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| Section | Weight | Objectives |
|---|---|---|
| Topic 1: Closing an ISO 9001 audit | 13.75% | - Management of audit records - Audit completion and follow-up - Audit report preparation |
| Topic 2: Preparing an ISO 9001 audit | 12.5% | - Audit feasibility - Roles and responsibilities of the audit team leader and members - Evidence types and their characteristics - Steps and activities to prepare a QMS audit |
| Topic 3: Managing an ISO 9001 audit program | 12.5% | - Audit program management - Audit program monitoring and improvement |
| Topic 4: Fundamental principles and concepts of a quality management system (QMS) | 12.5% | - Applicability and scope of ISO 9001 - Advantages of implementing a QMS based on ISO 9001 - Connection between ISO 9001 and other standards (ISO 9001, ISO/TS 9002, ISO 9004) |
| Topic 5: Quality management system (QMS) and ISO 9001 requirements | 13.75% | - Leadership and commitment, quality policy, roles and responsibilities (clause 5) - Structure of the standard - Context of the organization, interested parties, and QMS scope (clause 4) - Risks and opportunities |
| Topic 6: Conducting an ISO 9001 audit | 22.5% | - Audit techniques and evidence collection - Audit findings and conclusions - Audit conducting process |
| Topic 7: Fundamental audit concepts and principles | 12.5% | - Management of combined audits - Audit concepts and principles - Personal attributes and behaviors of a professional auditor |
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NEW QUESTION # 133
Scenario 5: Mechanical-Electro (ME) Audit Stages
Mechanical-Electro, better known as ME, is an American company that provides mechanical and electrical services in China. Their services range from air-conditioning systems, ventilation systems, plumbing, to installation of electrical equipment in automobile plants, electronic manufacturing facilities, and food processing plants.
Due to the fierce competition from local Chinese companies and failing to meet customer requirements, ME's revenue dropped significantly. In addition, customers' trust and confidence in the company decreased, and the reputation of the company was damaged.
In light of these developments, the top management of ME decided to implement a quality management system (QMS) based on ISO 9001. After having an effective QMS in place for over a year, they applied for a certification audit.
A team of four auditors was appointed for the audit, including Li Na as the audit team leader. Initially, the audit team conducted a general review of ME's documents, including the quality policy, operational procedures, inventory lists, QMS scope, process documentation, training records, and previous audit reports.
Li Na stated that this would allow the team to maintain a systematic and structured approach to gathering documents for all audit stages. While reviewing the documented information, the team observed some minor issues but did not identify any major nonconformities. Therefore, Li Na claimed that it was not necessary to prepare a report or conduct a meeting with ME's representatives at that stage of the audit. She stated that all areas of concern would be discussed in the next phase of the audit.
Following the on-site activities and the opening meeting with ME's top management, the audit team structured an audit test plan to verify whether ME's QMS conformed to Clause 8.2.1 (Customer Communication) of ISO 9001.
To do so, they gathered information through group interviews and sampling. Li Na conducted interviews with departmental managers in the first group and then with top management. In addition, she chose a sampling method that sufficiently represented customer complaints from both areas of ME' s operations.
The team members were responsible for the sampling procedure. They selected a sample size of 4 out of
45 customer complaints received weekly for electrical services and 2 out of 10 complaints for mechanical services.
Afterward, the audit team evaluated the evidence against the audit criteria and generated the audit findings.
Which stages of the audit were performed?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Understanding Audit Stages Based on ISO/IEC 17021-1:2015
ISO certification audits consist of two main stages:
* Stage 1 Audit (Readiness Review)
* The organization's documented information is reviewed to assess readiness for Stage 2.
* This ensures that the QMS is developed, implemented, and prepared for full assessment.
* Stage 2 Audit (On-Site Evaluation)
* Auditors assess process implementation and effectiveness through interviews, observations, and evidence collection.
* The audit team verifies if the organization meets ISO 9001 requirements in practice.
Why is the Correct Answer B?
* The audit team reviewed ME's documents, which is a Stage 1 activity.
* The audit team performed interviews, sampling, and on-site verification, which is a Stage 2 activity.
* There was no mention of an audit follow-up or a surveillance audit, which occur post-certification.
Why are the Other Options Incorrect?
* A (Audit follow-up and Stage 1 Audit) # Follow-up audits occur after certification, which was not the case here.
* C (Stage 2 Audit and Surveillance Audit) # Surveillance audits are post-certification audits and were not conducted yet.
Reference:
ISO/IEC 17021-1:2015, Clause 9.3.1 - Initial Certification Audit (Stage 1 & 2)
NEW QUESTION # 134
Scenario 2:
Bell is a Canadian food manufacturing company that operates globally. Their main products include nuts, dried fruits, and confections. Bell has always prioritized product quality and has maintained a good reputation for many years. However, the company's production error rate increased significantly, leading to more customer complaints.
