PECB ISO-9001-Lead-Auditor Exam With Confidence Using Practice Dumps

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

Comprehensive and Detailed In-Depth Explanation:

Stage 1 Audit (ISO 9001:2015, Clause 9.2.2) is a documentation review to assess the readiness for a Stage 2 Audit. The auditor must document:

Observations that could lead to nonconformities, ensuring they are addressed before Stage 2.

Areas needing improvement, such as missing documented information or unclear process definitions.

While understanding the auditee’s main processes is important, documenting interviews is not a requirement at Stage 1.

 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.