ISO 9000 is a series of standards that provide guidelines for quality management systems. It consists of several parts, including ISO 9001, ISO 9002, and ISO 9003. ISO 9001 is the most comprehensive standard, encompassing all 20 system elements, while ISO 9002 and ISO 9003 have more specific applications. These elements are crucial for organizations seeking ISO 9000 compliance and are designed to ensure effective quality management throughout various processes.
Key Facts
- ISO 9000 Compliance: ISO 9000 is a series of standards that provide guidelines for quality management systems. It includes ISO 9001, ISO 9002, and ISO 9003, with ISO 9001 requiring all 20 system elements.
- Management Responsibility: This element involves defining, documenting, and implementing a policy for quality.
- Quality System: It requires establishing, documenting, and maintaining a quality system, including a quality manual, system procedures, and quality planning.
- Contract Review: This element focuses on establishing and maintaining documented procedures for contract review.
- Design Control: It involves establishing and maintaining documented procedures to control and verify the design of the product to ensure conformance to specified requirements.
- Document and Data Control: This element requires establishing and maintaining documented procedures to control all documents and data, including standards and customer drawings.
- Purchasing: It involves establishing and maintaining documented procedures to ensure that purchased products, associated documents, and data conform to requirements. It also includes evaluating and selecting sub-contractors based on their ability to meet requirements.
- Control of Customer-Supplied Product: This element focuses on establishing and maintaining documented procedures for the control of verification, storage, and maintenance of customer-supplied products.
- Product Identification and Traceability: It requires establishing and maintaining documented procedures for identifying the product throughout its lifecycle, from receipt to delivery and installation.
- Process Control: This element involves identifying and planning the production, installation, and servicing processes that directly affect quality and ensuring they are carried out under controlled conditions.
- Inspection and Testing: It requires establishing and maintaining documented procedures for inspection and testing activities to verify that the specified requirements for the product are met.
- Control of Inspection, Measuring, and Test Equipment: This element focuses on establishing and maintaining documented procedures to control, calibrate, and maintain inspection, measuring, and test equipment used to demonstrate product conformance.
- Control of Non-Conforming Product: It involves establishing and maintaining documented procedures to prevent non-conforming products from unintended use or installation.
- Corrective and Preventive Action: This element requires establishing and maintaining documented procedures for implementing corrective and preventive actions to handle customer complaints, product non-conformities, and eliminate potential causes of non-conformities.
- Handling, Storage, Packaging, Preservation, and Delivery: It involves establishing and maintaining documented procedures to prevent damage or deterioration of products during handling, storage, packaging, preservation, and delivery.
- Control of Quality Records: This element requires establishing and maintaining documented procedures for the identification, collection, indexing, access, filing, storage, maintenance, and disposition of quality records.
- Internal Quality Audits: It involves establishing and maintaining documented procedures for planning and implementing internal quality audits to verify compliance with planned arrangements and determine the effectiveness of the quality system.
- Training: This element requires establishing and maintaining documented procedures for identifying training needs and providing training to personnel performing activities affecting quality.
- Servicing: It involves establishing and maintaining documented procedures for performing, verifying, and reporting that servicing meets specified requirements.
- Statistical Techniques: This element requires identifying the need for statistical techniques to establish, control, and verify process capability and product characteristics. Documented procedures should be established to implement and control their application.
Management Responsibility
This element focuses on the responsibility of management in defining, documenting, and implementing a policy for quality. It includes establishing a quality policy, defining responsibilities and authorities for personnel involved in quality management, and ensuring the implementation and maintenance of the quality management system.
Quality System
The quality system element requires organizations to establish, document, and maintain a quality system. This includes developing a quality manual that outlines the quality objectives and policies, documenting system procedures, and conducting quality planning to ensure that quality objectives are met.
Contract Review
Contract review involves establishing and maintaining documented procedures for reviewing contracts and purchase orders. This ensures that the requirements specified in the contracts are adequately defined, align with the organization’s capabilities, and can be effectively implemented.
Design Control
Design control focuses on establishing and maintaining documented procedures to control and verify the design of products. This element ensures that the design process meets specified requirements and includes activities such as planning the design project, defining design input parameters, documenting design outputs, verifying design outputs, and controlling design changes.
Document and Data Control
Document and data control requires organizations to establish and maintain documented procedures to control all relevant documents and data. This includes controlling the generation, distribution, and changes to documents, as well as controlling customer drawings and standards.
Purchasing
The purchasing element involves establishing and maintaining documented procedures to ensure that purchased products, associated documents, and data conform to requirements. It also includes evaluating and selecting subcontractors based on their ability to meet specified requirements.
Control of Customer-Supplied Product
This element focuses on establishing and maintaining documented procedures for the control of verification, storage, and maintenance of customer-supplied products. It ensures that customer-supplied products are protected against loss or damage.
Product Identification and Traceability
Product identification and traceability require organizations to establish and maintain documented procedures for identifying products throughout their lifecycle. This includes identifying products by item, batch, or lot during all stages of production, delivery, and installation.
Process Control
Process control involves identifying and planning the production, installation, and servicing processes that directly affect quality. It requires organizations to carry out these processes under controlled conditions, including documented instructions, in-process controls, approval of processes and equipment, and criteria for workmanship.
