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NEW QUESTION # 141
Which action indicates that an organization is meeting the requirements of ISO 9001 regarding nonconforming outputs?
Answer: C
Explanation:
Comprehensive and Detailed In-Depth Explanation:
ISO 9001:2015 requires organizations to identify and control nonconforming outputs to prevent unintended use or delivery.
Clause References:
* Clause 8.7 (Control of Nonconforming Outputs): Organizations must ensure that nonconforming outputs are identified and controlled to prevent unintended use or delivery.
* Clause 10.2 (Nonconformity and Corrective Action): Requires organizations to take appropriate actions when nonconformities are found, including during or after service provision.
Why is the Correct Answer C?
* If nonconforming products or services are identified after delivery or during service, organizations must take corrective actions to protect customers and stakeholders.
* Actions may include recalls, rework, customer notifications, compensation, or process improvements.
* This approach aligns with ISO 9001:2015, ensuring that products/services consistently meet requirements.
Why are the Other Options Incorrect?
* A (Retaining documentation only) # While documentation is required, it alone does not ensure proper handling of nonconforming outputs.
* B (Verifying conformity before correction) # While verification is good practice, ISO 9001 prioritizes corrective action over mere verification.
* D (Allowing employees to handle nonconformities without structure) # ISO 9001 requires documented procedures for handling nonconformities (Clause 8.7).
Reference:
ISO 9001:2015, Clause 8.7 - Control of Nonconforming Outputs
ISO 9001:2015, Clause 10.2 - Nonconformity and Corrective Action
NEW QUESTION # 142
Which two of the following work documents are not required for audit planning by an auditor conducting a certification audit?
Answer: A,E
NEW QUESTION # 143
(Select two applicable benefits of third-party certification of ISO 9001 quality management systems for an organisation:)
Answer: E,F
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 # 144
You are conducting an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation manufactures cosmetics for major retailers and the name of the retailer supplied appears on the product packaging. Sales turnover has increased significantly over the past five years You are interviewing the new Product Development Manager. You note that a software application called SWIFT is used to help control the product development process.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 clause 8.3 extracts to the audit evidence.
Answer:
Explanation:
Explanation:
The table below shows the possible matching of the ISO 9001 Clause 8.3 extract to the audit evidence.
Table
Audit evidence
ISO 9001 Clause 8.3 extract
Half of all new products launched in the past 12 months were late. The NPD Manager explains he has not got enough people on his team to cope with the demand for new products.
"8.3.2 e) ... internal ... resource needs for the design and development of products ..." The NPD Manager explains many changes are made to cosmetic formulations during product development owing to retailer feedback. Only when confirmed by the retailer is the agreed formulation documented on SWIFT.
"8.3.5 ... retain documented information ..."
The NPD Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails are kept on SWIFT.
"8.3.6 ... retain documented information ..."
The NPD Manager shows you evidence of consumer trials that are carried out for some new products prior to full-scale launch.
"8.3.4 d) ... conducted to ensure that the resulting products and services meet the requirements ..." The NPD Manager explains that an approved external laboratory is used to perform shelf-life stability trials on some formulations during product development.
"8.3.2 e) ... external ... resource needs for the design and development of products ..."
NEW QUESTION # 145
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 # 146
......
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