ISO 9001 QUALITY MANAGEMENT SYSTEM (CURRENT VERSION ISO 9001:2015)
ISO 9001 is an international quality standard developed by the International Organization for Standardization (ISO), a worldwide federation of national standards bodies representing some 119 countries.
Implementation of an effective quality management system in an organization creates a confidence among their stakeholders in the capability of their processes and the reliability of their products and or services; and at the same time, benefiting from improved risk management. In addition, an effective quality management system serves to create the basis for continual improvement leading to increased customer satisfaction and ultimately to the success of the organization.
ISO 9001 can be applied to any type and size of organization, from small family-run businesses to the world’s largest corporations and government institutions. It provides a structured yet flexible framework for a customer focused business management system that will drive business performance improvement.
ISO 9001 is based on the following eight Quality Management Principles, which are incorporated within the requirements of the standard, and can be applied to improve organizational performance:
The eight principles are:
1. Customer focus
Organizations can establish this focus by trying to understand and meet their customers’ current and future requirements and expectations.
Organizations succeed when leaders establish and maintain the internal environment in which employees can become fully involved in achieving the organization’s unified objectives.
3. Involvement of people
Organizations succeed by retaining competent employees, encouraging continuous enhancement of their knowledge and skills, and empowering them, encouraging engagement and recognizing achievements.
4. Process approach
Organizations enhance their performance when leaders manage and control their processes, as well as the inputs and outputs that tie these processes together.
5. System approach to management
Organizations sustain success when processes are managed as one coherent quality management system.
6. Continuous improvement
Organizations will maintain current levels of performance, respond to changing conditions, and identify, create and exploit new opportunities when they establish and sustain an ongoing focus on improvement.
7. Factual approach to decision making
Organizations succeed when they have established an evidence-based decision making process that entails gathering input from multiple sources, identifying facts, objectively analyzing data, examining cause/effect, and considering potential consequences.
8. Mutually beneficial supplier relationships
Organizations that carefully manage their relationships with suppliers and partners can nurture positive and productive involvement, support and feedback from those entities.
These principles form the conceptual foundation for the ISO portfolio of quality management standards and serve as the basis for the Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP) required by most government regulatory bodies. But these principles are not just the backbone of quality systems; they’re also simply good business principles to put into practice across an enterprise.
The standard covers all aspects of an organization’s activities, including identifying its key processes, defining roles and responsibilities, policies and objectives, documentation requirements, the importance of understanding and meeting customer requirements, communication, resource requirements, training, product and process planning, design processes, purchasing, production and service, monitoring and measurement of products and processes, customer satisfaction, internal audit, management review, and improvement processes.
Training’s target audience:
Management personnel, Internal Auditors, System implementers, those involved in the quality systems of an organization and anyone with a great interest in the quality management systems.