Conferencia 2 Control Interno

Welcome to the Quality Management System Audit Conference

Opening Remarks

• The conference begins with a warm welcome to participants, emphasizing gratitude for their presence on a Saturday morning.

• Introduction of Don Héctor Ocampo, an expert in auditing and quality management, who will share valuable insights during the session.

• Acknowledgment of faculty members present from various locations, including Ana Ramos and Luis Roberto Vargas.

Conference Agenda

• Overview of the session's agenda: opening remarks, general instructions, expert presentation by Don Héctor Ocampo, Q&A session, and closing remarks.

• Instructions for participants include keeping microphones muted to minimize distractions and using chat for questions throughout the presentation.

Introduction of Don Héctor Ocampo

Speaker Background

• Don Héctor is introduced as a licensed Industrial Engineer from the University of Costa Rica with extensive experience in quality management systems.

• He holds certifications in ISO 9001, ISO 4001, and ISO 45001 and has worked with various organizations since 1998.

Professional Experience

• His roles include being a partner at Evolución Gestión Empresarial and serving on boards related to accreditation standards in Costa Rica.

• With over 30 years of experience advising organizations across sectors on implementing ISO-based management systems.

Key Topics Discussed by Don Héctor Ocampo

Understanding Quality Management Systems

• Emphasis on understanding what constitutes a quality management system and its importance within organizational frameworks.

Changes in Standards

• Discussion about significant changes in Costa Rica's National Quality System law affecting current practices.

• Updates regarding ISO 9001 nearing publication; highlights upcoming changes that will be implemented soon.

Related Normative Changes

• Mention of other standards undergoing revisions alongside ISO 9001 such as ISO 9000 (terms/definitions), which are crucial for conceptual clarity.

Organizational Support Strategies

Strategic Focus Areas

• Four main focus areas when assisting clients: strategic direction, management systems approach, process orientation, and governance structures.

Governance Structures

• Importance of governance processes including corporate oversight bodies like boards and internal audit functions.

• Compliance with regulations is essential for effective risk management within organizations.

Performance Evaluation

• Highlighting performance evaluation through key indicators that measure results and impact.

• Internal audits play a critical role in assessing system effectiveness.

Continuous Improvement and Governance

Importance of Resource Management

• Organizations must manage various types of resources to enhance process capabilities, particularly for users.

Achieving Desired Outcomes

• The focus is on generating expected results across different management systems, including quality, environment, information security, and business continuity.

Operational Processes

• Key operational aspects include planning and controlling operations, purchases, production, service delivery, and customer distribution to ensure clients achieve desired outcomes.

Competitiveness and Sustainability

Differentiation from Competitors

• Clients should aim to distinguish themselves from direct competitors to become preferred choices among customers.

Contribution to Community Progress

• Organizations need to address sustainability by contributing positively to the social progress of both internal and external communities while maintaining environmental balance.

Outsourcing Governance Support

Role of Advisory Services

• The organization focuses on providing governance outsourcing services that help clients with strategic approaches, system integration, process management, and functional structuring.

Training for Clients

• Experts are available to provide training in various topics relevant to client needs as part of the advisory services offered.

Ecosystem for Conformity Evaluation

Understanding Internal Systems

• The discussion begins with evaluating the ecosystem for conformity within organizations and how they connect with national quality management systems and international bodies.

Key Topics in Certification

• Important themes include accreditation and certification across various domains such as management systems, products, and personnel qualifications.

Basic Concepts in Management Systems

Designing Management Disciplines

• Essential elements required daily for effective design within management disciplines will be discussed alongside basic concepts related to auditing these systems under ISO standards.

Drivers for Sustained Success

Identifying Key Drivers

• Organizations must recognize key drivers necessary for achieving sustained success amidst global challenges that present both threats and opportunities. This includes systematic monitoring of their context rather than passive awareness through news outlets.

Systematic Vigilance Protocol

Establishing Monitoring Protocol

• It’s crucial for organizations to establish a vigilance protocol that encompasses macro-environmental factors like political, economic, environmental, legal aspects along with stakeholder engagement including customers and suppliers.

Contextual Intelligence Development

Utilizing AI in Vigilance

• Developing contextual intelligence through AI can enhance organizational vigilance by alerting them about significant events that may impact business continuity or present new opportunities.

