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

ISO 9001:2015 requires audits to be planned and conducted to ensure the quality management system conforms to requirements and is effectively implemented. While ISO 9001 sets the requirement, it explicitly refers auditors to ISO 19011 for detailed guidance on audit planning and execution.

ISO 9001:2015, Clause 9.2.2 (NOTE) states that guidance for auditing management systems is provided in ISO 19011 .

Based on ISO 19011:2018 (Clause 6.3 – Initiating and preparing for the audit), the audit team leader is responsible for finalising key planning issues before documenting the audit plan, especially for multi-site and multi-country audits.

Explanation of the selected options:

A. Arrangement of translation of the audit report

ISO 19011 requires consideration of communication and language arrangements during audit preparation. Where sites are located in different countries, potential language difficulties must be addressed during planning, including translation needs for reports and communications.

C. Structuring the audit plan to account for audit trails

ISO 19011 requires audits to follow audit trails across processes, functions, and interfaces. The audit plan must be structured to allow logical progression through interrelated processes, which must be decided before the plan is documented.

D. Determining available IT infrastructure for remote participation

ISO 19011 allows the use of remote auditing techniques. When audit team members are located in different countries, the audit team leader must confirm the availability of IT infrastructure to support remote participation in opening and closing meetings as part of audit planning.

E. Considering processes not operating at the time of the audit

ISO 19011 requires the audit team leader to consider process availability. If some processes are not operating during the audit period, alternative audit methods (such as records review or rescheduling) must be planned in advance and reflected in the audit plan.

Explanation of why the other options are not selected:

B: ISO 19011 requires identification of roles and functions to be audited, not specific names, at the audit planning stage.

F: Moderation or grading of nonconformities is performed after audit findings are raised, not during audit planning.

G: Post-audit communication arrangements are addressed during reporting and follow-up activities, not before documenting the audit plan.

H: Follow-up audits are planned only if required after audit results are known, not during initial audit planning.

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 …”

B. Control of externally provided processes, products, and services: This is relevant because the organization has outsourced the manufacture of its own brand products to a supplier. According to ISO 9001, the organization must ensure that externally provided processes remain within the control of its quality management system.

C. Design and development of products and services: Even though the organization no longer manufactures in-house, it still needs to control the design and development of its products, especially since they are now being produced by an external provider.

F. Organisation roles and responsibilities: The change in strategy has led to a significant reduction in staff, which would have an impact on the roles and responsibilities within the organization. It is important to audit how these changes have been managed and communicated within the organization to ensure continued effectiveness of the quality management system.

These audit trails are aligned with the requirements of ISO 9001:2015, which emphasizes the importance of controlling externally provided processes and products, managing design and development, and clearly defining roles and responsibilities within the quality management system.