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| Certification Vendor: | PECB |
|---|---|
| Exam Name: | PECB Certified ISO 9001 Lead Auditor |
| Exam Number: | ISO-9001-Lead-Auditor |
| Exam Duration: | 180 minutes |
| Real Exam Qty: | 80 |
| Passing Score: | 70% |
| Available Languages: | English |
| Related Certifications: | PECB Master in Quality Management PECB Certified ISO 9001 Lead Implementer |
| Certificate Validity Period: | 3 Years |
| Exam Format: | Multiple Choice, Open Book |
| Exam Price: | USD 1000 |
| Sample Questions: | PECB ISO-9001-Lead-Auditor Sample Questions |
| Exam Way: | Online (PECB Exams application) or Paper-based (at training centers) |
| Pre Condition: | None (Recommended: Training course and experience in Quality Management) |
| Official Syllabus URL: | https://pecb.com/en/education-and-certification-for-individuals/iso-9001-lead-auditor |
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NEW QUESTION # 218
Who would be defined as a witness during a witness audit?
Choose two of the following options:
Answer: A,C
Explanation:
Comprehensive and Detailed Explanation: = According to the web search results from my internal tool, a witness audit is a technique used during an accreditation audit, where the accreditation body observes the performance and competence of the certification body auditors in conducting an audit12. A witness audit can also be used by a certification body to monitor and evaluate its own auditors3. During a witness audit, the following roles can be defined:
*An auditor: This is the person who is being witnessed by the accreditation body or the certification body. The auditor is responsible for conducting the audit according to the audit plan, criteria, and standards, and for providing audit evidence and findings123.
*An assessor for the accreditation body: This is the person who witnesses the auditor on behalf of the accreditation body. The assessor is responsible for evaluating the auditor's performance and competence, and for providing feedback and recommendations to the accreditation body123.
The other options are not defined as witnesses during a witness audit, according to the web search results from my internal tool. They are:
*Someone with a qualification from the certification body: This is not a specific role in a witness audit, as anyone who is involved in the audit process should have a qualification from the certification body.
Moreover, having a qualification does not necessarily mean that the person is a witness or an auditor4.
*An existing member of the audit team: This is not a specific role in a witness audit, as the audit team consists of the auditors who are conducting the audit, not the ones who are witnessing it. The witness audit is a separate activity from the audit itself, and the witness should not interfere with the audit process or influence the audit outcome123.
Therefore, the correct answer is B and D.
References: 1: DQS Inc. | Witness Audits | Auditor Training 2: Have you ever been involved with a witness audit? - IFSQN 3: Certac - Witness Audit of Certification Bodies 4: ISO 19011:2018 - Guidelines for auditing management systems
NEW QUESTION # 219
You are carrying out an audit at an organisation seeking certification to ISO 9001 for the first time. The organisation offers health and safety training to customers. Training courses are offered either as open courses, delivered at a public venue, or online, or as courses that are tailored to meet specific requirements.
The business operates from a single office and those who deliver the training are either full-time employees or subcontractors.
You have just completed the opening meeting. You are interviewing the Managing Director (MD).
You: "Good morning. I would like to gain an understanding of your business and its strategic direction." MD: "Of course. We are facing challenging times. The market is extremely competitive, and customers typically look for the least expensive option when arranging health and safety training. Our annual sales revenue has struggled to grow over the past two years. Most of our employed trainers are planning to retire over the next 12 months, and we are looking for more subcontract trainers. Achieving ISO 9001 certification will, I hope, give us the capability to improve our operational performance. Also, many of our competitors do not have any form of management system certification, so I hope it will give us that competitive edge needed to secure orders. We intend to promote our ISO 9001 certification on our website and across all other customer-facing media." Which three of the following audit trails would you take to explore the extent to which external and internal issues have been determined and used to enable the business to achieve the intended result(s) of its quality management system?
Answer: A,E,H
Explanation:
ISO 9001:2015 requires organisations to determine external and internal issues relevant to their purpose and strategic direction and to use this understanding to support planning and achievement of intended QMS results.
The key requirement is Clause 4.1 - Understanding the organisation and its context, supported by Clause
4.2 - Understanding the needs and expectations of interested parties.
