Question:* What does ISO stand for?
Answer: • the International Organization for Standardization
Question:* Design and Development of product requires planning per the ISO 9001 standard. What should the organization determine during planning of design and development?
Answer: • the design and development stages
Question:* What should an organization do if a piece of measuring equipment is found out of conformance to requirements?
Answer: • assess and record the validity of the previous measuring results
Question:* How does an organization verify purchased product required by the ISO 9001 standard?
Answer: • the organization shall establish and implement inspection activities
Question:* How does top management provide evidence of its commitment to meet the requirements of the ISO 9001 standard?
Answer: • by ensuring the availability of resources
Question:* The ISO 9001 standard requires an organization to identify, verify, protect and safeguard what?
Answer: • customer property provided for use
Question:* During the design and development planning within the ISO 9001 standard requirements, the organization is required to determine what?
Answer: • the responsibilities and authorities for design and development
Question:* Confirmation of the ability of computer software to satisfy the intended application would typically include:
Answer: • its verification and configuration management to maintain its suitability for use
Question:* The ISO 9001 standard requires an organization to implement effective arrangements for communicating what to customers?
Answer: • enquiries, contracts, or order handling including amendments
Question:* How should auditors conduct internal audits per the ISO 9001 standard?
Answer: • Auditors shall not audit own work
Question:* Preservation of product per the ISO 9001 standard includes:
Answer: • handling, packaging, and storage
Question:* Who is responsible for establishing the quality policy of an organization?
Answer: • top management
Question:* An organization must perform what to check how its quality management system is working?
Answer: • internal audits
Question:* How does an organization monitor and measure customer satisfaction?
Answer: • customer data on delivered product quality
Question:* The ISO 9001 standard requires an organization to ensure records of evidence of conformity are what?
Answer: • legible, readily identifiable and retrievable
Question:* The ISO 9001 standard refers to a methodology as PDCA. What does PDCA stand for?
Answer: • Plan, Do, Check, Act
Question:* The ISO 9001 standard requires an organization to take action to eliminate the causes of nonconformities in order to what?
Answer: • prevent recurrence
Question:* When nonconforming product is corrected, it shall be subject to what?
Answer: • re-verification to demonstrate conformity to the requirements
Question:* Why would an organization implement a quality management system that meets ISO 9001 standard requirements?
Answer: • to improve the efficiency and effectiveness of company operations
Question:* Per the ISO 9001 standard, an organization is required to plan an audit program that considers the results of what?
Answer: • previous audits
Question:* The ISO 9001 standard requires the output from the management review shall include any decisions and actions related to what?
Answer: • improvement of product related to customer requirements
Question:* The ISO 9001 standard requires a organization to ensure its personnel are aware of what?
Answer: • the established quality objectives
Question:* The ISO 9001 standard requires the organization to provide training, where applicable, or take other actions to achieve the necessary what?
Answer: • competence
Question:* The ISO 9001 standard requires an organization to apply suitable methods for monitoring and measuring the quality management system processes and shall demonstrate the ability to achieve planned results. When planned results are not achieved, what should happen?
Answer: • correction and corrective action shall be taken
Question:* The ISO 9001 standard requires an organization to establish processes to ensure that monitoring and measuring equipment is controlled. This includes:
Answer: • measuring equipment shall be calibrated and/or verified
Question:* An organization shall conduct internal audits when?
Answer: • determined planned intervals
Question:* How does the ISO 9001 standard define an "outsourced process?"
Answer: • a process that the organization needs for the quality management system and which the organization chooses to have performed by an external party
Question:* How does an organization become ISO 9001 certified?
Answer: • Through an independent certification body that determines the product, service or system in question meets ISO 9001 standard requirements
Question:* What does product design and development verification of the ISO 9001 standard require?
Answer: • to ensure the outputs have met the input requirements of the design and development
Question:* The ISO 9001 standard requires top management of an organization to ensure the quality policy includes what?
Answer: • a commitment to continually improve the effectiveness of the quality management system
Question:* The ISO 9001 standard requires an organization to review its quality management system at planned intervals. Why?
Answer: • to ensure its continuing effectiveness
Question:* The ISO 9001 standard requires an organization to establish a quality manual that includes:
Answer: • a justification of any exclusions to the requirements of the standard
Question:* The ISO 9001 standard requires an organization to handle nonconforming product how?
Answer: • by taking action to eliminate the detected nonconformity
Question:* ISO 9001 is considered compatible with what other ISO standard?
Answer: • ISO 14001
Question:* Clause 4.2 of the ISO 9001 standard requires a organization's quality management system to include a:
Answer: • documented quality objective statement
Question:* The required documentation for the ISO 9001 standard can be:
Answer: • in any form or type of medium
Question:* What does product design and development validation of the ISO 9001 standard require?
Answer: • to ensure that the resulting product is capable of meeting all specified requirements and intended uses
Question:* Who should the Management Representative be of an organization?
