Helping Hand Questions for ISO-9001-Lead-Auditor

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 focus

Leadership

Engagement of people

Process approach

Improvement

Evidence-based decision making

Relationship management

Therefore, risk-based approach is not a quality management principle under ISO 9001:2015.

B. Applicable procedure: SP-701

D. Identification number of the washing machine

H. The concentration of the cleaning liquid used vs the concentration fixed in SP-701

I. The planned duration of the process vs the minimum time required in SP-701

J. Weight of linen being washed vs the maximum weight required in SP-701

C. Competence record of the machine operator

According to the guidance on conducting the audit closing meeting1, the audit team leader should provide a summary of the audit findings and conclusions, invite discussions, and agree on timelines for any corrective actions. The audit team leader should also be respectful, constructive, and objective when presenting the nonconformities, and avoid any personal or emotional comments. The audit team leader should also consider the impact of the disruptive event (such as the Covid-19 pandemic) on the auditee’s context, interested parties, and risks2, and acknowledge any good practices or improvements observed during the audit. Therefore, option D is the best option, as it follows the best practices for the closing meeting and allows the auditee to understand the nonconformities and their implications, and to participate in the analysis and resolution of the issues. Option A is not correct, as it is not respectful, constructive, or objective, and it does not invite any discussion or feedback from the auditee. It also assumes that the audit team leader has the authority to recommend the removal of the supplier from the approved list, which may not be the case. Option B is not correct, as it does not provide enough information or explanation to the auditee, and it does not allow any discussion or feedback from the auditee. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, acknowledging any good practices, and agreeing on timelines for corrective actions. Option C is not correct, as it does not involve the other managers who are responsible for the functions or processes that were audited, and who may have valuable input or information to share. It also does not follow the best practices for the closing meeting, such as providing a summary of the audit, inviting discussions, and agreeing on timelines for corrective actions. References: 1: Conducting the Audit Closing Meeting: Sharing the Results2: Auditing ISO 9001:2015 in the Context of a Disruptive Event.