ISO 9001 監査プログラムの管理: このトピックでは、QMS 監査プログラムを確立および管理する能力を評価します。
PECB QMS ISO 9001:2015 Lead Auditor Exam 認定 ISO-9001-Lead-Auditor 試験問題 (Q162-Q167):質問 # 162
You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements.
The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.
You are interviewing the Training Manager (TM).
You: "What quality objectives apply to the training process?"
TM: "One of the quality objectives we aim for is a 90% minimum exam pass rate for all open training courses." You: "How do you measure this objective?" The Training Manager shows you a record on her computer and you see the following:
Which two of the following statements are true?
A. You would determine what corrective action was being taken to address the low pass rates.
B. You would raise a nonconformity as a requirement in clause 10.2 has not been fulfilled.
C. You would determine the relative difficulty of each training course by reviewing them.
D. You would check the training of personnel.
E. You would raise a nonconformity as a requirement in clause 8.7 has not been fulfilled.
F. You would determine how the exam pass rate figures were analysed.
正解：A、F
解説：
In this scenario, the organization has set a quality objective of achieving a 90% minimum exam pass rate for all courses. The auditor's task is to assess whether this objective is being monitored effectively and if appropriate actions are taken when the objective is not met.
B: You would determine how the exam pass rate figures were analysed: ISO 9001:2015, particularly Clause
9.1 (Monitoring, measurement, analysis, and evaluation), requires organizations to evaluate performance data.
The auditor should verify how the organization analyses the pass rate data to ensure trends are identified, and corrective actions are planned based on this analysis.
D: You would determine what corrective action was being taken to address the low pass rates: When performance falls short of the objective, as seen with Course 4 (where the pass rate is below 90% in all months), Clause 10.2 (Nonconformity and corrective action) requires organizations to take corrective actions to address issues. The auditor would need to check if corrective actions have been initiated to address consistently low pass rates.
Statements A, C, E, and F do not directly address the monitoring and corrective action required under ISO
9001:2015 in this context.
質問 # 163
One of the conflict resolution techniques is toning down. How is the conflict managed in that case?
A. Following negotiations, each party makes concessions in order to reach a common agreement.
B. The audit team leader uses their authority to solve the conflict.
C. The points of agreement are emphasized and the points of disagreement are put into perspective.
正解：C
解説：
Comprehensive and Detailed In-Depth Explanation:
Toning down (or de-escalation) is a conflict resolution technique where:
* Common agreements are emphasized to reduce tension.
* Disagreements are addressed with a rational and constructive approach.
Option A describes compromise, and Option B describes authoritative resolution, which are different conflict resolution techniques.
Reference:
ISO 19011:2018, Clause 7.1.3 (Managing Conflict During an Audit)
質問 # 164
ABC is a worldwide fast-food organisation. One of the branches, in downtown Cape Town, decided to implement an ISO 9001 quality management system and you are the audit team leader (with two other auditors) that will carry out the certification audits, Stage 2.
ABC receive the orders by phone or internet; some of the employees deliver the ordered food to indicated addresses. The normal menu includes 15 different types of hamburgers; however, in the last two weeks, due to a shortage of a special type of meat, they can only prepare six of the 15 varieties.
During the internal meeting of the audit team, you ask one of the auditors to describe what she has observed. She audited the reception of orders from customers (via phone or internet) and the communication of the orders to the kitchen. She noticed that the menu offering food on the website is still the normal one, with 15 different hamburgers, and during a 30-minute period, she observed many customers reluctantly accepting something other than the hamburger they preferred.
You, as audit team leader, inform the Quality Manager of your concern about the major nonconformity, since you consider this a serious breach of the basic principles of quality that lasted two weeks without action being taken.
Right at the beginning of the Closing meeting, you discuss the nonconformity with the General Manager.
She got quite upset and said she was going to make a complaint to the certification body and left the room; the Quality Manager was the only member of ABC left with the audit team. The Quality Manager said the General Manager would not come back to the meeting.
