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PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q152-Q157):

NEW QUESTION # 152
State the correct sequence of events in the certification process for an organisation to obtain third-party accredited certification to ISO 9001.

Answer:

Explanation:

Reference: ISO 9001:2015 Clause 9.2 emphasizes the planning of audits and their scheduling to achieve desired results.
Step 2: Conduct Certification Audit StagesThe certification process includes a two-stage audit.
Stage 1 Audit: Review of documentation to verify readiness and understanding of the Quality Management System (QMS).
Stage 2 Audit: A detailed evaluation of the implementation and effectiveness of the QMS against ISO 9001 requirements.Reference: Clause 8.1 of ISO 9001:2015 discusses operational planning and control, which includes the preparation for audit activities.
Step 3: Award ISO 9001 CertificateAfter successfully completing the certification audits and resolving any identified non-conformities, the certification body awards the ISO 9001 certificate. This certificate demonstrates that the organization's QMS meets the ISO 9001 standard.Reference: Clause 10 of ISO 9001:
2015 focuses on continual improvement and conformity, which leads to the certification issuance.
Step 4: Accredit Certification BodyCertification bodies must be accredited to ensure they meet international standards for certification. Accreditation is conducted by bodies like UKAS (United Kingdom Accreditation Service) or ANAB (ANSI National Accreditation Board), ensuring the credibility and global acceptance of the certification process.Reference: Clause 7.1.5 of ISO 9001 covers resource monitoring, which supports the integrity of the certification process.
By following these steps, organizations can ensure an effective and compliant certification process, achieving ISO 9001 certification.

NEW QUESTION # 153
In the context of a third-party certification audit, it is very important to have effective communication. Which is not the responsibility of the audit team leader?

A. Communicating the progress, any significant findings and any concerns to the auditee and audit client, as appropriate.
B. Planning formal communication arrangements, so an auditee can communicate with the auditor any time during the audit.
C. If audit objectives are unattainable, reporting the reasons to the accreditation body.
D. Confirming formal communication channels between the audit team and the auditee during the opening meeting.

Answer: C

Explanation:
Responsibilities of the Audit Team Leader:ISO 19011:2018 (guidelines for auditing management systems), which supports the principles in ISO 9001:2015, specifies the responsibilities of an audit team leader. These responsibilities include:
* Planning the audit and establishing effective communication between the audit team and auditee.
* Ensuring that formal communication channels are agreed upon and followed.
* Reporting the audit progress, significant findings, and any concerns to the auditee or audit client as necessary.
* Managing the audit team and ensuring adherence to the defined objectives and scope.
Analysis of Options:
* A. Reporting unattainable audit objectives to the accreditation body:Incorrect. This is not the responsibility of the audit team leader. The accreditation body oversees the certification body and is not directly involved in specific audits. If objectives are unattainable, the audit team leader would report them to the audit client (the certification body), not the accreditation body.
* B. Planning formal communication arrangements:Correct. This is one of the responsibilities of the audit team leader. They ensure auditees can communicate with auditors as needed during the audit process.
* C. Confirming communication channels during the opening meeting:Correct. During the opening meeting, the audit team leader must establish clear communication protocols to ensure effective information exchange between the audit team and auditee.
* D. Communicating progress, findings, and concerns:Correct. Keeping the auditee and audit client informed about progress and significant findings is a critical responsibility of the audit team leader to maintain transparency and ensure the audit objectives are met.
Why Option A is Correct:The audit team leader does not have any obligation to report unattainable objectives to the accreditation body. Instead, they are responsible for communicating issues to the audit client (typically the certification body). The accreditation body operates at a higher level and is concerned with overseeing certification bodies, not individual audits.
Relevant References:
* ISO 19011:2018, Clause 6.4 (Conducting the Audit): Emphasizes the responsibilities of the audit team leader, including communication with the auditee and client.
* ISO 9001:2015, Clause 9.2 (Internal Audit): Highlights the importance of planning and communication during audits, which is reflected in third-party audits as well.

NEW QUESTION # 154
The following are stages of an audit, put them in the order they would be conducted.

Answer:

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
To complete the sequence, you can drag and drop the options to the appropriate blank section.
Here is a brief explanation of each stage:
Establishing the audit programme objectives: This is the first stage of the audit process, where the purpose, scope, and criteria of the audit programme are defined. The audit programme objectives should be aligned with the strategic direction and policies of the organization, and should address the needs and expectations of the interested parties12.
Determining and evaluating the audit programme risks and opportunities: This is the second stage of the audit process, where the factors that can affect the achievement of the audit programme objectives are identified and assessed. The audit programme risks and opportunities should consider the internal and external issues, the requirements and changes of the interested parties, and the results and feedback from previous audits12.
Establishing the audit programme: This is the third stage of the audit process, where the audit programme is designed and implemented. The audit programme should include the audit programme procedures, the audit programme resources, the audit methods and techniques, the audit frequency and schedule, and the audit programme performance indicators12.
Initiating the audit: This is the fourth stage of the audit process, where the audit is prepared and planned. The audit initiation involves selecting the audit team, establishing the contact with the auditee, defining the audit objectives, scope, and criteria, developing the audit plan, and conducting the document review123.
Preparing all audit activity: This is the fifth stage of the audit process, where the audit activities are organized and coordinated. The audit preparation involves assigning the audit tasks, communicating with the auditee and the audit team, arranging the logistics, preparing the working documents, and conducting the opening meeting123.
Conducting the audit activities: This is the sixth and final stage of the audit process, where the audit evidence is collected and evaluated. The audit conduct involves performing the audit activities, such as interviews, observations, document reviews, and tests, documenting the audit findings, preparing the audit conclusions, and conducting the closing meeting123.
I hope this helps you with your ISO 9001 Lead Auditor objectives and content. If you have any further questions, please feel free to ask. # References: 1: ISO 19011:2018 - Guidelines for auditing management systems 2: Audit Process | Flowchart | Summary - Accountinguide 3: What are the Stages of the Auditing Process & Why it is Important ...

NEW QUESTION # 155
Which two of the following may be changed once a Stage 2 certification audit has commenced?

A. Agreed standard for the audit criteria
B. Audit checklist
C. Audit plan
D. Increase of audit duration
E. Agreed language of the audit
F. Audit scope

Answer: C,D

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 # 156
You are preparing for interviews with two members of top management. Based on the information that you gathered about the organization, you conclude that it is the top management who takes all the important decisions and closely supervises and controls employees. Based on this, which management style is practiced in the organization?

A. Laissez-faire
B. Autocratic
C. Centralized

Answer: B

Explanation:
Comprehensive and Detailed In-Depth Explanation:
An autocratic management style is characterized by:
* Top management making all decisions without delegation.
* Strict control over employees.
* A lack of employee input in decision-making.
Centralized management (Answer C) refers to decision-making being concentrated at the top, but it does not necessarily imply strict control. Laissez-faire management (Answer B) allows employees high independence, which contradicts the scenario.
Reference:
ISO 9001:2015, Clause 5.1 (Leadership and Commitment)

NEW QUESTION # 157
......

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