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PECB ISO-9001-Lead-Auditor Exam Syllabus Topics:

Topic
Details

Topic 1

Managing an ISO 9001 audit program: This topic evaluates your abilities to establish and managing a QMS audit program.

Topic 2

Conducting an ISO 9001 audit: It evaluates your skills to conduct a QMS audit.

Topic 3

Fundamental audit concepts and principles: Questions about interpreting and applying the main concepts and principles related to a QMS audit appear in this topic.

Topic 4

Quality management system (QMS) requirements: It assesses your abilities to point out and explain different requirements for a quality management system based on ISO 9001.

Topic 5

Preparing an ISO 9001 audit: This topic covers sub-topics related to preparing a quality management system audit.

PECB QMS ISO 9001:2015 Lead Auditor Exam Sample Questions (Q119-Q124):

NEW QUESTION # 119
An organisation decides to purchase products and services only from ISO 9001 certified suppliers.
Match the four organisational functions to a potential benefit.

Answer:

Explanation:

Explanation:
Reduced incoming inspection # A. Quality
Improved communication with suppliers # B. Procurement
Purchased materials received on time # C. Logistics
Reduced variability within processes # D. Production
According to ISO 9001:2015, Clause 8.4 - Control of externally provided processes, products and services, organisations are required to ensure that externally provided products and services conform to specified requirements. When an organisation sources from ISO 9001 certified suppliers, there is greater assurance of consistency in quality, delivery, and communication. This enhances internal operations across various functions:
* Reduced incoming inspection (Quality): ISO 9001 certified suppliers have robust quality controls (Clause 8.4.2), reducing the need for repeated inspections upon receipt. This aligns with Quality's responsibility for incoming inspection and verification.
* Improved communication with suppliers (Procurement): Clause 8.4.3 emphasizes the communication of detailed requirements to external providers. Procurement plays a key role in ensuring these requirements are understood and met.
* Purchased materials received on time (Logistics): Timely deliveries are often a result of structured supplier evaluation and selection (Clause 8.4.1). Logistics benefits through fewer delays and better scheduling of internal processes.
* Reduced variability within processes (Production): Consistency of supplied materials supports stable and predictable production processes, which is a key aspect of Clause 8.5 - Production and service provision.
References:
ISO 9001:2015 Clause 8.4.1 - General
ISO 9001:2015 Clause 8.4.2 - Type and extent of control
ISO 9001:2015 Clause 8.4.3 - Information for external providers
ISO 9001:2015 Clause 8.5 - Production and service provision

NEW QUESTION # 120
You are carrying out an audit at a single-site organisation seeking certification to ISO 9001 for the first time.
The organisation offers warehousing and export services to customers. Customers are invoiced for the time stock items are stored in the warehouse. Transport to and from the warehouse is controlled by the organisation and approved subcontract transport services are used. The organization does not have its own transport vehicles. Stock items are not purchased by the organisation.
You have gathered audit evidence as outlined in the table. Match the ISO 9001 Clause 8 extract to the audit evidence.

Answer:

Explanation:

Explanation:
The table below shows the possible matching of the ISO 9001 Clause 8 extract to the audit evidence.
Table
Audit evidence
ISO 9001 Clause 8 extract
Four of the 10 pallets of stock sampled in the warehouse were not labelled.
"8.5.2 ... shall use suitable means to identify outputs ..."
A damaged pallet of stock seen in the quarantine area was leaking liquid onto the floor.
"8.7.1 ... shall ensure that outputs that do not conform to their requirements are identified and controlled ..." One of the fork-lift truck drivers had no fork-lift truck driving licence.
"8.5.1 e ... shall include, as applicable ... the appointment of competent persons ..." There was no pest control provision in the warehouse.
"8.5.4 ... shall preserve the outputs during production and service provision ..." Two pallets of temperature-sensitive stock items were being stored at ambient as the chilled storage facility was full.
"8.1 ... shall plan, implement and control the processes ..."

NEW QUESTION # 121
Select the term which best describes the quality management system process of modifying a non-conforming product to bring it within acceptance criteria.

A. Concession
B. Correction
C. Preventive action
D. Corrective action

Answer: B

Explanation:
According to the ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, correction is defined as "action to eliminate a detected nonconformity". A nonconformity is defined as "non-fulfilment of a requirement". Therefore, the process of modifying a non-conforming product to bring it within acceptance criteria is a correction, as it eliminates the non-fulfilment of the product specification. The other options are not correct, as they have different definitions and purposes:
*Concession: permission to release or use a nonconforming product, service or process
*Corrective action: action to eliminate the cause of a nonconformity and to prevent recurrence
*Preventive action: action to eliminate the cause of a potential nonconformity or other undesirable potential situation References: ISO 9000:2015 - Quality management systems - Fundamentals and vocabulary, ISO 9001 nonconforming product: How to understand dispositions - Advisera