What would you do? Choose the best from the following options:
A. Ask the Quality Manager for a break to discuss the issue with the members of the audit team.
B. Inform the Quality Manager that you consider the meeting closed, and that you will report to the Certification Body for instructions.
C. Ask the Quality Manager to listen to the nonconformity the auditor will present and continue with the meeting until its closure.
D. Inform the Quality Manager that the certification process is put on hold and leave the room.
正解：C
質問 # 165
A Health Trust has contracted with Servitup, a catering services company that has been certified to ISO
9001 for one year. It provides services to 10 small rural hospitals in remote locations involving the purchase and storage of dry goods and fresh produce, preparing meals and loading heated trolleys for ward service by hospital staff. You, as auditor, are conducting the first surveillance audit at one site with the Deputy Catering Manager (DCM).
DCM: "I apologise for the absence of the Catering Manager. He has called in sick today and we are really short of staff." You: "I see. It really shouldn't affect the QMS so the audit can progress as normal." DCM: "The Catering Manager set up the system. I'm afraid I'm not as familiar with it as he is." You: "OK, let's start with the Quality Policy. What are the main issues for the QMS here?" DCM: Give me a minute. I need to look at the Quality Policy on the noticeboard in his office.
You find that two internal audits have been carried out in the first year by the Catering Manager. One of them indicates that complaints from patients are increasing in number, mainly due to food being served too cold. The DCM comments that the trolley thermometer is often unreliable.
Which two of the following actions would be "correction" in dealing with the complaints?
A. Purchase a new thermometer to replace the unreliable one used for the ward trolleys.
B. Calibrate thermometers more frequently to ensure accuracy of readings for food temperature on the trolleys.
C. Plug trolleys into ward electricity sockets to heat food to the correct temperature after a patient complains.
D. Monitor and record the temperature of food on the trolleys against defined standards before release to the wards.
E. Request ward staff to test the temperature of the food on the plates before serving to patients.
F. Keep a spare thermometer in case of a thermometer malfunction.
正解：A、B
質問 # 166
Consultancy ABC, which is a subsidiary of a certification body called ABC-CERT, provided consultancy services regarding the implementation of a QMS based on ISO 9001 to an organization.
Considering this, can ABC-CERT provide certification services to the organization which obtained consultancy services from Consultancy ABC?
A. Yes, if both parties sign an agreement which states that previous services by Consultancy ABC will not impact the judgment of auditors.
B. No, ABC-CERT is not allowed to provide certification services to that organization ever, as this would be a conflict of interest.
C. Yes, after a minimum period of two years has passed.
正解：B
解説：
Comprehensive and Detailed In-Depth Explanation:
Certification bodies must remain independent and impartial. If a certification body (ABC-CERT) provides consulting services to an organization through its subsidiary (Consultancy ABC), it cannot later certify the same organization.
Clause References:
* ISO/IEC 17021-1:2015, Clause 5.2.5 - Impartiality Requirements:
* A certification body must not certify an organization to which it has provided consultancy services.
* ISO/IEC 17021-1:2015, Clause 5.2.6:
* Subsidiaries of certification bodies must not provide consulting services to prevent conflicts of interest.
Why is the Correct Answer C?
* Certifying a client after providing consultancy creates a conflict of interest and violates ISO/IEC
17021-1:2015 impartiality rules.
* The certification body (ABC-CERT) and consultancy firm (Consultancy ABC) are related entities
, making it impossible to remain objective and independent.
Why are the Other Options Incorrect?
* A (Waiting two years) # ISO does not specify a time frame; the issue is impartiality, not just time.
* B (Signing an agreement to ensure objectivity) # Conflicts of interest cannot be resolved through an agreement; independence is required.
Reference:
ISO/IEC 17021-1:2015, Clause 5.2.5 - Impartiality Requirements