To increase efficiency and customer satisfaction, Bell implemented a Quality Management System (QMS) based on ISO 9001. The top management established a QMS implementation team comprising five middle managers from various departments, including Leslie, the quality manager.
Leslie was responsible for assigning responsibilities and authorities for QMS-related roles. He also suggested including a top management representative in the QMS team, but top management declined due to other priorities.
The team defined the QMS scope as:
"The scope of the QMS includes all activities related to food processing." Leslie established a quality policy and presented it to the team for review before top management approval
. Top management also proposed a new strategy for handling customer complaints, requiring biweekly customer surveys to monitor customer perceptions.
The quality policy was established by Leslie and approved by top management. Is this acceptable?
Please refer to scenario 2.
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015, Clause 5.2.1 (Establishing the Quality Policy) states that top management must establish, implement, and maintain a quality policy.
In the scenario, the quality manager (Leslie) created the policy, but top management did not establish it themselves, which violates Clause 5.2.1. While the policy can be drafted by a team, top management must take full ownership of its development and approval.
Reference:
ISO 9001:2015, Clause 5.2.1 - Establishing the Quality Policy
NEW QUESTION # 135
You are the supervisor in Production of a medium size manufacturing organisation. You are qualified as an internal auditor. The Quality Manager asks you to lead the next internal audit of Production and Logistics Dispatch. The audit team includes two other internal auditors.
Answer:
Explanation:
Explanation:
Here is the correct matching of actions to the statements in the context of leading the internal audit:
* If practicablecarry out a formal opening meeting
* You should notaudit production (as you are a supervisor in that area, and this would compromise audit objectivity)
* You need notchange the audit team (unless there is a specific reason, such as conflict of interest)
* You mustraise audit findings if necessary (this is a key responsibility of an auditor when nonconformities are found)
* You must notsend the audit report to the Quality Manager (the audit report must be reviewed first; it is typically part of the internal audit process to go through necessary channels before final submission)
* You shouldsend the audit report to the Quality Manager (after appropriate reviews and approvals) This reflects key principles of conducting an internal audit according to ISO 9001:2015, ensuring objectivity, proper documentation, and clear reporting procedures.
NEW QUESTION # 136
What type of audit evidence are policies and guidelines?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Policies and guidelines are considered documentary evidence because they are written records that demonstrate how an organization complies with ISO 9001 requirements.
Clause References:
* ISO 19011:2018, Clause 6.4.6 - Audit Evidence:
* Documentary evidence includes manuals, procedures, and policies.
Why is the Correct Answer C?
* Documentary evidence includes written records such as policies, procedures, and documented instructions that support QMS implementation.
* Auditors review policies to verify conformance with ISO 9001.
Why are the Other Options Incorrect?
* A (Confirmative evidence) # Not a recognized category in ISO auditing.
* B (Technical evidence) # Technical evidence refers to measurements, test results, or product data, not policies.
Reference:
ISO 19011:2018, Clause 6.4.6 - Audit Evidence
NEW QUESTION # 137
You are auditing an organisation that has been certified to ISO 9001 for 10 years. The organisation is a privately owned, multi-site car tyre fitting company. You are auditing one of the sites.
You have confirmed with the Workshop Supervisor that tyre batch numbers shall be recorded in the Work Schedule. You have sampled recent Work Schedule records and written the following in your audit notes:
No batch numbers for tyres fitted to customers' cars were recorded in the Work Schedule for job numbers 1/5,
1/16, 2/2, 2/7, 3/2, 3/5, 3/7 and 3/9. 15 jobs completed over the past five days were sampled. The Workshop Supervisor and the Tyre Fitter were aware of this missing information in the records, but no action had been taken.
You decide to raise a non-conformity.
Answer:
Explanation:
Explanation:
ISO 9001 Clause Number:
8.5.2
Nature of problem:
Tyre batch numbers have not been recorded in the Work Schedule.
ISO 9001 requirement that has not been fulfilled:
ISO 9001 - "The organization shall retain the documented information necessary to enable traceability." This is a traceability issue. The organisation requires tyre batch numbers to be recorded in the Work Schedule, but sampled records showed that batch numbers were missing for multiple completed jobs.
ISO 9001 clause 8.5.2 Identification and traceability requires the organisation to control unique identification when traceability is required and retain the documented information necessary to enable traceability.
Clause 7.2 competence and clause 7.3 awareness are not the best fit because the evidence shows the Workshop Supervisor and Tyre Fitter were aware of the missing records. The issue is the failure to retain required traceability information.
NEW QUESTION # 138
......
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