Aligning ISO 9001 with quality management principles

Introduction

In an increasingly competitive and globalized business environment, organizations are constantly looking for ways to improve their performance, satisfy their customers, and stay ahead in their respective markets. One of the most effective approaches to achieve this is through the implementation of a robust and well-structured quality management system (QMS). ISO 9001:2015 has become a global benchmark for establishing the requirements necessary to implement and maintain an effective quality management system.

The objective of this article is to explore how the alignment of ISO 9001 requirements with quality management principles can transform a quality management system, optimizing its performance and generating sustainable competitive advantages. Throughout this text, we will discuss not only the importance of this alignment but also how to carry it out effectively to maximize the benefits for the organization.

ISO 9001 fundamentals and the principles of quality management

To understand how to align the requirements of ISO 9001 with the principles of quality management, it is critical to first understand the fundamentals of each and how they interrelate. This section explores both the structure and requirements of ISO 9001:2015 as well as the seven principles of quality management that form the philosophical basis for excellence in organizational management.

Summary of ISO 9001:2015 standard

ISO 9001:2015 is an international standard that establishes the requirements for a quality management system. This standard is applicable to any organization, regardless of size or sector, that wishes to ensure the quality of its products and services, improve customer satisfaction, and seek continuous improvements in all its processes.

The standard is structured around a model based on the PDCA (Plan-Do-Check-Act) continuous improvement cycle and is organized in 10 sections, ranging from the context of the organization to continuous improvement. Sections 4 to 10 specify the clauses or requirements that an organization must meet to implement an effective quality management system, which are specified below:

1. Clause 4: Organizational Context – Requires the organization to understand its external and internal context, as well as the needs and expectations of relevant stakeholders. It also includes the scope of the QMS, as well as the process approach.
2. Clause 5: Leadership – Requires top management commitment to the development, implementation, and continual improvement of the QMS, as well as ensuring that the quality policy and quality objectives are aligned with the strategic direction of the organization.
3. Clause 6: Planning – deals with planning for the QMS, including the identification of risks and opportunities, change planning, and the definition of quality objectives consistent with the quality policy.
4. Clause 7: Support – Addresses the resources required for the QMS, such as competent personnel, infrastructure, appropriate environment, resources for measurement, competence, awareness, and communication.
5. Clause 8: Operation – Includes requirements related to planning and control of production and service delivery, control of non-conforming outputs, and management of operational activities.
6. Clause 9: Performance Evaluation – Requires the organization to monitor, measure, analyze, and evaluate the effectiveness of the QMS, using tools such as internal audits, management review, and customer satisfaction data collection.
7. Clause 10: Improvement – Focused on continuous improvement of the QMS by proactively identifying nonconformities, taking corrective actions, and implementing improvements.

Quality management principles

The seven principles of quality management are fundamental concepts that guide organizations in improving their performance and effectively implementing a quality management system. These principles serve as the philosophical foundation of ISO 9001 and are designed to help organizations achieve long-term success through continuous improvement of their processes and customer satisfaction. The seven principles are:

• Customer focus: Organizations depend on their customers, so they must understand their current and future needs, meet their requirements, and strive to exceed their expectations.
• Leadership: Leaders establish the unity of purpose and direction of the organization. It is crucial that they create and maintain an internal environment that engages people in achieving quality objectives.
• People commitment: For an organization to function effectively, it is essential that all people are committed and competent.
• Process-based approach: Desired results are achieved more efficiently when activities and related resources are managed in terms of processes forming a coherent system.
• Continuous improvement: Continuous improvement of the organization’s overall performance should be a permanent objective.
• Evidence-based decision-making: Effective decisions are based on the analysis of data and information.
• Relationship management: Organizations must manage their relationships with relevant stakeholders, such as suppliers, partners, and customers, to optimize their impact on overall performance.

Strategies for aligning ISO 9001 requirements with quality management principles

Aligning the specific requirements of ISO 9001 with the principles of quality management is essential to developing a quality management system that not only meets international standards but also creates value for the organization and its stakeholders. This alignment requires a strategic and systematic approach to ensure that each requirement of the standard is implemented in a manner that supports the fundamental principles of quality management. The following are vital strategies for achieving this effective alignment.

Customer focus: Translating expectations into operational requirements

The customer focus principle states that organizations should understand and anticipate the needs and expectations of their customers in order to consistently satisfy them. To align this principle with the requirements of ISO 9001, organizations may wish to consider:

• Identification of customer needs: Uses clause 8.2 of the standard, which deals with the determination of requirements related to products and services. Conducts customer satisfaction surveys, feedback analysis, and market research to identify customer expectations and needs.
• Translation into operational requirements: Convert customer needs into clear and measurable operational requirements that can be incorporated into production and service delivery processes. For example, if customers value fast delivery, incorporate these requirements into production and logistics planning (clause 8.1).
• Monitoring and measuring customer satisfaction: Establishes processes to measure and analyze customer satisfaction (clause 9.1.2) on an ongoing basis. Uses this information to continuously improve processes and products, thus ensuring that customer requirements are met, and customer expectations are exceeded.

