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NEW QUESTION # 223
Knowledge and skills are requirements of the auditor's competence. Select two from the following topics of knowledge that apply to every member of an audit team auditing an ISO 9001 quality management system.
Answer: B,F
Explanation:
According to ISO 9001:2015, clause 7.2, an auditor shall have the competence to:
Understand the requirements of ISO 9001 and how they relate to the audit Understand the organization's quality management system and its processes Understand the applicable legal, regulatory, contractual and other requirements that affect the audit Understand the needs and expectations of interested parties other than customers Plan and conduct audits in accordance with ISO 19011 Evaluate audit evidence and draw appropriate conclusions Communicate audit findings effectively1 Therefore, knowledge of ISO 9001 requirements and ISO 19011 audit principles are essential for every member of an audit team auditing an ISO 9001 quality management system.
References:
ISO 9001:2015 - Quality management systems - Requirements
ISO 19011:2018 - Guidelines for auditing management systems
NEW QUESTION # 224
Which two of the following work documents are not required for audit planning by an auditor conducting a certification audit?
Answer: D,E
NEW QUESTION # 225
Scenario 4:
TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.
To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.
After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.
Anne reviewed the document and approved the audit mandate. The certification body and TD's top management signed the certification agreement.
Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.
Scenario 4 mentions that Anne received a document that contained the audit scope, criteria, duration, and the limits to the audit engagement. What did Anne receive in this case?
Answer: D
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Before conducting an audit, the certification body must provide an audit offer, which outlines the audit scope, criteria, and duration.
Clause References:
* ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning: Requires the certification body to communicate key audit details before finalizing the audit process.
Why is the Correct Answer C?
* The audit offer includes scope, criteria, duration, and engagement limits before the certification agreement is signed.
* The certification body sends this to the auditee before finalizing the contract.
Why are the Other Options Incorrect?
* A (Certification Agreement) # This is the contract signed after the audit offer is accepted.
* B (Audit Plan) # The audit plan details the day-to-day audit schedule and is created after the agreement.
* D (Audit Mandate) # This is an internal document for the certification body.
NEW QUESTION # 226
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,B,F
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 # 227
During an internal audit, it was discovered that the calibration of a spectrometer used daily for production had expired, causing a nonconformance under Clause 7.1.5.2 of ISO 9001:2015. The root cause was the organization not considering the risk of the calibration provider leaving the country.
Which corrective action is the best one?
Answer: D
Explanation:
Understanding Clause 7.1.5.2 - Measurement Traceability:ISO 9001:2015 requires organizations to ensure that measuring equipment (e.g., spectrometers) is calibrated and traceable to recognized standards. The failure to maintain calibration within valid dates directly violates this clause and raises concerns about the reliability of the measurement results.
Root Cause of the Nonconformity:The organization failed to plan for the possibility that the calibration service provider (X-TECH) might become unavailable, leading to expired calibration. This indicates inadequate risk-based thinking, which is required under Clause 6.1 of ISO 9001:2015.
Option Analysis:
A). Select one sample for external lab analysis to use as an internal standard:Incorrect. While using an internal standard could provide short-term verification of results, this action does not address the root cause (failure to consider risks associated with external providers).
B). Look for a local company to provide this service:Incorrect. While finding a new local service provider resolves the immediate calibration issue, it does not address the risk of future provider unavailability.
C). Double-check one out of ten samples externally:Incorrect. This corrective action ensures some quality assurance for batch release but does not resolve the nonconformance related to expired calibration.
D). Add this issue to the external issue register, assess its associated risk, and plan action to address that risk:
Correct. This approach directly addresses the root cause (failure to anticipate the calibration provider leaving) and ensures proper risk management. ISO 9001:2015 emphasizes risk-based thinking under Clause 6.1, requiring organizations to identify risks and opportunities and implement plans to mitigate them.
Why D is the Best Option:
By adding the issue to the external issue register, the organization ensures it is monitored and tracked.
Assessing the risk ensures proactive measures are in place for similar issues in the future.
Planning actions to address the risk ensures a sustainable solution is implemented, such as identifying multiple service providers or ensuring backup plans for calibration services.
ISO 9001 References:
Clause 6.1 (Actions to Address Risks and Opportunities): Requires organizations to consider risks and opportunities that could affect the intended results of the QMS.
Clause 7.1.5.2 (Measurement Traceability): Mandates that measuring equipment must be calibrated and traceable to ensure valid results.
Clause 10.2 (Nonconformity and Corrective Action): Requires organizations to determine the root cause of nonconformities and take actions to ensure they do not recur.
NEW QUESTION # 228
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