QUESTION: 37

Select which one of the following statements is true.

The team leader shall be an auditor that is qualified in the scheme.
An audit team can include non-qualified auditors.
A technical expert can replace a qualified auditor on an audit team.
Audits leading to auditor qualification are undertaken annually.

Answer(s): A

Explanation:

According to the ISO 19011:2018 standard, which provides guidelines for auditing management systems, the team leader of an audit team should be an auditor who has demonstrated the competence to manage an audit of the relevant management system scheme. This means that the team leader should have the appropriate knowledge, skills, and experience to plan, conduct, report, and follow-up an audit of the specific management system, such as ISO 9001 for quality management systems. The other options are false because: B. An audit team can include non-qualified auditors, but only as observers or trainees who do not contribute to the audit findings or conclusions. C. A technical expert can assist a qualified auditor on an audit team, but cannot replace them, as a technical expert does not have the competence to perform audits. D. Audits leading to auditor qualification are not undertaken annually, but rather as part of a certification process that involves meeting certain criteria, such as education, work experience, audit experience, and examination.

Reference:

ISO 19011:2018, PECB Certified ISO 9001 Lead Auditor Exam Preparation Guide, ISO 9001:2015 Quality Management Systems Lead Auditor Training Course

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QUESTION: 38

Select one option that must be considered when determining the scope of a QMS to ISO 9001.

Business improvement
Performance of business processes
External issues of the organisation's context
Competence of top management

Answer(s): C

Explanation:

According to ISO 9001:2015, clause 4.3, the organization is required to determine the scope of its quality management system (QMS) by considering the external and internal issues referred to in clause 4.1. Clause 4.1 requires the organization to determine the external and internal issues that are relevant to its purpose and strategic direction, and that affect its ability to achieve the intended results of its QMS. These issues can include positive and negative factors or conditions for consideration, such as legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local. The organization is also required to monitor and review these issues.
Therefore, the correct answer is C, as external issues of the organization's context are one of the factors that must be considered when determining the scope of the QMS. The other options are either not directly related to the scope of the QMS, or are not explicitly mentioned in clause 4.3.

Reference:

ISO 9001:2015(en), Quality management systems -- Requirements, clause 4.1 and 4.3 ISO 9001:2015 How to determine the scope of your QMS - Advisera, section "Considerations for determining the scope of the QMS in ISO 9001"
ISO 9001 Lead Auditor Training Course | IRCA Certified | BSI, section "Learning objectives"

ISO 9001 Lead Auditor Course Material | 3FOLD Education Centre, module 4

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QUESTION: 39

DRAG DROP (Drag and Drop is not supported)
The following list gives examples of records that may be evidence of how an organisation has fulfilled the requirements of clause 8.4 of ISO 9001. Match the records to the appropriate requirement of clause 8.4.

See Explanation section for answer.

Answer(s): A

Explanation:

The following table shows the possible matching of the records to the requirements of clause 8.4:
Table
Requirements Records

Define product requirements Product specification

Criteria for selection List of requirements to be met by the external provider

Evaluation of potential external provider External provider questionnaire

External provider selection Approved external provider list

Communicate requirements Purchase order

Monitoring of performance External provider delivery times and quality issues Comprehensive and Detailed = According to clause 8.4 of ISO 9001:2015, the organization should ensure that externally provided processes, products, and services conform to the specified requirements. To do so, the organization should:
Define the product requirements that are relevant for the external provision, such as specifications, drawings, standards, codes, etc. These should be documented and communicated to the external provider. A record of the product specification can be used as evidence of this requirement. Establish the criteria for the selection, evaluation, and re-evaluation of external providers, based on their ability to provide processes, products, and services in accordance with the requirements. The criteria should be documented and applied consistently. A record of the list of requirements to be met by the external provider can be used as evidence of this requirement. Evaluate the potential external providers before selecting them, using the established criteri a. The evaluation methods may include questionnaires, audits, references, samples, etc. The results of the evaluation should be documented and reviewed. A record of the external provider questionnaire can be used as evidence of this requirement.
Select the external providers that have demonstrated their competence and conformity to the requirements. The selection should be based on the evaluation results and the organization's needs. The selection should be documented and approved. A record of the approved external provider list can be used as evidence of this requirement.
Communicate the requirements for the processes, products, and services to be provided by the external provider, including the verification and validation activities, the acceptance criteria, the documentation requirements, the changes control, etc. The communication methods may include purchase orders, contracts, agreements, etc. The communication should be clear, complete, and timely. A record of the purchase order can be used as evidence of this requirement. Monitor the performance and conformity of the external provider, using the established criteria and methods. The monitoring methods may include inspections, tests, audits, feedback, complaints, etc. The monitoring results should be documented and analyzed. A record of the external provider delivery times and quality issues can be used as evidence of this requirement.

Reference:

ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Scope], Mastering the Scope of ISO 9001 Quality Management Systems

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QUESTION: 40

An audit team leader arrives at a printing organisation to carry out a Stage 2 audit for a certification body. At a meeting with the Quality Manager, she is told that they have won their biggest contract from a computer manufacturer to print and compile computer documentation packages. They have leased the unit next door for space reasons but have never worked in this sector before. The Quality Manager wants the ISO 9001 certificate to cover the new contract.

During the audit, a team member finds that a number of print jobs have been rejected by several clients over a number of months due to spelling errors in the print run. The Print Manager blames the new employees they had to take on because of a big contract. The auditor raises a nonconformance against clause 10.2.1.b of ISO 9001.

Which one of the evidence statements would support this finding?

There was no record that the organisation evaluated the effectiveness of the training given to new employees.
There was no evidence that a check of spelling took place before the release of printing to the client.
The actions taken to deal with customer complaints did not prevent recurrence of the problem.
The organisation did not provide the correct resources to prevent nonconformity.

Answer(s): C

Explanation:

According to clause 10.2.1.b of ISO 9001:2015, the organization should evaluate the need for action to eliminate the causes of nonconformities, in order to prevent their recurrence. This means that the organization should identify and address the root causes and contributing factors of the nonconformities, and implement appropriate corrective actions that are effective and proportional to the impact of the nonconformities. In this case, the evidence statement that supports the finding of nonconformance is C, because it shows that the organization did not take effective actions to prevent the recurrence of the spelling errors in the print run, which resulted in repeated customer rejections and dissatisfaction. The other options are not directly related to clause 10.2.1.b, although they may indicate other nonconformities or weaknesses in the organization's QMS. For example, option A may relate to clause 7.2 on competence, option B may relate to clause 8.6 on release of products and services, and option D may relate to clause 7.1 on resources.

Reference:

ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Nonconformity and Corrective Action], ISO 9001 Clause 10. Improvement - ISO-templates.com

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