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

Nonconformity report

ISO 9001 Clause Number: 9.3.1 Nature of problem: Management review has not been conducted at the defined frequency. ISO 9001 requirement that has not been fulfilled: ISO 9001 - “Top management shall review the organization’s quality management system at planned intervals.” Evidence: The last management review took place nine months ago, and the previous one took place one year before the latest review. The planned interval is six months.

According to ISO 19011:2018, clause 6.3.2, an audit plan should include the following information:

The audit objectives, scope, and criteria

The audit team members and their roles and responsibilities

The audit schedule, including the sequence and timings of audit activities, such as opening meeting, document review, interviews, observations, closing meeting, etc.

The expected time and duration of each audit activity and location

The name and contact details of the auditee’s representative and other relevant parties

The allocation of appropriate resources to support the audit activities

The audit methods and techniques to be used, such as interviews, observations, sampling, etc.

The audit documents and records to be prepared and retained

The audit language and communication methods

The audit risks and opportunities and how to address them

The audit follow-up arrangements, if applicable

Therefore, the correct answer is D and F, as they are essential elements of an audit plan. The other options are either irrelevant or optional for an audit plan. References:

ISO 19011:2018(en), Guidelines for auditing management systems, clause 6.3.2

ISO 19011: Guidelines for Auditing Management Systems | ASQ, section “Making audit arrangements”

ISO 19011 Management Systems Audit Checklist | Process Street, task 6.3.2

Comprehensive and Detailed In-Depth Explanation:

ISO 9001:2015 recognizes change management as essential for maintaining process integrity and preventing nonconformities.

Clause References:

Clause 6.3 (Planning of Changes) → Focuses on long-term changes that may impact QMS integrity.

Clause 8.5.6 (Control of Changes) → Focuses on changes occurring during production and service provision to ensure conformity.

Why is the Correct Answer A?

Clause 8.5.6 applies specifically to operational changes, ensuring that modifications in production or service processes do not compromise quality.

Organizations must document who approves changes, how they are controlled, and how they affect product/service conformity.

Why are the Other Options Incorrect?

B (Changes during design and development) → Covered under Clause 8.3 (Design and Development), not 8.5.6.

C (Changes to legal and regulatory requirements) → Addressed under Clause 4.2 (Interested Parties' Requirements).

D (Leadership responsibilities) → Covered under Clause 5.1 (Leadership and Commitment), not 8.5.6.