ISO 9001 CHAPTER 5 Flashcards
GIVE ME MORE THAN 20 FLASHCARDS ABOUT CHAPTER 4 OF ISO 9001 DEFINITION AND TECHNIQUES
The operation of the QMS, specifically how organizations plan, implement, and control their processes to meet customer requirements.
What is meant by “operational planning and control” in ISO 9001?
Organizations must plan, implement, and control processes to meet requirements and deliver quality products and services.
How does ISO 9001 define “process control”?
Ensuring that all processes are planned, carried out, monitored, and controlled according to established criteria.
What is the role of customer communication in the operation process?
It ensures that customer requirements are understood and fulfilled, including inquiries, contracts, and feedback.
Why is customer feedback important in the operation phase of ISO 9001?
It provides insights into customer satisfaction and helps the organization improve products and services.
What does ISO 9001 require regarding the determination of product requirements?
Organizations must ensure they understand customer requirements, including legal and regulatory needs, before delivering products or services.
What are “contract reviews” in ISO 9001?
Reviews of contracts or orders to ensure that requirements are clear and can be fulfilled by the organization.
What is the importance of design and development in ISO 9001 operations?
It ensures that products and services meet customer requirements and are designed in a controlled and effective manner.
What are the stages of design and development in ISO 9001?
Planning, inputs, outputs, controls, and changes in design to meet customer requirements and legal obligations.
What is required for the control of external providers (suppliers) in ISO 9001?
Organizations must ensure that externally provided processes, products, and services meet their requirements through evaluation, selection, and monitoring.
What is the significance of the “control of production and service provision” in ISO 9001?
Ensuring that production and service processes are controlled to meet requirements and deliver consistent quality.
What should organizations do to ensure proper control over outsourced processes?
Establish criteria for evaluation and monitor performance to ensure outsourced processes meet quality and regulatory standards.
How does ISO 9001 address product identification and traceability?
Organizations must control identification and traceability to ensure products are traceable through all stages of production and service provision.
Why is property belonging to customers or external providers important in ISO 9001?
Organizations must safeguard customer or provider property to ensure its integrity during use or storage in the QMS.
What is meant by “preservation” in ISO 9001?
Ensuring that products maintain their conformity to requirements during internal processing, delivery, and storage.
How should organizations handle “post-delivery activities”?
Plan for and control activities after delivery, such as warranties, maintenance, and disposal, to meet customer and regulatory requirements.
What is the role of “control of nonconforming outputs” in ISO 9001?
To ensure that products or services that do not meet requirements are identified, controlled, and prevented from being delivered.
What actions should be taken when nonconforming products are identified?
Isolate the product, determine its disposition, and take corrective actions to prevent recurrence.
What is the significance of “monitoring and measuring activities” in operations?
It ensures that processes are measured and monitored to verify that they meet customer and regulatory requirements.
How are changes to operational processes handled in ISO 9001?
Changes must be controlled to ensure they do not adversely affect the QMS and are properly evaluated before implementation.
What is “process validation” in ISO 9001?
Ensuring that processes are capable of producing consistent and conforming products or services under real-world conditions.
How does ISO 9001 define the criteria for product acceptance?
Organizations must establish criteria for the acceptance of products or services based on customer and legal requirements.
What is the purpose of “inspection and testing” in the QMS?
To verify that products or services meet specified requirements at key stages of production or service delivery.
Why is planning for delivery and post-delivery important in ISO 9001?
It ensures that customer requirements are fulfilled after delivery and that any post-delivery responsibilities are met.
What is the role of customer property in the operational process?
Ensuring that customer property (e.g., materials or equipment) is used, maintained, and stored in accordance with customer expectations.
How does ISO 9001 handle contingency plans for operations?
Organizations must plan for potential disruptions or risks in the operation to ensure consistent product or service quality.
What does ISO 9001 say about “review of requirements” for products and services?
Organizations must review customer requirements before committing to supply a product or service to ensure they can meet expectations.
How are “delivery and installation” controlled in ISO 9001?
Delivery and installation processes must be planned, monitored, and controlled to ensure the product or service is delivered in accordance with specifications.