Governance Structure Assessment

Importance of Effective Governance

• Assessing governance structures is vital; poor governance leads to disorganization akin to a body without a head—clarity in leadership roles is essential for effective decision-making processes within organizations.

Corporate Governance Levels

Understanding Corporate Governance

• Corporate governance involves two levels: the highest level (the corporate government), which oversees understanding stakeholder needs while guiding corporate management decisions based on internal/external contexts affecting performance outcomes.

Importance of Management Systems in Governance

Planning and Implementation

• High management must plan governance systems to ensure effective implementation and verification through indicators, internal audits, and management reviews.

Continuous Improvement vs. Accountability

• Organizations can either focus on continuous improvement or accountability by reporting progress to the Board of Directors based on prior guidance.

Risk Awareness in Governance

• Effective governance requires awareness of risks, opportunities, compliance with regulations, stakeholder commitments, and the role of internal auditors.

The Role of Internal Auditors

Legal Framework for Internal Auditing

• The law governing internal control provides a framework for how organizations should manage their internal auditing processes.

Corporate Governance vs. Corporate Management

• Corporate governance is likened to a clean slate while corporate management is compared to Earth, where practical results are achieved.

Key Success Drivers in Organizations

Importance of Strong Governance

• Properly implemented governance is crucial; weak governance often leads to high failure rates among small businesses within three years.

Competitiveness as a Success Driver

• Competitiveness involves surpassing direct competitors and becoming the preferred choice for customers through strong brand image.

Customer Experience Dimensions

Attraction, Satisfaction, and Loyalty

• Three key verbs—attraction, satisfaction, loyalty—are essential for achieving competitiveness through positive customer experiences.

Customer Journey Insights

• Customers begin their journey by identifying needs and searching for solutions via online searches or recommendations from acquaintances.

Stages of Customer Interaction

Purchase Decision Process

• After deciding on a product or service purchase, customers experience it which leads to satisfaction assessment and feedback opportunities.

Feedback Mechanisms

• Post-experience feedback can be reactive or proactive; satisfied customers may become brand advocates promoting the organization further.

Security Considerations in Business Operations

Nature-Specific Security Needs

• Security requirements vary by business type; common concerns include business continuity and information security relevant across sectors.

Strategic Agenda: Sustainability

Societal License to Operate

• Organizations must prioritize sustainability in their strategic agendas to gain societal acceptance for operations today.

Reputation Over Image

• Demonstrating environmental balance is critical amidst climate change challenges.

• Social progress focuses on community well-being influenced by organizational activities.

• Economic growth includes job creation and responsible tax contributions.

Profitability as an Outcome

Trust Building with Stakeholders

• Trust encourages current owners' continued investment while attracting new investors.

• Revenue growth should ideally be consistent year-over-year or exponential over time.

Productivity Focus

• Emphasizing productivity helps reduce costs related to sales expenses and operational overhead while maintaining cash flow efficiency.

Indicators of Organizational Health

Sustainable Customer Experience Cycle

• The organization's ability to monitor performance relies heavily on its operational cycle concerning sustainable customer experiences.

Innovation as a Core Strategy

• Innovation can occur across various dimensions including customer experience enhancement, safety improvements, environmental initiatives, revenue generation strategies, and productivity enhancements.

Importance of Competitive Marketing in Lead Generation

Role of Sales in Closing Opportunities

• The marketing strategy should focus on attracting leads that fit the ideal customer profile, known as the buyer persona.

• Sales teams are responsible for closing these opportunities, emphasizing the need to maximize case closures.

Customer Experience and Operational Planning

Planning and Control of Operations

• Customer experience involves planning and controlling operations based on sales demand and value propositions derived from innovation.

• Effective planning is essential for managing necessary purchases, which extend beyond raw materials to include services and processes.

Distribution Challenges Post-Production

Market Distribution Strategies

• Once production capabilities are established, companies must strategize distribution for both national markets and exports.

• Service-oriented businesses also require effective market entry strategies similar to manufacturing firms.

The Customer Journey: From Innovation to Loyalty

Stages of Customer Engagement

• The process begins with innovation leading to sales, followed by supply chain management, culminating in customer service aimed at loyalty.

• Each stage is interconnected; successful organizations audit their attractiveness, customer satisfaction, and loyalty metrics regularly.

