What is ISO 9001? Nature, content and requirements
ISO 9001: What is it? The essence, content, and requirements that this International Standard sets for establishing a Quality Management System (QMS) – how does it all work? Let's explore together with KNA CERT.
Introduction to the ISO 9000 Standard Series
ISO 9000 is an International Standard series developed by the International Organization for Standardization (ISO) to help companies effectively document the essential factors for quality management and assurance. These standards are not industry-specific and can be applied to organizations of all sizes.
ISO 9000 can assist a company in satisfying its customers, meeting regulatory requirements, and achieving continuous improvement. It should be considered the initial step or the foundation of a quality management system.
What is ISO 9001?
ISO 9001 is a standard within the ISO 9000 series. Applicable to all types of organizations, from commercial companies to non-profit organizations, government agencies, and non-governmental organizations, ISO 9001 focuses on building a robust quality management system. This system includes processes, policies, and methods to ensure continuous improvement and customer satisfaction.
What is ISO 9001?
ISO 9001 standard is an international standard for quality management system (QMS - Quality Management System). ISO 9001 sets out the quality management requirements that organizations need to comply with to achieve effective operations and meet customer requirements.
ISO 9001 standards can be applied to all organizations and businesses, regardless of industry, field, size or geographical location, all units that need to improve the quality of products and services. Everyone can apply ISO 9001 standards to build a qualified quality management system.
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Versions of the ISO 9001 series of standards
ISO 9001 standard was developed and issued by the Technical Council ISO / TC 176 / SC2 Quality systems. ISO 9001 is managed by the International Organization for Standardization (ISO).
The latest version currently is ISO 9001:2015.
ISO 9001 was developed after the end of World War I and II in industrialized countries. The evolution of ISO 9001 is reflected in revisions and inheritances from versions as follows:
- ISO 9001:1987 (March 1987)
- ISO 9001:1994 (June 1994)
- ISO 9001:2000 (December 2000)
- ISO 9001:2008 (November 2008)
- ISO 9001:2015 (September 2015)
As of now, ISO 9001:2015 is the latest version of the standard for Quality Management Systems.
Content of ISO 9001:2015:
Scope of Application
Normative References
Terms and Definitions
Context of the Organization
- Understanding the organization and its context
- Understanding the needs and expectations of interested parties
- Determining the scope of the Quality Management System
- Quality Management System and its processes
Leadership
- Leadership and commitment
- Establishing quality policy and communicating information about the quality policy
- Roles, responsibilities, and authorities within the organization
Planning
- Actions to address risks and opportunities
- Quality objectives and planning to achieve them
- Planning changes
Support
- Resources
- Competence
- Awareness
- Information exchange
- Establishing and updating, controlling textual information
Operation
- Planning and controlling the implementation
- Requirements for products and services
- Design and development of products, services
- Controlling the processes, products, and services provided by external providers
- Production and service provision
- Release of products and services
- Control of nonconforming outputs
- Evaluation of Performance Results
Monitoring, measurement, analysis, and evaluation
Input and output reviews by leadership
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- Continuous Improvement
- Nonconformity and corrective action
- Continuous improvement
What is a Quality Management System (QMS) according to ISO 9001?
A Quality Management System (QMS) according to ISO 9001 is a system that outlines quality management requirements for an organization to adhere to, ensuring efficient operations and meeting customer requirements.
Specifically, the clauses of ISO 9001 will be applied following the PDCA cycle as follows:
P (Plan) – Planning: Businesses need to identify issues that need resolution and establish specific plans to address those issues (corresponding to clauses 4, 5, 6, 7 of ISO 9001:2015).
D (Do) – Doing: After the plan is agreed upon and approved, businesses must implement the planned activities, ensuring they align with the set objectives and schedule (corresponding to clause 8 of ISO 9001:2015).
C (Check) – Checking: Businesses need to monitor and measure the results obtained from the plan implementation process. Subsequently, analyze and check if the initial objectives are achieved or not (corresponding to clause 9 of ISO 9001:2015).
A (Act) – Action: The results of monitoring and measurement activities allow businesses to evaluate the overall effectiveness of operations. Based on this, recommendations are made for new operational processes in the future. If the implemented process does not achieve the desired effectiveness, the business needs to find solutions to address persistent issues. Continuous improvement should take place to continually enhance the QMS (corresponding to clause 10 of ISO 9001:2015).
ISO 9001 is applied through PDCA (Plan-Do-Check-Act).
