ISO 9004 AND RISK MANAGEMENT IN PRACTICE.pdf

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How to Apply ISO 9004 and Risk Management in Practice

ISO 9004 is a standard that provides guidelines for enhancing an organization's ability to achieve sustained success. It is consistent with the quality management principles given in ISO 9000:2015[^2^]. One of the key aspects of ISO 9004 is the integration of risk management into the organization's processes and activities.

Risk management is the coordinated activities to direct and control an organization with regard to risk. It involves identifying, analyzing, evaluating, treating, monitoring and communicating risks that may affect the organization's objectives and performance. Risk management can help an organization to improve its resilience, innovation and competitiveness.

In this article, we will present some practical steps to apply ISO 9004 and risk management in practice. These steps are based on the model proposed by [^1^], which integrates risk management into the four main components of ISO 9004: context of the organization, leadership, planning and support.

Step 1: Understand the context of the organization

The first step is to understand the internal and external issues that are relevant to the organization's purpose and strategic direction. These issues may include factors such as market trends, customer needs, legal requirements, technological changes, stakeholder expectations, organizational culture, values and capabilities.

To understand the context of the organization, it is important to conduct a SWOT analysis (strengths, weaknesses, opportunities and threats) and a PESTLE analysis (political, economic, social, technological, legal and environmental factors). These tools can help to identify the strengths and weaknesses of the organization, as well as the opportunities and threats that may arise from its external environment.

By understanding the context of the organization, it is possible to identify the risks that may affect its ability to achieve sustained success. These risks can be classified into strategic risks (related to the organization's vision, mission and goals), operational risks (related to the organization's processes and activities), financial risks (related to the organization's income and expenditure) and compliance risks (related to the organization's legal obligations).

Step 2: Establish leadership commitment

The second step is to establish leadership commitment to ISO 9004 and risk management. This means that the top management of the organization should demonstrate leadership and support for enhancing the quality of the organization and managing its risks effectively.

To establish leadership commitment, it is important to communicate the benefits of ISO 9004 and risk management to all levels of the organization. These benefits may include improved customer satisfaction, increased efficiency and effectiveness, reduced costs and losses, enhanced reputation and trust, increased innovation and learning, and improved resilience and adaptability.

Leadership commitment also involves establishing a clear vision, mission and values for the organization, as well as setting SMART objectives (specific, measurable, achievable, relevant and time-bound) that are aligned with ISO 9004 and risk management. Moreover, leadership commitment requires allocating adequate resources (such as human, financial, technological and physical resources) for implementing ISO 9004 and risk management.

Step 3: Plan for ISO 9004 and risk management

The third step is to plan for ISO 9004 and risk management. This means that the organization should develop a quality policy that expresses its commitment to enhancing its quality and managing its risks. The quality policy should be communicated to all relevant parties (such as employees, customers, suppliers, partners and regulators) and reviewed periodically for its suitability.

To plan for ISO 9004 and risk management, it is also necessary to establish a quality management system (QMS) that defines how the organization will achieve its quality objectives and manage its risks. The QMS should be based on a process approach that identifies the inputs, outputs, activities, resources and interactions of each process within the organization. The QMS should also be documented in a quality manual that describes its scope, structure a474f39169