QUESTION: 25

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

Concession
Correction
Corrective action
Preventive action

Answer(s): 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

Reference:

ISO 9000:2015 - Quality management systems -- Fundamentals and vocabulary, ISO 9001 nonconforming product: How to understand dispositions - Advisera

Reveal Solution Next Question

QUESTION: 26

Which one of the following options best describes the purpose of a Stage 1 third-party audit?

To determine the auditees understanding of ISO 9001.
To get to know the organisation's customers.
To learn about the organisation's procurement processes.
To introduce the audit team to the client.

Answer(s): A

Explanation:

The purpose of a Stage 1 third-party audit is to determine an organization's readiness for their Stage 2 Certification Audit. During the Stage 1, the auditor will review the organization's management system documented information, evaluate the site-specific conditions, and have discussions with personnel. The objective is to assess the alignment of the organization's design with ISO 9001 requirements and to identify any areas of concern that could be classified as a nonconformance during the Stage 2 Audit. The auditor will also use the Stage 1 Audit to complete Stage 2 Audit planning, including a review of the allocation of resources and details for the next phase of the audit. Therefore, the option that best describes the purpose of a Stage 1 third-party audit is A, to determine the auditees understanding of ISO 9001. The other options are not correct, as they are not the main focus of a Stage 1 audit:
· B. To get to know the organization's customers: This is not the purpose of a Stage 1 audit, as the auditor is not interested in the specific details of the organization's customers, but rather in the organization's ability to meet customer and applicable statutory and regulatory requirements. · C. To learn about the organization's procurement processes: This is not the purpose of a Stage 1 audit, as the auditor is not interested in the specific details of the organization's procurement processes, but rather in the organization's ability to control externally provided processes, products and services.
· D. To introduce the audit team to the client: This is not the purpose of a Stage 1 audit, as the auditor is not there to make introductions, but rather to conduct a preliminary examination of the organization's compliance with ISO 9001 standards.

Reference:

What is the difference between Stage 1 and Stage 2 Audits? - ISO Update, The ISO 9001

Audit Process Explained | ISO Explained, What is an ISO Stage 2 Audit? -- RiskOptics - Reciprocity

Reveal Solution Next Question

QUESTION: 27

Which two of the following auditors would not participate in a first-party audit?

An auditor employed by an external consultancy organisation
An auditor from an interested party
An auditor trained in-house
An auditor trained in the IRCA scheme
An auditor certified by IRCA
An auditor from a customer

Answer(s): A,F

Explanation:

A first-party audit is an internal audit conducted by auditors who are employed by the organization being audited but who have no vested interest in the audit results of the area being audited1. The purpose of a first-party audit is to assess the conformity of the organization's quality management system to the requirements of ISO 9001 and to identify opportunities for improvement2. Therefore, the two auditors who would not participate in a first-party audit are:
· A. An auditor employed by an external consultancy organization: This auditor is not employed by the organization being audited, and therefore does not qualify as a first-party auditor. This auditor may be hired to conduct a second-party audit (if the external consultancy organization is a customer or supplier of the organization being audited) or a third-party audit (if the external consultancy organization is a certification body or registrar).
· F. An auditor from a customer: This auditor is not employed by the organization being audited, and therefore does not qualify as a first-party auditor. This auditor may be hired to conduct a second-party audit, as a customer is an interested party that has specific requirements for the organization being audited.
The other options are not correct, as they could participate in a first-party audit, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited:
· B. An auditor from an interested party: This auditor could be a first-party auditor, as long as the interested party is within the organization being audited. For example, an auditor from the finance department could audit the production department, as long as they are not involved in the production process or affected by its outcomes.
· C. An auditor trained in-house: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. The source of the auditor's training is not relevant for determining the type of audit, as long as the auditor is competent and qualified to perform the audit. · D. An auditor trained in the IRCA scheme: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. The IRCA scheme is a professional certification scheme for auditors of management systems, which provides recognition of the auditor's competence and credibility3. However, being trained in the IRCA scheme does not determine the type of audit, as long as the auditor is competent and qualified to perform the audit.
· E. An auditor certified by IRCA: This auditor could be a first-party auditor, as long as they are employed by the organization being audited and have no vested interest in the audit results of the area being audited. Being certified by IRCA means that the auditor has met the requirements of the IRCA scheme and has demonstrated their competence and credibility as an auditor of management systems3. However, being certified by IRCA does not determine the type of audit, as long as the auditor is competent and qualified to perform the audit.

Reference:

First Party Audits: The 5 Steps to Success - Sync Resource Inc, ISO 9001 Auditing Practices

Group, IRCA - International Register of Certificated Auditors

Reveal Solution Next Question

QUESTION: 28

Which two of the following are the key expected results of a quality management system that conforms to the requirements of ISO 9001:2015?

Consistently provide products that meet customers' requirements
Decreased number of management system nonconformities
Decreased number of warranty claims
Decreased number of nonconforming products in all stages of the manufacturing cycle
Enhanced customer satisfaction
Increased profits

Answer(s): A,E

Explanation:

The key expected results of a quality management system that conforms to the requirements of ISO 9001:2015 are stated in clause 0.1 of the standard, which says: "The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. The potential benefits to an organization of implementing a quality management system based on this International Standard are: a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; b) facilitating opportunities to enhance customer satisfaction; c) addressing risks and opportunities associated with its context and objectives; d) the ability to demonstrate conformity to specified quality management system requirements." Therefore, the two options that best match these benefits are A and E, as they directly relate to providing products and services that meet customer requirements and enhancing customer satisfaction. The other options are not explicitly mentioned as key expected results, although they may be possible outcomes of implementing a quality management system.

Reference:

ISO 9001:2015 - Quality management systems -- Requirements, Key Elements of an ISO 9001:2015

Quality Management System, What is ISO 9001 2015 as a Quality Management Systems?

Reveal Solution Next Question

Free ISO-9001-Lead-Auditor Exam Braindumps (page: 7)

QUESTION: 25

Explanation:

Reference:

QUESTION: 26

Explanation:

Reference:

QUESTION: 27

Explanation:

Reference:

QUESTION: 28

Explanation:

Reference: