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NEW QUESTION # 102
According to the guidance provided in ISO 19011, a second-party opening meeting should cover many elements.
From the following options, select the four items that should not be included in the opening meeting.
Answer: C,E,F,H
NEW QUESTION # 103
During the opening meeting of a third-party audit of a pharmaceutical organisation (CD9000) with seven COVID-19 testing laboratories in various terminals at a major international airport, you are asked if you could visit all laboratories. As audit team leader you say that, based on sampling criteria, you had planned to audit only three of them as CD9000 is a multisite organisation.
They tell you that they have worked so hard to get ready for the audit that the supervisors of those laboratories that would not be visited would be quite disappointed.
The following are possible responses to the request, select the two best responses:
Answer: A,D
Explanation:
In this scenario, the audit team leader must balance maintaining the integrity of the audit plan while considering the auditee's request. The two best responses allow for flexibility without compromising the audit's rigor:
A: I could audit the other laboratories virtually at the end of this audit: Virtual audits can be a valid option, especially in multi-site audits. ISO 9001:2015 does not prohibit virtual audits, and in certain situations, they are practical for reviewing documentation or observing operations remotely.
C: I could try to revise the audit programme to see if I can audit all laboratories: Revising the audit programme to accommodate additional site visits is a reasonable compromise. ISO 9001:2015 audits are based on risk and sampling, but the audit team leader has the flexibility to adjust the audit scope if it fits within the audit duration and resources.
The other options, such as extending the audit duration (B, F) or strictly adhering to the original plan (D, E), may not be practical or necessary. Revising the plan to audit all laboratories or using virtual auditing ensures that the audit remains efficient while addressing the organization's concerns.
NEW QUESTION # 104
Which statement below indicates that an organization has developed its communication strategy by taking into account the principle of appropriateness?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 emphasizes the importance of communication as part of an effective Quality Management System (QMS).
Clause References:
* Clause 7.4 (Communication): This requires organizations to establish what, when, with whom, and how communication should take place to ensure effectiveness.
* Quality Management Principle - Engagement of People: Effective communication allows stakeholders (employees, suppliers, customers) to fully participate and contribute to quality objectives.
Why is the Correct Answer A?
* Appropriate communication means ensuring that messages are clear, relevant, and accessible to the intended audience.
* Different stakeholders (employees, customers, regulatory bodies, suppliers) may require different formats, languages, or media to ensure they fully understand and engage.
* This aligns with ISO 9001:2015, which emphasizes that communication must be tailored to the needs of the recipient for maximum effectiveness.
Why are the Other Options Incorrect?
* B (Timely responses) # Important but does not specifically refer to appropriateness in communication.
* C (Communicating processes and assumptions to all interested parties) # Communication should be relevant; sharing all details might not be necessary or appropriate.
* D (Only top management handling external communication) # Communication must be distributed across relevant functions, not restricted to leadership.
Reference:
ISO 9001:2015, Clause 7.4 - Communication
ISO 9001:2015, Quality Management Principles - Engagement of People
NEW QUESTION # 105
Scenario 3:
Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.
To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.
The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.
The audit team began by gathering information about Fin-Pro's understanding of ISO 9001 requirements.
While reviewing documented information, they noticed missing records of training and awareness sessions.
They conducted employee interviews to verify attendance.
The team also reviewed the organizational chart and job descriptions to confirm employee competence. They observed the company's working environment (social, psychological, and physical conditions).
The audit team analyzed the evidence and prepared an audit report with findings and conclusions.
Based on the last paragraph of scenario 3, which audit principle did the audit team follow?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Auditors must report findings truthfully and accurately to ensure an unbiased assessment of the QMS.
Clause References:
ISO 19011:2018, Clause 4 - Principles of Auditing:
Fair Presentation # Requires auditors to report truthfully and accurately, without bias or omission.
Integrity # Ensures auditors adhere to ethical conduct.
Why is the Correct Answer A?
The audit team reported findings truthfully, based on collected evidence.
Fair presentation ensures that both positive and negative findings are included in the audit report.
Objective evidence was gathered through interviews, document reviews, and observations.
Why are the Other Options Incorrect?
B (Integrity) # Related to ethics and professional conduct, but not specifically about presenting findings.
C (Confidentiality) # Important, but does not apply to the principle of reporting findings accurately.
D (Objectivity) # Ensures impartiality, but "fair presentation" directly addresses accurate reporting of findings.
Reference:
ISO 19011:2018, Clause 4 - Principles of Auditing (Fair Presentation)
NEW QUESTION # 106
You are conducting an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.
Answer:
Explanation:
Explanation:
The table below shows the possible matching of the ISO 9001 Clause 8.3 extract to the audit evidence.
Table
Audit evidence
ISO 9001 Clause 8.3 extract
Half of all new products launched in the past 12 months were late. The NPD Manager explains he has not got enough people on his team to cope with the demand for new products.
"8.3.2 e) ... internal ... resource needs for the design and development of products ..." The NPD Manager explains many changes are made to cosmetic formulations during product development owing to retailer feedback. Only when confirmed by the retailer is the agreed formulation documented on SWIFT.
"8.3.5 ... retain documented information ..."
The NPD Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails are kept on SWIFT.
"8.3.6 ... retain documented information ..."
The NPD Manager shows you evidence of consumer trials that are carried out for some new products prior to full-scale launch.
"8.3.4 d) ... conducted to ensure that the resulting products and services meet the requirements ..." The NPD Manager explains that an approved external laboratory is used to perform shelf-life stability trials on some formulations during product development.
"8.3.2 e) ... external ... resource needs for the design and development of products ..."
NEW QUESTION # 107
......
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