Key Success Factors in Business Operations

Essential Capitals for Organizational Growth

• Organizations require strong financial capital to facilitate growth; poor financial management can hinder adaptation efforts.

• Human capital is crucial; competent internal staff or outsourced personnel significantly impact operational success. Physical infrastructure varies by industry but remains critical for production or service delivery needs.

Embracing Digital Transformation

The Role of Digital Capital

• Digital transformation is increasingly vital; companies failing to adapt within three years risk obsolescence.

• Integration of digital tools like ERPs enhances operational efficiency while supporting sustainability initiatives such as carbon footprint calculations through ESG modules.

National Quality System Framework

Overview of Legal Framework

• The National Quality System established by law 10473 aims to create a robust ecosystem for technical standardization in Costa Rica, enhancing organizational compliance with international standards through INTECO's coordination with ISO and IEC entities.

Technical Normalization and Regulation in Costa Rica

Overview of Technical Normalization

• The speaker discusses the importance of voluntary technical normalization in Costa Rica, highlighting their direct participation in Committee 776 during the review of standards like Series 9000.

• Emphasis is placed on the establishment of a National Council for Technical Regulation by the Ministry of Economy, Industry, and Commerce, marking a significant development in regulatory practices.

Role of International Organizations

• The transition of accreditation responsibilities from the Ministry of Science and Technology to the Ministry of Economy signifies an important shift in oversight.

• Participation in international forums such as the International Accreditation Forum (IAF) allows Costa Rica to align with global accreditation standards across various sectors including laboratories and certification bodies.

Metrology and Market Surveillance

• The role of metrology is crucial for managing physical variables; Costa Rica's metrology laboratory operates under the Ministry's guidance alongside international organizations like the International Bureau of Weights and Measures.

• Market surveillance conducted by the Ministry ensures that efforts in technical normalization, regulation, accreditation, and metrology positively impact the Costa Rican market.

Quality Policy Development

• A new national quality policy has been introduced through legislation aimed at strengthening long-term quality planning within Costa Rica’s National Quality System.

• The previous law (8279 from 2002) was updated with this new law published in May 2024, reflecting two decades' worth of changes needed for modern governance.

Strengthening Public Procurement Processes

Enhancements to Public Procurement

• New regulations incentivize public procurement processes by awarding additional points to companies that present certifications for their management systems or products during bidding.

Implications for Businesses

• This approach encourages businesses to adopt quality management systems as it provides them competitive advantages when selling to state entities.

Understanding Management Systems within ISO Framework

Introduction to ISO Standards

• Discussion shifts towards understanding basic concepts related to planning, evaluating, and improving management systems under ISO norms.

High-Level Structure Decision by ISO

• In 2012, ISO established a high-level structure aimed at harmonizing various management system standards which previously had inconsistent structures making integration difficult.

Benefits of Harmonized Structure

• This harmonized structure mandates that all future standards adhere to minimum requirements ensuring consistency across different certifications such as ISO 9001 (Quality), ISO 14001 (Environment), etc.

Estructura de Normas y Requisitos Básicos

Introducción a la Estructura de Alto Nivel

• Se establece que todas las normas comparten una estructura común de 10 capítulos, lo cual es fundamental para su comprensión y aplicación.

• Las normas utilizan terminología uniforme y definiciones básicas sobre sistemas de gestión, permitiendo una integración más sencilla entre ellas.

Alcance y Objetivos

• Cada norma incluye una introducción que aborda el ciclo PHVA (Planificar, Hacer, Verificar, Actuar), integrando temas como procesos y pensamiento basado en riesgos.

• La lógica del ciclo PHVA se refleja en los requisitos establecidos en los capítulos posteriores, donde se planifica primero antes de implementar y evaluar.

Elementos Clave del Sistema de Gestión

Definición del Contexto Organizacional

• Es crucial definir el alcance del sistema de gestión dentro de la organización, estableciendo límites claros para su aplicación.

• Se deben definir políticas claras (ej. política de calidad o ambiental), así como objetivos alineados con estas políticas.

Responsabilidades y Liderazgo

• El capítulo 5 enfatiza la responsabilidad de la alta dirección en demostrar liderazgo y compromiso hacia las políticas establecidas.

• Es esencial establecer roles claros dentro de la estructura organizativa para asegurar un funcionamiento efectivo.

