ISO 9001 CHAPTER 8 Flashcards
What is the main focus of Chapter 8 of ISO 9001?
It focuses on the operational planning and control processes to ensure that products and services meet customer requirements.
What does ISO 9001 require in terms of operational planning and control?
Organizations must plan, implement, and control the processes necessary to meet the requirements for product and service delivery.
How should organizations determine requirements for products and services in ISO 9001?
They must determine customer needs, legal requirements, and other applicable regulations to ensure product conformity.
What is the purpose of communicating with customers in ISO 9001?
Effective communication helps ensure customer requirements are understood, managed, and fulfilled throughout the process.
What does ISO 9001 say about handling changes in customer requirements?
Organizations must control any changes to customer requirements, ensuring they do not negatively impact product or service quality.
What are “contract reviews” in ISO 9001?
A process to review and clarify customer requirements before acceptance, ensuring the organization can meet them.
How should design and development processes be managed under ISO 9001?
These processes must be planned and controlled to ensure that products meet customer requirements and regulatory needs.
What are the stages of design and development according to ISO 9001?
Design and development planning, inputs, outputs, controls, and design changes are the key stages.
How should organizations control outsourced processes in ISO 9001?
Organizations must ensure outsourced processes meet their quality requirements by selecting, evaluating, and monitoring suppliers.
What are the key requirements for controlling production and service provision in ISO 9001?
Organizations must implement control methods to ensure consistent production and delivery that meets customer specifications.
How does ISO 9001 address the use of resources in operational processes?
Resources such as equipment, infrastructure, and personnel must be suitable for ensuring product and service conformity.
What does ISO 9001 say about process validation?
Validation is required for processes where outputs cannot be fully verified through subsequent measurement or monitoring.
How does ISO 9001 address traceability in production and service provision?
Organizations must ensure that products and services are traceable at all stages of production to maintain quality control.
What is meant by the control of customer property in ISO 9001?
Customer property (materials, equipment, etc.) must be identified, verified, and safeguarded while under the organization’s control.
What is the significance of “preservation” in the production process in ISO 9001?
Organizations must ensure that products are preserved during internal processing, storage, and delivery to prevent damage or deterioration.
How should organizations handle post-delivery activities in ISO 9001?
Organizations must plan for and manage post-delivery activities, such as warranty service and product maintenance, to meet customer requirements.
What does ISO 9001 say about controlling nonconforming outputs?
Nonconforming products or services must be identified and controlled to prevent unintended use or delivery.
What actions should be taken when nonconforming products are detected?
Organizations must decide whether to correct, rework, or dispose of nonconforming products, and record these actions.
What does ISO 9001 require regarding corrective actions for nonconformities?
Organizations must identify the cause of nonconformities and take corrective actions to prevent recurrence.
How does ISO 9001 address the handling of externally provided processes, products, and services?
Organizations must ensure that suppliers provide products or services that meet their requirements through control, evaluation, and monitoring.
What is the purpose of monitoring and measurement in ISO 9001 operational processes?
It ensures that the processes remain effective and the products or services consistently meet customer and regulatory requirements.
What is the significance of performance measurement in ISO 9001?
It helps evaluate the effectiveness and efficiency of processes, identifying areas for improvement and ensuring that objectives are met.
What does ISO 9001 say about the identification of potential risks in operations?
Organizations must identify risks and take actions to minimize their impact on product quality and operational performance.
How should operational changes be managed in ISO 9001?
Any operational changes must be controlled to ensure they do not adversely affect the QMS or product quality.
How does ISO 9001 ensure that production equipment is well-maintained?
Equipment must be regularly maintained and calibrated to ensure it remains effective and produces conforming products.
What is the importance of supplier evaluation and re-evaluation in ISO 9001?
To ensure that suppliers continue to meet the organization’s quality standards and requirements for products or services.
What are the methods for controlling outputs in the service industry under ISO 9001?
ervice outputs must be monitored to ensure that they meet customer specifications and any applicable regulations.
What does ISO 9001 say about maintaining records of operational activities?
Organizations must maintain records of all operational processes, ensuring transparency and traceability for audits and performance reviews.
How should organizations handle customer complaints in the operational process under ISO 9001?
Customer complaints must be recorded, investigated, and addressed promptly to maintain customer satisfaction and process integrity.
What role does preventive maintenance play in the operational planning of ISO 9001?
Preventive maintenance ensures that equipment and infrastructure continue to function properly, reducing the risk of breakdowns that could impact product quality.
