Gestion des Risques en Organisme

Introduction

• ISO 9000: Focuses on understanding quality management systems, principles, and vocabulary.
• ISO 9001: Applies the knowledge gained from ISO 9000, focusing on practical implementation of quality standards (requirements).
• ISO 9004: Aims to establish and maintain a robust quality management system aiming for excellence.
• Key aspects revised from 2000 to 2015: Globalization, increased competition, accelerated business relations, evolving customer relationships (from loyalty to trust through transparency), and changing demands across the ecosystem.

Vocabulary

• Process: A structured set of interconnected activities that transforms inputs into outputs.
• Process approach: Management framework that employs consistent and methodical identification and coordination of processes.
• Product: Outcome or result of a process.
• Requirement: Explicit or implied demands or expectations.
• Customer satisfaction: Customer's perception of the quality of the output against their expectations.
• Capacity: Capability of an organization to deliver quality products or services.
• Competence: Proven ability to execute tasks using knowledge and practical skills.
• System: A collection of interconnected elements, working together for a streamlined system.
• Management: Coordinated functions that guide and oversee a given system.
• Management system: A structured approach to planning, implementing and directing objectives for an enterprise.
• Continuous improvement: Ongoing activities that boost the ability to align operations with demands.
• Effectiveness: The degree to which planned activities are successfully accomplished.
• Efficiency: The ratio of desired outcomes to the resources used.
• Organisation: The combination of structures, personnel and processes used in an enterprise.
• Infrastructure: System of installations, equipment and services required for the smooth operation of an organisation.
• Work environment: All conditions under which work takes place.
• Customer: The final recipient of the products or services given or supplied.
• Supplier: Party that delivers products and services for use in an organisation's products or services.
• Project: A unique and structured series of activities, with defined start and end dates.
• Design and development: The process of transforming requirements into the actual design and manufacturing of a product or process.
• Procedure: Prescribed way to perform a particular activity or task.
• Traceability: Ability to track the history, location, or execution of a particular product or service.
• Compliance: Fulfilment of a particular demand or standard.
• Defect: Failure to meet a specified requirement.
• Preventative action: Measures taken to address potential non-compliance issues.
• Corrective action: Measures to address identified non-compliance issues.
• Audit: A methodical approach to gathering and assessing evidence—to determine the compliance with established criteria.
• Quality management: A management strategy across an organisation to establish activities geared towards producing or supplying quality products and services.
• Certifications: Measures involved in achieving certification, and are contrasted against traditional management practices that focus on outcomes.

### Chapter 4: Context of the Organization

• Understanding the organization's environment: Identifying relevant internal and external factors.
• Examples covered: Upcoming competition, significant staff departures, and large-scale infrastructure projects.
• Determining operational elements.
• Identifying all associated stakeholders.
• Defining the specific boundaries of the quality management system operations.
• Detailing products/services delivered.
• Justifying excluded elements from the scope of the quality management system.

Chapter 5: Leadership

• Responsibilities of leadership in quality management systems.
• Establishing clear direction for quality processes.
• Providing clear objectives for quality work.
• Establishing commitment to meeting requirements.
• Ensuring ongoing improvement of the quality management strategy.
• Communication of quality policy.

Chapter 6: Planning

• Developing, implementing actions related to risks or opportunities.
• Understanding impact on products and services.
• Setting measurable and achievable targets.
• Creating an overarching framework with clear plans and targets.
• Defining necessary resources based on activities and targets.
• Ensuring deadlines and reporting procedures are clearly defined.

Chapter 7: Support

• Identifying and providing necessary resources.
• Considering internal capacity limitations.
• Access to external services, suppliers and contractors for necessary provisions.
• Maintaining resources aligned with quality system operation.

Chapter 8: Operational Activities Realization

• Planning and controlling operational processes, meeting requirements for products and services.
• Defining resource needs and controlling processes.
• Implementing changes related to products/services.
• Managing any external supplier or contractor processes, ensuring compliance with all requirements.
• Establishing and maintaining identification methods
• Ensuring traceability for all procedures and outcomes.
• Managing products and services once they leave the organisation's direct control.

Chapter 9: Performance Evaluation

• Evaluating the performance and effectiveness of the quality management system.
• Establishing and maintaining a reliable method of recording and tracking performance indicators.
• Assessing customer satisfaction levels.
• Implementing internal audits regularly, as scheduled, to assess the efficacy of quality systems.
• Reviewing directorial input to maintain alignment with overall quality strategy.

Chapter 10: Improvement

• Identifying and prioritizing improvement opportunities.
• Setting up the proper infrastructure of required resources for improvement projects.
• Establishing and initiating processes for correcting any non-conformance found.
• Establishing and maintaining the procedures to monitor the improvement activities.