From Quality Infrastructure to Sustainability: A 14-Step Roadmap for Voluntary Conformity Assessment in Brazil and Beyond

Abstract

Quality Infrastructure (QI) underpins safe, sustainable, and competitive markets through metrology, standardization, accreditation, conformity assessment, and market surveillance. While mandatory schemes address immediate safety concerns, voluntary conformity assessments offer strategic advantages for emerging technologies by enabling market differentiation, regulatory anticipation, and gradual adaptation without compliance burdens. Focusing on Brazil’s National Institute of Metrology, Quality, and Technology (Inmetro), this study addresses operational gaps in implementing voluntary schemes under the modernized regulatory framework introduced by Inmetro’s Ordinance No. 30/2022. Using electric mobility to illustrate sustainability pathways, we show how voluntary assessments can operationalize and enable measurement of environmental and social co-benefits. Our five-stage qualitative methodology integrated documentary analysis of Brazilian regulations; comparative examination of approaches in the European Union, the United States, and South Korea; development of a 14-step methodological roadmap aligned with ISO/IEC standards; expert validation through a structured questionnaire with twelve specialists from government, industry, academia, and certification bodies; and systematic consolidation of feedback. The roadmap provides operational guidance on product definition, technical requirements, certification processes, and continuous improvement, with optional modules for advanced technologies and ESG criteria. Expert validation confirmed viability while identifying barriers (costs, laboratory capacity, cultural limitations) and enablers (fiscal incentives, procurement recognition). When applied to electric mobility, voluntary battery certification enhances safety and performance, charging infrastructure assessment improves reliability, and component schemes enable circular economy principles, directly supporting the Sustainable Development Goals. We conclude that strategically designed voluntary conformity schemes can accelerate regulatory convergence, strengthen competitiveness, and contribute to sustainability outcomes in modernizing economies.

1. Introduction

Quality Infrastructure (QI) represents a critical institutional framework underpinning market functionality, consumer protection, and sustainable development through the systematic integration of metrology, standardization, accreditation, conformity assessment, and market surveillance [1,2,3]. Beyond its traditional role in ensuring product safety and technical compliance, QI increasingly serves as a strategic instrument for operationalizing sustainability transitions, particularly in emerging sectors where regulatory frameworks are still evolving [2,3,4].

The concept of voluntary conformity assessment has gained prominence as economies seek to balance innovation incentives and precautionary governance. Unlike mandatory regulatory schemes that impose immediate compliance obligations, voluntary assessments offer manufacturers strategic advantages, such as market differentiation through quality signaling, early adaptation to emerging standards, reduced regulatory uncertainty, and enhanced stakeholder trust [2,5]. These mechanisms are particularly valuable in technology-intensive sectors experiencing rapid innovation cycles, where prescriptive regulations may quickly become obsolete or stifle technological development.

In Brazil, the National Institute of Metrology, Quality, and Technology (Inmetro) serves as the central executive body of the National System of Metrology, Standardization, and Industrial Quality (Sinmetro). Its mandate encompasses drafting technical regulations, conducting conformity assessments, and exercising administrative enforcement powers to ensure market compliance with legal and technical requirements [6]. However, the country’s QI landscape has undergone a significant transformation following the introduction of Ordinance No. 30/2022 [7], which established a modernized regulatory model emphasizing flexibility, results orientation, and risk-based approaches aligned with Industry 4.0 principles and the demands of the digital economy.

This regulatory modernization creates both opportunities and challenges. While Inmetro’s new framework explicitly recognizes voluntary conformity assessment as a scalable approach for risk mitigation and enhancement of industrial competitiveness [7], operational guidance for developing and implementing such schemes is limited. This gap is particularly problematic for emerging sectors such as electric mobility, where voluntary assessments can facilitate sustainability transitions while preserving innovation flexibility [8,9].

1.1. The Case for Voluntary Conformity Assessment

Extensive international experience demonstrates that voluntary conformity schemes deliver measurable benefits beyond traditional regulatory compliance. First, they provide market differentiation mechanisms that reward quality leadership, enabling premium positioning and consumer trust [1,10]. Since 1992, the Energy Star program has exemplified this approach, mobilizing thousands of partners in a voluntary, government-backed effort recognized by nearly 90% of U.S. households and helping save 5 trillion kWh of electricity, avoid more than $500 billion in energy costs, and prevent 4 billion metric tons of greenhouse gas emissions [11]. Second, voluntary schemes serve as regulatory testing grounds, allowing policymakers to evaluate technical requirements and implementation approaches before mandating compliance [2,12]. In the European Union, voluntary environmental labeling initiatives, such as the EU Ecolabel, were already in place before the 2005 Ecodesign framework introduced mandatory minimum requirements for energy-using products. Together with green public procurement policies and voluntary management schemes, these instruments helped build consumer trust and encouraged market uptake [13,14,15,16].

Third, voluntary assessment enables gradual supply chain adaptation, particularly benefiting small- and medium-sized enterprises (SMEs) that require time to develop compliance capabilities. Brazil’s Habitat Quality and Productivity Program (PBQP-H) demonstrates this principle: participation, initially voluntary in pilot arrangements, expanded toward broader sectoral coverage as technical capacity matured [17]. Fourth, voluntary schemes facilitate international harmonization by adopting global standards ahead of bilateral agreements, enhancing export competitiveness, and reducing technical barriers to trade [4].

1.2. Sustainability Integration and Electric Mobility

Electric mobility represents an ideal testbed for the sustainability potential of voluntary conformity assessments. As Brazil pursues its energy transition commitments under the Paris Agreement and Nationally Determined Contributions, electric vehicle adoption faces technical, economic, and institutional barriers, many of which can be mitigated through voluntary quality schemes that pilot requirements, verify performance, and build stakeholder trust [18]. Voluntary battery certification can enhance thermal safety standards beyond the minimum regulatory requirements, thereby reducing fire risks and extending operational lifespans. Charging infrastructure assessment can improve system reliability and interoperability, addressing key consumer adoption barriers while supporting grid integration [19,20,21].

These applications directly support multiple Sustainable Development Goals (SDG): SDG 7 (Affordable and Clean Energy) through improved charging system efficiency, SDG 9 (Industry, Innovation, and Infrastructure) via quality-assured technology deployment, SDG 12 (Responsible Consumption and Production) through extended product lifespans and circular economy principles, and SDG 13 (Climate Action) via accelerated clean technology adoption [1,12,22,23]. Thus, voluntary schemes transform technical conformity assessment from regulatory compliance to active sustainability implementation.

1.3. International Regulatory Models and Learning

A comparative analysis of international QI systems reveals convergent trends toward voluntary assessment integration, despite different institutional arrangements. The European Union uses harmonized standards that provide a presumption of conformity with legal essential requirements; their application is voluntary, offering manufacturers a recognized pathway to comply without prescribing specific technical solutions [24,25]. The United States relies on consensus-based voluntary standards coordinated through the American National Standards Institute (ANSI), and federal agencies preferentially use and adopt successful voluntary standards and programs in their regulatory and procurement practices [26]. South Korea operates a centrally coordinated standards and conformity assessment system and leverages digital safety surveillance platforms. Its laws also allow provisional conformity routes (including new product assessments and supplier declarations) and voluntary programs, which governments can use to trial requirements before tightening regulations [27,28,29,30,31].

These models demonstrate that voluntary conformity assessment succeeds when it is embedded within supportive institutional frameworks that provide market incentives, stakeholder engagement mechanisms, and technical infrastructure. Brazil’s challenge lies in adapting these international experiences to domestic institutional characteristics while addressing specific sectoral needs, such as electric mobility development.