Characteristics of the Latest ISO 9001 Standard
Customer Focus:
Explains the importance of customers in the quality management system and requirements related to understanding and meeting customer needs.
Leadership:
Emphasizes the role of leadership in building and maintaining the ISO 9001 quality management system.
Employee Engagement:
Discusses the significance of active employee engagement throughout the entire quality management process.
Process Approach:
Emphasizes the need for resources and activities to be interconnected for efficiency.
Continuous Improvement:
Evaluates the importance of continuous improvement in the ISO 9001 quality management system and its implementation methods.
Decision Based on Data:
Addresses requirements for decision-making based on data and practical application in quality management.
Relationship Management:
Establishes connections between internal and external relationships to enhance operational effectiveness.
Benefits of ISO 9001 Quality Standard
Improvement of Product and Service Quality:
ISO 9001:2015 focuses on quality and customer satisfaction. By complying with ISO 9001:2015 requirements, organizations enhance control processes and ensure the quality of their products and services. This translates to increased product and service reliability, reduced production errors, and better customer service.
Enhanced Performance and Operational Efficiency:
ISO 9001 encourages the establishment of clear work processes and optimization of procedures. Consequently, organizations can improve their performance and operational efficiency, minimize waste, increase labor productivity, and optimize resources.
Enhancing Trust and Reputation
Adhering to international standards like ISO 9001 significantly contributes to building trust and reputation for an organization. ISO 9001:2015 certified organizations are often recognized as reliable and quality-driven, providing a substantial competitive advantage in the market.
Improving Customer Satisfaction
ISO 9001 places importance on customer requirements and expectations. Implementing ISO 9001 helps organizations enhance understanding and responsiveness to customer needs, delivering higher quality products and services. This translates into increased customer satisfaction and establishes a sustainable relationship between the organization and its customers.
Boosting Competitive Edge
Applying ISO 9001:2015 provides a competitive edge for organizations. Compliance with this international standard helps create an effective quality management system, reducing risks, and enhancing competitiveness in the market. Organizations can leverage ISO 9001:2015 certification as a marketing tool, demonstrating their commitment to quality and customer focus.
Meeting Legal Requirements and Regulations
ISO 9001 requires organizations to comply with legal requirements and regulations relevant to their operations. Applying ISO 9001:2015 helps organizations establish a clear legal management system, ensuring compliance and reducing legal risks.
Enhancing Continuous Improvement Processes
ISO 9001 encourages the application of the PDCA (Plan-Do-Check-Act) method for continuous improvement of organizational processes and activities. Through ongoing evaluation, adjustment, and continuous improvement, organizations can optimize their operations, foster sustainable development, and adapt to changes in the business environment.
Building Trust and Commitment of Employees
ISO 9001 mandates the participation and commitment of all employees within an organization. Applying ISO 9001 helps create a positive work environment, fostering trust and commitment among employees. Employees become aware of their roles in ensuring quality and continuous improvement, contributing to the success and development of the organization.
Expanding Market Opportunities
Achieving ISO 9001 certification creates opportunities to expand the market for organizations. Many customers and partners highly value organizations with a certified ISO 9001 quality management system. This opens up market expansion opportunities for organizations. With ISO 9001 certification, organizations have the potential to access new markets that may have been previously inaccessible. Many customers and partners, especially in industries requiring high quality and adherence to international standards, often demand this certification from their suppliers and partners.
ISO 9001 brings many special benefits to businesses, especially in terms of expansion and development.
Attracting Partners and Investments
The benefits of implementing ISO 9001 demonstrate an organization's commitment to quality and quality management. This attracts the attention of partners and investors who often prioritize collaboration with organizations with reliable and efficient quality management systems.
Reducing Costs and Waste
Applying the ISO 9001 standard creates conditions for organizations to optimize processes and reduce waste. Improving performance and efficiency in production and service delivery helps reduce operating costs and material usage, leading to cost savings and increased competitiveness for the organization.
Building a Foundation for Sustainable Development
ISO 9001 focuses not only on short-term quality but also directs organizations toward building sustainable development. By creating an effective quality management system, ISO 9001:2015 encourages organizations to seize new opportunities, adapt to changes, and align with future development trends.
Above are the details about what ISO 9001 is, its essence, content, and requirements. KNA Certification provides ISO 9001 certification services for all industries and sectors. Please contact the hotline at 0968.038.122 or email salesmanager@knacert.com for more detailed information about our services.