Inspection and Testing
Inspection and testing require organizations to establish and maintain documented procedures for verifying that the specified requirements for the product are met. This includes conducting inspections and tests at various stages of production to ensure product conformity.
Control of Inspection, Measuring, and Test Equipment
This element focuses on establishing and maintaining documented procedures to control, calibrate, and maintain inspection, measuring, and test equipment used to demonstrate product conformance. It ensures that the equipment is accurate and reliable.
Control of Non-Conforming Product
Control of non-conforming product involves establishing and maintaining documented procedures to prevent non-conforming products from unintended use or installation. It includes identifying, segregating, evaluating, and disposing of non-conforming products appropriately.
Corrective and Preventive Action
Corrective and preventive action requires organizations to establish and maintain documented procedures for implementing actions to address customer complaints, product non-conformities, and eliminate potential causes of non-conformities. This element aims to continuously improve the quality management system.
Handling, Storage, Packaging, Preservation, and Delivery
This element involves establishing and maintaining documented procedures to prevent damage or deterioration of products during handling, storage, packaging, preservation, and delivery. It ensures that products are protected and delivered in a satisfactory condition to customers.
Control of Quality Records
Control of quality records requires organizations to establish and maintain documented procedures for the identification, collection, indexing, access, filing, storage, maintenance, and disposition of quality records. This ensures that important records are properly managed and retained.
16. Internal Quality Audits
Internal quality audits involve establishing and maintaining documented procedures for planning and implementing audits to verify compliance with planned arrangements and assess the effectiveness of the qualitysystem. These audits are conducted internally within the organization to identify areas for improvement and ensure compliance with ISO 9000 standards.
17. Training
Training requires organizations to establish and maintain documented procedures for identifying training needs and providing training to personnel involved in activities affecting quality. It ensures that employees have the necessary skills and knowledge to perform their tasks effectively.
18. Servicing
The servicing element involves establishing and maintaining documented procedures for performing, verifying, and reporting that servicing activities meet specified requirements. It applies to organizations that provide services and ensures that the service delivered meets the expected quality standards.
19. Statistical Techniques
The statistical techniques element requires organizations to identify the need for statistical techniques to establish, control, and verify process capability and product characteristics. Documented procedures should be established to implement and control the application of these techniques.
Conclusion
The elements of ISO 9000 provide a comprehensive framework for ensuring quality management within organizations. From management responsibility to statistical techniques, each element plays a crucial role in establishing and maintaining an effective quality management system. By adhering to these elements, organizations can enhance customer satisfaction, improve processes, and achieve ISO 9000 compliance.
Sources:
- The 20 ISO 9000 quality assurance system elements. Retrieved from http://www.jdunman.com/ww/Business/ISO/The%2020%20elements%20of%20ISO.htm
- Appendix D Elements of ISO 9000 | Statistics, Testing, and Defense Acquisition: New Approaches and Methodological Improvements | The National Academies Press. Retrieved from https://nap.nationalacademies.org/read/6037/chapter/16
- Notes on ISO 9000. Retrieved from http://mason.gmu.edu/~sdas/omc_iso.htm
FAQs
What is ISO 9000?
ISO 9000 is a series of standards that provide guidelines for quality management systems. It helps organizations establish and maintain effective quality management practices to ensure customer satisfaction and continuous improvement.
What is the purpose of ISO 9000?
The purpose of ISO 9000 is to provide a framework for organizations to implement quality management systems. It helps them define processes, procedures, and responsibilities to consistently deliver products and services that meet customer requirements.
How many parts are there in ISO 9000?
ISO 9000 consists of several parts. The main ones are ISO 9001, ISO 9002, and ISO 9003. ISO 9001 is the most comprehensive standard, encompassing all 20 system elements, while ISO 9002 and ISO 9003 have more specific applications.
What is the significance of management responsibility in ISO 9000?
Management responsibility is a critical element of ISO 9000. It emphasizes that top management has the responsibility to define, document, and implement a quality policy, establish objectives, and ensure the effective operation of the quality management system.
How does ISO 9000 address the control of non-conforming products?
ISO 9000 includes an element called “Control of Non-Conforming Product.” It requires organizations to establish procedures to identify, segregate, evaluate, and dispose of non-conforming products appropriately, preventing their unintended use or installation.
What is the purpose of internal quality audits in ISO 9000?
Internal quality audits are an important element of ISO 9000. They involve conducting audits within the organization to verify compliance with planned arrangements and assess the effectiveness of the quality management system. These audits help identify areas for improvement and ensure ongoing compliance with ISO 9000 standards.
How does ISO 9000 address the training of personnel?
ISO 9000 includes an element called “Training.” It requires organizations to establish procedures for identifying training needs and providing training to personnel involved in activities affecting quality. This ensures that employees have the necessary skills and knowledge to perform their tasks effectively.
What role do statistical techniques play in ISO 9000?
ISO 9000 recognizes the importance of statistical techniques for establishing, controlling, and verifying process capability and product characteristics. It requires organizations to identify the need for statistical techniques and establish procedures to implement and control their application effectively.