1.4. Research Objectives and Contribution

This study addresses three interconnected objectives: (i) analyze Brazil’s modernized regulatory model through a comparative examination of approaches in the European Union, the United States, and South Korea, identifying convergent principles and adaptive mechanisms; (ii) develop a methodological roadmap for structuring voluntary conformity assessment schemes aligned with Inmetro’s risk-based framework and international standards; and (iii) evaluate practical implementation challenges and policy recommendations through expert validation and electric mobility case applications.

Our contribution to the regulatory governance literature lies in bridging the gap between regulatory modernization intent and operational implementation. While existing research broadly addresses QI systems or focuses on specific sectoral applications, few studies have examined voluntary scheme development methodologies or their potential for sustainability integration. By providing actionable guidance grounded in international best practices and domestic institutional realities, this study supports both the academic understanding of adaptive governance mechanisms and practical QI development.

The electric mobility focus enables a concrete demonstration of sustainability linkages, often claimed but rarely operationalized in the QI literature. Rather than treating sustainability as an abstract policy goal, we show how voluntary conformity assessment generates measurable environmental and social co-benefits through enhanced product safety, improved energy efficiency, and reduced waste from premature failure or recalls. This approach contributes to the sustainability transition literature by demonstrating how technical standards and conformity assessments serve as policy instruments for achieving environmental objectives.

2. Materials and Methods

This study employs a qualitative, exploratory, and descriptive research design to develop and validate a methodological roadmap for voluntary conformity assessment schemes. Our approach integrates documentary analysis, comparative institutional analysis, expert validation, and systematic consolidation within a pragmatic research paradigm that prioritizes actionable knowledge generation for QI practitioners.

The research philosophy adopts a critical realist perspective, recognizing that regulatory institutions exist independently of our knowledge while acknowledging that our understanding is mediated through the interpretive frameworks. This positioning enables the examination of objective institutional structures (laws, standards, and organizational arrangements) while also incorporating subjective stakeholder perspectives on implementation challenges and opportunities.

Our methodological approach follows the established protocols for qualitative policy analysis and institutional comparisons [32,33,34]. The five-stage design ensures methodological rigor through triangulation of data sources, systematic analysis procedures, and iterative validation processes [32,33,35,36]. Each stage builds on the previous findings while maintaining analytical independence, enabling both cumulative knowledge development and critical evaluation of intermediate conclusions [35,37].

2.1. Stage 1: Analysis of Inmetro’s Regulatory Model

The first stage involved a systematic documentary analysis of Brazil’s modernized QI framework, focusing primarily on Inmetro Ordinance No. 30/2022 [7] and its supporting regulatory instruments. This analysis employed directed content analysis techniques [34,35,37] using predetermined coding categories derived from the regulatory modernization literature: flexibility mechanisms, risk-based approaches, stakeholder participation, digital integration, and international harmonization.

Document selection followed purposive sampling criteria, including (i) official regulatory instruments issued by Inmetro and related agencies (2020–2024); (ii) technical reports supporting regulatory modernization; (iii) public consultation documents and stakeholder submissions; and (iv) comparative studies commissioned during the modernization process. The primary sources included Ordinance No. 30/2022 [7], Ordinance No. 286/2022 [38], GM/MDIC Ordinance No. 301/2023 [39], and National Quality Infrastructure Strategy (ENIQ) documentation [40,41].

The analysis procedures followed the established documentary analysis protocols [32,33,37]. First, chronological mapping identified regulatory evolution patterns and key decision-making points. Second, we used thematic coding to extract the core principles, implementation mechanisms, and stakeholder requirements. Third, a gap analysis comparing regulatory intentions with operational guidance availability revealed a voluntary conformity assessment implementation deficit that motivated this research. Data validation involved multiple analyst reviews and source triangulation [34,37]. Discrepancies were resolved through discussion and examination of the source materials.

2.2. Stage 2: Comparative Analysis of International Regulatory Models

The second stage examined regulatory approaches in the European Union, United States, and South Korea through systematic institutional comparison. Country selection was theoretically motivated rather than convenience-based, following established frameworks for comparative institutional analyses [32,33]. The three cases represent distinct institutional arrangements that collectively span the range of contemporary QI governance models in the public sector.

The European Union exemplifies supranational harmonization through multilevel governance, where harmonized directives enable member-state adaptation while maintaining coherence in the single market. This model demonstrates voluntary conformity integration through the presumption of conformity mechanisms and staged regulatory implementation [24,25,42]. The United States represents decentralized federalism with strong private sector participation, emphasizing consensus-based, voluntary standards and market-driven compliance incentives [26]. South Korea illustrates centralized coordination combined with intensive digital technology applications, demonstrating how emerging economies can achieve regulatory agility through technological innovation [27,28,30,31].

Data collection employed structured institutional analysis protocols [32,37]. For each country, we examined: (i) legal frameworks defining QI governance structures; (ii) voluntary conformity assessment integration mechanisms; (iii) stakeholder participation procedures; (iv) market surveillance approaches; and (v) digital technology applications. Sources included primary legislation, regulatory agency publications, official guidance documents, and academic analyses of the operation of each system.

Analytical procedures followed the established comparative institutional methods [32,33,35]. First, the within-case analysis identified each system’s core characteristics, institutional logics, and operational mechanisms. Second, the cross-case pattern analysis revealed convergent trends and persistent differences. Third, adaptive mechanism identification examined how each system addresses similar challenges (innovation speed, market access, consumer protection) through different institutional arrangements.

The comparative framework employed four analytical dimensions derived from the regulatory governance literature: structural arrangements (centralized vs. decentralized authority), stakeholder integration (government-led vs. consensus-based), enforcement mechanisms (administrative vs. market-based), and technological integration (traditional vs. digital-first approaches). This framework enables a systematic comparison while respecting each system’s institutional context.

2.3. Stage 3: Development of the Methodological Roadmap

The third stage synthesized the findings from Stages 1–2 to develop a 14-step methodological roadmap for voluntary conformity assessment schemes. Roadmap development followed established research design protocols [32,34,36], treating the roadmap as a design artifact that requires both theoretical grounding and practical utility validation.

The theoretical foundations were drawn from three sources: (i) international conformity assessment standards, particularly ISO/IEC 17000:2020 [43], ISO/IEC 17065:2012 [44], and ISO/IEC 17067:2013 [45]; (ii) regulatory best practices identified through comparative analysis; and (iii) Inmetro’s risk-based regulatory model requirements. This multi-source grounding ensures international compatibility and domestic institutional alignment.

The design principles prioritized were as follows: logical sequencing of implementation steps, proportionality of requirements to risk levels, adaptability across sectors, and operational clarity for practitioners. Each step includes guiding questions to facilitate practical application and decision criteria to support the implementation choices. Optional modules (Steps 12–14) address advanced applications while maintaining the core process integrity.

The 14-step structure emerged through an iterative analysis of the conformity assessment lifecycle requirements. The core steps (1–11) address fundamental processes, including product definition, technical requirements, certification body selection, laboratory acceptance, scheme design, testing and audits, decision-making, mark usage, surveillance, nonconformity management, and continuous improvement. Optional steps address technological enhancement (Step 12), sectoral adaptation (Step 13), and sustainability and environmental, social and governance (ESG) integration (Step 14).

Each step specification includes clear objectives, input requirements, process descriptions, output deliverables, and quality criteria. This structured approach enables both systematic implementation and adaptive modification based on sectoral and organizational needs. The modular design of the roadmap allows for selective application while maintaining process coherence.

2.4. Stage 4: Expert Validation Through Structured Consultation

The fourth stage validated the methodological roadmap through structured expert consultation, using purposive/theory-based sampling to secure balanced representation across key QI stakeholder groups. Twelve experts participated—three each from academia, industry, the regulatory body (Inmetro), and certification bodies—an intentionally information-rich and manageable panel size for qualitative analysis that helps reduce single-perspective bias [32,34].

