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NEW QUESTION # 114
Which quality management principle does an organization fulfill when it assesses risks, consequences, and impacts before taking action?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
One of the seven quality management principles in ISO 9001:2015 is Improvement, which emphasizes continual enhancement of processes, products, and services.
Clause 10.3 (Continual Improvement) states that organizations must continuously assess risks, consequences, and impacts to improve their QMS.
* Risk-based thinking (Clause 0.3.3) supports improvement by identifying and mitigating risks before they affect performance.
* Clause 6.1 (Actions to Address Risks and Opportunities) requires organizations to take a proactive approach, ensuring long-term success.
Other options do not fully align with the question:
* Process approach (A) focuses on managing interrelated activities.
* Leadership (B) ensures commitment but does not directly address risk assessment.
* Relationship management (D) deals with interested parties, not risk mitigation.
Reference:
ISO 9001:2015, Clause 10.3 - Continual Improvement
ISO 9001:2015, Clause 6.1 - Actions to Address Risks and Opportunities
ISO 9001:2015, Clause 0.3.3 - Risk-Based Thinking
NEW QUESTION # 115
ABC is a fast food shop that receives orders by phone or the internet. The normal menu includes 15 different types of hamburgers; however, in the last two days, due to a shortage of a special type of meat, they can only prepare six of the 15 varieties.
You are performing a third-party audit of ABC; you observed that the menu offering food on the website is still the normal one, with 15 different hamburgers. During a 30-minute period, you observed several customers reluctantly accepting other than the hamburger they preferred. You decided to raise the following nonconformity as follows:
"There is evidence that ABC has not reviewed the ability to provide customers the offered products".
The restaurant manager does not accept the nonconformity. She says that ABC had an extensive training programme for all personnel, which you have already seen when auditing Human Resources. This shortage of some hamburgers cannot be considered a management system failure.
Which one would be your answer from the following options?
Answer: A
Explanation:
The appropriate response in this situation would be:
C: I will raise it as a minor nonconformity; you have the option to appeal to our Certification Body.
This response acknowledges the restaurant manager's point that the shortage of some hamburgers may not constitute a management system failure. However, the fact remains that the menu was not updated to reflect the current availability of products, which led to customer dissatisfaction. This is a deviation from the ISO
9001 standard, which requires that the organization ensures the availability of resources needed to provide products and services as promised1. Raising it as a minor nonconformity allows the organization to address the issue within a specified timeframe and provides an opportunity for appeal if the organization disagrees with the auditor's decision2.
NEW QUESTION # 116
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation offers warehousing and export services to customers. Customers are invoiced for the time stock items are stored in the warehouse. Transport to and from the warehouse is controlled by the organisation and approved subcontract transport services are used. The organization does not have its own transport vehicles. Stock items are not purchased by the organisation.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 Clause 8 extract to the audit evidence.
Answer:
Explanation:
Explanation:
The table below shows the possible matching of the ISO 9001 Clause 8 extract to the audit evidence.
Table
Audit evidence
ISO 9001 Clause 8 extract
Four of the 10 pallets of stock sampled in the warehouse were not labelled.
"8.5.2 ... shall use suitable means to identify outputs ..."
A damaged pallet of stock seen in the quarantine area was leaking liquid onto the floor.
"8.7.1 ... shall ensure that outputs that do not conform to their requirements are identified and controlled ..." One of the fork-lift truck drivers had no fork-lift truck driving licence.
"8.5.1 e ... shall include, as applicable ... the appointment of competent persons ..." There was no pest control provision in the warehouse.
"8.5.4 ... shall preserve the outputs during production and service provision ..." Two pallets of temperature-sensitive stock items were being stored at ambient as the chilled storage facility was full.
"8.1 ... shall plan, implement and control the processes ..."
NEW QUESTION # 117
Match the process descriptions below to the process names:
Answer:
Explanation:
Explanation:
Match the process descriptions below to the process names:
The process by which the accuracy of test equipment is checked against a known standard. = Calibration The process by which a product or service is visually examined to determine conformity to requirements. = Evaluation The process by which data is examined in detail to reach a specific answer or answers. = Analysis The process by which a parameter of a product or service is examined to determine a specific value. = Measurement According to the ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, the definitions of the process names are as follows:
Calibration: operation that, under specified conditions, in a first step, establishes a relation between the quantity values with measurement uncertainties provided by measurement standards and corresponding indications with associated measurement uncertainties and, in a second step, uses this information to establish a relation for obtaining a measurement result from an indication.
Evaluation: determination of the suitability, adequacy or effectiveness of an object to achieve established objectives.
Analysis: detailed examination of the elements or structure of something.
Measurement: process to experimentally obtain one or more quantity values that can reasonably be attributed to a quantity.
Therefore, the process descriptions can be matched to the process names based on these definitions.
References:
ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary
NEW QUESTION # 118
Technical experts must operate under the supervision of:
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 19011:2018, Clause 5.5 (Determining Audit Team Competence), technical experts:
* Provide specialized knowledge in an audit.
* Must operate under the supervision of an auditor to ensure compliance with audit protocols.
* Cannot work independently or under the auditee's supervision, as they are not responsible for the audit's findings.
The audit team leader has overall responsibility, but technical experts are supervised by an auditor during the audit process.
Reference:
ISO 19011:2018, Clause 5.5 (Determining Audit Team Competence)
NEW QUESTION # 119
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