QUESTION NO: 1
For a third-party, match the Activity with the Responsibility for conducting it.
For a third-party, match the Activity with the Responsibility for conducting it.
Correct Answer:
Explanation:
Approve Certification Body: Accreditation Body
Award certification: Certification Body
Recommend certification: Audit Team Leader
Maintain certification:
Comprehensive Detailed Explanation
In the context of a third-party ISO 9001 audit, different entities play specific roles in the certification process.
Here ' s a detailed explanation of the responsibilities:
Approve Certification Body: Accreditation BodyThe Accreditation Body is responsible for approving Certification Bodies. Accreditation Bodies are independent entities that evaluate the competence of Certification Bodies, ensuring they meet international standards like ISO/IEC 17021, which sets out the criteria for bodies providing audit and certification of management systems. In this role, they confirm that the Certification Body is capable of conducting ISO 9001 audits and granting certifications in accordance with international guidelines.
Award Certification: Certification BodyThe Certification Body is the entity that ultimately awards the certification to an organization after verifying that it meets the ISO 9001 standards. Certification Bodies conduct audits, either directly or through a team of auditors, and based on the audit outcomes, they issue the certification, indicating that the organization complies with ISO 9001.
Recommend Certification: Audit Team LeaderThe Audit Team Leader is responsible for leading the audit and making a recommendation to the Certification Body. This recommendation is based on the audit findings- whether the organization meets the ISO 9001 requirements or if there are areas of non-compliance that need corrective action. The final decision on certification is not made by the Audit Team Leader but by the Certification Body.
Maintain Certification: Certification BodyMaintaining certification refers to the ongoing process of ensuring that an organization continues to comply with ISO 9001 requirements. The Certification Body conducts regular surveillance audits (e.g., annually) and may also perform recertification audits (typically every three years). This ongoing monitoring ensures that the certified organization continues to adhere to the quality management standards over time.
This breakdown clearly assigns responsibility based on the defined roles of Accreditation Bodies, Certification Bodies, and Audit Teams in the ISO 9001 certification process.
QUESTION NO: 2
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?
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?
Correct Answer: B
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QUESTION NO: 3
A Health Trust has contracted with Servitup, a catering services company that has been certified to ISO
9001 for one year. It provides services to 10 small rural hospitals in remote locations involving the purchase and storage of dry goods and fresh produce, preparing meals and loading heated trolleys for ward service by hospital staff. You, as auditor, are conducting the first surveillance audit at one site with the Deputy Catering Manager (DCM).
DCM: " I apologise for the absence of the Catering Manager. He has called in sick today and we are really short of staff. " You: " I see. It really shouldn ' t affect the QMS so the audit can progress as normal. " DCM: " The Catering Manager set up the system. I ' m afraid I ' m not as familiar with it as he is. " You: " OK, let ' s start with the Quality Policy. What are the main issues for the QMS here? " DCM: Give me a minute. I need to look at the Quality Policy on the noticeboard in his office.
You find that two internal audits have been carried out in the first year by the Catering Manager. One of them indicates that complaints from patients are increasing in number, mainly due to food being served too cold. The DCM comments that the trolley thermometer is often unreliable.
Which two of the following actions would be " correction " in dealing with the complaints?
A Health Trust has contracted with Servitup, a catering services company that has been certified to ISO
9001 for one year. It provides services to 10 small rural hospitals in remote locations involving the purchase and storage of dry goods and fresh produce, preparing meals and loading heated trolleys for ward service by hospital staff. You, as auditor, are conducting the first surveillance audit at one site with the Deputy Catering Manager (DCM).
DCM: " I apologise for the absence of the Catering Manager. He has called in sick today and we are really short of staff. " You: " I see. It really shouldn ' t affect the QMS so the audit can progress as normal. " DCM: " The Catering Manager set up the system. I ' m afraid I ' m not as familiar with it as he is. " You: " OK, let ' s start with the Quality Policy. What are the main issues for the QMS here? " DCM: Give me a minute. I need to look at the Quality Policy on the noticeboard in his office.
You find that two internal audits have been carried out in the first year by the Catering Manager. One of them indicates that complaints from patients are increasing in number, mainly due to food being served too cold. The DCM comments that the trolley thermometer is often unreliable.
Which two of the following actions would be " correction " in dealing with the complaints?
Correct Answer: A,E
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QUESTION NO: 4
In the context of a third-party certification audit, how can the auditor demonstrate confidentiality? Select two.
In the context of a third-party certification audit, how can the auditor demonstrate confidentiality? Select two.
Correct Answer: A,E
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QUESTION NO: 5
Auditor competence is a combination of knowledge and skills. Which two of the following activities are predominately related to ' knowledge ' ?
Auditor competence is a combination of knowledge and skills. Which two of the following activities are predominately related to ' knowledge ' ?
Correct Answer: D,E
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QUESTION NO: 6
You are leading a Stage 2 certification audit of a multi-site organisation and have received the audit schedule below; Head Office and Site 1 - Day 1 Site 2 (150 km from HQ) - Days 2 and 3 During Day 1 of the audit, the client informs you that the laboratory at Site 2 has been closed for decontamination due to a serious outbreak of an infectious disease among workers. In Site 2, all other functions could be audited as planned.
As the audit team leader, what would you do?
Choose the best acceptable action you could take:
You are leading a Stage 2 certification audit of a multi-site organisation and have received the audit schedule below; Head Office and Site 1 - Day 1 Site 2 (150 km from HQ) - Days 2 and 3 During Day 1 of the audit, the client informs you that the laboratory at Site 2 has been closed for decontamination due to a serious outbreak of an infectious disease among workers. In Site 2, all other functions could be audited as planned.
As the audit team leader, what would you do?
Choose the best acceptable action you could take:
Correct Answer: A
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QUESTION NO: 7
(Select the six statements that are required as part of a second-party audit to ISO 9001 carried out by an organisation to a key supplier (ABC), taking into account recommendations from ISO 19011.)
(Select the six statements that are required as part of a second-party audit to ISO 9001 carried out by an organisation to a key supplier (ABC), taking into account recommendations from ISO 19011.)
Correct Answer: A,C,E,F,G,I
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QUESTION NO: 8
(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.)
(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.)
Correct Answer: A,C,D,F
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QUESTION NO: 9
Even though past audits have highlighted a consistently large number of nonconformities within an organisation ' s design team, the organisation has not varied the frequency or duration of audits on its audit plan.
The decision for whether this situation is acceptable or not should be governed by which of the following?
Even though past audits have highlighted a consistently large number of nonconformities within an organisation ' s design team, the organisation has not varied the frequency or duration of audits on its audit plan.
The decision for whether this situation is acceptable or not should be governed by which of the following?
Correct Answer: D
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