2.4.1. Expert Selection Criteria and Profiles

Academic experts were selected based on master’s or doctoral-level qualifications in relevant fields (for example, engineering/production/materials) and a minimum of eight years’ experience in quality infrastructure or related regulatory studies, with at least one PhD represented in the cohort. Industry representatives were required to be employed by firms subject to conformity assessment—mandatory or voluntary—and possess at least ten years of sectoral experience. Inmetro participants comprised technical staff from the national regulator with 15–30 years of professional experience in QI-related functions and policy implementation. Certification-body experts were required to be affiliated with recognized Brazilian certification bodies, to have a minimum of eight years of experience in conformity assessment, and to demonstrate involvement in the operation of voluntary schemes.

The 12-expert panel is consistent with qualitative expert-validation practice: purposeful, information-rich sampling with small, non-probabilistic panels judged by analytic adequacy rather than statistical power; while larger samples help quantification, qualitative consultation prioritizes depth, variation, and saturation over representativeness, and balanced institutional composition improves coverage while preserving feasibility [32,34,36,37].

2.4.2. Questionnaire Design and Data Collection

The validation questionnaire (detailed in Appendix A) employed a mixed-methods design that combined closed-ended assessment items with open-ended reflection questions [32,37]. Closed-ended questions addressed roadmap step clarity (5-point Likert scale), sectoral applicability assessment, implementation feasibility evaluation, and international standard alignment verification. Open-ended questions explored practical implementation challenges, missing elements or redundancies, sectoral adaptation requirements, and policy support recommendations.

Question development followed established survey-design principles—clear, single-focus items, avoidance of double-barreled wording, balanced scales, and cognitive pretesting—with two pilot interviews conducted with QI practitioners not included in the main sample [32,34]. The questions avoided double-barreling, employed clear language accessible to diverse professional backgrounds, and provided sufficient response space for detailed qualitative feedback.

Data collection employed online survey administration to accommodate geographical distribution and scheduling limitations. Participants received comprehensive briefing materials, including the full roadmap specification, a comparative analysis summary, and contextual background on Brazil’s regulatory modernization. The survey remained open for four weeks, with two reminder communications to ensure an adequate response time.

2.4.3. Analytical Approach

The analysis employed a convergent parallel mixed-methods design, analyzing quantitative and qualitative data streams independently before integration [32,36]. Closed-ended Likert items (n = 12) were summarized with simple counts and central tendency (means/medians) to orient interpretation; given the small purposive sample and the exploratory design, we refrain from inferential tests. The qualitative stream provided the primary evidence base, and integration focused on the convergence between frequencies of agreement and thematic explanations [34,35,37].

Integration analysis examined the convergence and divergence between quantitative assessments and qualitative explanations, revealing nuanced stakeholder perspectives on roadmap utility and implementation requirements. This approach enables both the validation of roadmap components and the identification of enhancement opportunities.

2.5. Stage 5: Systematic Consolidation and Refinement

The final stage consolidated expert feedback into roadmap refinements using systematic analysis and integration procedures. Consolidation employed established consensus-building techniques adapted from Delphi method protocols [32,34,37], although it was implemented through a single-round consultation due to resource constraints.

The analysis procedures included: (i) convergence identification across stakeholder groups on core roadmap elements; (ii) divergence analysis revealing different implementation priorities or concerns; (iii) gap identification where expert feedback revealed missing elements or unclear specifications; and (iv) enhancement prioritization based on the frequency of recommendations and potential impact assessment.

Refinement decisions balanced expert recommendations with theoretical and practical feasibility. Changes were implemented only when supported by multiple experts from different institutional backgrounds and were consistent with international conformity assessment standards. This approach ensured expert input integration while maintaining roadmap coherence and theoretical validity.

The consolidation process generated: (i) refined step specifications incorporating clarity improvements; (ii) enhanced implementation guidance addressing identified challenges; (iii) sectoral adaptation examples based on expert suggestions; and (iv) policy recommendation synthesis addressing systemic implementation barriers.

3. Results

This section presents the findings from the five methodological stages, organized into four analytical blocks: (i) analysis of Inmetro’s modernized regulatory model; (ii) comparative synthesis of international regulatory approaches; (iii) proposed 14-step methodological roadmap with a visual representation; and (iv) expert validation findings.

3.1. Analysis of Inmetro’s Modernized Regulatory Model

Inmetro Ordinance No. 30, published on 25 February 2022 [7], represents a paradigmatic shift from prescriptive, compliance-focused regulation to flexible, risk-based governance aligned with Industry 4.0 principles and digital economy demands. The modernized framework emphasizes four core principles: regulatory flexibility enabling adaptive responses to technological change, transparency through enhanced stakeholder participation, results-orientation prioritizing outcomes over procedural compliance, and systematic risk assessment informing proportionate regulatory responses [7].

This transformation addresses the documented limitations of Brazil’s previous regulatory approach, which was characterized by rigid technical requirements, bureaucratic processes, and limited stakeholder engagement [7]. The modernization process incorporated extensive public consultation, receiving over 900 stakeholder contributions that informed the final policy design [9]. This participatory approach enhances regulatory legitimacy by incorporating diverse sectoral perspectives on implementation challenges and opportunities.

The new model explicitly recognizes voluntary conformity assessment as a strategic instrument for regulatory risk mitigation, balancing implementation costs with standard effectiveness, while encouraging public–private collaboration [7]. This recognition creates opportunities for scalable, proportionate approaches to emerging technologies, where mandatory regulations might stifle innovation or impose disproportionate compliance burdens on smaller enterprises [7,8].

However, significant implementation gaps persist between regulatory intent and operational guidance. While Ordinance No. 30 establishes voluntary conformity assessment principles, it provides limited operational direction for scheme development, implementation, and performance evaluation [7,9]. This gap particularly affects emerging sectors, such as electric mobility, where voluntary schemes could facilitate technology adoption while building regulatory experience for future mandatory requirements.

Supporting regulatory instruments provide an additional implementation structure. Ordinance No. 286/2022 [38] established governance frameworks for regulatory transition management, creating oversight mechanisms and establishing stakeholder participation protocols. GM/MDIC Ordinance No. 301/2023 [39] operationalized technical advisory committees to support regulatory development through expert consultations and sectoral analyses. The National Quality Infrastructure Strategy (ENIQ), launched in 2023 with a ten-year implementation horizon, prioritizes regulatory modernization, digital transformation, and international integration [41].

The ENIQ provides a strategic direction for the evolution of the QI system while identifying priority sectors and implementation timelines. However, voluntary conformity assessment receives limited specific attention within ENIQ frameworks, reinforcing the operational guidance gap addressed in this study.

3.2. Comparative Analysis of International Regulatory Models

A systematic comparison of the European Union, the United States, and South Korean regulatory approaches reveals convergent trends toward voluntary assessment integration, despite different institutional arrangements and governance philosophies.

Table 1. Comparative Analysis of International Regulatory Models.

Dimension	European Union [24,25,42]	United States [26]	South Korea [27,28,30,31]
Structural Arrangement	Multilevel supranational governance; harmonized directives with member state implementation	Decentralized federalism; agency-specific authority with state autonomy	Centralized coordination; ministry-led with digital platform integration
Voluntary Assessment Integration	Presumption of conformity through harmonized standards; optional compliance ahead of mandates	Consensus-based voluntary standards; market-driven adoption with agency recognition	Conformity assessment aligned to international norms; risk-based method selection
Stakeholder Participation	Formal consultation in harmonized standard development; industry representation in technical committees	Public hearings; transparent consensus development through ANSI coordination	Digital platform feedback; industry-government collaboration in standard development
Market Surveillance	Coordinated network approach; ICSMS digital platform for information sharing; joint enforcement actions	Decentralized agency-specific surveillance; accident database integration; judicial enforcement emphasis	Intensive digital monitoring; CISS incident tracking; rapid corrective action protocols
Technology Integration	Digital documentation requirements; electronic conformity declarations	Voluntary technology adoption; industry-led innovation with regulatory recognition	Competent authority may set up and manage a product-safety information network; big data analysis system
Enforcement Philosophy	Administrative sanctions with criminal penalties in serious cases; proportionate response to risk levels	Civil liability emphasis; judicial system enforcement; market-based compliance incentives	Mandatory corrective actions; recalls for high risks; preventive intervention focus

summarizes the key characteristics across the analytical dimensions.

