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NEW QUESTION # 168
What does the application of the process approach in a QMS enable?
Answer: A
NEW QUESTION # 169
How can an organization ensure the objectivity and impartiality of the internal audit function?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 5.1 (Impartiality):
* Internal auditors must not audit areas where they have direct responsibilities to avoid conflicts of interest.
* Outsourcing (C) is not required, as long as impartiality is maintained internally.
Thus, B is the correct answer.
NEW QUESTION # 170
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation which manufactures sacrificial anodes for the oil and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. As one of the auditors, you find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality Manager explains that the Managing Director authorised the release of the anodes to avoid late delivery as penalties would be imposed. The customer was not informed since the tests rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
During the audit team meeting in preparation for the Closing meeting, the second auditor disagreed with the clause of ISO 9001 selected for the above nonconformity. He thinks it should be clause 9.1.1.
Choose three options for how the audit team leader should best respond to the situation:
Answer: C,D,H
Explanation:
A: the audit team leader, it is crucial to manage differing opinions constructively and ensure that the correct clause is selected for the nonconformity based on solid evidence. Here's how the situation should be handled:
E: Invite you and the second auditor to fully explain your point of view and then decide which clause to select: This promotes collaboration and transparency, allowing both auditors to present their rationale for choosing the specific clause.
F:Review the evidence with you and the second auditor, and then decide which clause of ISO 9001 would best apply: Reviewing the evidence in relation to the specific requirements of ISO 9001 is essential for determining which clause is most appropriate.
H: Try to obtain a consensus between you and the second auditor after a discussion of the different opinions:
Consensus-building is a crucial skill for an audit team leader. Achieving agreement ensures the nonconformity is addressed accurately and with full team support.
Options such as overruling immediately (D) or deferring the decision without full discussion (B) could undermine team dynamics and the audit process. Consulting the quality manager (A) or selecting an entirely different clause (G) is unnecessary, as the team should resolve the issue internally.
NEW QUESTION # 171
Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.
A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.
In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.
Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.
Based on the scenario above, answer the following question:
According to Scenario 6, the audit team required DC's top management to submit corrective action plans within two weeks. Is this action acceptable?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions) states:
The auditor can set a reasonable deadline for corrective actions.
10 to 60 days is a best practice timeframe for the auditee to respond.
The auditee must propose corrective actions, but the audit team has the authority to set the deadline.
A 7-day deadline (A) is too short, and the audit team-not the auditee-determines the timeframe (B).
Reference:
ISO 17021-1:2015, Clause 9.4.9 (Corrective Actions)
NEW QUESTION # 172
(Select from the options which two of the following documented information examples are prepared by the auditor as a member of an audit team.)
Answer: C,D
Explanation:
ISO 9001:2015 refers auditors to ISO 19011:2018 for guidance on audit planning, preparation, conduct, and reporting.
As members of an audit team, auditors commonly prepare working documents that assist them in conducting audits effectively and obtaining objective evidence.
Correct Answers
A). Audit Sampling Plan
An auditor frequently develops or contributes to an audit sampling plan.
Sampling is necessary because:
* It is usually impractical to examine every record, process, or transaction.
* Auditors select representative samples to obtain sufficient objective evidence.
ISO 19011 recognizes sampling as a normal audit activity and auditors prepare sampling arrangements as part of audit preparation.
Therefore, this document can be prepared by an auditor.
B). Checklist
Audit checklists are one of the most common auditor working documents.
They are used to:
* Organize audit activities.
* Ensure audit criteria are covered.
* Record objective evidence.
* Support consistency during interviews and document review.
ISO 19011 identifies checklists as typical audit working papers prepared by auditors.
Therefore, this document can be prepared by an auditor.
Why the Other Options Are Incorrect
C). Management Review Record
This is documented information generated by the auditee organization , typically as evidence of compliance with ISO 9001 Clause 9.3.
It is reviewed by auditors but not prepared by them.
D). Internal Audit Record
This is normally a record created by the organization ' s own internal audit process under Clause 9.2.
A third-party audit team reviews these records but does not prepare them.
E). List of Staff Required at the Closing Meeting
This is generally arranged by the auditee and coordinated through the audit team leader. It is not typically an auditor-prepared audit document.
F). Scope
The audit scope is established by the audit client, certification body, audit programme manager, or audit team leader during audit planning.
Individual auditors do not normally prepare the audit scope.
ISO-Aligned Summary
Documented Information
Prepared by Auditor?
Audit sampling plan
Yes
Checklist
Yes
Management review record
No
Internal audit record
No
List of staff required at the closing meeting
No
Scope
No
NEW QUESTION # 173
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