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NEW QUESTION # 92
Which two of the following aspects of a quality management system must the organisation continually improve?
Answer: C,D
Explanation:
Effectiveness and efficiency are two of the seven quality management principles that form the basis of ISO
9001. According to ISO 9000:2015, clause 3.2.14, effectiveness is the "extent to which planned activities are realized and planned results achieved". According to clause 3.2.15, efficiency is the "relationship between the result achieved and the resources used". In other words, effectiveness is about doing the right things, and efficiency is about doing things right. ISO 9001:2015, clause 10.3, requires the organisation to continually improve the suitability, adequacy, and effectiveness of the quality management system. This implies that the organisation should also improve the efficiency of its processes, products, and services, as efficiency is a key factor in achieving customer satisfaction, reducing costs, and increasing profitability. Some of the ways that the organisation can improve its effectiveness and efficiency are: - Establishing SMART (specific, measurable, achievable, relevant, and time-bound) objectives and monitoring their progress - Implementing the Plan-Do-Check-Act (PDCA) cycle to plan, execute, evaluate, and improve its activities - Applying the process approach to manage its interrelated processes as a coherent system - Using evidence-based decision making to analyse data and information and take appropriate actions - Seeking feedback from customers and other interested parties and addressing their needs and expectations - Identifying and addressing risks and opportunities that can affect its performance and conformity - Encouraging innovation and creativity to find new and better ways of doing things - Benchmarking its performance against best practices and industry standards - Providing training and development opportunities for its personnel to enhance their competence and motivation 12345 References:
1: ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary
2: ISO 9001:2015 - Quality management systems - Requirements
3: ISO 9001 Explained: A Comprehensive Guide to Quality Management Systems - ISMS.online
4: The 7 Principles of ISO 9001 | ISO Standards Explained
5: Key Elements of an ISO 9001:2015 Quality Management System
NEW QUESTION # 93
In the context of a third-party management system certification audit, which two of the following statements are correct?
Answer: B,F
NEW QUESTION # 94
XYZ Corporation is an organisation that employs 100 people. As audit team leader, you are conducting a certification audit at Stage 1. When reviewing the quality management system (QMS) documentation, you find that quality objectives have been set for every employee in the organisation except top management.
The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost. He asks for your opinion on whether this is the correct method of setting objectives.
Three months after Stage 1, you return to XYZ Corporation to conduct a Stage 2 certification audit as Audit Team Leader with one other auditor. You find that the Quality Manager has cancelled the previous quality objectives for all employees and replaced them with a single objective for himself. This states that "The Quality Manager will drive multiple improvements in the QMS in the next year". The Quality Manager indicates that this gives him the authority to issue instructions to department managers when quality improvement is needed. He says that this approach has the full backing of senior management. He shows you the latest Quality Improvement Request that was included in the last management review.
After further auditing, the issues below were found. Select three statements that apply to the term 'audit trail'
Answer: A,D,E
Explanation:
Based on the scenario and the concept of an 'audit trail' within the context of ISO 9001, the three statements that apply would likely be:
A). Decisions on improvement action timescales not involving departmental managers. This indicates a lack of involvement and communication with those responsible for implementing the improvements, which is a key part of an effective audit trail1.
B). Evaluation of the results of the improvement action not always documented by the Quality Manager.
Proper documentation is essential for an audit trail, as it provides evidence that actions have been evaluated and are effective1.
C). Limited knowledge of the content of Quality Improvement Requests by departmental staff. An audit trail should ensure that all relevant parties are aware of and understand the actions being taken, which is not the case here1.
These points suggest issues with the communication, documentation, and involvement of relevant personnel in the quality management system processes, which are crucial for maintaining an effective audit trail and, by extension, a robust quality management system.
NEW QUESTION # 95
(Which of the following two activities can be carried out on-site by an auditor with no human interaction?)
Answer: B,F
Explanation:
ISO 9001:2015 requires audits to be objective, evidence-based, and independent. While the standard does not prescribe detailed audit techniques, it clearly supports the use of objective evidence that can be obtained without human interaction, particularly through observation and review of documented information.
# C. Observing work performed
* Observation is a recognized audit technique where the auditor watches activities being carried out without questioning personnel.
* ISO 9001 emphasizes verifying that processes are implemented as planned and achieve intended results.
* Observation provides direct, objective evidence of process implementation.
# Supported by:
* Clause 9.2.1 - Internal audits must determine whether the QMS is effectively implemented and maintained
* Clause 4.4.1 - Processes must be implemented and controlled as planned Observation can therefore be done on-site, silently, and without interaction.
# F. Conducting a document review
* Reviewing documented information (procedures, records, logs, policies) does not require interaction with auditees.
* ISO 9001 explicitly requires the use and control of documented information and allows auditors to verify conformity by reviewing it independently.
# Supported by:
* Clause 7.5.1 - The QMS shall include documented information required by ISO 9001
* Clause 9.2.2 - Audit evidence shall demonstrate conformity to requirements Document review can be conducted on-site, at a desk, without speaking to anyone.
# Why the other options are NOT correct
* A. Completing a questionnaire for the auditeeRequires interaction and responses from people.
* B. Audit understanding of Business ContextRequires discussions with top management and review of strategic inputs (Clause 4.1).
* D. Audit customer communications about order handling enquiriesNormally requires discussion, clarification, or explanation of communication processes.
* E. Conducting interviewsBy definition requires human interaction.
NEW QUESTION # 96
Select the term which best describes the quality management system process of modifying a non-conforming product to bring it within acceptance criteria.
Answer: B
Explanation:
According to the ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, correction is defined as "action to eliminate a detected nonconformity". A nonconformity is defined as "non-fulfilment of a requirement". Therefore, the process of modifying a non-conforming product to bring it within acceptance criteria is a correction, as it eliminates the non-fulfilment of the product specification. The other options are not correct, as they have different definitions and purposes:
*Concession: permission to release or use a nonconforming product, service or process
*Corrective action: action to eliminate the cause of a nonconformity and to prevent recurrence
*Preventive action: action to eliminate the cause of a potential nonconformity or other undesirable potential situation References: ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, ISO 9001 nonconforming product: How to understand dispositions - Advisera
NEW QUESTION # 97
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