3.2.1. Convergent Trends Across Models

Three convergent trends emerged across all examined systems, suggesting universal principles for modern QI governance. First, risk-proportionate flexibility enables adaptive responses to different product categories, with voluntary schemes primarily applied to lower-risk products or emerging technologies, where premature mandatory regulation might impede innovation and slow market learning.

Second, international standard adoption provides robust technical harmonization mechanisms, with all three systems incorporating ISO/IEC conformity assessment standards (for example, ISO/IEC 17025 [46], 17065 [44], and 17000 series) into their national frameworks and guidance. This convergence facilitates international trade and regulatory interoperability while reducing technical barriers and total compliance costs for multinational manufacturers seeking timely market entry and cross-border acceptance.

Third, digital technology integration enhances surveillance effectiveness and stakeholder communication, although implementation approaches vary significantly. The EU emphasizes cross-border information sharing through the Information and Communication System for Market Surveillance (ICSMS) [24], the US relies on industry-generated data and consumer reporting systems [26], and South Korea employs comprehensive digital monitoring with predictive analytics [31].

3.2.2. Distinctive Approaches and Adaptive Mechanisms

Despite convergent trends, each system maintains a distinctive approach that reflects institutional legacies and governance philosophies. The EU’s supranational harmonization enables economies of scale in standard development while accommodating member-state diversity through flexible implementation mechanisms [24,25]. The presumption of conformity principle allows voluntary compliance with harmonized standards to satisfy regulatory requirements, thereby creating market incentives for early adoption.

The United States’ decentralized approach emphasizes consensus building and voluntary participation, with regulatory agencies adopting successful voluntary standards rather than developing parallel, mandatory requirements [26]. This approach minimizes the regulatory burden while leveraging private sector expertise and market mechanisms for compliance assurance.

South Korea’s centralized digital approach enables a rapid response to safety issues while maintaining innovation flexibility [30]. The Consumer Injury Surveillance System (CISS) processes more than 70,000 annual incident reports, providing real-time data for regulatory adjustments and immediate corrective actions when necessary [31].

3.2.3. Implications for Brazilian Context

Comparative analysis revealed several principles adaptable to Brazil’s institutional context. The EU’s reliance on essential requirements with voluntary harmonized standards that provide a presumption of conformity is consistent with risk-based, proportionate regulation and aligns with Inmetro’s modernized philosophy [24]. Likewise, the United States’ emphasis on consensus-based voluntary standards coordinated through the ANSI supports stakeholder buy-in and leverages private sector expertise [26].

South Korea’s digital integration strategies are particularly relevant to Brazil’s Industry 4.0 ambitions. However, successful adaptation requires careful attention to institutional capacity, stakeholder engagement, and existing regulatory culture [12].

3.3. Proposed 14-Step Methodological Roadmap

Based on the findings from the regulatory analysis and international comparison, we propose a structured 14-step methodological roadmap for voluntary conformity assessment scheme development. The roadmap integrates Inmetro’s risk-based principles with international best practices while providing operational guidance for practitioners.

3.3.1. Roadmap Logic and Sequential Structure

The roadmap follows a logical implementation sequence while maintaining flexibility for sectoral adaptation. The core steps (1–11) address fundamental conformity assessment requirements following the ISO/IEC 17067 scheme models [45]. Each step builds on the previous outputs while allowing iterative refinement based on stakeholder feedback and pilot implementation experience.

Steps 1–2 establish the foundational elements: clear product definition and technical requirements specification. These elements determine subsequent implementation choices and ensure alignment between the scheme’s objectives and market needs. Steps 3–4 address institutional requirements, ensuring that adequate certification bodies and laboratory capacities exist or can be developed.

Steps 5–8 operationalize the certification process through scheme design, testing protocols, decision procedures, and market communication mechanisms. These steps translate technical requirements into operational procedures while maintaining consistency with the principles of international conformity assessment.

Steps 9–11 address ongoing scheme management through surveillance, nonconformity handling, and continuous improvement. These elements ensure the scheme’s credibility over time while enabling adaptation to changing technical requirements or market conditions.

Optional steps (12–14) address advanced applications that may enhance the scheme’s effectiveness but are not essential for basic implementation. Step 12 incorporates digital technologies that can improve efficiency, transparency, and surveillance capabilities. Step 13 provides sectoral adaptation guidance for specialized industries with unique requirements. Step 14 integrates sustainability and Environmental, Social, and Governance (ESG) criteria for schemes targeting environmental or social outcomes.

The resulting framework is detailed in

Table 2. 14-Step Methodological Roadmap for Voluntary Conformity Assessment Schemes.

Step	Title	Guiding Question	Core Requirements
1	Product or Service Definition	What is to be certified?	Clear scope definition; risk assessment; market analysis
2	Technical Requirements and Assessment Standards	Which standards and regulations apply?	Standard selection; requirement specification; performance criteria
3	Certification Bodies	Which accredited bodies will perform review and decision?	ISO/IEC 17065 accreditation; technical competence; independence
4	Selection and Acceptance of Testing Laboratories	Are laboratories available per ISO/IEC 17025?	Laboratory accreditation; technical capability; capacity assessment
5	Certification Scheme	Which scheme model and why?	Scheme selection per ISO/IEC 17067; risk-proportionate design
6	Initial Testing and Audits	What initial verification is necessary?	Test protocol development; audit procedures; conformity evidence
7	Review and Certification Decision	Do results demonstrate conformity?	Decision criteria; review procedures; appeals process
8	Certification and Use of Marks of Conformity	How will certification be communicated?	Mark design; usage rules; market communication
9	Surveillance and Periodic Audits	How will conformity be monitored?	Surveillance frequency; monitoring procedures; nonconformity detection
10	Nonconformity Management	How will nonconformities be addressed?	Corrective action procedures; suspension/withdrawal criteria
11	Periodic Review and Continuous Improvement	How will schemes stay current?	Review frequency; stakeholder feedback; technical updates
12	Use of Advanced Technologies (Optional)	How can technology enhance efficiency?	Digital tools; AI applications; blockchain integration
13	Adaptation to Sectoral Context (Optional)	What sectoral adaptations are needed?	Sector-specific requirements; stakeholder engagement; pilot testing
14	Sustainability and ESG Criteria (Optional)	How can ESG practices be incorporated?	Environmental criteria; social impact; governance requirements

, which aligns each step with its guiding questions and essential implementation requirements.

3.3.2. Visual Representation and Implementation Guidance

Figure 1 provides a visual representation of the roadmap structure, illustrating the sequential relationships between steps while highlighting optional modules and feedback loops for continuous improvement. The flowchart format facilitates practitioner understanding by emphasizing decision points and adaptive pathways.

Each step includes detailed implementation guidance addressing input requirements, process activities, output deliverables, quality criteria, and common implementation challenges. This structured approach enables systematic implementation while allowing flexibility for organizational and sectoral adaptation.

3.4. Expert Validation Results

Expert consultation with 12 balanced stakeholders (three each from academia, industry, Inmetro, and certification bodies) provided both quantitative assessments and qualitative recommendations regarding the roadmap’s viability, relevance, and implementation requirements.

