'XYZ' has already sent to you a list with all documented procedures and work instructions related to the services provided to 'ABC' (a quality manual is not included in the list).
To complete the audit planning which additional information would you ask to XYZ to submit? Select four.
Answer : A, C, D, E
The ISO 9001 Lead Auditor exam requires the auditor to have a thorough understanding of the ISO 9001:2015 standard and its requirements, as well as the organization's context, processes, risks, opportunities, and performance. Therefore, the auditor needs to ask for additional information that can help them verify these aspects during the audit planning stage. Some of the information that can be useful are:
A description of responsibilities and authorities of the key roles of XYZ: This can help the auditor to identify who is accountable for what in the organization and how they communicate with each other.
The number of personnel involved in activities related to the quality management system: This can help the auditor to assess if there are enough resources and competencies to support the QMS implementation and operation.
Information to understand XYZ's operations: This can help the auditor to understand how XYZ produces or delivers its products or services and what are its main processes and inputs.
The results of XYZ's last internal audit: This can help the auditor to evaluate if XYZ has implemented corrective actions based on previous audit findings and if it has maintained its QMS effectiveness.
The results of the last two management reviews: This can help the auditor to determine if XYZ has monitored its QMS performance against its objectives and if it has identified any significant changes or opportunities for improvement.
The quality manual (B) is not a required document for ISO 9001 certification, but it may be useful for internal reference or training purposes. It is not necessary for audit planning.
Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:2015 are true?
During the Stage 1 audit, the audit team:
Answer : B, E
The Stage 1 audit is a readiness review that verifies the organization's ability to conduct the Stage 2 audit. It involves reviewing the documented information, evaluating the site-specific conditions, and having discussions with personnel. The auditor does not verify the degrees of customer satisfaction, the compliance with legal requirements, or the results of the last management review during the Stage 1 audit. These are done during the Stage 2 audit or later in the certification process.Reference:
In the context of a third-party certification audit, it is very important to have effective communication. Which is not the responsibility of the audit team leader?
Knowledge and skills are requirements of the auditor's competence. Select two from the following topics of knowledge that apply to every member of an audit team auditing an ISO 9001 quality management system.
Answer : A, B
According to ISO 9001:2015, clause 7.2, an auditor shall have the competence to:
Understand the requirements of ISO 9001 and how they relate to the audit
Understand the organization's quality management system and its processes
Understand the applicable legal, regulatory, contractual and other requirements that affect the audit
Understand the needs and expectations of interested parties other than customers
Plan and conduct audits in accordance with ISO 19011
Evaluate audit evidence and draw appropriate conclusions
Therefore, knowledge of ISO 9001 requirements and ISO 19011 audit principles are essential for every member of an audit team auditing an ISO 9001 quality management system.
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