PECB ISO-9001-Lead-Auditor 問題集

質問 1：
Audit criteria are a set of requirements used as a reference against which objective evidence is compared.
Which two of the following are not potential audit criteria?
A. Organisation's documented information
B. Verbal agreements with interested parties
C. Claims made on the organisation's website
D. Verbal statements by the general manager
E. Written agreements with interested parties
F. Health and safety notices
G. Commercial advertisements
H. Commitment to follow principles issued by an NGO
I. Environmental aspects register
J. ISO management system standards
正解：C,G
解説: (Topexam メンバーにのみ表示されます)

質問 2：
In the context of a third-party certification audit, how can the auditor demonstrate confidentiality? Select two.
A. Remove audit evidence without the permission of the auditee.
B. Share audit conclusions with competitor organisations.
C. Confirm the confidentiality arrangements with the auditee regarding the use of mobile devices/cameras.
D. Discuss sensitive personal information with the guides appointed by the auditee.
E. Adhere to the CQI Professional Code of Conduct.
正解：C,E
解説: (Topexam メンバーにのみ表示されます)

質問 3：
You are conducting an ISO 9001 audit of a Materials Recycling Facility (MRF). The organisation processes waste plastics into raw materials for plastic bottle manufacturers. You reach the manual picking line where operators are removing contaminant materials from incoming products, such as plastic bags, plastic film and badly contaminated items that would compromise the recycling process. You interview the line supervisor.
You: "Why are these plastic items being rejected at this stage?"
Auditee: "They do not meet our processing standards."
You: "What is the reason for that?"
Auditee: "These items are likely to damage the machinery down the line. They can also compromise our quality standards. We need to protect our reputation for good quality output materials." You: "What happens to the rejected items?" Auditee: "Some get melted down in another process later on and some are disposed of as waste products that cannot be recycled." You: "What happens to the waste products?" Auditee: "I'm not sure. I suppose they go to landfill." Which two. of the following actions would you take to investigate further?
A. Ask about operator PPE (Personal Protective Equipment).
B. Find out if operators have regular hearing tests.
C. Ask to review the percentage of waste materials.
D. Determine whether there are quality objectives for reducing rejected material.
E. Check the process for handling nonconforming items.
F. Determine what happens to the waste products.
正解：E,F
解説: (Topexam メンバーにのみ表示されます)

質問 4：
Select the phrase that best describes the purpose of a quality management system to ISO 9001 in relation to the performance of an organization.
A. Improves the performance
B. Monitors the performance
C. Dictates the performance
D. Manages the performance
正解：A
解説: (Topexam メンバーにのみ表示されます)

質問 5：
For a third-party, match the Activity with the Responsibility for conducting it.

正解：

Explanation:

* Approve Certification Body: Accreditation Body
* Award certification: Certification Body
* Recommend certification: Audit Team Leader
* Maintain certification:
Comprehensive Detailed ExplanationIn the context of a third-party ISO 9001 audit, different entities play specific roles in the certification process. Here's a detailed explanation of the responsibilities:
* Approve Certification Body: Accreditation BodyThe Accreditation Body is responsible for approving Certification Bodies. Accreditation Bodies are independent entities that evaluate the competence of Certification Bodies, ensuring they meet international standards like ISO/IEC 17021, which sets out the criteria for bodies providing audit and certification of management systems. In this role, they confirm that the Certification Body is capable of conducting ISO 9001 audits and granting certifications in accordance with international guidelines.
* Award Certification: Certification BodyThe Certification Body is the entity that ultimately awards the certification to an organization after verifying that it meets the ISO 9001 standards. Certification Bodies conduct audits, either directly or through a team of auditors, and based on the audit outcomes, they issue the certification, indicating that the organization complies with ISO 9001.
* Recommend Certification: Audit Team LeaderThe Audit Team Leader is responsible for leading the audit and making a recommendation to the Certification Body. This recommendation is based on the audit findings-whether the organization meets the ISO 9001 requirements or if there are areas of non- compliance that need corrective action. The final decision on certification is not made by the Audit Team Leader but by the Certification Body.
* Maintain Certification: Certification BodyMaintaining certification refers to the ongoing process of ensuring that an organization continues to comply with ISO 9001 requirements. The Certification Body conducts regular surveillance audits (e.g., annually) and may also perform recertification audits (typically every three years). This ongoing monitoring ensures that the certified organization continues to adhere to the quality management standards over time.
This breakdown clearly assigns responsibility based on the defined roles of Accreditation Bodies, Certification Bodies, and Audit Teams in the ISO 9001 certification process.

質問 6：
The following actions need to be carried out during a third-party audit planning stage. Which two actions correspond to the individual(s) managing the audit program before the involvement of the audit team leader'
A. Select the audit team members
B. Assign responsibilities within the audit team
C. Review the reports of previous audits
D. Prepare the audit plan
E. Provide the resources needed
F. Prepare the checklists
正解：C,E
解説: (Topexam メンバーにのみ表示されます)

質問 7：
Whistlekleen is a national dry cleaning and laundry company with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. 80% of complaints originate from five shops in the same region. Most of these complaints relate to customer laundry not being cleaned as customers require. The Quality Manager tells you that these are the oldest shops in the company. The cleaning equipment needs replacing but the company cannot afford it now. You learn that the shop managers were told to dismiss most of the complaints because of the poor quality of the laundered materials.
On raising the matter with senior management, you are told that there are plans to replace the equipment in these shops over the next five years.
You raised a nonconformity against clause 8.5.1 of ISO 9001.
Based on the scenario, select the three options which best describe the evidence for raising such a nonconformity.
A. The organisation failed to control the laundry operations in 5 shops adequately.
B. The organisation failed to maintain all of its equipment to an adequate standard.
C. The management failed in planning to replace obsolete equipment.
D. Shop managers were told to make excuses to customers with complaints.
E. Customer complaints are not taken seriously by the organisation.
F. The operators did not check the laundry before release to the customer.
G. Some equipment used was not suitable for the laundry process.
H. The operators did not check the condition of the customer's product upon receipt.
正解：A,D,E