3.4.1. Quantitative Assessment and Roadmap Validation

The expert panel (n = 12) evaluated the roadmap using a 5-point Likert scale (1 = strongly disagree; 5 = strongly agree) across seven dimensions. All of them received strong endorsement, with means ranging from 4.17 to 4.83. The highest consensus was for ISO/IEC integration (mean = 4.83; 10 of 12 experts gave the maximum score), confirming that the roadmap is aligned with international conformity assessment standards. Structure and coherence (mean = 4.67) and roadmap adequacy (mean = 4.58) also scored highly, thereby validating the 14-step framework’s internal logic and completeness. Technology integration received comparatively lower scores (mean = 4.17), suggesting that although experts recognized the relevance of digital tools (Step 12), the implementation details and practical feasibility still required further specification. As a simple consensus indicator, the share of ‘agreement’ (scores 4–5) ranged from ~92% to 100% across the seven dimensions.

Table 3. Expert Validation: Likert Scale Assessment Results (n = 12).

Assessment Dimension	Mean	Median	Score 5	Score 4	Score 3	Score 2	Score 1
Structure & Coherence	4.67	5	8	4	0	0	0
Comparative Analysis	4.25	4	4	7	1	0	0
Roadmap Adequacy	4.58	5	7	5	0	0	0
ISO/IEC Integration	4.83	5	10	2	0	0	0
Technology Integration	4.17	4	3	8	1	0	0
ESG Criteria	4.33	4	4	8	0	0	0
Sectoral Adaptation	4.25	4	4	7	1	0	0

summarizes the quantitative results.

3.4.2. Qualitative Feedback and Enhancement Recommendations

Open-ended responses yielded high participation rates: all 12 experts (100%) responded to suggestions for improvement and implementation challenges, while 11 experts (92%) provided policy recommendations. Three recurrent themes emerged from the qualitative analysis.

First, visual aids and operational guidance were frequently requested. Five experts (42%) explicitly called for flowcharts, comparative tables, or diagrams to complement textual descriptions. One academic expert emphasized: “Producing a figure that addresses the 14 steps as a flow or relationship diagram would be valuable. Identifying bottlenecks and critical points is essential. Work presented only in text becomes more difficult to interpret”.

Second, performance indicators and monitoring mechanisms emerged as priorities for systematic evaluation. Three experts (25%) explicitly recommended incorporating Key Performance Indicators (KPIs) to enable continuous improvement tracking. One academic expert stated: “The inclusion of KPIs can make the conformity assessment process more transparent and measurable”. This feedback directly informed the enhancement of Step 11 (Periodic Review and Continuous Improvement) to include specific performance metrics.

Third, regulatory impact analysis as a foundational prerequisite was deemed essential by one Inmetro representative, who explicitly stated: “The choice of a regulatory alternative for creating a voluntary certification program should come from a Regulatory Impact Analysis (RIA). It is as if RIA were ‘step 0’, because it is through RIA that one understands the regulatory problem to be solved and/or the benefits to be achieved. Thus, the objectives of the voluntary program need to be clearly described and linked to solving a real problem”. This recommendation was incorporated into the methodological guidance preceding Step 1, thereby establishing RIA as a foundational prerequisite for voluntary scheme development.

3.4.3. Implementation Challenges and Barriers

Expert responses identified four primary implementation barriers, ranked by their frequency of mention:

Cost and financing constraints (mentioned by 10 of 12 experts; 83%): Initial certification costs, laboratory testing fees, and ongoing surveillance expenses create prohibitive barriers, particularly for SMEs. One academic expert noted: “High costs related to the implementation of certification systems; high costs with continuous investments in technology; additional costs related to information security”. Another certification body expert emphasized: “It is quite interesting to address more deeply the limitations of companies regarding the issue of investing in the costs of implementing metrological services. This is still a major challenge in the national scenario. It is worth reinforcing the thesis that SMEs often do not have resources available to qualify their products and end up not carrying out conformity programs”.

Limited voluntary assessment culture (mentioned by 10 of 12 experts; 83%): Experts consistently emphasized Brazil’s weak tradition in voluntary conformity schemes. One academic expert elaborated: “Our country does not have a strong tradition in voluntary conformity assessment systems”. One academic expert detailed: “Resistance from sectors: Lack of understanding and conformity culture—Smaller sectors may be resistant to adopting conformity programs due to lack of knowledge about the benefits of these initiatives”.

Laboratory capacity limitations (mentioned by 9 of 12 experts; 75%): Several experts noted that specialized testing capabilities for emerging technologies remain concentrated in a few laboratories, creating bottlenecks and increasing costs. One academic expert observed: “Part of the laboratories, especially in regions with less investment in R&D, may not meet the requirements demanded by the standards. There is also a lack of trained personnel and technical limitations in the laboratories”. One Inmetro representative highlighted the circular dependency: “Limitation of laboratory infrastructure, usually dependent on demand, which in cases where certification is voluntary, depends more on goodwill than on a legal requirement, which leads to difficulties in guaranteeing demand and consequently to a decrease in available laboratory infrastructure, especially for very specific tests”.

Knowledge gaps among SMEs (mentioned by 4 of 12 experts; 33%): Some experts highlighted that smaller enterprises frequently lack awareness of conformity assessment benefits and procedures. One academic expert noted awareness challenges among “smaller sectors”, while one certification body expert emphasized: “SMEs often do not have resources available to qualify their products and end up not carrying out conformity programs”.

3.4.4. Policy Enablers and Support Mechanisms

Experts identified four policy interventions to facilitate voluntary scheme adoption:

Fiscal incentives (mentioned by 7 of 12 experts; 58%): Tax credits, reduced fees, or accelerated depreciation for quality-related investments could offset certification costs and incentivize participation. One academic expert stated: “Align this with the government for fiscal incentives”. One Inmetro representative provided a concrete example: “For example, there are programs in PBE (Brazilian Energy Efficiency Labeling Program) that are voluntary to this day (such as the vehicle program), but articulation with other policies—such as fiscal policy, with the IPI (Brazilian Federal Tax on Industrialized Products) discount—motivates the industry to value and seek labeling”.

Stakeholder engagement platforms (mentioned by 6 of 12 experts; 50%): Regular forums bringing together regulators, industry associations, certification bodies, and consumer groups can ensure that schemes remain responsive to evolving needs. One certification body expert emphasized: “Arguments aimed at including more stakeholders in the sectoral development of programs, with the focus on increasing acceptance and reducing resistance of companies in general to voluntary certification”. One Inmetro representative noted the importance of communication: “Communication to society in general about the existence and importance of the topic creates demand for certified products to be prioritized by the consumer”.

Public procurement preferences (mentioned by 3 of 12 experts; 25%): Integrating voluntary certifications into government procurement scoring systems could create tangible market advantages for certified suppliers. One academic expert suggested: “Align with large stakeholders that dominate the supply chain governance, so that this becomes part of supplier evaluation programs”. One Inmetro representative referenced an existing model: “See the case of PBQP-H, in which the Ministry of Cities endorses the coordination of certification programs by sectoral entities”.

International cooperation and mutual recognition (mentioned by 2 of 12 experts; 17%): Bilateral or multilateral mutual recognition agreements (MRAs) reduce redundant testing requirements for exporters. One certification body expert mentioned: “International normative harmonization, through the adoption of standards such as ISO/IEC, can facilitate mutual recognition of certificates and reduce technical barriers to trade”.

4. Discussion

This section critically analyzes the findings by situating them within the existing literature on regulatory governance, QI, and sustainability transitions. We examine how the evidence contributes to theoretical understanding while addressing the practical implementation challenges identified through expert validation. The discussion demonstrates concrete applications to electric mobility as a sustainability testbed, elucidating the mechanisms through which voluntary conformity assessment can be operationalized and evaluated against environmental and social outcomes.

4.1. Theoretical Contributions to Regulatory Governance Literature

Our findings contribute to three intersecting streams of regulatory governance scholarship: adaptive regulation theory, QI evolution, and sustainability transitions. The proposed roadmap advances the adaptive regulation literature by providing operational mechanisms for implementing risk-based and flexible regulatory approaches that balance innovation incentives and precautionary governance.

