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

 Clause: 8.5.4

 Nature of Problem: Cleaning and sanitising records are not available for every batch.

 Unfulfilled Requirement: "The organization shall implement production provision under controlled conditions."

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 ISO 9001:2015, clause 9.2.2.e, the organization is required to retain documented information as evidence of the implementation of the audit programme and the audit results. This includes the records of the nonconformities identified during the internal audits and the corrective actions taken to address them. The organization is also required to verify the effectiveness of the corrective actions, as per clause 10.2.2.

Therefore, in the scenario given, the Quality Manager’s decision to automatically close any nonconformance over 3 years old without obtaining any confirmation from the relevant departments or verifying the effectiveness of the corrective actions is a clear violation of the requirements of clause 9.2.2.e. This indicates a lack of control and follow-up of the internal audit process, as well as a potential risk of recurrence or occurrence of the nonconformities in other areas. This also undermines the credibility and value of the internal audit programme, as well as the risk-based approach claimed by the Quality Manager.

Hence, the best course of action to take is D, to raise a nonconformance report against clause 9.2.2.e of ISO 9001, and to communicate the audit findings to the relevant management. The other options are either insufficient or irrelevant to address the issue, as they do not directly relate to the noncompliance with clause 9.2.2.e.