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| Section | Weight | Objectives |
|---|---|---|
| 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) |
| Preparing an ISO 9001 audit | 12.5% | - Roles and responsibilities of the audit team leader and members - Steps and activities to prepare a QMS audit - Evidence types and their characteristics - Audit feasibility |
| Conducting an ISO 9001 audit | 22.5% | - Audit conducting process - Audit techniques and evidence collection - Audit findings and conclusions |
| Fundamental audit concepts and principles | 12.5% | - Audit concepts and principles - Management of combined audits - Personal attributes and behaviors of a professional auditor |
| Closing an ISO 9001 audit | 13.75% | - Audit completion and follow-up - Management of audit records - Audit report preparation |
| Managing an ISO 9001 audit program | 12.5% | - Audit program monitoring and improvement - Audit program management |
| 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) - Applicability and scope of ISO 9001 - Advantages of implementing a QMS based on ISO 9001 |
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NEW QUESTION # 205
What is a horizontal audit?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:A horizontal audit examines one process across multiple departments to assess consistency.
Thus, A is the correct answer.
NEW QUESTION # 206
Noitol is an organisation specialising in the design and production of e-learning training materials for the insurance market. During an ISO 9001 audit of the development department, the auditor asks the Head of Development about the process used for validation of the final course design. She states that they usually ask customers to validate the product with volunteers. She says that the feedback received often leads to key improvements.
The auditor samples the design records for a recently completed course for the 247 Insurance organisation.
Design verification was carried out but there was no validation report. The Head of Development advises that this customer required the product on an urgent basis, so the validation stage was omitted. When asked, the Head estimates that this occurs about 50% of the time. She confirms that they always ask for feedback and often make changes. There is no record of feedback in the design file for the course.
The auditor raises a nonconformity against ISO 9001. Which one of the following options is the basis for the nonconformity?
Answer: B
Explanation:
Clause 8.3.4.d of ISO 9001:2015 requires that design and development validation be performed to ensure that the resulting products or services meet the requirements for their specified application or intended use.
Validation is critical to confirm that the product works as intended in real-world conditions.
In this case, Noitol omitted the design validation step approximately 50% of the time, which is a direct violation of Clause 8.3.4.d. Although they collect feedback after the fact, this is not a substitute for formal validation before the product is released. The nonconformity arises because the process of validation was neglected, not the recording of improvements or feedback.
Other options, such as documenting improvements (A) or issues with planning verification (B), are important but do not directly address the primary concern: the lack of consistent design validation before product release. Option D (8.6) concerns product release, but this nonconformity focuses on the validation stage, not just approval for release.
NEW QUESTION # 207
An audit team leader arrives at a printing organisation to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer manufacturer to print and compile computer documentation packages. They have leased the unit next door for space reasons but have never worked in this sector before. The Quality Manager wants the ISO 9001 certificate to cover the new contract.
Which one of the options is the correct response by the auditor?
Answer: D
Explanation:
When an organization wishes to extend the scope of their current certification to include new services or activities, such as the printing and compilation of computer documentation packages, it requires an extension to the scope of the audit. This involves a formal application process with the certification body to ensure that the new activities are included in the audit plan and that the organization's quality management system encompasses these new processes12. References: = The answer is based on the ISO 9001 Auditing Practices Group guidance on scope and applicability, which outlines the need for a formal application process when there is a change in the scope of the quality management system that affects the certification1. Additionally, the UKAS guide on the extension to scope (ETS) process provides information on how changes to the scope, including the addition of new services, require a formal application2.
NEW QUESTION # 208
Which one of the following documents addresses audit time calculation for third-party certification audits?
Answer: A
Explanation:
ISO/IEC 17021-1 is the standard that specifies requirements for bodies providing audit and certification of management systems. It includes provisions for determining audit time for third-party certification audits, ensuring that the audits are conducted in a consistent, comparable, and reliable manner, which can be applied to a variety of management systems, including ISO 9001.
References: ISO/IEC 17021-1; IAF Mandatory Document for the Determination of Audit Time of Quality and Environmental Management Systems Certification
NEW QUESTION # 209
What competence, among others, should each audit team member have?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Auditors must have competence in risk-based auditing to effectively assess an organization's QMS performance and compliance.
Clause References:
* ISO 19011:2018, Clause 7.2.3 - Determining Auditor Competence:
* Auditors must have knowledge of risk-based thinking to assess risk impact on processes.
* ISO 9001:2015, Clause 0.3.3 - Risk-Based Thinking:
* The standard emphasizes proactive risk management, which auditors must understand.
Why is the Correct Answer B?
* Risk-based auditing ensures audits focus on high-risk areas, improving audit effectiveness.
* Auditors must assess how organizations apply risk-based thinking in decision-making, process control, and improvement.
Why are the Other Options Incorrect?
* A (Industry knowledge) # While helpful, it is not mandatory for all auditors.
* C (Expertise in all domains) # Auditors are not required to be experts in all areas, just in audit methodology.
* D (Formal degree in quality management) # ISO does not require a formal degree, just competence in audit principles and methods.
Reference:
ISO 19011:2018, Clause 7.2.3 - Determining Auditor Competence
ISO 9001:2015, Clause 0.3.3 - Risk-Based Thinking
NEW QUESTION # 210
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