Answer: • member of the organization's management
Question:* The implementation of a organization's ISO 9001 management system is influenced by:
Answer: • its products, processes, and size
Question:* Under 4.0, the ISO 9001 standard requires an organization to control required documents. One of these controls is:
Answer: • to ensure changes and current revision status of documents are identified
Question:* The ISO 9001 standard promotes the adoption of a process approach because:
Answer: • this approach enhances customer satisfaction by meeting customer requirements
Question:* Audits are a vital part of ISO 9001's management system approach as they enable the organization to:
Answer: • check how far their achievements meet their objectives
Question:* The ISO 9001 standard requires an organization to determine requirements specified by the customer to include requirements for what?
Answer: • delivery and post-delivery activities
Question:* The ISO 9001 standard requires the organization's quality manual to include:
Answer: • a description of the interaction between the processes of the quality management system
Question:* The ISO 9001 standard requires an organization to plan and implement the monitoring, measurement, analysis and improvement of processes needed to what?
Answer: • continually improve the effectiveness of the quality management system
Question:* The ISO 9001 standard can be applied to:
Answer: • any organization, large or small, whatever its product or service and regardless of its sector of activity.
Question:* The ISO 9001 standard requires top management to ensure that appropriate communication processes are established within the organization and that communication takes place regarding what?
Answer: • the effectiveness of the quality management system
Question:* ISO 9001 requires an organization to implement a quality management system to demonstrate:
Answer: • the organization's ability to consistently provide product that meets customer requirements
Question:* The ISO 9001 standard requires a organization to determine and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes what?
Answer: • software and hardware
Question:* Per the ISO 9001 standard, documents required by the organization's quality management system shall be:
Answer: • controlled
Question:* The organization is required to conduct a review prior to the commitment to supply a product to the customer and shall ensure that the organization has the ability to meet what?
Answer: • the defined requirements
Question:* Clause 7.0 of the ISO 9001 standard is Product Realization. The standard requires a organization to plan and develop the processes needed for product realization. What does planning product realization include?
Answer: • the need to determine the required monitoring activities specific to the product
Question:* The organization is required to determine and provide the resources needed to enhance customer satisfaction by what?
Answer: • meeting customer requirements
Question:* The recommendations for improvement is considered an input for what?
Answer: • management review
Question:* When monitoring and measuring product, what type of records shall be maintained by the organization per ISO 9001?
Answer: • evidence of conformity with the acceptance criteria
Question:* What purpose would an organization seek an ISO 9001 certification?
Answer: • To provide the organization's customers assurance of consistent, good quality products or services
Question:* The ISO 9001 standard requires planning from top management. What shall be measurable and consistent with the quality policy?
Answer: • quality objectives
Question:* Under 4.0, the ISO 9001 standard requires an organization to monitor, measure and analyze processes to determine if they are:
Answer: • effective
Question:* Which should an organization use to continually improve the effectiveness of the quality management system per the ISO 9001 standard?
Answer: • quality policy, management review, audit results
Question:* The ISO 9001 standard requires an organization to take action to eliminate the causes of potential nonconformities. What is this called?
Answer: • preventive action
Question:* The ISO 9001 standard requires the organization to determine and provide the resources needed to enhance customer satisfaction by meeting:
Answer: • customer requirements
Question:* A documented procedure for preventive actions shall be established to define requirements for what?
Answer: • determining potential nonconformities and their causes
Question:* A review of the design and development of product is required by the ISO 9001 standard. The review shall:
Answer: • identify any problems and propose necessary actions
Question:* The ISO 9001 standard requires control of production and service provisions under controlled conditions. Controlled conditions shall include:
Answer: • the availability of work instructions
Question:* The model of a process-based quality management system illustrates process linkages based on the ISO 9001 standard clauses 4 - 8. What process plays a significant role in determining inputs?
Answer: • Customer Requirements
Question:* Certification is performed by external certification bodies, which are largely private. When choosing a certification body it is a good idea to:
Answer: • bear in mind that the cheapest could be more costly in the long run if its auditing is below standard
Question:* The ISO 9001 standard requires an organization to identify what by suitable means throughout its realization?
Answer: • product
Question:* The organization is required by the ISO 9001 standard to collect and analyze appropriate data to demonstrate effectiveness of the quality management system. This analysis of data shall include:
Answer: • customer satisfaction data
Question:* The ISO 9001 standard requires an organization to determine post-delivery activities related to product. This might include:
Answer: • final disposal
Question:* The ISO 9001 standard requires an organization to review requirements related to product prior to supplying the product. What should this review include?
Answer: • changes to orders
Question:* Conformity assessment is the process used to show that a product, service or system meets specified requirements. The main forms of conformity assessment are certification, inspection and what?
Answer: • testing
Question:* The ISO 9001 standard requires "document procedures" to how many specific elements in an organization's quality management system?
Answer: • 6
Question:* Although ISO does not perform certification, what committee has produced a number of standards that relate to the certification process?
Answer: • CASCO (Committee on Conformity Assessment)
Question:* The ISO 9001 standard requires an organization to review its quality management system at planned intervals. What "inputs" shall management review records include?
Answer: • changes that could affect the quality management system
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