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NEW QUESTION # 104
A small cleaning services organisation is about to start work on a hospital cleaning contract for the local Health Trust. You, as auditor, are conducting a Stage 2 audit to ISO 9001 and review the contract with the Service Manager. The contract requires that a cleaning plan is produced.
You: "How was the cleaning plan for the contract developed?"
Service Manager: "We have a basic template that covers the materials, labour requirements and cleaning methods to be employed. Some of that is specified by the customer." You: "How does the plan deal with locations like the intensive care wards and the operating theatres, which are included in the contract?" Service Manager: "The basic plan covers general wards, but we will do more frequent cleaning in those areas if the hospital requests it." You: "Are you aware of the regulatory requirements for cleaning standards in hospitals?" Service Manager: "No. We depend on the hospital to look after that side of things in the contract." You decide to raise a non-conformity against section 8.2.2.a.1 of ISO 9001.
You decide to raise another non-conformity against section 8.2.4 of ISO 9001 when finding that the cleaning plan was amended without the agreement of the Health Trust. A different cleaning chemical was substituted to that specified in the contract. At the follow-up audit, the corrective action proposed was to
"obtain a concession from the Health Trust for use of the new chemical." Which one of the following options is the reason why you did not accept this action taken?
Answer: C
NEW QUESTION # 105
In the context of a third-party audit, match the activity with the party responsible in relation to the audit process.
Answer:
Explanation:
Explanation:
In the context of a third-party audit, the activities and the parties responsible can be matched as follows:
* Review the organization's processes: This is typically the responsibility of the audit team. They examine the processes to ensure they comply with the specified standards1.
* Review the audit results: The audit team leader usually reviews the audit findings to ensure accuracy and completeness before they are finalized1.
* Issue the certificate: The certification body is responsible for issuing the certificate if the audit is successful and the organization meets the required standards1.
* Select the audit team: The individual(s) managing the audit programme are responsible for selecting the audit team. This ensures that the team has the appropriate skills and knowledge for the audit1.
These roles are essential to maintain the integrity and effectiveness of the audit process. The audit team conducts the actual audit, the team leader oversees the audit process, the certification body grants the certification, and the management of the audit program ensures that the right team is in place to conduct the audit1.
Based on the description of the image you've provided, here's how the activities match with the responsible parties in the context of a third-party audit:
* Review the organization's processes: This activity is typically the responsibility of the Audit Team.
They are tasked with examining the processes to ensure they meet the requirements of the standard being audited.
* Review the audit results: The Audit Team Leader is usually responsible for this activity. They oversee the audit process and are in charge of reviewing the findings and ensuring that the audit objectives are met.
* Issue the certificate: The Certification Body is responsible for issuing the certificate if the organization's management system is found to be in compliance with the standard.
* Select the audit team: The Individual(s) managing the audit programme are responsible for selecting the audit team. They ensure that the team has the appropriate competence and resources to effectively conduct the audit.
These roles are defined within the framework of ISO 9001:2015 and are essential for the proper conduct of a third-party audit. The audit team and its leader play a critical role in the operational aspects of the audit, while the certification body and those managing the audit programme have overarching responsibilities for the audit' s governance and integrity.
NEW QUESTION # 106
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME's QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME' s operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of
45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
According to scenario 5, Li Na conducted group interviews with departmental managers and top management by herself. Is this in accordance with audit best practices?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 19011:2018, Clause 6.4.6 (Conducting Interviews), group interviews should be conducted with at least two auditors to ensure objectivity and accuracy.
* This prevents bias or misinterpretation of responses.
* It allows for cross-validation of information.
* It ensures that the audit results remain objective and impartial.
Since Li Na conducted the group interviews alone, she did not follow audit best practices. The correct approach would have been to have another auditor present during the interviews.
NEW QUESTION # 107
In the context of a third-party management system certification audit, which two of the following statements are correct?
Answer: B,F
NEW QUESTION # 108
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oil and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. You, as one of the auditors, 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 very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
At the Closing meeting, the audit team leader presents the findings of the audit and comes to the above nonconformity. The Quality Manager produces the test report for Project DK, which shows an acceptable galvanic efficiency, and presents an email from the customer confirming acceptance of the anodes. He asks that the nonconformity be withdrawn.
Which two of the following responses by the audit team leader would be acceptable?
Answer: D,F
NEW QUESTION # 109
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