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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: 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 |
| Topic 2: Preparing an ISO 9001 audit | 12.5% | - Evidence types and their characteristics - Audit feasibility - Roles and responsibilities of the audit team leader and members - Steps and activities to prepare a QMS audit |
| Topic 3: Quality management system (QMS) and ISO 9001 requirements | 13.75% | - Leadership and commitment, quality policy, roles and responsibilities (clause 5) - Context of the organization, interested parties, and QMS scope (clause 4) - Risks and opportunities - Structure of the standard |
| Topic 4: Closing an ISO 9001 audit | 13.75% | - Management of audit records - Audit report preparation - Audit completion and follow-up |
| Topic 5: Fundamental audit concepts and principles | 12.5% | - Audit concepts and principles - Personal attributes and behaviors of a professional auditor - Management of combined audits |
| Topic 6: Conducting an ISO 9001 audit | 22.5% | - Audit techniques and evidence collection - Audit conducting process - Audit findings and conclusions |
| Topic 7: Managing an ISO 9001 audit program | 12.5% | - Audit program monitoring and improvement - Audit program management |
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NEW QUESTION # 218
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: B,F
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 # 219
(Which of the following two activities can be carried out on-site by an auditor with no human interaction?)
Answer: A,F
Explanation:
ISO 9001:2015 requires audits to be objective, evidence-based, and independent. While the standard does not prescribe detailed audit techniques, it clearly supports the use of objective evidence that can be obtained without human interaction, particularly through observation and review of documented information.
# C. Observing work performed
* Observation is a recognized audit technique where the auditor watches activities being carried out without questioning personnel.
* ISO 9001 emphasizes verifying that processes are implemented as planned and achieve intended results.
* Observation provides direct, objective evidence of process implementation.
# Supported by:
* Clause 9.2.1 - Internal audits must determine whether the QMS is effectively implemented and maintained
* Clause 4.4.1 - Processes must be implemented and controlled as planned Observation can therefore be done on-site, silently, and without interaction.
# F. Conducting a document review
* Reviewing documented information (procedures, records, logs, policies) does not require interaction with auditees.
* ISO 9001 explicitly requires the use and control of documented information and allows auditors to verify conformity by reviewing it independently.
# Supported by:
* Clause 7.5.1 - The QMS shall include documented information required by ISO 9001
* Clause 9.2.2 - Audit evidence shall demonstrate conformity to requirements Document review can be conducted on-site, at a desk, without speaking to anyone.
# Why the other options are NOT correct
* A. Completing a questionnaire for the auditeeRequires interaction and responses from people.
* B. Audit understanding of Business ContextRequires discussions with top management and review of strategic inputs (Clause 4.1).
* D. Audit customer communications about order handling enquiriesNormally requires discussion, clarification, or explanation of communication processes.
* E. Conducting interviewsBy definition requires human interaction.
NEW QUESTION # 220
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?
Answer: B
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 17021-1:2015, Clause 9.4.10 (Corrective Actions for Major Nonconformities):
* If a major nonconformity is not corrected within six months, the certification body must reject the certification request.
* Another Stage 2 audit (C) is not required unless the organization reapplies for certification.
* Restarting all audit activities (B) is unnecessary; instead, certification is denied.
Thus, A is the correct answer.
NEW QUESTION # 221
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.
Answer: B,E,G
Explanation:
The nonconformity was raised against ISO 9001:2015 Clause 8.5.1 - Control of production and service provision. This clause requires organisations to carry out production and service provision under controlled conditions, including:
* the use of suitable infrastructure and equipment,
* the availability and use of appropriate monitoring and control, and
* the prevention of nonconforming outputs being delivered to customers.
In this scenario, the evidence shows a systemic failure in operational control, not isolated human error.
Explanation of the selected evidence:
E). The organisation failed to control the laundry operations in 5 shops adequately.
Clause 8.5.1 requires consistent control of service provision. The fact that 80% of complaints come from five specific shops demonstrates a lack of effective operational control in those locations.
G). The organisation failed to maintain all of its equipment to an adequate standard.
Clause 8.5.1 requires suitable infrastructure for service provision. Management acknowledged that equipment in these shops is old and cannot currently be replaced, meaning it is not being maintained at a level necessary to ensure conformity of service.
H). Some equipment used was not suitable for the laundry process.
The poor cleaning outcomes and high complaint levels directly indicate that the equipment is not fit for purpose, which is a clear breach of the requirement to provide suitable resources for controlled service provision under Clause 8.5.1.
Explanation of why the other options are not appropriate evidence for Clause 8.5.1:
* A relates to strategic planning and investment decisions, not directly to operational control.
* B and C relate to inspection activities, which were not evidenced in the scenario.
* D and F relate to complaint handling behaviour, which would align more closely with Clause 9.1.2 (customer satisfaction) or Clause 10.2 (nonconformity and corrective action), not Clause 8.5.1.
ISO-aligned conclusion:
The nonconformity is justified because the organisation is continuing to provide services using unsuitable and inadequately maintained equipment, resulting in repeated service failures in multiple locations. This demonstrates a clear failure to control service provision as required by ISO 9001:2015 Clause 8.5.1, supported by evidence E, G and H.
NEW QUESTION # 222
(A third-party audit has been planned at a single-site organisation. The audit team comprises one audit team leader, one auditor and one auditor who is undertaking his first third-party audit.
During the on-site audit, the auditor who is undertaking his first third-party audit shall...)
Answer: D,E
Explanation:
An auditor undertaking their first third-party audit is normally treated as an auditor under supervision. They may participate in audit activities, but should be monitored and supported by the audit team leader.
They should therefore review their auditing performance with the audit team leader and conduct interviews only with the audit team leader present.
They should not lead the closing meeting, independently interview auditees, or decide nonconformity grading alone. ISO 9001:2015 requires audits to be conducted objectively and by competent auditors, and ISO 9001 refers to ISO 19011 for audit guidance.
NEW QUESTION # 223
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