4.1.1. Adaptive Regulation and Institutional Learning

The 14-step roadmap operationalizes key principles from adaptive regulation theory, particularly the concept of regulatory experimentation through voluntary schemes prior to mandatory implementation. Our comparative analysis reveals that successful QI systems employ voluntary assessment as a form of “regulatory sandbox,” enabling policymakers to test technical requirements, evaluate implementation approaches, and build stakeholder capacity before imposing mandatory compliance requirements.

The roadmap’s modular structure (core steps 1–11 plus optional enhancements 12–14) reflects this theoretical insight, enabling graduated regulatory engagement that adapts to sectoral characteristics and institutional capacity.

4.1.2. QI as Institutional Innovation

Our research contributes to the emerging literature on QI evolution by demonstrating how traditional compliance-focused systems can be transformed into strategic innovation enablers. Comparative analysis reveals that leading QI systems increasingly function as “institutional entrepreneurs,” creating new governance mechanisms that bridge public regulation and private market dynamics.

The Brazilian case illustrates this transformation process, with Inmetro’s modernized regulatory model representing a shift from bureaucratic control to collaborative governance. However, our findings reveal significant implementation gaps between regulatory intent and operational capacity, consistent with institutional change literature emphasizing the challenge of translating policy innovation into practice.

4.1.3. Sustainability Transitions and Technical Standards

This study addresses a significant gap in the sustainability transition literature by demonstrating how technical standards and conformity assessments function as policy instruments for environmental objectives. While transition literature extensively examines technology innovation, policy frameworks, and market dynamics, limited attention has been paid to the role of QI in enabling or constraining sustainability outcomes.

Our electric mobility analysis shows how voluntary conformity assessment generates measurable sustainability benefits: enhanced battery safety reduces fire risks and waste from premature failures, improved charging system efficiency supports grid integration, and component-level certification enables circular economy practices through traceability and recyclability verification.

4.2. Justification and Application of the 14-Step Roadmap

The roadmap’s structure reflects the systematic integration of international best practices with Brazil’s institutional context and emerging sector requirements. Each component addresses specific implementation challenges while maintaining coherence with the established conformity assessment principles.

4.2.1. Foundational Steps (1–2): Strategic Positioning

Step 1: Product or Service Definition addresses a critical implementation challenge identified across all examined regulatory systems: scope ambiguity, which undermines scheme credibility and market acceptance. In electric mobility applications, this precision is essential given the technological complexity and rapid evolution of the sector. Voluntary certification of electric vehicle batteries requires a clear specification of whether the assessment covers individual cells, integrated modules, or complete battery packs. IEC 62660-1:2018 [47] provides performance criteria for cells, while complete system assessment requires additional standards addressing thermal management, electrical safety, and energy efficiency.

Step 2: Technical Requirements and Assessment Standards operationalizes the risk-based approach central to modern regulatory philosophy. Rather than prescriptive compliance, this step emphasizes performance-based criteria that enable innovation while ensuring safe and high-quality outcomes. The European Union’s harmonized standards approach exemplifies this balance, providing a “presumption of conformity” for compliance with recognized technical specifications while allowing alternative demonstration methods to be used. This flexibility particularly benefits emerging sectors, where established standards may not capture all relevant performance characteristics.

4.2.2. Institutional Framework (Steps 3–4): Capacity Building

Step 3: Certification Bodies address institutional capacity requirements that constrain voluntary scheme implementation, particularly in emerging sectors. Our comparative analysis reveals that successful QI systems maintain robust accreditation frameworks that ensure certification body competence while avoiding unnecessary barriers to market access. Brazil’s challenge lies in expanding the capacity of certification bodies beyond traditional mandatory sectors to emerging areas such as electric mobility, renewable energy, and digital technologies. Expert consultations emphasized the need for laboratory capacity-building programs and the creation of certification body competence criteria for emerging sectors, necessitating targeted capacity building and international cooperation.

Step 4: Laboratory Infrastructure represents a critical bottleneck for voluntary scheme success, particularly in technology-intensive sectors that require specialized testing capabilities. For electric mobility, specialized testing requirements include battery performance evaluation, charging system compatibility, electromagnetic compatibility, and environmental stress testing. Domestic laboratory capacity development requires significant investment, but provides long-term benefits through reduced certification costs and faster market access for Brazilian manufacturers.

4.2.3. Operational Implementation (Steps 5–8): Process Design

Step 5: Certification Scheme Selection translates the ISO/IEC 17067 [45] scheme models into practical implementation guidelines. The standard provides multiple scheme options but limited guidance for selecting appropriate models based on product characteristics, risk levels, and market conditions. Our roadmap provides decision criteria based on risk assessment, supply chain characteristics, and regulatory contexts. For electric mobility components, Type 1a schemes (testing plus ongoing surveillance) are suitable for high-volume standardized products, such as charging cables, whereas Type 5 schemes (quality management system assessment plus product testing) better address complex integrated systems requiring ongoing design control.

Steps 6–8: Testing, Decision, and Communication address the operational core of conformity assessment while emphasizing transparency and stakeholder communication. The Energy Star program demonstrates effective voluntary mark communication, achieving high consumer recognition while delivering documented energy savings and cost reductions. Brazil’s challenge lies in developing similar market recognition for voluntary marks while avoiding consumer confusion regarding mandatory certification requirements.

4.2.4. Ongoing Management (Steps 9–11): Sustainability and Evolution

Step 9: Surveillance and Periodic Audits address scheme credibility over time, preventing the “race to the bottom” dynamic that can undermine voluntary program effectiveness. Our comparative analysis reveals that successful voluntary schemes maintain rigorous surveillance while adapting procedures to product risk levels and market feedback.

Step 10: Nonconformity Management provides systematic approaches for addressing compliance failures while maintaining the scheme’s integrity. Expert consultation highlighted the importance of establishing reputation management systems to prevent voluntary mark devaluation and maintain scheme credibility over time.

Step 11: Continuous Improvement institutionalizes scheme evolution, ensuring adaptation to technological changes, market developments, and regulatory updates. This step reflects adaptive regulation principles by embedding learning mechanisms into operational procedures.

4.2.5. Advanced Applications (Steps 12–14): Innovation and Integration

Step 12: Advanced Technologies addresses the growing role of digital tools in conformity assessment, from blockchain-based certificate verification to AI-enhanced surveillance systems. Although optional, technology integration can significantly enhance the efficiency, transparency, and market acceptance of a scheme.

Step 13: Sectoral Adaptation recognizes that different industries require tailored approaches while maintaining core conformity-assessment principles. Electric mobility exemplifies this need, with unique requirements for battery safety, charging infrastructure interoperability, and vehicle-grid integration that cannot be adequately addressed by generic schemes.

Step 14: Sustainability and ESG Integration respond to the growing demand for environmental and social impact assessments within quality frameworks. This step operationalizes the connection between technical conformity and sustainability outcomes, addressing a major gap in the existing QI literature.

4.3. Electric Mobility as Sustainability Implementation Testbed

Electric mobility provides an ideal demonstration of the sustainability potential of voluntary conformity assessment, revealing the concrete mechanisms through which QI delivers measurable environmental and social benefits.

4.3.1. Battery Safety and Circular Economy Integration

Voluntary battery certification beyond the minimum regulatory requirements can significantly enhance thermal safety, extend operational lifespan, and reduce fire risks that undermine consumer confidence in electric vehicle adoption. Enhanced safety standards also support circular economy principles by enabling second-life battery applications in stationary energy storage, maximizing resource utilization, and reducing waste generation.

