Explanation:
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 References:
* 1: ISO 19011:2018 - Guidelines for auditing management systems

Explanation:

According to the ISO - Management system standards page, the key benefits of an effective management system include improved operational effectiveness and efficiency, improved risk management and protection of people and the environment, and enhanced drive for innovation. The Integrated Use of Management System Standards (IUMSS) handbook also states that the purpose and objectives of management system standards are to help organizations improve their performance by specifying repeatable steps that organizations consciously implement to achieve their goals and objectives.
Therefore, the complete sentence is:
"The purpose of a management system standard is to improve the performance of an organisation."

Explanation:

The table below shows the possible matching of the ISO 9001 Clause 8.3 extract to the audit evidence.
Table
Audit evidence
ISO 9001 Clause 8.3 extract
Half of all new products launched in the past 12 months were late. The NPD Manager explains he has not got enough people on his team to cope with the demand for new products.
"8.3.2 e) ... internal ... resource needs for the design and development of products ..." The NPD Manager explains many changes are made to cosmetic formulations during product development owing to retailer feedback. Only when confirmed by the retailer is the agreed formulation documented on SWIFT.
"8.3.5 ... retain documented information ..."
The NPD Manager explains that the customer confirms their approval to proceed with a new formulation by email. These emails are kept on SWIFT.
"8.3.6 ... retain documented information ..."
The NPD Manager shows you evidence of consumer trials that are carried out for some new products prior to full-scale launch.
"8.3.4 d) ... conducted to ensure that the resulting products and services meet the requirements ..." The NPD Manager explains that an approved external laboratory is used to perform shelf-life stability trials on some formulations during product development.
"8.3.2 e) ... external ... resource needs for the design and development of products ..."

Clause Reference - ISO 9001:2015 Clause 8.6 (Release of Products and Services):ISO 9001 requires that products and services are not released to the customer until:
* All planned verification activities have been completed.
* Acceptance criteria have been met.
* Any necessary approvals have been obtained.
In this scenario:
* The sacrificial anodes for Project DK were shipped before the galvanic efficiency test results were analyzed.
* This constitutes a nonconformity against Clause 8.6 because the products were released without completing the required tests.
Option Analysis:
* A. A retrospective concession was not sought from the customer once the test results had been approved by the Quality Manager:Incorrect. While obtaining a concession might mitigate the situation, the nonconformity pertains to the process failure of releasing the products without completing required tests, not the absence of a concession.
* B. Release of the product without acceptable test results has been accepted by the customer for Project DK:Incorrect. The customer was not informed before the release, and there is no indication that this was accepted beforehand. Furthermore, ISO 9001 requires planned processes to be followed, regardless of later acceptance.
* C. Products for Project DK have been released before product approval through the quality control process:Correct. This description accurately reflects the nonconformity. The quality control process required test results to be analyzed and verified before release, which did not happen.
* D. The untested product was not recalled until the galvanic efficiency of the anodes was verified:
Incorrect. The issue is not about recalling the product but about releasing it without completing the required tests. Recalling the product is not mentioned in the scenario.
Why C is Correct:
* The nonconformity is a clear breach of Clause 8.6, where the products were released without meeting the planned verification requirements.
* This demonstrates a failure in adhering to quality control processes, which is a critical aspect of ISO
9001 compliance.
Key ISO 9001 Reference:
* Clause 8.6: Products and services shall not be released to the customer until all planned activities (e.g., testing) have been satisfactorily completed, or the customer has approved the release with knowledge of deviations.

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 Explanation: = 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 criteria. 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.
References: ISO 9001:2015, [ISO 9001 Auditing Practices Group Guidance on Scope], Mastering the Scope of ISO 9001 Quality Management Systems