Free PECB ISO-9001-Lead-Auditor Exam Dumps Questions & Answers

An internal auditor of a manufacturer of polystyrene packaging products for the electronics industry raised a nonconformity against section 10.3 of ISO 9001 in Report IA202. The nonconformity (NC 3) stated:
" The reject rate of the finished product of 9.7% needs improvement as it doesn ' t meet the stated objective of top management of 5%. " As the third-party auditor reviewing the internal audit process, you come across the nonconformity. For corrective action, the Quality Manager conducted an investigation into the reject rates. He reported that the collection baskets for products ejecting from the moulding machines were not large enough. About 6% of products fell onto the wet and dirty factory floor. Management stated that replacing the baskets was too costly and ordered the Maintenance Manager to ensure that the floor was kept clean and dry to prevent rejects. The auditor later checked the factory floor, which was wet and dirty in places.
From the following nonconformities, select three that the auditor could raise to ISO 9001.

• A.7.3 - Staff were not aware that products were falling onto the factory floor.
• B.7.1.1 - The organisation failed to provide the required resources to prevent nonconforming products.
• C.9.2.2 - Report IA202 contained a poorly worded nonconformity (NC 3).
• D.10.3 - The organisation did not continuously improve. Reject rates were unchanged.
• E.8.6 - Dirty products were released to the customer.
• F.8.5.1 - Production operations were not properly controlled to avoid reject products.
• G.10.2.1 - Conduct of an investigation was not sufficient to understand the cause of the nonconformity.
• H.7.1.4 - The factory environment is not suitably maintained to prevent dirty products.

(In the context of a second-party quality management system audit , select the two correct statements from the following:)

• A.A guide is a person appointed by the audit team leader to assist the audit team in performing the audit.
• B.When needed, a translator appointed by the auditee.
• C.A technical expert is part of the audit team.
• D.An auditor is a person who conducts an audit.
• E.The audit team cannot include auditors-in-training.
• F.An observer is a person appointed by the auditee who provides information about the organisation to the audit team.

You have been just hired as the Internal Lead Auditor of a large organisation, responsible for internal audits.
Your first job is to analyse the answers to nonconformities included in the report of a recent internal audit to Top Management.
The report contained one nonconformity as follows:
There is no evidence of Top Management ensuring the availability of resources to operate the QMS, the establishment of objectives, the promotion of continual improvement, and the promoting of the process approach.
Which four of the following Top Management actions can be considered ' corrections to the nonconformity ' ?

• A.Objectives have been established
• B.All these actions will be reviewed during the Top Management meetings
• C.Resources have been provided
• D.Improvement action has been promoted
• E.Process approach has been communicated to the personnel
• F.Top Management completed a course on ISO 9001
• G.Top Management appoints a senior manager to oversee the quality manangement system
• H.Top Management review will be carried out every six months instead of annually

You are conducting an ISO 9001 audit of a Materials Recycling Facility. 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. " After further auditing, you have gathered additional evidence. Match the following statements to the correct ISO 9001 standard clause shown.
To complete the table, click on the blank section you want to complete so that it is highlighted in red, and then click on the applicable text from the options below.
Alternatively, drag and drop each option to the appropriate blank section.

Correct Answer:

Explanation:
A # 8.4.3.a
B # 7.2.b
C # 10.2.2
D # 10.2.1
E # 6.2
F # 5.2.2.c
8.4.3.a - No specification is issued to the suppliers of waste plastic:This clause refers to the information provided to external providers, including requirements for products and services. If no specification is issued, it means the organization is not complying with this clause, which states:
"The organization shall ensure that the requirements for the products and services to be provided are adequately defined prior to communication to the external provider."
7.2.b - The picking operators have been trained:This falls under Competence requirements. Clause 7.2(b) requires that persons are competent on the basis of education, training, or experience:
"Ensure that these persons are competent on the basis of appropriate education, training, or experience."
10.2.2 - No documentation is retained for rejected materials:This relates to corrective action documentation.
Clause 10.2.2 requires organizations to retain documented information as evidence of nonconformities and actions taken:
"The organization shall retain documented information as evidence of: the nature of the nonconformities and any subsequent actions taken..."
10.2.1 - The rejected materials are segregated:This links to the treatment of nonconforming outputs. Clause
10.2.1 discusses actions such as containment or segregation for nonconforming outputs:
"Deal with nonconforming outputs in one or more of the following ways: correction; segregation, containment..."
6.2 - Management has set an objective for the level of recycling:This refers to quality objectives. Clause 6.2 requires that measurable quality objectives be established, and this includes setting performance targets:
"The organization shall establish quality objectives at relevant functions... The quality objectives shall be measurable..."
5.2.2.c - The quality policy appears in promotional material:Clause 5.2.2(c) requires the quality policy to be available to relevant interested parties. Using it in promotional material ensures that it is communicated externally:
"The quality policy shall be... available to relevant interested parties, as appropriate." References:
ISO 9001:2015, Clause 8.4.3 - Information for external providers
Clause 7.2 - Competence
Clause 10.2.2 - Corrective action documentation
Clause 10.2.1 - Nonconforming outputs
Clause 6.2 - Quality objectives
Clause 5.2.2 - Communicating the quality policy

The certification body has not been able to verify the implementation of corrective actions for any identified major nonconformity within six months after the last day of the Stage 2 audit. What must the certification body do in this case?

• A.It must issue an unfavorable recommendation of certification
• B.It must conduct all audit activities from the beginning
• C.It must conduct another Stage 2 audit before granting certification