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| Section | Weight | Objectives |
|---|---|---|
| Managing an ISO 9001 audit program | 12.5% | - Audit program management - Audit program monitoring and improvement |
| 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 |
| Quality management system (QMS) and ISO 9001 requirements | 13.75% | - Leadership and commitment, quality policy, roles and responsibilities (clause 5) - Structure of the standard - Risks and opportunities - Context of the organization, interested parties, and QMS scope (clause 4) |
| Closing an ISO 9001 audit | 13.75% | - Management of audit records - Audit report preparation - Audit completion and follow-up |
| 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 |
| Conducting an ISO 9001 audit | 22.5% | - Audit techniques and evidence collection - Audit findings and conclusions - Audit conducting process |
| Fundamental audit concepts and principles | 12.5% | - Personal attributes and behaviors of a professional auditor - Management of combined audits - Audit concepts and principles |
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NEW QUESTION # 245
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation 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:
NEW QUESTION # 246
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation offers warehousing and export services to customers. Customers are invoiced for the time stock items are stored in the warehouse. Transport to and from the warehouse is controlled by the organisation and approved subcontract transport services are used. The organization does not have its own transport vehicles. Stock items are not purchased by the organisation.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 Clause 8 extract to the audit evidence.
Answer:
Explanation:
Explanation:
The table below shows the possible matching of the ISO 9001 Clause 8 extract to the audit evidence.
Table
Audit evidence
ISO 9001 Clause 8 extract
Four of the 10 pallets of stock sampled in the warehouse were not labelled.
"8.5.2 ... shall use suitable means to identify outputs ..."
A damaged pallet of stock seen in the quarantine area was leaking liquid onto the floor.
"8.7.1 ... shall ensure that outputs that do not conform to their requirements are identified and controlled ..." One of the fork-lift truck drivers had no fork-lift truck driving licence.
"8.5.1 e ... shall include, as applicable ... the appointment of competent persons ..." There was no pest control provision in the warehouse.
"8.5.4 ... shall preserve the outputs during production and service provision ..." Two pallets of temperature-sensitive stock items were being stored at ambient as the chilled storage facility was full.
"8.1 ... shall plan, implement and control the processes ..."
NEW QUESTION # 247
Scenario 3:
Fin-Pro is a financial institution in Austria offering commercial banking, wealth management, and investment services. The company faced a significant loss of customers due to failing to improve service quality as they expanded.
To regain customer confidence, top management implemented a QMS based on ISO 9001. After a year, they contacted ACB, a local certification body, to pursue ISO 9001 certification.
The audit team was led by Emilia, an experienced lead auditor, and included three auditors. After an agreement was reached, ACB sent the audit objectives to the audit team.
The audit team began by gathering information about Fin-Pro's understanding of ISO 9001 requirements.
While reviewing documented information, they noticed missing records of training and awareness sessions. They conducted employee interviews to verify attendance.
The team also reviewed the organizational chart and job descriptions to confirm employee competence.
They observed the company's working environment (social, psychological, and physical conditions).
The audit team analyzed the evidence and prepared an audit report with findings and conclusions.
In scenario 3, the audit team required access to see the organizational chart and job descriptions to verify the employees' competence. Based on audit best practices, is this acceptable?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires organizations to ensure competence of personnel whose work affects quality performance.
Clause References:
* Clause 7.2 - Competence: Organizations must determine, provide, and evaluate competence of employees performing work under the QMS.
* ISO 19011:2018, Clause 6.4.6 - Audit Evidence: Auditors should use a combination of document review, interviews, and observation to verify competence.
Why is the Correct Answer C?
* The organizational chart shows reporting structures and helps verify roles and responsibilities.
* Job descriptions outline required qualifications, skills, and competencies for each role.
* These documents provide objective audit evidence that personnel meet the required competencies for their positions.
Why are the Other Options Incorrect?
* A (Sufficient evidence) # Partially correct, but competence verification often requires multiple sources of evidence, including training records, certifications, and observations.
* B (Not relevant) # Incorrect because verifying competence is crucial for ensuring effective QMS implementation.
* D (Direct observation only) # Observation alone is insufficient; documentation and interviews are also required to confirm competence.
Reference:
ISO 9001:2015, Clause 7.2 - Competence
ISO 19011:2018, Clause 6.4.6 - Audit Evidence
NEW QUESTION # 248
Who maintains ownership of the audit report?
Answer: A
Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 17021-1:2015, Clause 9.4.8 (Audit Reporting):
* The certification body retains ownership of the audit report as it is responsible for the certification decision.
* The auditee may receive a copy, but it does not own the report.
* The audit team leader compiles the report but does not own it.
Thus, C is the correct answer.
NEW QUESTION # 249
Scenario 4:
TD Advertising is a print management company based in Chicago. The company offers design services, digital printing, storage, and distribution. As TD expanded, its management recognized that success depended on adopting new technologies and improving quality.
To ensure customer satisfaction and quality improvement, the company decided to pursue ISO 9001 certification.
After implementing the QMS, TD hired a well-known certification body for an audit. Anne Key was appointed as the audit team leader. She received a document listing the audit team members, audit scope, criteria, duration, and audit engagement limits.
Anne reviewed the document and approved the audit mandate. The certification body and TD's top management signed the certification agreement.
Before contacting TD, Anne reviewed the audit scope and noticed that TD made changes to it due to the adoption of new printing equipment. However, Anne disagreed with the changes, stating they would affect the audit timeline. She considered withdrawing from the audit.
Based on scenario 4, conducting which of the activities below is NOT the responsibility of Anne?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires specific roles and responsibilities for audit leaders and certification bodies.
Clause References:
* ISO 19011:2018, Clause 5.5 - Conducting the Audit: Defines audit team leader responsibilities.
* ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning: Defines certification body responsibilities, including the certification agreement.
Why is the Correct Answer D?
* The certification agreement is signed between the certification body and the auditee (TD Advertising).
* Anne (audit team leader) does NOT have authority to sign the agreement-that is the responsibility of the certification body's management.
Why are the Other Options Incorrect?
* A (Establishing audit criteria and objectives) # Correct responsibility of the audit leader as per ISO 19011.
* B (Determining audit feasibility) # Audit leaders assess feasibility but do not sign agreements.
* C (Assigning responsibilities for the audit team) # This is part of the audit leader's role in planning audits.
Reference:
ISO 19011:2018, Clause 5.5 - Conducting the Audit
ISO/IEC 17021-1:2015, Clause 9.1.2 - Audit Planning
NEW QUESTION # 250
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