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NEW QUESTION # 106
Which two of the following may be changed once a Stage 2 certification audit has commenced?
Answer: D,F
Explanation:
Comprehensive and Detailed In-Depth Explanation:
Once a Stage 2 certification audit has commenced, certain logistical or planning-related elements may still be adjusted, while others are fixed by prior agreement and cannot be changed.
# C. Audit Plan:
The audit plan is a document that outlines the scope, objectives, criteria, and logistics of the audit. According to ISO/IEC 17021-1:2015 (the standard for bodies providing audit and certification of management systems), clause 9.2.3.3 allows for modification of the audit plan based on real-time conditions during the audit - such as availability of auditees or changes in process access.
# F. Increase of Audit Duration:
Audit duration is generally determined during audit planning based on factors like employee count, risk, complexity, etc. However, if during Stage 2 it is found that more time is needed (e.g., due to additional processes, scope not fully covered, or significant findings), auditors are permitted to extend the audit. This ensures full coverage of all required areas as per ISO/IEC 17021-1 clause 9.1.4 and IAF MD 5.
# A. Agreed Language of the Audit:
This is determined and agreed upon in the contract and audit planning stages. Changing it during Stage 2 would create communication and documentation issues, especially in multi-site or multi-national audits.
# B. Audit Scope:
The audit scope is defined in the contract and certification agreement based on clause 4.3 of ISO 9001:2015.
Changing it mid-audit would invalidate planning, required competencies, and potentially even the certification basis.
# D. Agreed Standard for the Audit Criteria:
Changing the standard (e.g., from ISO 9001 to ISO 13485) is fundamentally altering the purpose and contractual basis of the audit and is not permissible once Stage 2 has started.
# E. Audit Checklist:
The checklist is a tool prepared by the auditor as part of audit preparation and is based on the audit plan and standard requirements. While it may be adapted during the audit (e.g., if new risks arise), it does not constitute a formal change like duration or scope.
Relevant References:
* ISO/IEC 17021-1:2015 Clause 9.2.3.3 (Audit Plan Modification)
* IAF MD 5:2019 (Duration of QMS Audits)
* ISO 9001:2015 Clause 4.3 (Scope of the QMS)
* ISO/IEC 17021-1:2015 Clause 9.1.4 (Audit Duration)
NEW QUESTION # 107
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: B
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 # 108
You will lead a third-party audit next Monday on ABC, an organisation that provides services for cleaning windows from the outside of tall buildings. They work on demand, and usually have 4-5 orders per week. All documented information on these activities is kept at the central office.
On Friday evening, before the audit, you are informed by mail that customers cancelled all orders for the next week; therefore, the auditors will not have the chance to see them working at the customer's premises, but the field supervisors will be available at the ABC offices.
You have prepared the audit plan and the checklist. Choose the best action you would take:
Answer: C
Explanation:
According to ISO 19011:2018, clause 6.3.3, the audit plan should be reviewed and revised as necessary to address changes that occur during the audit planning. The audit plan should be agreed upon, preferably in writing, by the audit team leader, the audit client and the auditee1. Therefore, if there is a significant change in the auditee's situation, such as the cancellation of all orders for the next week, the audit plan should be reviewed and revised accordingly, with the agreement of all parties involved.
According to ISO/IEC 17021-1:2015, clause 9.1.4, the certification body should have a process to ensure that the audit team has the competence to achieve the audit objectives, and that the audit methods are appropriate for the scope and complexity of the audit. The certification body should also have a process to ensure that the audit is conducted under reasonable conditions and within a reasonable time frame2. Therefore, if there is a risk that the audit objectives cannot be achieved, or that the audit methods are not suitable, due to the change in the auditee's situation, the certification body should be consulted and informed on how to proceed with the audit.
Therefore, the best action to take is B, ask the certification body you work for how to proceed with the audit.
This action will ensure that the audit plan is revised and agreed upon by all parties, and that the audit team has the competence and the methods to conduct the audit effectively and efficiently. The other options are not correct, as they may compromise the quality and validity of the audit:
*A. Start the audit on Monday at ABC's as planned, interviewing the functions that regularly work at the central office, and plan visits to ABC customers wherever they may be working during the following week:
This action may not be feasible or acceptable, as it may extend the audit duration and cost beyond the agreed terms, and it may not provide sufficient and appropriate audit evidence to verify the conformity and effectiveness of the auditee's processes. Moreover, this action may not be agreed upon by the audit client and the auditee, and it may not be approved by the certification body.
