquímicas, Información Comercial y Métodos de Prueba) published in the Official Gazette on 4 September 2019.

← 4. The LFMN defines interested parties as all accredited entities, users of accreditation services, professional associations or academics, industrial and trade chambers, higher education institutions, research centres and public entities involved in the activities subject to accreditation.

← 5. In November 2017, COFECE launched an investigation over possible barriers to entry and competition in the normalisation, accreditation and evaluation sectors.

← 6. Ministry of Economy Guidelines on the composition, organisation and co-ordination of Evaluation Committees (Lineamientos para la integración, organización y coordinación de los Comités de Evaluación, dictados por la Secretaría de Comercio y Fomento Industrial).

← 7. LFMN, Article 108.

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