Published: July 21, 2025 by Rungreung Huanraluek
What is ISO 9001:2015?
Standards Related to Data, Image, and Sound Communication Systems, Part 6
ISO 9001:2015 is an international standard for Quality Management Systems (QMS) issued by the International Organization for Standardization (ISO). Organizations or businesses certified to ISO 9001 demonstrate that they have a good quality management system, their products and services meet customer requirements, they comply with relevant laws and regulations, and they continuously develop and improve. This increases customer confidence in the quality of their products and services. The meaning of the characters in ISO 9001:2015 is as follows:
- ISO means International Standard for Quality Management Systems.
- 9001 means the code for the quality standard.
- 2015 means the year of the latest revision (currently the latest version).
A key feature of ISO 9001:2015 is "Risk-Based Thinking," which requires top management to be involved and play a significant role in overseeing the quality system. It is also designed to be easily integrated with other ISO standards, such as ISO 14001 (Environmental Management System) and ISO 45001 (Occupational Health and Safety Management System).
Which Types of Organizations Is ISO 9001:2015 Suitable For?
ISO 9001:2015 is suitable for organizations of all types and sizes, whether small, medium, or large businesses, as well as government agencies, state enterprises, industrial factories, private companies, hospitals, educational institutions, or even non-profit organizations. This is because ISO 9001:2015 does not focus solely on product manufacturing processes but emphasizes the overall management system for quality across the entire organization. This ensures that products and services consistently meet customer needs, are efficient, continuous, and can be developed and improved regularly.
Seven Quality Management Principles The seven Quality Management Principles are fundamental concepts used by the International Organization for Standardization (ISO) as a framework for developing quality management systems. They enable organizations to effectively meet customer needs, ensure quality, and continuously improve. These principles are "values" that should be upheld to create a culture of quality within the organization.
- Customer Focus
Organizations should prioritize the needs and expectations of their customers. Every process should be designed and operated with the customer at its center to build sustainable customer satisfaction, in terms of product quality, service, and user experience. - Leadership
Leaders within the organization should have a clear vision, be able to set direction, and effectively communicate shared goals. Good leadership helps motivate and serves as a role model in fostering a culture of quality throughout the entire organization. - Engagement of People
Encouraging the involvement of personnel at all levels in quality-related activities leads to collaboration, responsibility, and continuous development within the organization, both at individual and team levels, resulting in overall system efficiency. - Process Approach
Operating systematically with clear and consistent processes helps organizations control quality well, reduce errors, and increase overall efficiency. Analyzing each process makes it easier to identify strengths and areas for improvement. - Continual Improvement
Organizations should be committed to continuous improvement at all levels and in all processes, whether in terms of efficiency, results, or customer satisfaction, to enable the organization to compete and grow in the long term. - Evidence-Based Decision
Making Good decision-making requires reliable data and evidence. Systematic data analysis helps reduce risks, increase accuracy, and make decision-making processes more effective. - Relationship Management
Organizations should build and maintain good relationships with all interested parties, such as customers, suppliers, partners, and relevant agencies, to foster sustainable cooperation and promote the success of both the organization and its business network.
Main Clauses of ISO 9001:2015 Standard The 7 main clauses of ISO 9001:2015 form the crucial structure that organizations must implement to develop and maintain a tangible Quality Management System (QMS). The content covers everything from defining the organizational context, planning, operation, performance evaluation, to continuous improvement. These clauses are used for internal audits and official ISO 9001 certification.
ISO 9001:2015 is a standard that focuses on creating a "Quality Management System" that controls and verifies quality at every step of operations. It specifies a total of 7 main clauses that cover all important parts of an organization, from planning, management, and operation to monitoring and improvement. This ensures that the organization can work efficiently, develop continuously, and sustainably meet customer needs. The details of each clause are as follows:
- Context of the Organization
The organization must understand various factors affecting its operations, such as external/internal environment, interested parties' needs and expectations, and the scope of the QMS, to plan and manage appropriately. - Leadership
Leaders or top management must demonstrate their role in setting quality policy, motivating, and supporting involvement throughout the organization to ensure the quality system truly becomes the organization's culture. - Planning
The organization must plan systematically, focusing on risk and opportunity analysis, setting Quality Objectives, and defining methods for monitoring results to ensure the system can achieve its goals and continuously develop. - Support
This element focuses on necessary resources such as competent personnel, infrastructure, work environment, organizational knowledge, as well as communication and control of documented information to ensure accuracy and currency. - Operation
This is the core of operations, including designing and developing products or services, controlling production or service delivery, and effectively managing customer requirements to achieve results consistent with the standard. - Performance Evaluation
The organization must regularly monitor, measure, analyze, and evaluate various processes, including internal audits and management reviews. - Improvement
The organization must focus on systematic problem-solving, including continual improvement, to further develop the quality management system, accommodate changes, and increase customer satisfaction.
Table: Linkage of Quality Management Principles and ISO 9001:2015 Clauses
The connection between the Seven Quality Management Principles and the 7 clauses of the ISO 9001:2015 Quality Management System standard helps organizations build a comprehensive, flexible, and practically applicable quality management system across various types of businesses, including manufacturing, services, and public or private organizations, regardless of size or type of business.