*C. Start the audit on Monday as planned, interviewing the functions that regularly work at the central office, and visit another customer's premises they cleaned the week before: This action may not be relevant or reliable, as it may not reflect the current performance and condition of the auditee's processes. The audit evidence collected from the previous customer may not be valid or representative of the audit criteria, and it may not address the risks and opportunities associated with the auditee's context and objectives. Moreover, this action may not be agreed upon by the audit client and the auditee, and it may not be approved by the certification body.
*D. Complete the audit but ask the quality manager to clean some windows at the ABC's office, simulating the process they carry out at customers' premises: This action may not be objective or impartial, as it may introduce bias and influence in the audit process. The audit evidence collected from the simulated process may not be accurate or authentic, and it may not demonstrate the actual capability and effectiveness of the auditee's processes. Moreover, this action may not be ethical or professional, as it may compromise the integrity and credibility of the audit and the certification.
References: ISO 19011:2018(en), Guidelines for auditing management systems, ISO/IEC 17021-1:2015(en), Conformity assessment - Requirements for bodies providing audit and certification of management systems
- Part 1: Requirements
NEW QUESTION # 109
What does the application of the process approach in a QMS enable?
Answer: D
NEW QUESTION # 110
(Select two applicable benefits of third-party certification of ISO 9001 quality management systems for an organisation:)
Answer: C,D
Explanation:
ISO 9001:2015 is a management system standard , and third-party certification provides independent assurance that an organisation ' s quality management system has been assessed against ISO 9001 requirements.
Explanation of the Correct Answers
A). Demonstrates that the quality management system conforms to ISO 9001.
This is a primary purpose and benefit of third-party certification.
Certification by an accredited certification body demonstrates that the organisation ' s quality management system has been audited and found to conform to the requirements of ISO 9001.
Relevant ISO 9001 requirements include:
* Clause 4 to Clause 10 , which define the requirements that must be met for certification.
* Certification confirms conformity of the management system , not individual products.
Therefore, this statement is correct.
B). Demonstrates that the quality management system is capable of consistently achieving its stated quality policy and objectives.
ISO 9001 is designed to ensure that organisations establish, implement, maintain, and continually improve processes that support achievement of quality objectives and intended results.
Relevant requirements include:
* Clause 5.2 - Quality Policy
* Clause 6.2 - Quality Objectives
* Clause 9.1 - Monitoring, measurement, analysis and evaluation
* Clause 10.3 - Continual improvement
Certification provides confidence that the management system is capable of consistently achieving planned results when effectively implemented.
Therefore, this statement is correct.
Why the Other Options Are Incorrect
C). Demonstrates that the quality management system can ensure the quality of their supplier.
ISO 9001 requires organisations to control external providers under Clause 8.4 , but certification does not guarantee supplier quality.
The organisation remains responsible for supplier evaluation and control.
Therefore, this is not a benefit guaranteed by certification.
D). Demonstrates that the quality management system can ensure their product has also been certified.
ISO 9001 certification applies to the management system , not to products.
A product can only be certified under a separate product certification scheme where applicable.
Therefore, this statement is incorrect.
E). Demonstrates that the quality management system does not have any non-conformities.
Certification does not mean there are no nonconformities.
During certification and surveillance audits, organisations may still receive nonconformities and maintain certification provided they address them appropriately.
Therefore, this statement is incorrect.
F). Guarantees that the organisation will not be audited by their customers.
Many customers continue to perform supplier audits even when suppliers hold ISO 9001 certification.
Certification may reduce the frequency of customer audits, but it does not guarantee they will not occur.
Therefore, this statement is incorrect.
ISO-Aligned Conclusion
Third-party ISO 9001 certification provides independent confidence that:
* The quality management system conforms to ISO 9001 requirements , and
* The quality management system is capable of consistently achieving its quality policy and objectives.
Therefore, the correct answers are:
A). Demonstrates that the quality management system conforms to ISO 9001.
B). Demonstrates that the quality management system is capable of consistently achieving its stated quality policy and objectives.
NEW QUESTION # 111
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