4.3.2. Charging Infrastructure and Grid Integration

The voluntary certification of electric vehicle supply equipment (EVSE) beyond basic safety requirements can address the key barriers to electric mobility adoption: charging reliability, interoperability, and grid integration capability. Enhanced certification covering communication protocols, load management, and renewable energy integration directly supports grid modernization and clean energy deployment.

The roadmap’s sectoral adaptation module (Step 13) enables specific requirements for smart charging capabilities, vehicle-to-grid communication, and renewable energy certificate integration (RECI). These enhancements transform the charging infrastructure from a simple energy transfer to active grid management components that support electricity system sustainability.

4.3.3. Supply Chain Transparency and Social Impact

Voluntary certification can address the growing concerns regarding the sustainability of electric vehicle supply chains, particularly regarding battery mineral extraction and processing. Certification schemes that incorporate supply chain traceability, labor standards, and environmental impact assessments provide consumers and businesses with credible sustainability information while incentivizing responsible sourcing practices.

This application demonstrates how voluntary conformity assessments serve as governance mechanisms for global value chains, extending regulatory influence beyond national borders through market-based incentives. Brazilian manufacturers participating in voluntary schemes with sustainability criteria gain competitive advantages in increasingly ESG-conscious global markets.

4.4. Implementation Challenges and Policy Recommendations

Expert consultations and international comparisons have identified several key implementation challenges that require coordinated policy responses.

4.4.1. Financial and Capacity Constraints

Cost barriers disproportionately affect smaller enterprises that cannot absorb certification expenses without immediate market benefits. Expert consultation specifically highlighted that micro and small enterprises often lack available resources to qualify their products and frequently do not participate in conformity programs because of limited financial capacity and proportionally higher compliance costs. Several mitigation strategies may include graduated fee structures based on enterprise size, collective certification mechanisms that enable shared costs, and tax incentives for voluntary participation in the program.

Laboratory capacity limitations require strategic investments in specialized testing infrastructure, particularly for emerging technologies. Expert consultation emphasized the critical need for Brazil to increasingly invest in laboratory capacity and regional partnerships, including research centers and universities, while promoting policies with business associations, especially in areas distant from metropolitan centers. Strengthening these regional networks can facilitate access to metrological services and increase the dissemination of conformity assessment practices, promoting the inclusion of different company profiles, and productive sectors.

4.4.2. Cultural and Institutional Barriers

Brazil’s historically mandatory-focused regulatory culture creates unfamiliarity with the benefits of voluntary participation among both regulators and the industry. Successful cultural transformation requires sustained education, demonstration projects, and success story dissemination to show the value of voluntary schemes. Expert consultation recommended the implementation of training and continuous capacity programs, especially aimed at micro and small enterprises or sectors with less access to technical and financial resources, to expand the understanding of requirements and facilitate adherence to voluntary programs.

Institutional barriers include unclear scheme ownership, limited regulatory recognition, and inadequate stakeholder engagement. Expert consultation emphasized the need for enhanced stakeholder inclusion in sectoral program development, focusing on increasing acceptance and reducing resistance from companies to voluntary certification through systematic consultation processes that ensure the meaningful participation of all relevant parties. Addressing these challenges requires formal governance frameworks, institutional capacity building, and sustained political commitment to promote voluntary assessments. Recommendations include the development of tiered certification marks to enable gradual compliance building and the creation of support programs that amplify productive inclusion and allow greater adherence to the system.

4.4.3. Market Recognition and Incentive Alignment

Voluntary schemes fail without adequate market recognition or participation incentives. Expert consultation emphasized the fundamental importance of structuring communication strategies directed at society, consumers, and suppliers, promoting the value of certified products, and encouraging their prioritization in the market. Policy mechanisms for enhancing scheme value include: public procurement preferences for certified products, integration with environmental labeling programs, and recognition in regulatory fast-track procedures.

Industry representatives specifically recommended developing tiered certification marks to enable gradual compliance building, creating a differentiation philosophy similar to energy efficiency labels for air conditioners that could be adapted to other industrial segments. This approach would stimulate competitiveness and expand market acceptance of voluntary conformity, as demonstrated by successful experiences such as the Brazilian Vehicle Labeling Program (PBEV), where articulation with fiscal policies provides direct incentives for industry participation.

International cooperation agreements enabling the mutual recognition of certification results can expand market access while sharing implementation costs and technical expertise. These agreements should facilitate regular consultation processes and ensure that certified suppliers have clear benefits, such as reduced commercial barriers and greater access to international markets. Brazil’s Mercosur leadership position provides opportunities for regional voluntary scheme harmonization, creating larger markets for certified products and building collective technical capacity.

Expert consultation also highlighted the importance of defining and systematically monitoring Key Performance Indicators (KPIs) for voluntary conformity assessment programs. These indicators, such as adherence rates, certification time, incidence of non-conformities, and participant satisfaction levels, contribute to transparency, measurability of results, and guidance for continuous improvements in the system.

4.4.4. Regulatory Integration and Governance

Successful voluntary scheme implementation requires integration with broader regulatory modernization initiatives under ENIQ and Inmetro’s risk-based model. This integration demands clear governance frameworks, adequate institutional capacity, and systematic performance measurements that enable adaptive management. Expert consultation emphasized that a key challenge is the actual institutional implementation of regulatory changes. Despite the innovations proposed by Ordinance 30/2022, its practical operationalization remains limited, revealing institutional obstacles that still need to be overcome for the effectiveness of the new regulatory model.

A fundamental aspect of the legitimacy and formal recognition of voluntary conformity assessment programs is the clear definition of the program owner (“scheme owner”). According to Ordinance Inmetro 30/2022, this responsibility can be assumed by Inmetro itself or by sectoral entities, provided that there is endorsement or formal legitimation by a competent body. The transparent identification of the scheme owner and formal recognition of the program by public bodies expand governance, credibility, and the potential use of these programs as support for official regulations.

As a preliminary step to voluntary scheme development, the RIA ensures a systematic evaluation of costs, benefits, and alternative approaches before implementation. Expert consultation emphasized the importance of integrating this process into voluntary scheme planning to establish an evidence-based foundation for decision making. This alignment with international best practices strengthens institutional credibility and supports transparent, data-driven scheme designs.

4.5. Research Limitations and Future Directions

This study has several limitations that create opportunities for future research. The expert validation sample, while balanced across stakeholder groups, remains limited to 12 participants and may not capture the full diversity of perspectives within each institutional category. Future research should employ larger samples and more diverse geographical representations to enhance generalizability.

While providing a concrete sustainability demonstration, the focus on electric mobility limits the sectoral generalizability of the findings. Future research should examine roadmap applications across different technological sectors and risk profiles to refine implementation guidance and identify sector-specific requirements.

The methodological limitations include reliance on documentary analysis and expert consultation without direct implementation observation. Future research should conduct longitudinal case studies on voluntary scheme implementation, examining real-world application challenges and adaptive responses over time.

Priority Research Directions

Several research directions have emerged from this analysis. First, an empirical analysis of existing voluntary conformity assessment schemes conducted by Inmetro would provide a baseline understanding of current practices, documenting successes and failures to identify factors favoring scheme acceptance, effectiveness, and sustainability.

Second, a comparative analysis of voluntary scheme implementation across different Brazilian sectors would reveal sectoral adaptation requirements while identifying common implementation patterns and challenges. This research can inform targeted policy support and capacity-building initiatives.

Third, a longitudinal impact assessment of voluntary schemes on sustainability outcomes would strengthen the evidence base for QI contributions to environmental and social objectives. Such research could develop metrics for measuring scheme effectiveness while identifying optimization opportunities for future studies.

Fourth, international comparative research examining voluntary scheme mutual recognition mechanisms could inform Brazil’s strategy for regional and global QI integration, supporting export competitiveness while reducing compliance costs for multinational manufacturers.

