Which one of the following is not an ISO 9000:2015 quality management principle?
Answer(s): D
According to the ISO 9000:2015 quality management principles document1, risk-based approach is not one of the seven quality management principles that ISO 9000, ISO 9001 and other related quality management standards are based on. The seven quality management principles are:Customer focusLeadershipEngagement of peopleProcess approachImprovementEvidence-based decision makingRelationship managementTherefore, risk-based approach is not a quality management principle under ISO 9001:2015.
ISO - Quality management principles
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(s): 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 19011Evaluate audit evidence and draw appropriate conclusions Communicate audit findings effectively1Therefore, 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.
ISO 9001:2015 - Quality management systems -- Requirements ISO 19011:2018 - Guidelines for auditing management systems
DRAG DROPAn organisation wants to certify their ISO 9001:2015-based QMS for the first time. Arrange the activities in the correct sequence from 2 to 5.To complete the sequence, click on the blank section you want to complete so it is highlighted in red and then click on the applicable text from the options below. Alternatively, drag and drop the options to the appropriate blank section.
Answer(s): A
To certify an organization's ISO 9001:2015-based Quality Management System (QMS) for the first time, the correct sequence of activities would be:Establish the management system (already in place).Supplier auditInternal auditManagement reviewInitial certification audit stage 1Initial certification audit stage 2 (already in place). This sequence follows the typical path for preparing and ensuring that a QMS is functioning as required, leading up to certification.
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?
Responsibilities of the Audit Team Leader:ISO 19011:2018 (guidelines for auditing management systems), which supports the principles in ISO 9001:2015, specifies the responsibilities of an audit team leader. These responsibilities include:Planning the audit and establishing effective communication between the audit team and auditee. Ensuring that formal communication channels are agreed upon and followed. Reporting the audit progress, significant findings, and any concerns to the auditee or audit client as necessary.Managing the audit team and ensuring adherence to the defined objectives and scope.Analysis of Options:A . Reporting unattainable audit objectives to the accreditation body:Incorrect. This is not the responsibility of the audit team leader. The accreditation body oversees the certification body and is not directly involved in specific audits. If objectives are unattainable, the audit team leader would report them to the audit client (the certification body), not the accreditation body.B . Planning formal communication arrangements:Correct. This is one of the responsibilities of the audit team leader. They ensure auditees can communicate with auditors as needed during the audit process. C . Confirming communication channels during the opening meeting:Correct. During the opening meeting, the audit team leader must establish clear communication protocols to ensure effective information exchange between the audit team and auditee.D . Communicating progress, findings, and concerns:Correct. Keeping the auditee and audit client informed about progress and significant findings is a critical responsibility of the audit team leader to maintain transparency and ensure the audit objectives are met.Why Option A is Correct:The audit team leader does not have any obligation to report unattainable objectives to the accreditation body. Instead, they are responsible for communicating issues to the audit client (typically the certification body). The accreditation body operates at a higher level and is concerned with overseeing certification bodies, not individual audits.Relevant
ISO 19011:2018, Clause 6.4 (Conducting the Audit): Emphasizes the responsibilities of the audit team leader, including communication with the auditee and client. ISO 9001:2015, Clause 9.2 (Internal Audit): Highlights the importance of planning and communication during audits, which is reflected in third-party audits as well.
Which two of the following statements related to Stage 1 of an initial certification audit against ISO 9001:2015 are true?
Answer(s): 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.
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