Abordaje de Riesgos y Oportunidades

Planificación Estratégica

• Desde 2012, se ha incluido un enfoque sistemático para identificar riesgos y oportunidades basados en el contexto organizacional.

• Se requiere planificar acciones específicas para abordar estos riesgos dentro de los procesos operativos.

Implementación Práctica

• La implementación efectiva implica gestionar recursos humanos, comunicación e información documental necesaria para el éxito del sistema.

Evaluación del Desempeño

Indicadores y Auditorías Internas

• La evaluación del desempeño incluye la generación de indicadores clave que reflejan resultados e impactos significativos sobre el sistema gestionado.

• Las auditorías internas son fundamentales para revisar el cumplimiento normativo; difieren significativamente entre gestión corporativa y gestión interna.

Ciclo Continuo de Mejora

• El proceso culmina en un ciclo continuo donde se ajustan políticas, objetivos y procesos según las necesidades cambiantes del entorno organizacional.

Análisis Estratégico

Diagnóstico Organizacional

• Realizar un análisis contextual permite formular estrategias efectivas alineadas con misión, visión y valores organizacionales.

Establecimiento de Límites

• Definir claramente los límites aplicables a cada disciplina asegura que se aborden adecuadamente aspectos críticos como calidad, sostenibilidad económica y social.

Estrategias de Gestión y Políticas Organizacionales

Importancia del Alcance y las Políticas

• La necesidad de trabajar en el alcance se relaciona con la apuesta a temas relevantes para la organización.

• Se plantean políticas de calidad y ambientales que reflejan intenciones y compromisos hacia el futuro.

Gestión de Riesgos

• Es crucial identificar, analizar, evaluar riesgos y oportunidades para establecer estrategias adecuadas.

• Se presentan cuatro estrategias para gestionar riesgos:

• Terminar el riesgo (dejar de hacer la actividad).

• Tratar el riesgo (implementar controles operacionales).

• Transferir el riesgo (apoyarse en terceros).

• Tolerar el riesgo (no actuar si es bajo).

Tratamiento de Riesgos

• Las acciones para abordar riesgos deben ser definidas dentro de los procesos organizacionales, asegurando que sean medibles y coherentes con las políticas establecidas.

• La planificación de cambios es esencial para adaptar la organización a nuevas realidades, trabajando en procesos mediante gobernanza, apoyo y operación.

Auditorías y Estructura Organizacional

Requisitos para Auditorías

• Para realizar auditorías internas o externas, es necesario tener políticas, objetivos claros y controles establecidos; sin esto no se puede auditar efectivamente.

Nuevas Realidades en la Estructura Organizacional

• La estructura organizativa debe considerar tanto personal interno como externo e incluso robots desempeñando roles específicos dentro de la empresa. Esto refleja una transformación digital significativa.

Digitalización y Competencias Necesarias

Cambios en Normativas ISO

• La inminente publicación de la ISO 1911 destaca cómo las empresas están automatizadas; los auditores deben adaptarse a esta nueva realidad digitalizada.

Desafíos para Auditores

• Los auditores necesitan habilidades digitales avanzadas para auditar sistemas automatizados; aquellos que no se adapten corren el riesgo de quedar obsoletos.

Habilitadores Clave en Procesos Organizacionales

Evaluación del Desempeño

• Los capítulos 4 a 9 de las normas abordan desde la gestión hasta la mejora continua, incluyendo indicadores clave y revisiones por parte de la dirección. Esto es fundamental para asegurar un desempeño óptimo dentro del marco normativo establecido.

Estructura Corporativa Moderna

• Las organizaciones deben entender que pueden tercerizar o robotizar funciones sin depender exclusivamente del personal interno; esto elimina excusas sobre falta de recursos humanos disponibles.

Automation in Internal Auditing and Governance Structures

The Role of Automation in Internal Auditing

• The board of directors, technical support committees, and control bodies are increasingly utilizing automation for internal audits.

• Mention of "Waxon," an IBM-developed software that conducts comprehensive audits rather than sampling, identifying movements that trigger alerts.

• Global trends show significant automation in internal auditing, compliance with regulations, and risk management.

Governance Structure Overview

• Control bodies play a crucial role in understanding, guiding, and supervising corporate governance execution.

