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

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.

Comprehensive and Detailed Explanation: = According to the web search results from my internal tool, a witness audit is a technique used during an accreditation audit, where the accreditation body observes the performance and competence of the certification body auditors in conducting an audit12. A witness audit can also be used by a certification body to monitor and evaluate its own auditors3. During a witness audit, the following roles can be defined:

•An auditor: This is the person who is being witnessed by the accreditation body or the certification body. The auditor is responsible for conducting the audit according to the audit plan, criteria, and standards, and for providing audit evidence and findings123.

•An assessor for the accreditation body: This is the person who witnesses the auditor on behalf of the accreditation body. The assessor is responsible for evaluating the auditor’s performance and competence, and for providing feedback and recommendations to the accreditation body123.

The other options are not defined as witnesses during a witness audit, according to the web search results from my internal tool. They are:

•Someone with a qualification from the certification body: This is not a specific role in a witness audit, as anyone who is involved in the audit process should have a qualification from the certification body. Moreover, having a qualification does not necessarily mean that the person is a witness or an auditor4.

•An existing member of the audit team: This is not a specific role in a witness audit, as the audit team consists of the auditors who are conducting the audit, not the ones who are witnessing it. The witness audit is a separate activity from the audit itself, and the witness should not interfere with the audit process or influence the audit outcome123.

Therefore, the correct answer is B and D.

In this scenario, the time allocated by the audit team leader for the Human Resources audit is fixed, and as an auditor, you must work within that constraint. Although the sampling criteria suggests reviewing 25 personnel files, it is acceptable to adjust the sample size based on time and resource limitations. ISO 9001:2015 emphasizes risk-based thinking and practical resource management (Clause 7.1), so it is reasonable to review a smaller sample if the time is insufficient.

Option B is a pragmatic approach, allowing you to focus on quality over quantity by reviewing as many cases as time allows without compromising the audit schedule.

Options like extending the audit (A, C, D) are impractical in a structured audit environment, especially for second-party audits where maintaining the agreed schedule is important​​.