Explanation of the correct audit trails:
A). Establish how the organisation determines its relevant interested parties Clause 4.2 requires the organisation to determine interested parties that are relevant to the QMS and their requirements. Understanding interested parties is essential to identifying external and internal issues that influence strategic direction and QMS outcomes.
C). Establish how the organisation documents its external and internal issues Clause 4.1 requires the organisation to determine relevant external and internal issues. While documented information is not explicitly mandated, auditors must verify how these issues are identified and captured to demonstrate systematic application and use in planning.
D). Establish how the organisation reviews information about external and internal issues Clause 4.1 also requires the organisation to monitor and review information relating to external and internal issues. This audit trail confirms that context analysis is not static and is actively used to support QMS planning and intended results.
Explanation of why the other options are not selected:
* B: Determining scope (Clause 4.3) uses context as an input, but does not itself demonstrate how issues are determined and used.
* E and G: Trainer competence relates to Clause 7.2, not to determination and use of organisational context.
* F: Maintaining training products relates to operational control, not context analysis.
* H: Training room structure is an operational detail unrelated to external and internal issues.
ISO-aligned conclusion:
To explore how external and internal issues are determined and used to achieve intended QMS results, the auditor must follow audit trails that confirm:
* Identification of relevant interested parties,
* Determination and capture of issues affecting the organisation, and
* Ongoing review of those issues to support planning and performance.
NEW QUESTION # 220
In the context of a third-party audit, match the event with the responsibility for conducting it.
Answer:
Explanation:
Explanation:
The correct answer is:
Event
Selecting audit team = Individual(s) managing the audit programme
Conducting the audit = Audit team
Preparing the audit plan = Audit team leader
Requesting the audit = Audit client
To complete the table, click on the blank section you want to complete so that it is highlighted in red, and then click on the applicable text from the options below. Alternatively, drag and drop each option to the appropriate blank section. Responsibility:- Individual(s) managing the audit programme Audit team Audit team leader Audit client According to ISO 19011:2018, clause 5.3, the individual(s) managing the audit programme are responsible for selecting the audit team, taking into account the competence and availability of the auditors and any experts needed. 1 According to clause 6.2, the audit team is responsible for conducting the audit, which includes collecting and verifying audit evidence, evaluating audit findings, and preparing the audit report. 1 According to clause 6.1, the audit team leader is responsible for preparing the audit plan, which includes defining the audit objectives, scope, criteria, and duration, as well as assigning roles and responsibilities to the audit team members. 1 According to clause 5.2, the audit client is the person or organization that requests the audit, which can be the auditee (the person or organization being audited) or any other person or organization that has an interest in the audit results. 1 References:
1: ISO 19011:2018 - Guidelines for auditing management systems
NEW QUESTION # 221
You are leading a team that is auditing a fruit juice manufacturer (ORANGE+), which markets its products in bottles of 0.5 and 1 litre. It is 4 pm, and the audit is close to an end; you are having an internal meeting with the team to decide what will be presented to the auditee during the closing meeting. The closing meeting was scheduled for 5 pm.
ORANGE+ has two manufacturing lines: M1 is a clean room for manufacturing and bottling the juices, and M2 is for packing and labelling the filled bottles in packets of 50 bottles each to be sent to retailers.
Auditor 1 audited the two manufacturing lines.
You: "What findings would you report?"
Auditor 1: "I have one issue. Earlier today, in the morning in M1, I observed a batch of 'sugarless orange juice' being filled into bottles with the label 'standard orange juice' on them." You: "How would you write the non-conformity?" Auditor 1: "Some bottles from a batch of 'sugarless orange juice' were labelled as 'standard orange juice'." What information would you add to this text to complete the non-conformity report? Select six.
Answer: A,C,E,F,H,J
Explanation:
A properly written nonconformity statement should contain:
* A clear description of the objective evidence.
* Reference to the audit criteria not fulfilled.
* Identification of where and when the evidence was found.
* Sufficient traceability to allow investigation and corrective action.
* Classification/grade where required by the certification body ' s process.
Why B is Correct
If any of the ORANGE+ procedures for bottling and labelling products were not being met.
The nonconformity should reference the specific internal procedure or audit criterion that was not followed.