• The board directs corporate management starting from the CEO down to operational roles where internal auditing is vital.

Distinction Between Types of Internal Audits

• Clarification on the difference between corporate governance internal audit and corporate management internal audit; both serve different functions within the organization.

• Corporate governance audits are independent while management audits may involve personnel from various departments.

Organizational Management Support

• Staff supporting general management focuses on planning, evaluating, and improving management systems across various organizational aspects like finance and human resources.

Governance Lines Explained

• Introduction of a new terminology: "first line of governance" replaces "first line of defense," emphasizing proactive engagement in fulfilling organizational missions.

• The second line consists of three entities focused on understanding, guiding, and supervising operations.

• The third line represents independent internal auditing aimed at oversight.

Changes Introduced by ISO Standards

Key Changes in ISO Normative Framework

• Summary provided on major changes introduced by the ISO standards focusing on organizational context regarding climate change impacts (Chapter 4).

Climate Change Considerations

• Organizations must adapt to climate change effects as per ISO 9001 requirements affecting supply chains and infrastructure.

Stakeholder Engagement Adjustments

• New emphasis on stakeholder verification concerning climate change requirements; previously a requirement now noted for consideration.

Cultural Integration into Quality Management

• Chapter 5 introduces culture as a critical element alongside quality ethics; leadership must demonstrate commitment to these values.

Risk vs. Opportunity Planning Enhancements

• Chapter 6 separates risks from opportunities into distinct sections (6.1.1 for risks; 6.1.2 for addressing risks; 6.1.3 for opportunities), urging organizations to focus equally on both aspects.

Operational Changes Overview

• Minimal changes noted in Chapter 8 related to operational processes; however, adjustments were made throughout other chapters including performance evaluation (Chapter 9).

Final Adaptations in Improvement Processes

• Chapter 10 consolidates previous sections into two main areas aligning with harmonized structures without introducing disruptive changes but enhancing maturity levels overall.

Cambios en la Norma ISO 9001:2026

Introducción a los cambios normativos

• La norma está evolucionando desde 2015 y se implementará en 2026, marcando un cambio de madurez más que disruptivo.

• Se espera que las empresas tomen tiempo para revisar estos cambios con calma, dado el periodo de casi 11 años entre versiones.

Importancia de los cambios

• Aunque los cambios son significativos, se esperaba algo más innovador; sin embargo, esto es lo que regirá durante los próximos siete años.

• A partir del año cinco tras la publicación, habrá una consulta sobre si la norma se mantendrá o cambiará nuevamente.

Proceso de transición

• Las empresas tendrán tres años de transición después de la publicación en septiembre de 2026 para adaptarse a la nueva norma sin perder su certificación actual (ISO 9001:2015).

Auditorías y Normativa ISO 19.011

Actualización sobre auditorías

• La versión actual de la norma ISO 19.011 es del 2018 y se publicará una nueva edición en 2026.

Planificación de auditorías

• Es crucial planificar auditorías anualmente, semestralmente o trimestralmente para verificar el cumplimiento del sistema con la norma ISO 9001:2015.

Conceptos Básicos sobre Auditoría

Definición y metodología

• Una auditoría debe ser un proceso sistemático, independiente y documentado con criterios claros para garantizar objetividad e imparcialidad.

Tipos de auditorías

• Existen tres tipos principales:

• Primera parte (auditoría interna).

• Segunda parte (auditoría por clientes o proveedores).

• Tercera parte (auditorías externas por entes acreditadores).

Competencias Requeridas para Auditores

Nuevas exigencias digitales

• Se enfatiza la necesidad de competencias digitales en auditores internos debido al aumento en auditorías remotas y mixtas según lo estipulado por la norma ISO 19.011.

Gestión del Riesgo en Auditorías

Enfoque crítico en auditorías

• La nueva normativa enfatiza auditar aspectos críticos e importantes para las organizaciones, integrando gestión de riesgos como un componente clave del programa anual de auditoría.

Establecimiento del Alcance y Objetivos

Detalles operativos del plan de auditoría

• El alcance y objetivos deben estar claramente definidos antes de realizar cada auditoría, incluyendo ubicación física o virtual y actividades específicas a auditar.

Criterios y Evidencia en Auditoría

Definición clara de criterios

• Los criterios incluyen sistemas ya establecidos como políticas, objetivos y requisitos legales aplicables a calidad según el negocio específico.

