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

According to clause 8.3 of ISO 9001:2015, the organization should establish, implement, and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services. The design and development process should include the following activities:

•Determining the requirements for the products and services to be designed and developed, considering the intended use, the statutory and regulatory requirements, the customer and other relevant interested parties’ needs and expectations, and the potential risks and opportunities.

•Defining the design and development objectives, stages, responsibilities, and authorities, and ensuring the availability of adequate resources and competence.

•Implementing design and development controls, such as reviews, verification, and validation, to ensure that the design and development outputs meet the design and development inputs, and to identify and resolve any problems or errors.

•Maintaining documented information on the design and development inputs, outputs, reviews, verification, validation, and changes, and ensuring the traceability and conformity of the products and services to the requirements.

•Managing the design and development changes, by identifying, reviewing, and controlling them, and evaluating their effects on the products and services and the QMS.

In this case, the evidence statements that provide a meaningful audit trail for the design and development process are B, E, and F, because they relate to the design and development controls, the documented information, and the verification activities that are required by the standard. These options can help the auditor to assess the effectiveness and conformity of the design and development process, and to identify any nonconformities or opportunities for improvement. The other options are not directly related to clause 8.3, although they may be relevant for other aspects of the QMS, such as clause 7.2 on competence, clause 7.3 on awareness, clause 7.4 on communication, clause 8.2 on requirements for products and services, clause 8.4 on externally provided processes, products, and services, and clause 8.7 on control of nonconforming outputs. References: ISO 9001:2015, ISO 9001 Auditing Practices Group Guidance on Design and Development, ISO 9001 Clause 8.3 Design and development of products and services

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 requires organizations to assess both internal and external issues that could impact the effectiveness of their Quality Management System (QMS).

Clause Reference:

Clause 4.1 – Understanding the Organization and Its Context states that organizations must determine external and internal issues that affect their ability to achieve intended results.

Internal issues include:

Knowledge within the organization (documented or undocumented)

Organizational culture

Resource availability

Technological advancements

Infrastructure and capabilities

Why is the Correct Answer C?

Knowledge (Clause 7.1.6) is a critical internal factor that directly affects the implementation and maintenance of a QMS.

Organizations must identify, maintain, and make available the necessary knowledge to achieve quality objectives and meet customer requirements.

Why are the Other Options Incorrect?

A (Social and economic environments) → These are considered external issues rather than internal.

B (Competitive environment) → Competition is external, not an internal issue affecting the QMS.

D (Expectations of suppliers) → Supplier expectations relate to external interested parties, covered under Clause 4.2 (Understanding the Needs and Expectations of Interested Parties).

ISO 9001 audits (including second-party audits) must be conducted in line with audit principles of fairness, objectivity, and impartiality, with guidance provided by ISO 19011:2018 for audit activities, including closing meetings.

Relevant ISO guidance

ISO 19011 – Closing meeting guidance states that the purpose of the closing meeting is to:

present audit findings and conclusions,

ensure the auditee understands the non-conformities,

explain the next steps, including reporting and follow-up.

Auditors must not:

prescribe solutions,

analyse or design corrective actions,

make commercial or approval decisions on behalf of the audited organisation.

Explanation of the correct option:

C. Present the non-conformities and inform them that the report will be sent within ten working days, close the meeting and leave the site.

This option correctly reflects the auditor’s role:

The non-conformities are presented clearly and transparently in the closing meeting.

The auditee is informed of the reporting process and timeline.

The auditor does not analyse solutions, recommend actions, or influence supplier approval decisions.

The meeting is closed professionally and objectively, in line with ISO 19011.

Explanation of why the other options are incorrect:

A: Closing meetings must be conducted with the agreed auditee representatives; hiding findings undermines transparency and audit integrity.

B: Analysing how to overcome the situation constitutes consulting, which compromises auditor impartiality.

D: Recommending removal from an approved supplier list exceeds the auditor’s authority and violates audit independence.

ISO-aligned conclusion:

The auditor’s responsibility at the closing meeting is limited to presenting findings and explaining next steps, not advising, consulting, or making business decisions. Therefore, the correct and ISO-compliant option is C.