NEW QUESTION # 122
Scenario 1: AL-TAX is a company located in California which provides financial and accounting services. The company manages the finances of 17 companies and now is seeking to expand their business even more The CEO of AL-TAX, Liam Durham, claims that the company seeks to provide top- notch services to their clients Recently, there were a number of new companies interested in the services provided by AL-TAX.
In order to fulfill the requirements of new clients and further improve quality, Liam discussed with other top management members the idea of implementing a quality management system (QMS) based on ISO 9001. During the discussion, one of the members of the top management claimed that the size of the company was not large enough to implement a QMS. In addition, another member claimed that a QMS is not applicable for the industry in which AL TAX operates. However, as the majority of the members voted for implementing the QMS. Liam initiated the project.
Initially, Liam hired an experienced consultant to help AL-TAX with the implementation of the QMS.
They started by planning and developing processes and methods for the establishment of a QMS based on ISO 9001. Furthermore, they ensured that the quality policy is appropriate to the purpose and context of AL TAX and communicated to all employees. In addition, they also tried to follow a process that enables the company to ensure that its processes are adequately resourced and managed, and that improvement opportunities are determined.
During the implementation process, Liam and the consultant focused on determining the factors that could hinder their processes from achieving the planned results and implemented some preventive actions in order to avoid potential nonconformities Six months after the implementation of the QMS.
AL-TAX conducted an internal audit. The results of the internal audit revealed that the QMS was not fulfilling all requirements of ISO 9001. A serious issue was that the QMS was not fulfilling the requirements of clause 5.1.2 Customer focus and had also not ensured clear and open communication channels with suppliers.
Throughout the next three years, the company worked on improving its QMS through the PDCA cycle in the respective areas. To assess the effectiveness of the intended actions while causing minimal disruptions, they tested changes that need to be made on a smaller scale. After taking necessary actions, AL-TAX decided to apply for certification against ISO 9001.
Based on the scenario above, answer the following question:
Scenario 1 indicates that AL-TAX did not ensure clear and open communication channels with interested parties. Which quality management principle did the organization not follow in this case?

A. Relationship management
B. Leadership
C. Evidence-based decision making

Answer: A

Explanation:
Comprehensive and Detailed In-Depth Explanation:ISO 9001:2015 is based on seven quality management principles, one of which is Relationship Management. This principle emphasizes the importance of maintaining open communication and collaboration with interested parties, including suppliers and customers.
Clause 7.4 (Communication) requires organizations to determine what, when, with whom, and how communication should take place. Since AL-TAX failed to ensure clear communication channels, it did not adhere to this principle. Effective relationship management helps improve supply chain performance, customer satisfaction, and overall QMS effectiveness.

NEW QUESTION # 123
Scenario 6: Davis Clinic (DC) is an American medical center focused on integrated health care. Since its establishment DC was committed to providing qualitative services for its clients, which is the reason why the company decided to implement a quality management system (QMS) based on ISO 9001. After a year of having an active QMS in place, DC applied for a certification audit.
A team of five auditors, from a well-known certification body, was selected to conduct the audit. Eva was appointed as the audit team leader. After three days of auditing, the team gathered to review and examine their findings. They also discussed the audit findings with DC's top management and then drafted the audit conclusions.
In the closing meeting, which was held between the audit team and the top management of DC. Eva presented two nonconformities that were detected during the audit. Eva stated that the company did not retain documented information regarding its outsourced services for an analysis laboratory and regarding the conducted management reviews. During the closing meeting, the audit team required from DCs top management to come up with corrective action plans within two weeks. Although the top management did not agree with the audit findings, the audit team insisted that the auditee must submit corrective actions within the given time frame in order for the audit activities to continue.
Once the action plans were evaluated, the audit team began preparing the audit report. Eva required from the team to provide accurate descriptions of the audit findings and the audit conclusions. The report was then distributed to all the interested parties involved in the audit, including the certification body Based on the report, the certification body together with Eva, as the audit team leader, made the certification decision.
Based on the scenario above, answer the following question:
The audit team delayed audit activities until DC's top management submitted their action plans. Is this acceptable?

A. No, the audit report should be prepared and submitted to the certification body prior to the submission of action plans by the auditee
B. Yes, DC's top management promised the submission of action plans within a short period of time
C. Yes, the audit report can be prepared once the auditee submits the action plans in cases of minor nonconformities

Answer: A

Explanation:
Comprehensive and Detailed In-Depth Explanation:According to ISO 17021-1:2015, Clause 9.4.8 (Audit Reporting):
* The audit report must be submitted to the certification body regardless of corrective actions.
* Corrective actions are reviewed after the audit, but the audit process should not be delayed.
* Certification decisions should be made based on the audit findings and evidence, not pending corrective actions.
Thus, delaying audit activities until corrective actions are submitted is not acceptable.

NEW QUESTION # 124
......

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