Importancia de evidencia objetiva

• Los informes deben basarse en hechos verificables; ejemplos incluyen declaraciones directas durante entrevistas que confirmen el cumplimiento o incumplimiento dentro del sistema auditado.

Auditing Processes and Findings

Observational Techniques in Auditing

• Observations are crucial for identifying non-compliance with operational criteria, such as product storage methods. For instance, finding products on the floor instead of on wooden pallets indicates a violation of business rules.

• Additional verification can be conducted through laboratory tests to ensure that products meet established requirements, providing a more comprehensive understanding of compliance.

Generating Audit Findings

• Once evidence is collected, it is compared against established criteria to identify audit findings. These findings can indicate either conformity or non-conformity based on whether operations align with planned objectives.

• Non-conformities may vary in severity (major or minor) depending on their potential impact and likelihood of occurrence, highlighting the importance of risk assessment in auditing processes.

Classifying Audit Findings

• Audit findings can be categorized into three types:

• Conformity: Operations are effective and aligned with plans.

• Non-Conformity: Operations deviate from plans or do not meet requirements.

• Observations: Situations where there is a high risk of future non-conformance despite current compliance. This allows auditors to recommend preventive actions rather than corrective ones.

Conclusions from Audit Findings

• Comparing audit findings against initial objectives leads to conclusions regarding the convenience, adequacy, or effectiveness of systems in place:

• Convenience: Systems tailored effectively to needs.

• Adequacy: Compliance with all audit criteria and successful implementation.

• Effectiveness: Achievement of expected results such as timely delivery and legal compliance in manufacturing contexts.

Environmental and Safety Considerations

• Effectiveness also encompasses environmental impacts like reduced energy consumption and pollution control measures across various domains including air, water, soil, and wildlife protection efforts. Additionally, workplace safety metrics focus on minimizing accidents and health issues among employees.

Establishing an Effective Audit Program

Setting Clear Objectives

• It is essential to define clear objectives for the overall audit program while assessing risks or opportunities that could affect these goals; this includes establishing a detailed calendar for upcoming audits alongside other strategic initiatives like digital transformation within auditing practices.

Preparing for Audits

• The preparation phase involves creating an audit plan that includes checklists and sampling strategies before conducting site audits which typically start with an opening meeting between auditors and auditees to clarify details about risks and timelines involved in the process.

Conducting Audits

• During audits, data collection occurs through systematic observation leading up to report generation which outlines findings along with recommendations followed by a closing meeting where results are discussed comprehensively before finalizing reports for distribution.

Follow-Up Activities Post-Audit

Ensuring Corrective Actions

• After delivering reports, follow-up activities focus on ensuring that identified non-conformities have been addressed adequately by verifying corrective actions taken by auditees while also monitoring ongoing compliance with established schedules for audits and training programs aimed at enhancing auditor competencies especially concerning digitalization efforts within auditing frameworks.

Understanding Non-Conformities

Identifying Specific Issues

• An example highlighted involves quality management where failure to document the scope of the quality management system was noted as a significant issue during an audit review indicating a lack of adherence to required standards outlined in relevant regulations (e.g., ISO). This emphasizes the need for thorough documentation practices within organizations' quality systems as part of maintaining compliance standards set forth by governing bodies like ISO 9001 standards outlined specifically under section 4.3 regarding documented information requirements related directly back towards organizational performance metrics being evaluated during audits themselves .

Understanding Quality Management System Audits

Importance of Requirements in Planning

• The lack of awareness regarding requirements can hinder effective planning for policies, objectives, and processes.

Contextualizing Findings

• Each finding, particularly non-conformities, must be contextualized before drafting reports. For instance, the scope of the quality management system should be documented accurately.

Justifying Scope and Context

• It is crucial to justify the significance of findings; understanding the context helps determine how they affect other elements within the quality management system based on stakeholder expectations.

Observations vs Non-Conformities

• An observation indicates conformity but carries a high risk of becoming a non-conformity if not addressed properly. This distinction is vital during audits.

Independence in Auditing Teams

• A case highlighted that auditors from the area being audited may compromise objectivity; thus, it’s essential to ensure independence in audit teams to maintain impartiality.