5. Conclusions

This study addresses the operational gap between Brazil’s modernized regulatory framework and the practical implementation of voluntary conformity assessment schemes, demonstrating how structured QI approaches can deliver measurable sustainability outcomes while strengthening industrial competitiveness. Our findings contribute to the regulatory governance literature while providing actionable guidance for QI practitioners in Brazil and comparable modernizing economies.

5.1. Addressing Research Objectives

Our first objective—analyzing Brazil’s modernized regulatory model through international comparison—reveals that Inmetro’s risk-based framework aligns with global trends toward adaptive, flexible governance while facing implementation challenges common to institutional transformation processes. The comparative analysis of European Union, United States, and South Korean approaches demonstrates convergent principles: risk-proportionate flexibility, international standard adoption, and digital technology integration, despite different institutional arrangements and governance philosophies.

These findings extend the adaptive regulation theory by demonstrating how voluntary conformity assessment serves as a bridging mechanism between market-based governance and command-and-control regulation. The Brazilian case illustrates both the opportunities and challenges of translating policy innovation into operational practice, consistent with the institutional change literature that emphasizes implementation complexity.

Our second objective—developing a methodological roadmap for voluntary scheme structuring—produces a theoretically grounded, practically validated framework integrating international best practices with Brazil’s institutional context. The 14-step roadmap operationalizes key principles of modern regulatory governance: systematic risk assessment, stakeholder engagement, continuous improvement, and performance-based requirements.

Expert validation confirmed the roadmap’s viability and relevance while identifying implementation barriers (cost constraints, laboratory capacity limitations, and cultural unfamiliarity with voluntary assessment) and enablers (fiscal incentives, public procurement recognition, and international cooperation) that require coordinated policy responses. The roadmap’s modular structure enables adaptive implementation across different sectors and institutional capacities while maintaining the integrity of conformity assessment.

Our third objective—evaluating practical implementation through the electric mobility application—demonstrates the concrete mechanisms through which voluntary conformity assessment generates sustainability outcomes. Battery certification beyond the minimum requirements enhances thermal safety and enables circular economy applications through extended lifecycles and second-life utilization of batteries. Charging infrastructure assessment improves system reliability and grid integration capability, thereby supporting clean energy deployment and electricity system modernization.

These applications directly advance multiple SDGs: SDG 7 through improved energy efficiency and renewable integration; SDG 9 via quality-assured infrastructure deployment; SDG 12 through responsible consumption enabled by product transparency and traceability; and SDG 13 via accelerated clean technology adoption. This concrete demonstration addresses a significant gap in the sustainability transitions literature by showing how technical standards function as policy instruments for environmental objectives.

5.2. Theoretical and Practical Contributions

Theoretically, this study contributes to three intersecting literature streams. In regulatory governance, we demonstrate how voluntary conformity assessments operationalize adaptive regulation principles through systematic implementation frameworks that balance innovation incentives and precautionary governance. In QI evolution, we show how traditional compliance systems transform into strategic innovation enablers through collaborative governance mechanisms. In sustainability transitions, we provide expert-informed and practice-oriented insights into how technical standards can enable environmental and social co-benefits and their future measurement.

Practically, the validated roadmap bridges the operational gap between regulatory modernization intent and implementation. Unlike existing guidance that emphasizes what should be done, our framework provides systematic directions on how voluntary schemes can be developed, implemented, and maintained. The roadmap’s integration of core conformity assessment requirements with optional modules for technology integration, sectoral adaptation, and sustainability criteria enables flexible application while maintaining the systematic rigor of the process.

5.3. Policy Implications and Recommendations

Successful voluntary conformity assessment implementation requires coordinated policy support to address identified barriers while leveraging available enablers. Financial constraints affecting smaller enterprises can be mitigated through graduated fee structures, collective certification mechanisms, and tax incentives that recognize the public benefits of voluntary participation. Laboratory capacity limitations require strategic investment in specialized testing infrastructure, potentially through government-industry partnerships, following South Korea’s successful model.

Cultural transformation from mandatory-focused to voluntary-inclusive regulatory approaches requires sustained education, demonstration projects, and success story dissemination to show scheme value for innovation, competitiveness, and sustainability. Institutional barriers, including unclear governance frameworks and limited regulatory recognition, require formal policy attention through scheme ownership definitions, stakeholder engagement protocols, and integration with broader regulatory-modernization initiatives.

Market recognition and participation incentives can be enhanced through public procurement preferences, environmental labeling integration, and fast-track regulatory procedures for certified products. International cooperation agreements enabling mutual recognition expand market access while sharing implementation costs and technical expertise, leveraging Brazil’s regional leadership position for Mercosur’s harmonization initiatives.

5.4. Sustainability and Competitive Advantages

The electric mobility application demonstrates how voluntary conformity assessments transform technical compliance into active sustainability implementation. Enhanced battery certification reduces environmental impact through improved safety, extended lifecycles, and circular economy enablement. Charging infrastructure assessment supports grid modernization and renewable energy integration, which are essential for the successful energy transition.

These sustainability benefits can create competitive advantages for Brazilian manufacturers in increasingly ESG-conscious global markets while supporting domestic policy objectives, including the Paris Agreement commitments and energy transition goals for Brazil. Thus, voluntary schemes align private sector incentives with public sustainability objectives through market-based mechanisms rather than regulatory mandates.

The sustainability integration of the roadmap (Step 14) provides systematic approaches for incorporating environmental and social criteria into technical conformity assessments, addressing the growing demand for comprehensive impact evaluation. This integration transforms QI from regulatory compliance to strategic sustainability implementation, supporting a broader transformation toward a circular economy and responsible production practices.

5.5. Implementation Pathway and Next Steps

Successful roadmap implementation requires a phased approach, beginning with pilot applications in receptive sectors such as electric mobility, renewable energy, or digital technologies, where voluntary certification provides clear market advantages. Pilot programs enable the accumulation of implementation experience, stakeholder capacity building, and approach refinement before broader sectoral application.

Priority implementation steps include: establishing clear governance frameworks defining scheme ownership and institutional responsibilities, developing stakeholder engagement mechanisms that ensure representative participation in scheme design, creating financial support programs that address cost barriers for smaller enterprises, and building laboratory capacity in priority technological areas through strategic investment and international cooperation.

Regulatory integration requires the formal recognition of voluntary schemes within Inmetro’s modernized framework, including integration with Regulatory Impact Analysis procedures and alignment with National Quality Infrastructure Strategy objectives. Performance measurement systems that enable adaptive management and continuous improvement should be implemented from program inception rather than added retrospectively.

5.6. Final Reflection

QI’s evolution from compliance enforcement to strategic innovation enablement reflects a broader transformation in governance approaches that emphasize collaboration, adaptability, and outcome orientation over prescriptive control. Voluntary conformity assessment represents a key mechanism in this transformation, enabling graduated regulatory engagement that supports innovation while ensuring safety, quality, and sustainability.

Brazil’s experience with regulatory modernization and voluntary scheme development provides valuable insights for other modernizing economies facing similar challenges in balancing innovation promotion, consumer protection, and environmental responsibility. The proposed roadmap contributes to this broader learning process while addressing Brazil’s specific implementation needs.

The connection between technical conformity assessment and sustainability outcomes demonstrated through electric mobility applications shows how QI can serve as a policy instrument for achieving environmental and social objectives. This connection is becoming increasingly important as societies worldwide grapple with sustainability transitions that require coordinated technological, economic, and institutional changes.

We conclude that strategically designed voluntary conformity assessment schemes, implemented through systematic methodological approaches and supported by appropriate policy frameworks, can accelerate regulatory convergence, strengthen industrial competitiveness, and deliver quantifiable sustainability outcomes in Brazil and comparable modernizing economies. The proposed framework provides actionable guidance for realizing this potential, while contributing to broader debates on adaptive governance and sustainability transitions.