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NEW QUESTION # 151
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 # 152
What are the criteria for reviewing documented information?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
According to ISO 9001:2015, Clause 7.5.2 (Creating and Updating Documented Information), the criteria for reviewing documented information include:
* Content - The accuracy and relevance of the information.
* Format - Ensuring readability and proper structuring (e.g., language, versioning).
* Procedure for managing documented information - Ensuring control, access, and updates.
Other options, such as internal audit reports and client feedback, are important for overall QMS evaluation but are not the main criteria for reviewing documented information.
Reference:
ISO 9001:2015, Clause 7.5.2 (Creating and Updating Documented Information)
NEW QUESTION # 153
During a third-party audit of a pharmaceutical organisation (CD9000) site of seven COVID-19 testing laboratories in various terminals at a major international airport, you interview the CD 9000's General Manager (GM), who was accompanied by Jack, the legal compliance expert. Jack is acting as the guide in the absence of the Technical Manager due to him contracting COVID-19.
You: "What external and internal issues have been identified that could affect CD9000 and its quality management system?" GM: "Jack guided us on this. We identified issues like probable competition of another laboratory organisation in the airport, legal requirements on COVID-19 continuously changing, the shortage of competent laboratory analysists, the epidemic declining soon, shortage of chemicals for the analysis. It was quite a good experience." You: "Did you document these issues?" GM: "No. Jack said that ISO 9001 does not require us to document these issues." You: "How did you determine the risks associated with the issues and did you plan actions to address them?" GM: "I am not sure. The Technical Manager is responsible for this process. Jack may be able to answer this question in his absence." Select two options for how you would respond to the General Manager's suggestion:
Answer: A,D
Explanation:
According to the ISO 9001:2015 standard, clause 4.1 requires organizations to determine the external and internal issues that are relevant to their purpose and that affect their ability to achieve the intended outcomes of their quality management system. Clause 6.1 requires organizations to plan actions to address the risks and opportunities associated with these issues. These actions must be integrated into the quality management system processes and evaluated for effectiveness.
In this scenario, the General Manager of the pharmaceutical organization has shown a lack of understanding and involvement in the process of identifying and addressing the external and internal issues that affect their quality management system. The General Manager has relied on the legal compliance expert, who is not an employee of the organization, to guide them on this process. The General Manager has also admitted that they did not document these issues, which is contrary to the requirement of retaining documented information on the context of the organization. The General Manager has also delegated the responsibility of determining and planning the actions to address the risks and opportunities to the Technical Manager, who is absent due to COVID-19.
Based on this information, you can respond to the General Manager's suggestion by taking two options:
B: I would ask for a different guide instead of the legal compliance expert: You can request to have a different guide who is an employee of the organization and who is familiar with the quality management system processes and the external and internal issues that affect them. The legal compliance expert may not have the necessary knowledge and authority to answer your questions or provide you with the relevant evidence.
C: I would look for evidence that the actions resulting from the risk assessment had been taken: You can verify whether the organization has implemented and evaluated the actions to address the risks and opportunities associated with the external and internal issues. You can look for evidence such as records of risk analysis, action plans, monitoring and review results, and improvement measures.
These two options would help you to assess the conformity and effectiveness of the organization's quality management system with respect to the requirements of clauses 4.1 and 6.1.
NEW QUESTION # 154
According to ISO 9000, what is quality?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9000:2015 defines quality as "the degree to which a set of inherent characteristics of an object fulfills requirements." Clause 3.6.2 (Quality) confirms this definition.
Quality is determined by how well an object (product, service, or process) meets defined requirements (customer, regulatory, or internal).
The other options do not align with the official ISO definition:
Option A refers to performance capability but does not define quality.
Option C describes work conditions, not quality.
Option D focuses on efficiency rather than fulfilling requirements.
Reference:
ISO 9000:2015, Clause 3.6.2 - Quality
NEW QUESTION # 155
(In the context of a second-party quality management system audit, select the two correct statements from the following:)
Answer: C,D
Explanation:
ISO 9001:2015 does not define detailed audit role terminology itself, but it explicitly refers to ISO 19011 for audit guidance. This makes ISO 19011 authoritative for defining audit roles and responsibilities within ISO
9001 audits.
ISO 9001:2015, Clause 9.2.2 - NOTE:
"See ISO 19011 for guidance."
Therefore, the correctness of the statements is determined using ISO 19011 (Auditing management systems) principles, which are fully applicable to second-party audits.
# B. An auditor is a person who conducts an audit
# Correct
* ISO 19011 defines an auditor simply and clearly as "a person who conducts an audit."
* This definition applies equally to first-, second-, and third-party audits.
This statement is universally correct and fully aligned with ISO auditing terminology.
# F. When needed, a translator appointed by the auditee
# Correct
* ISO 19011 allows the use of translators/interpreters to support communication during audits.
* Translators are typically appointed by the auditee, not the audit team.
* Translators are not members of the audit team and do not influence audit conclusions.
This is a valid and correct statement for second-party audits.
# Why the other options are incorrect
# A. Guide appointed by the audit team leader
* In ISO 19011, a guide is appointed by the auditee, not by the audit team leader.
* The guide assists with logistics and access, not audit execution.
# Incorrect appointment authority.
# C. The audit team cannot include auditors-in-training
* ISO 19011 explicitly allows auditors-in-training to be part of the audit team under supervision.
# Incorrect restriction.
# D. Observer provides information about the organisation
* An observer does not provide information or participate in the audit.
* Observers may attend (e.g. regulators, accreditation bodies) but remain passive.
# Incorrect role description.
# E. A technical expert is part of the audit team
* A technical expert supports the audit team, but is not considered an auditor.
* They provide subject-matter expertise under the direction of auditors.
# The statement is misleading and therefore incorrect.
NEW QUESTION # 156
......
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