Addressing Audit Findings

Documenting Observations

• When documenting observations related to auditor selection, it's important to note potential risks associated with bias due to internal affiliations within audit teams.

Recommendations for Auditor Selection

• It is advisable that auditors do not belong to the department being audited; external auditors or cross-departmental collaboration can enhance objectivity and fairness in audits.

Digital Transformation in Documentation

• The use of software for managing documentation ensures compliance with standards by automating processes like creation, updating, and archiving documents effectively.

Conformance and Compliance

Conclusion on Conformance Findings

• The auditor concluded that conformance was achieved as the organization utilized appropriate software for document management which aligns with quality management standards.

Clarity in Reporting Audit Findings

• Reports should be concise and focused on key findings without excessive detail; clarity enhances communication effectiveness during audits.

Future Trends in Quality Management Standards

Evolving Standards: ISO 19011:2026

• Upcoming changes emphasize risk-based approaches and require auditors to possess competencies relevant to digital systems increasingly used today (e.g., automation and AI).

Challenges Ahead for Costa Rica

• Questions arise about Costa Rica's readiness for new ISO standards given their complexity; understanding terms like "observation" versus "finding" will be critical as organizations adapt.

This structured summary captures key insights from the transcript while providing timestamps for easy reference back to specific discussions within the content.

Transitioning to New Standards in Management Systems

Overview of Organizational Transition

• The transition to new management standards is not expected to be significant for many organizations, as some have already adapted well.

• Cultural aspects will require attention, particularly for companies that are still developing their risk management strategies.

• The speaker expresses disappointment that the ISO 9001 standard did not change significantly despite suggestions from the committee.

Importance of Auditor Training

• Emphasizes the need for auditors to be trained in auditing mixed systems, including both remote and on-site audits.

• Highlights a shift in auditing focus towards how robots are trained within automated systems, such as those seen at Amazon.

Digital Transformation Challenges

• Auditors must understand digital systems like ERPs and apps to effectively conduct audits; this knowledge is crucial due to ongoing digital transformation.

• The speaker notes that recent legislation has improved national infrastructure, which supports smoother transitions for organizations adopting management systems.

The Role of Management Systems in Business Growth

Encouraging Adoption of Management Systems

• The main challenge lies in encouraging more companies to adopt management systems rather than addressing issues with those already established.

Insights on Audit Findings Terminology

• A participant discusses a shift from using "findings" to "results" within an internal audit context, emphasizing the importance of outcomes over mere compliance checks.

Understanding Audit Results and Findings

Clarifying Definitions

• Discussion on whether findings should be termed results; highlights confusion between these terms based on different contexts (e.g., Contraloría).

Types of Audit Outcomes

• Audit results can include various categories beyond conformity or non-conformity, such as obstacles encountered during the audit process.

Documentation and Compliance Issues

Evidence Requirements in Audits

• All findings must be supported by objective evidence; assumptions cannot replace documented proof during audits.

Maintaining Documentation Standards

• Organizations must maintain updated documentation regarding their scope, policies, and objectives as per ISO standards.

• Differentiates between maintaining necessary information versus conserving documented evidence generated through processes.

Understanding Documented Information Requirements in Management Systems

Importance of Documented Information

• When managing a system manually, reliance on paper forms or Excel is common; however, automated systems like ERP retain data automatically.

• The standard mandates that documented information from management reviews must be preserved, including meeting minutes detailing the date, participants, discussions, and agreements.

• While some aspects of the standard require documentation (e.g., management review), others do not mandate it (e.g., context analysis).

Compliance and Non-Conformity

• If documentation is required by the standard and is absent, it constitutes a non-conformity. Conversely, if documentation isn't mandated but is created voluntarily, it becomes part of the system's requirements.

• A lack of required documents leads to non-conformity against specific clauses (e.g., clause 7.5).

Observations vs. Non-Conformities

• An observation indicates compliance but highlights potential weaknesses in controls that could lead to risks materializing.

• Observations are considered conformities; they serve as warnings rather than violations.

Closing Remarks and Group Activities

• The session concludes with a request for group photos involving colleagues and students to document participation.

• Participants are encouraged to turn on their cameras for group pictures as a way to foster community engagement.

Technical Adjustments for Group Photos

• There’s a suggestion to increase the number of visible participants in the video call from 25 to 49 for better photo opportunities.