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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Managing an ISO 9001 audit program | 12.5% | - Audit program management - Audit program monitoring and improvement |
| Topic 2: Conducting an ISO 9001 audit | 22.5% | - Audit techniques and evidence collection - Audit findings and conclusions - Audit conducting process |
| Topic 3: Quality management system (QMS) and ISO 9001 requirements | 13.75% | - Structure of the standard - Risks and opportunities - Leadership and commitment, quality policy, roles and responsibilities (clause 5) - Context of the organization, interested parties, and QMS scope (clause 4) |
| Topic 4: Closing an ISO 9001 audit | 13.75% | - Management of audit records - Audit completion and follow-up - Audit report preparation |
| Topic 5: Preparing an ISO 9001 audit | 12.5% | - Evidence types and their characteristics - Steps and activities to prepare a QMS audit - Audit feasibility - Roles and responsibilities of the audit team leader and members |
| Topic 6: Fundamental audit concepts and principles | 12.5% | - Audit concepts and principles - Personal attributes and behaviors of a professional auditor - Management of combined audits |
| Topic 7: Fundamental principles and concepts of a quality management system (QMS) | 12.5% | - Advantages of implementing a QMS based on ISO 9001 - Connection between ISO 9001 and other standards (ISO 9001, ISO/TS 9002, ISO 9004) - Applicability and scope of ISO 9001 |
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NEW QUESTION # 114
Whistlekleen is a national dry cleaning and laundry organization with 50 shops. You are conducting a surveillance audit of the Head Office and are sampling customer complaints. You find that 80% of complaints originate from five shops in the same region. Most of these complaints relate to damage to customer laundry.
The Quality Manager tells you that those are the oldest shops in the organization. The cleaning equipment needs replacing, but the organization cannot afford it now. Complaining customers are offered a financial incentive to close the complaint.
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.
Select the one option which correctly describes the non-conformity to be raised against ISO 9001.
Answer: D
NEW QUESTION # 115
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organization manufactures cosmetics for major retailers.
You are interviewing the Manufacturing Manager (MM).
You: " I would like to begin by looking at the cleaning controls. "
MM: " We record the cleaning of the equipment at the end of every batch. This document details the minimum cleaning frequency and the procedures to follow for all areas and each item of equipment. The person who carries out the cleaning puts their initial on the document and records the time and date alongside.
"
Narrative: You sample production records over 3-days and note down evidence of nonconformity as per the table below.
Answer:
Explanation:
Explanation:
Nonconformity report
ISO 9001 Clause Number: 8.5.4 Nature of problem: Cleaning and sanitising records are not available for every batch. ISO 9001 requirement that has not been fulfilled: ISO 9001 - "The organization shall implement planned arrangements, at appropriate stages, to verify that the product requirements have been met." Evidence: 40 cleaning records are available for 63 batches.
NEW QUESTION # 116
XYZ Corporation is an organisation that employs 100 people. As the audit team leader, you conduct a certification audit at Stage 1. When reviewing the quality management system (QMS), you find that the objectives have been defined by an external consultant using those of a competitor, but nothing is documented. The Quality Manager complains that this has created a lot of resistance to the QMS, and the Chief Executive is asking questions about how much it will cost.
Which two options describe the circumstances in which you could raise a nonconformity against clause 6.2 of ISO 9001?
Answer: C,D
Explanation:
According to ISO 9001:2015, clause 6.2.1, the organization is required to establish quality objectives at relevant functions, levels, and processes for the quality management system (QMS). The quality objectives must be consistent with the quality policy, measurable, monitored, communicated, and updated as appropriate.
The organization is also required to maintain documented information on the quality objectives, as per clause
7.5.1.
Therefore, in the scenario given, the quality objectives defined by the external consultant are not in alignment with the organization's quality policy, as they are based on those of a competitor, rather than the organization' s own purpose, strategic direction, and customer requirements. This creates a mismatch between the organization's vision and goals, and the quality objectives that are supposed to guide and measure the QMS performance. Moreover, the quality objectives are not maintained as documented information, which makes it difficult to communicate, monitor, and update them, as well as to demonstrate evidence of their implementation and achievement.
Hence, the circumstances in which a nonconformity against clause 6.2 of ISO 9001 could be raised are B and C, as they indicate a failure to comply with the requirements of clause 6.2.1. The other options are either irrelevant or not directly related to clause 6.2, as they do not pertain to the establishment and documentation of quality objectives.
References:
ISO 9001:2015(en), Quality management systems - Requirements, clause 6.2.1 and 7.5.1 ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.4.4 and 6.7.2 ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives" ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 5 and 6
NEW QUESTION # 117
A Health Trust has contracted with Servitup, a catering services company certified to ISO 9001, for one year.
You, as auditor, are conducting the first surveillance audit at one site with the Deputy Catering Manager.
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. A pre-heated food trolley is sent to the wards from the kitchen. The Deputy Catering Manager comments that the trolley thermometer is often unreliable. Evidence of calibration of the thermometer cannot be produced.
Which four of the following actions could prevent the complaints from recurring?
Answer: A,B,C,D
Explanation:
ISO 9001 requires corrective action to address the cause of a nonconformity and prevent recurrence. The issue is repeated complaints about food being too cold, supported by evidence that the trolley thermometer is unreliable and calibration evidence is missing.
B is correct because replacing an unreliable thermometer supports effective monitoring.
E is correct because preheating plates helps maintain food temperature during service.
F is correct because calibrated measuring equipment is needed to ensure valid temperature readings.
H is correct because checking food temperature before serving verifies that service requirements are met.
A may introduce uncontrolled local reheating and is not the best preventive action. C is only investigation, not prevention. D is reactive after complaint. G is useful contingency but does not directly ensure food is served at the correct temperature.
NEW QUESTION # 118
Select the two statements that are true.
Answer: D,E
Explanation:
* Analyzing Each Statement:
* A.Incorrect. The audit team leader must communicate concerns as they arise, not just during the closing meeting. Per ISO 19011:2018 Clause 6.4.9, significant concerns should be shared promptly with the auditee and audit client during the audit process to allow for immediate understanding and potential resolution.
* B.Incorrect. The auditor or team leader is not specifically required to inform the general manager about uncontrolled documents. Instead, the issue is communicated within the framework of the audit findings to the audit client or auditee, as appropriate.
Reference: ISO 19011:2018, Clause 6.6.2.
D:Incorrect. Changes to the audit scope require the approval of the audit client (e.g., the certification body), not just the auditee. The scope is agreed upon in advance, and significant changes must be communicated with all stakeholders.
E:Correct. The audit team leader is responsible for periodically assessing the audit progress to ensure it aligns with the audit objectives and planned scope.Reference: ISO 19011:2018, Clause 6.4.5.
F:Incorrect. While immediate and significant risks should be communicated to the auditee, notifying the certification body is not an immediate responsibility of the audit team leader. The communication process depends on the procedures defined by the audit programme manager.
Why Options C and E Are Correct:
C: Communicating unattainable audit objectives ensures the audit remains effective and prevents unnecessary effort or misalignment with goals.
E: Periodic assessments by the team leader help in maintaining alignment with the scope, objectives, and time constraints, ensuring the audit's success.
Relevant References from ISO Standards:
ISO 19011:2018, Clause 6.6.2: Describes procedures for when audit objectives are unattainable.
ISO 19011:2018, Clause 6.4.5: Emphasizes the audit team leader's responsibility for ongoing assessment of audit progress.
NEW QUESTION # 119
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