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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Quality management system (QMS) and ISO 9001 requirements | 13.75% | - Risks and opportunities - Leadership and commitment, quality policy, roles and responsibilities (clause 5) - Context of the organization, interested parties, and QMS scope (clause 4) - Structure of the standard |
| Topic 2: Fundamental audit concepts and principles | 12.5% | - Audit concepts and principles - Personal attributes and behaviors of a professional auditor - Management of combined audits |
| Topic 3: Conducting an ISO 9001 audit | 22.5% | - Audit techniques and evidence collection - Audit conducting process - Audit findings and conclusions |
| Topic 4: Managing an ISO 9001 audit program | 12.5% | - Audit program monitoring and improvement - Audit program management |
| Topic 5: Fundamental principles and concepts of a quality management system (QMS) | 12.5% | - Connection between ISO 9001 and other standards (ISO 9001, ISO/TS 9002, ISO 9004) - Advantages of implementing a QMS based on ISO 9001 - Applicability and scope of ISO 9001 |
| Topic 6: Preparing an ISO 9001 audit | 12.5% | - Steps and activities to prepare a QMS audit - Audit feasibility - Roles and responsibilities of the audit team leader and members - Evidence types and their characteristics |
| Topic 7: Closing an ISO 9001 audit | 13.75% | - Management of audit records - Audit report preparation - Audit completion and follow-up |
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NEW QUESTION # 98
At the end of a second-party audit, the audit team enters the meeting room to hold the closing meeting; only two people are present and waiting for them: the Health and Safety supervisor and the Administrative Officer.
Neither has participated in the audit. However, the team had previously agreed with the auditee Quality Manager on two nonconformities identified during the audit (NC1 and NC2).
They said:
Health and Safety Supervisor: "Good evening. We are sorry to inform you that the general manager was involved in a serious car accident, and the other two managers have had to leave urgently to attend to the emergency." The Administration Officer: "Concerning 'nonconformity 2', the General Manager left a message asking us to tell you that he does not accept it and requests you not to include it in the audit report. Here is a note in which he explains why." Which one of the following would be your preferred answer (as team leader) to the General Manager's request?
Answer: B
NEW QUESTION # 99
You are conducting an ISO 9001 audit of a Materials Recycling Facility (MRF). The company processes waste plastics into raw material 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.
Answer:
Explanation:
Explanation:
A # 8.4.3.a
B # 7.2.b
C # 10.2.2
D # 10.2.1
E # 6.2
Comprehensive and Detailed Explanation From Exact Extract:
# A. There is no specification for incoming materials # 8.4.3.a
Clause 8.4.3(a) relates to the control of externally provided processes, products, and services, specifically the requirement to communicate appropriate specifications and requirements to suppliers:
"The organization shall ensure the adequacy of requirements prior to their communication to the external provider." Failure to specify requirements for incoming materials (e.g., what is acceptable waste plastic) risks compromising product quality.
# B. The picking operators have been trained # 7.2.b
Clause 7.2(b) relates to Competence and mandates:
"Ensure that these persons are competent on the basis of appropriate education, training, or experience." Training is a critical part of establishing and maintaining operator competence in quality-affecting tasks.
# C. The picked reject materials are not documented # 10.2.2
This clause focuses on the retention of documented information regarding nonconformities and actions taken:
"The organization shall retain documented information as evidence of: the nature of the nonconformities and any subsequent actions taken..." If rejects are not recorded, traceability and root cause analysis for quality failures are weakened.
# D. The rejected materials are segregated # 10.2.1
Clause 10.2.1 relates to nonconformity and corrective action, including containment activities such as:
"Deal with nonconforming outputs in one or more of the following ways: correction; segregation, containment..." Segregation ensures nonconforming material doesn't contaminate acceptable output.
# E. Management has set an objective for the level of rejects # 6.2
Clause 6.2 is about quality objectives. It requires organizations to:
"Establish quality objectives at relevant functions... The quality objectives shall be measurable..." Setting a measurable reject-level target aligns with improving process control and reducing waste.
References:
ISO 9001:2015 Clause 8.4.3.a - Information for External Providers
ISO 9001:2015 Clause 7.2.b - Competence
ISO 9001:2015 Clause 10.2.2 - Documentation of Nonconformity
ISO 9001:2015 Clause 10.2.1 - Control of Nonconforming Outputs
ISO 9001:2015 Clause 6.2 - Quality Objectives
NEW QUESTION # 100
Which of the following is a record related to the audit program that should be managed and maintained?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:ISO 19011:2018, Clause 5.4 (Audit Records Management) states that the audit schedule must be maintained as a key record.
Thus, C is the correct answer.
NEW QUESTION # 101
Which of the following three options could be considered potential threats to impartiality in an audit context?
Answer: B,C,E
Explanation:
Potential threats to impartiality in an audit context include familiarity (having a close relationship with the auditee), intimidation (being coerced or feeling pressured), and self-audit (auditing one's own work). These factors can compromise the auditor's objectivity and the audit's integrity. References: = The information is based on the ISO 9001 Auditing Practices Group documents which discuss threats to auditor impartiality and how they may compromise an auditor's objectivity123.
NEW QUESTION # 102
(When raising a non-conformity during an audit, which two of the following items should you include in the non-conformity statement?)
Answer: A,D
Explanation:
ISO 9001:2015 requires that nonconformities be objective, evidence-based, and referenced against defined requirements, not personal, prescriptive, or solution-driven.
When a nonconformity is raised, it must clearly show what requirement was not met and what objective evidence demonstrates this failure.
# Why D (Audit criteria) is required
* A nonconformity must reference the requirement that was not fulfilled (e.g., ISO 9001 clause, procedure, contract, or legal requirement).
* ISO 9001 defines nonconformity as "non-fulfilment of a requirement".
* Without audit criteria, there is no basis for declaring a nonconformity.
# Supported by:
* Clause 9.2.2 - Internal audits must determine whether the QMS conforms to requirements
* Clause 10.2.2 - Documented information shall describe the nature of the nonconformity
# Why E (Relevant audit evidence) is required
* ISO 9001 requires decisions and conclusions (including audit findings) to be based on evidence.
* Audit evidence ensures objectivity and prevents subjective or opinion-based findings.
# Supported by:
* Clause 9.1.3 - Analysis and evaluation shall be based on data and information
* Clause 9.2.2 - Audit results must demonstrate conformity or nonconformity based on evidence
# Why the other options are NOT correct
* A (Name of person responsible)ISO 9001 focuses on system and process failures, not blaming individuals.
* B (Target time for corrective action)This is part of corrective action planning, not the nonconformity statement itself (Clause 10.2).
* C (Name of technical expert)ISO 9001 does not require identifying auditors or experts in the nonconformity statement.
* F (Action to eliminate the nonconformity)Auditors must not prescribe solutions. The auditee determines corrective actions (Clause 10.2).
NEW QUESTION # 103
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