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| Section | Objectives |
|---|---|
| Quality Management System (QMS) Fundamentals | - Quality Principles
|
| Audit Principles and Fundamentals | - Auditor Competence
|
| Audit Planning and Preparation | - Audit Preparation
|
| Audit Reporting and Follow-up | - Audit Reporting
|
| Conducting Audit Activities | - Audit Evidence Collection
|
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NEW QUESTION # 208
During a Stage 1 audit, the Quality Manager asks that the audit includes coverage of a new work area they have expanded into since the application was made.
Which of the following two actions should the auditor take?
Answer: A,C
Explanation:
A Stage 1 audit is a preliminary assessment to evaluate the readiness of the organisation for the Stage 2 certification audit. The audit scope is defined by the audit client and the certification body based on the application and the contract. If the organisation wants to include a new work area that was not part of the original scope, the auditor should advise the Quality Manager that an extension of the scope is possible but will have to go through established procedures, such as submitting a formal request, providing relevant information, and paying additional fees. The auditor should also suggest that the Quality Manager will advise the programme manager, who is responsible for managing the audit programme, that the audit scope should be revised to include the new work area. The programme manager will then decide whether to approve or reject the request, and communicate the decision to the auditor and the Quality Manager. The auditor should not proceed with the audit of the new work area without the approval of the programme manager and the confirmation of the audit scope. 1234 References:
1: ISO 19011:2018 - Guidelines for auditing management systems
2: ISO 9001 Certification Audits | Stage 1 and Stage 2 - 9001. Simplified
3: What is the difference between Stage 1 and Stage 2 Audits? - ISO Update
4: Getting Certified to ISO 9001 - the Stage 1 Audit
NEW QUESTION # 209
An audit team of three people is conducting a Stage 2 audit to ISO 9001 of an engineering organisation that manufactures sacrificial anodes for the oil and gas industry in marine environments. These are aluminium products designed to prevent corrosion of submerged steel structures. You, as one of the auditors, find that the organisation has shipped anodes for Project DK in the Gulf of Mexico before the galvanic efficiency test results for the anodes have been fully analysed and reported as required by the customer. The Quality Manager explains that the Managing Director authorised the release of the anodes to avoid late delivery as penalties would be Imposed. The customer was not informed since the tests very rarely fall below the required efficiency. You raise a nonconformity against clause 8.6 of ISO 9001.
At the Closing meeting, the audit team leader presents the findings of the audit and comes to the above nonconformity. The Quality Manager produces the test report for Project DK, which shows an acceptable galvanic efficiency, and presents an email from the customer confirming acceptance of the anodes. He asks that the nonconformity be withdrawn.
Which two of the following responses by the audit team leader would be acceptable?
Answer: A,B
NEW QUESTION # 210
During an internal audit, it was discovered that the calibration of a spectrometer used daily for production had expired, causing a nonconformance under Clause 7.1.5.2 of ISO 9001:2015. The root cause was the organization not considering the risk of the calibration provider leaving the country.
Which corrective action is the best one?
Answer: A
Explanation:
* Understanding Clause 7.1.5.2 - Measurement Traceability:ISO 9001:2015 requires organizations to ensure that measuring equipment (e.g., spectrometers) is calibrated and traceable to recognized standards. The failure to maintain calibration within valid dates directly violates this clause and raises concerns about the reliability of the measurement results.
* Root Cause of the Nonconformity:The organization failed to plan for the possibility that the calibration service provider (X-TECH) might become unavailable, leading to expired calibration. This indicates inadequate risk-based thinking, which is required under Clause 6.1 of ISO 9001:2015.
* Option Analysis:
* A. Select one sample for external lab analysis to use as an internal standard:Incorrect. While using an internal standard could provide short-term verification of results, this action does not address the root cause (failure to consider risks associated with external providers).
* B. Look for a local company to provide this service:Incorrect. While finding a new local service provider resolves the immediate calibration issue, it does not address the risk of future provider unavailability.
* C. Double-check one out of ten samples externally:Incorrect. This corrective action ensures some quality assurance for batch release but does not resolve the nonconformance related to expired calibration.
