PECB ISO-9001-Lead-Auditor - QMS ISO 9001:2015 Lead Auditor Exam

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

Documented information is a means by which an organization demonstrates compliance. It communicates what we do and how we do things, it communicates what happened and what results were achieved. It is, essentially, a tool for communication. ISO 9001:2015 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to determine the correct amount of documented information needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. The standard states that the organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned. Therefore, the purpose of retaining documented information is to support the operation of the processes of the QMS, not to facilitate auditing, provide confidence or safeguard integrity, which are secondary benefits of documented information. References: Guidance on the requirements for Documented Information of ISO 9001:2015, ISO 9001:2015 documented information | CQI | IRCA, Documented Information Required by ISO 9001:2015 - 9000 Store

In the context of a third-party audit, the activities and the parties responsible can be matched as follows:

Review the organization’s processes: This is typically the responsibility of the audit team. They examine the processes to ensure they comply with the specified standards1.

Review the audit results: The audit team leader usually reviews the audit findings to ensure accuracy and completeness before they are finalized1.

Issue the certificate: The certification body is responsible for issuing the certificate if the audit is successful and the organization meets the required standards1.

Select the audit team: The individual(s) managing the audit programme are responsible for selecting the audit team. This ensures that the team has the appropriate skills and knowledge for the audit1.

These roles are essential to maintain the integrity and effectiveness of the audit process. The audit team conducts the actual audit, the team leader oversees the audit process, the certification body grants the certification, and the management of the audit program ensures that the right team is in place to conduct the audit1.

Based on the description of the image you’ve provided, here’s how the activities match with the responsible parties in the context of a third-party audit:

Review the organization’s processes: This activity is typically the responsibility of the Audit Team. They are tasked with examining the processes to ensure they meet the requirements of the standard being audited.

Review the audit results: The Audit Team Leader is usually responsible for this activity. They oversee the audit process and are in charge of reviewing the findings and ensuring that the audit objectives are met.

Issue the certificate: The Certification Body is responsible for issuing the certificate if the organization’s management system is found to be in compliance with the standard.

Select the audit team: The Individual(s) managing the audit programme are responsible for selecting the audit team. They ensure that the team has the appropriate competence and resources to effectively conduct the audit.

These roles are defined within the framework of ISO 9001:2015 and are essential for the proper conduct of a third-party audit. The audit team and its leader play a critical role in the operational aspects of the audit, while the certification body and those managing the audit programme have overarching responsibilities for the audit’s governance and integrity.

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.

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015, Clause 6.2 (Quality Objectives and Planning to Achieve Them) states that an organization must establish measurable and relevant quality objectives to improve QMS effectiveness.

Bell's strategy for handling customer complaints aligns with this requirement because it includes specific, measurable goals (biweekly customer surveys) to enhance customer satisfaction and service quality.

Other options are not directly related to defining quality objectives:

Option B (Implementing a QMS) refers to the overall system, not specific objectives.

Option C (Creating a QMS team) is an implementation step, not an objective.

Option D (Assigning responsibilities) is necessary for QMS but does not define objectives.

Comprehensive and Detailed In-Depth Explanation:

Group interviews allow auditors to gather more information in less time by:

Obtaining input from multiple participants simultaneously.

Encouraging discussions that might highlight inconsistencies.

Reducing the number of individual interviews needed.

While auditors strive for fairness, equal time for each interviewee is not guaranteed, and paying attention to each individual is more difficult in a group setting.

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.