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

Table

Statement

First-party audits

Second-party audits

Third-party audits

The audit scope is typically determined by the organisation being audited.

Yes

No

No

The outcome of the audit is typically certification to a recognised standard.

No

No

Yes

The audit scope is typically confined to service/product provision capability.

No

Yes

No

Here is a brief explanation of each statement:

The audit scope is typically determined by the organisation being audited: This statement applies to first-party audits, also known as internal audits, where the organisation audits its own processes and activities to ensure conformity and improvement1. The organisation can decide the scope of the audit based on its own needs and objectives2. This statement does not apply to second-party audits, where the customer audits the supplier, or third-party audits, where an independent body audits the organisation. In these cases, the audit scope is determined by the customer or the certification body, respectively34.

The outcome of the audit is typically certification to a recognised standard: This statement applies to third-party audits, where an independent body audits the organisation to verify that it meets the requirements of a specific standard, such as ISO 9001, and issues a certificate of conformity if the audit is successful34. This statement does not apply to first-party audits or second-party audits, where the outcome of the audit is not certification, but rather self-improvement or supplier qualification13.

The audit scope is typically confined to service/product provision capability: This statement applies to second-party audits, where the customer audits the supplier to ensure that they are meeting the requirements specified in the contract, such as service or product quality, delivery, or performance34. The audit scope is usually focused on the specific aspects of the service or product that are of interest to the customer3. This statement does not apply to first-party audits or third-party audits, where the audit scope is broader and covers the entire quality management system or the relevant clauses of the standard14.

According to clause 8.3 of ISO 9001:2015, the organization should establish, implement, and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services. The design and development process should include the following activities:

•Determining the requirements for the products and services to be designed and developed, considering the intended use, the statutory and regulatory requirements, the customer and other relevant interested parties’ needs and expectations, and the potential risks and opportunities.

•Defining the design and development objectives, stages, responsibilities, and authorities, and ensuring the availability of adequate resources and competence.

•Implementing design and development controls, such as reviews, verification, and validation, to ensure that the design and development outputs meet the design and development inputs, and to identify and resolve any problems or errors.

•Maintaining documented information on the design and development inputs, outputs, reviews, verification, validation, and changes, and ensuring the traceability and conformity of the products and services to the requirements.

•Managing the design and development changes, by identifying, reviewing, and controlling them, and evaluating their effects on the products and services and the QMS.

In this case, the evidence statements that provide a meaningful audit trail for the design and development process are B, E, and F, because they relate to the design and development controls, the documented information, and the verification activities that are required by the standard. These options can help the auditor to assess the effectiveness and conformity of the design and development process, and to identify any nonconformities or opportunities for improvement. The other options are not directly related to clause 8.3, although they may be relevant for other aspects of the QMS, such as clause 7.2 on competence, clause 7.3 on awareness, clause 7.4 on communication, clause 8.2 on requirements for products and services, clause 8.4 on externally provided processes, products, and services, and clause 8.7 on control of nonconforming outputs. References: ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Design and Development, ISO 9001 Clause 8.3 Design and development of products and services

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Comprehensive and Detailed In-Depth Explanation:

Clause 8.3.2 e) – Internal Resource Needs:Delays due to staff shortages highlight a lack of internal resources, directly relating to this clause that requires internal resource planning for design and development.

Clause 8.3.6 – Design and Development Changes:Ongoing formulation changes due to feedback need to be documented and reviewed. This clause requires retention of documented information on changes.

Clause 8.3.5 – Design and Development Outputs:Customer approvals for formulations are outputs of the design process and must be retained as documented information, as per this clause.

Clause 8.3.4 d) – Design and Development Controls:Consumer trials are a validation activity. This clause ensures such trials are conducted to confirm that resulting products meet defined requirements.

Clause 8.3.2 e) – External Resource Needs:Shelf-life tests done by an external lab are part of the external resources needed for development and are referenced here.

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 (Conformity Assessment – Requirements for Certification Bodies), Clause 9.3.1.2, the Stage 1 Audit typically consumes around 30% of the total audit time.

This time is allocated to:

Reviewing documented information.

Assessing the readiness for Stage 2.

Identifying potential nonconformities.

A 20% allocation (Answer A) is too low, and 40% (Answer C) is excessive, as the majority of the audit should be spent on Stage 2 (on-site verification).

In this scenario, the audit team leader must balance maintaining the integrity of the audit plan while considering the auditee’s request. The two best responses allow for flexibility without compromising the audit's rigor:

A. I could audit the other laboratories virtually at the end of this audit: Virtual audits can be a valid option, especially in multi-site audits. ISO 9001:2015 does not prohibit virtual audits, and in certain situations, they are practical for reviewing documentation or observing operations remotely.

C. I could try to revise the audit programme to see if I can audit all laboratories: Revising the audit programme to accommodate additional site visits is a reasonable compromise. ISO 9001:2015 audits are based on risk and sampling, but the audit team leader has the flexibility to adjust the audit scope if it fits within the audit duration and resources.

The other options, such as extending the audit duration (B, F) or strictly adhering to the original plan (D, E), may not be practical or necessary. Revising the plan to audit all laboratories or using virtual auditing ensures that the audit remains efficient while addressing the organization's concerns​.

Based on the scenario provided, there is evidence of nonconformity with the requirements defined in:

C. Clause 7.5.1 Documented information - General: The scenario indicates that there is no formal process for informing users about updates to the SWIFT database, which suggests a lack of control over documented information. This could lead to users being unaware of important changes and not using the latest version of the software, which is required by the quality management system1.

E. Clause 7.5.3 Control of documented information: The Operations Director’s approach to updating the SWIFT database and the lack of communication to users about these updates indicate that the documented information is not adequately controlled. Allowing users to revert to earlier versions of the software at their discretion further suggests that the organization does not have a proper mechanism in place to ensure the integrity and suitability of documented information2.

These clauses are part of the ISO 9001:2015 standard, which requires organizations to have a systematic approach to controlling and managing documented information as part of their quality management system. The scenario described shows a casual approach to managing critical software updates, which could affect the organization’s ability to consistently meet customer and regulatory requirements.