* D. Add this issue to the external issue register, assess its associated risk, and plan action to address that risk:Correct. This approach directly addresses the root cause (failure to anticipate the calibration provider leaving) and ensures proper risk management. ISO 9001:2015 emphasizes risk-based thinking under Clause 6.1, requiring organizations to identify risks and opportunities and implement plans to mitigate them.
* Why D is the Best Option:
* By adding the issue to the external issue register, the organization ensures it is monitored and tracked.
* Assessing the risk ensures proactive measures are in place for similar issues in the future.
* Planning actions to address the risk ensures a sustainable solution is implemented, such as identifying multiple service providers or ensuring backup plans for calibration services.
* ISO 9001 References:
* Clause 6.1 (Actions to Address Risks and Opportunities): Requires organizations to consider risks and opportunities that could affect the intended results of the QMS.
* Clause 7.1.5.2 (Measurement Traceability): Mandates that measuring equipment must be calibrated and traceable to ensure valid results.
* Clause 10.2 (Nonconformity and Corrective Action): Requires organizations to determine the root cause of nonconformities and take actions to ensure they do not recur.
NEW QUESTION # 211
(As the audit team leader, you are planning an audit at an organisation that is seeking certification to ISO 9001. You have confirmed and agreed on the audit scope and audit date with the auditee. The audit team comprises of you and one other auditor. The auditee has two sites and one of these sites is the Head Office where the top management team are based.
The other site is referred to as Site 1, which is located in another country. Apart from that, each site is essentially similar in terms of customer service provision. The other auditor has been selected to audit Site 1 as she lives nearby.
Select four issues you need to finalise before documenting the audit plan.)
Answer: A,B,C,D
Explanation:
ISO 9001:2015 requires audits to be planned and conducted to ensure the quality management system conforms to requirements and is effectively implemented. While ISO 9001 sets the requirement, it explicitly refers auditors to ISO 19011 for detailed guidance on audit planning and execution.
ISO 9001:2015, Clause 9.2.2 (NOTE) states that guidance for auditing management systems is provided in ISO 19011 .
Based on ISO 19011:2018 (Clause 6.3 - Initiating and preparing for the audit), the audit team leader is responsible for finalising key planning issues before documenting the audit plan, especially for multi-site and multi-country audits.
Explanation of the selected options:
A). Arrangement of translation of the audit report
ISO 19011 requires consideration of communication and language arrangements during audit preparation.
Where sites are located in different countries, potential language difficulties must be addressed during planning, including translation needs for reports and communications.
C). Structuring the audit plan to account for audit trails
ISO 19011 requires audits to follow audit trails across processes, functions, and interfaces. The audit plan must be structured to allow logical progression through interrelated processes, which must be decided before the plan is documented.
D). Determining available IT infrastructure for remote participation
ISO 19011 allows the use of remote auditing techniques. When audit team members are located in different countries, the audit team leader must confirm the availability of IT infrastructure to support remote participation in opening and closing meetings as part of audit planning.
E). Considering processes not operating at the time of the audit
ISO 19011 requires the audit team leader to consider process availability. If some processes are not operating during the audit period, alternative audit methods (such as records review or rescheduling) must be planned in advance and reflected in the audit plan.
Explanation of why the other options are not selected:
* B: ISO 19011 requires identification of roles and functions to be audited, not specific names, at the audit planning stage.
* F: Moderation or grading of nonconformities is performed after audit findings are raised, not during audit planning.
* G: Post-audit communication arrangements are addressed during reporting and follow-up activities, not before documenting the audit plan.
* H: Follow-up audits are planned only if required after audit results are known, not during initial audit planning.
NEW QUESTION # 212
According to the ISO 9001 standard, which one of the following is a defined responsibility of top management?
Answer: D
Explanation:
Top management is responsible for establishing, implementing, and maintaining the quality policy. The quality policy provides a framework for setting quality objectives and must be compatible with the context of the organization and support its strategic direction. It should also provide a commitment to satisfy applicable requirements and to continuous improvement.
References: ISO 9001:2015, Clause 5.2
NEW QUESTION # 213
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