Why C is Correct
The grade of nonconformity (major or minor).
In certification audits, nonconformities are typically classified according to certification body rules.
Why D is Correct
The date on which the evidence was identified.
The audit record should identify when the evidence was observed.
Why F is Correct
Batch number audited.
The batch number provides traceability and allows the organisation to investigate the affected product.
Why H is Correct
The description of the ISO 9001:2015 requirement not being complied with and the clause number.
A nonconformity must reference the audit criterion that was not fulfilled.
Why I is Correct
The place where the bottles with the wrong label were found.
The location where the evidence was observed should be recorded as part of the objective evidence.
Why the Other Options Are Incorrect
A). The regulatory requirements that apply to the juice being bottled.
May be relevant background information, but it is not essential information required to complete the nonconformity statement.
E). Composition of both sugar and sugarless juices.
Not required to establish the nonconformity.
G). Name of the supervisor and of the workers who were responsible for the bottling process.
Auditors report system failures, not assign blame to individuals.
J). The signature of the M1's supervisor accepting the non-conformity.
ISO 9001 and ISO 19011 do not require the auditee ' s signature to validate a nonconformity.
ISO-Aligned Conclusion
The six items that should be added to complete the nonconformity report are:
B). If any of the ORANGE+ procedures for bottling and labelling products were not being met.
C). The grade of nonconformity (major or minor).
D). The date on which the evidence was identified.
F). Batch number audited.
H). The description of the ISO 9001:2015 requirement not being complied with and the clause number.
I). The place where the bottles with the wrong label were found.
NEW QUESTION # 222
The following are stages of an audit, put them in the order they would be conducted.
Answer:
Explanation:
Explanation:
Establishing the audit programme objectives
Determining and evaluating the audit programme risks and opportunities
Establishing the audit programme
Initiating the audit
Preparing all audit activity
Conducting the audit activities
According to ISO 19011:2018, clause 5, the audit programme is a set of one or more audits planned for a specific time frame and directed towards a specific purpose. The audit programme includes all activities necessary to plan, organize, and conduct the audits. The audit programme management involves the following steps1:
Establishing the audit programme objectives: The audit programme objectives define the intended outcomes of the audit programme, such as verifying conformity, evaluating performance, identifying improvement opportunities, etc. The audit programme objectives should be aligned with the strategic direction and policies of the organization and the needs and expectations of the interested parties.
Determining and evaluating the audit programme risks and opportunities: The audit programme risks and opportunities are the factors that can affect the achievement of the audit programme objectives, such as changes in the internal or external context, availability of resources, competence of auditors, etc. The audit programme risks and opportunities should be identified, analyzed, and evaluated to determine the appropriate actions to address them.
Establishing the audit programme: The audit programme is established by defining the audit programme scope, criteria, methods, and resources. The audit programme scope defines the extent and boundaries of the audit programme, such as the processes, functions, sites, activities, etc. that will be audited. The audit programme criteria are the set of policies, procedures, or requirements used as a reference for the audits. The audit programme methods are the techniques used to conduct the audits, such as interviews, observations, document review, sampling, etc. The audit programme resources are the human, technical, and financial resources needed to implement the audit programme.
Initiating the audit: The audit initiation is the process of formally establishing the arrangements for an individual audit within the audit programme. The audit initiation involves contacting the auditee and the audit client, confirming the audit objectives, scope, and criteria, and obtaining the necessary information and access for the audit.
Preparing all audit activity: The audit preparation is the process of developing the audit plan and the audit work documents for an individual audit. The audit plan is a document that provides the basis for agreement regarding the conduct of the audit, such as the audit schedule, the audit team, the audit methods, the audit language, the audit report, etc. The audit work documents are the records that provide evidence of the audit activities, such as the audit checklist, the audit notes, the audit findings, etc.
Conducting the audit activities: The audit activities are the processes of collecting and verifying audit evidence and evaluating it against the audit criteria to make the audit conclusions. The audit activities include the opening meeting, the communication during the audit, the roles and responsibilities of the audit team and the auditee, the audit evidence collection and verification, the audit findings generation and recording, the closing meeting, and the audit report preparation and distribution.
References: ISO 19011:2018(en), Guidelines for auditing management systems
NEW QUESTION # 223
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