Leadership: Fostering a quality culture

The leadership principle focuses on the fundamental role of leaders in establishing a clear vision and direction for the organization in terms of quality. To align this principle with ISO 9001 it would be desirable:

• Top management commitment: Ensure that top management is committed to the development, implementation, and continual improvement of the quality management system (clause 5.1). Leaders should demonstrate this commitment by communicating the importance of quality and supporting improvement initiatives.
• Establish quality policy and objectives: Develop a quality policy (clause 5.2) that is aligned with the organization’s strategic direction and quality management principles. Define clear and measurable quality objectives (clause 6.2) that support this policy and ensure that quality efforts are focused and effective.
• Promoting quality culture: Leaders should promote a quality culture within the organization by encouraging the participation of all employees in quality improvement activities and ensuring that everyone understands their role in achieving quality objectives.

Engaging people: Encouraging participation and competition

The people engagement principle emphasizes the importance of the active participation of all employees in the quality management system. To align this principle with the requirements of ISO 9001, organizations could advance in actions such as:

• Competency development: Implements a process to determine the competencies required for employees performing activities that affect quality, and provides training to ensure that they have the necessary competencies (clause 7.2).
• Encourage active participation: Create a work environment where employees feel valued and motivated to contribute to continuous improvement. Use work teams, improvement groups, and suggestions from employees to encourage their active participation in the improvement of the quality management system.
• Effective communication: Establish effective communication channels (clause 7.4) to ensure that all employees understand the quality policy, quality objectives, and how their work contributes to the achievement of these objectives. This may include regular meetings, newsletters, and other means of internal communication.

Process-based approach: Optimizing processes for quality

The process-based approach involves managing activities and resources as interrelated processes to achieve the desired results more efficiently. To align this principle with ISO 9001 requirements it is suggested:

• Process identification and management: Identifies the processes required for the quality management system (clause 4.4), documents their sequence and interaction, as well as their characterization. This includes planning, production, delivery, and support processes.
• Process monitoring and measurement: Establish methods for monitoring and measuring processes (clause 9.1.1) to ensure that they are effective and efficient. Use this data to identify opportunities for improvement and adjust processes accordingly.
• Process Improvement: Uses continuous improvement tools, such as root cause analysis, problem-solving techniques, and process improvement teams, to continuously improve the effectiveness and efficiency of processes.

Continuous improvement: Establishment of a permanent improvement cycle

The principle of continual improvement is fundamental to an effective and sustainable quality management system. To align this principle with the requirements of ISO 9001 would be beneficial:

• PDCA cycle implementation: Adopts the Plan-Do-Check-Act (PDCA) cycle as a fundamental tool to manage and improve processes continuously. Plans improvements, implements changes, verifies results, and adjusts as necessary.
• Internal audits and management review: Conduct periodic internal audits (clause 9.2) and management reviews (clause 9.3) to assess the conformity and effectiveness of the Quality Management System. Use the results of these activities to identify areas for improvement and develop action plans.
• Corrective and preventive actions: Establishes procedures for managing nonconformities and taking corrective (clause 10.2) and preventive actions to avoid the recurrence of problems and improve the quality of products and services.

Evidence-based decision making: Using data to drive quality

Evidence-based decision-making involves the use of accurate and reliable data to make informed decisions. To align this principle with ISO 9001 requirements, organizations could advance actions such as:

• Establishment of performance indicators: Define key performance indicators (KPIs) that are relevant to the organization’s quality objectives (clause 9.1.1). Use these KPIs to monitor the performance of the quality management system and make data-driven decisions.
• Data and trend analysis: Performs data and trend analysis to identify areas for improvement and opportunities for innovation. This includes analysis of customer satisfaction, and process performance, among others.
• Statistical tools usage: Uses statistical and data analysis tools, such as control charts, histograms, and Pareto analysis, to identify root causes of quality problems and improve processes.

Relationship management: Building strategic partnerships

The relationship management principle stresses the importance of managing stakeholder relationships to optimize the impact on the overall performance of the organization. To align this principle with ISO 9001 requirements it is suggested:

• Stakeholder identification: Identify relevant stakeholders (clause 4.2) and understand their needs and expectations. This includes customers, suppliers, employees, and other strategic partners.
• Supplier relationship management: Develop mutually beneficial relationships with suppliers and other key partners. Implements supplier evaluation and selection criteria based on their ability to meet quality requirements (clause 8.4).
• Collaboration and communication: Promotes collaboration and continuous communication with stakeholders to improve the quality and sustainability of products and services. Establishes clear agreements and contracts that define expectations and responsibilities.

Conclusions

Aligning the requirements of ISO 9001 with the principles of quality management not only ensures more effective implementation of quality management systems but also enhances the competitiveness of organizations in the marketplace. This alignment allows principles such as customer focus, continual improvement, and evidence-based decision-making to become the driving force behind all organizational activities, ensuring that processes are more efficient, consistent, and capable of satisfying all stakeholders.

Furthermore, the effective integration of these elements creates a robust framework that facilitates adaptation to changes in the environment and promotes a culture of quality within the organization. This, in turn, contributes to the achievement of strategic objectives, enhances customer satisfaction, and reinforces long-term sustainability. Organizations that succeed in aligning these aspects not only comply with regulatory requirements but also advance toward operational excellence and leadership in their respective industries.

References

1. ISO (2015). ISO 9001:2015 Quality management systems – Requirements.
2. ISO (2015). ISO 9000:2015 Quality management systems – Fundamentals and vocabulary.
3. Lugo Marín, J. (2016). La gerencia de la calidad en la economía digital. Editorial Lulu.
4. Kotter, P., Kartajaya, H,, Setiawan, I (2024). Marketing 6.0. El futuro es inmersivo. Editorial LID. Madrid.