QMS Standard - 9.2 Internal Audit Assessment

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Questions and Answers

What is the maximum period between audits as specified in EN ISO/IEC 80079-34 for Explosive Atmospheres?

18 months

14 months (correct)

16 months

12 months

What is the purpose of performing a re-audit of a noncompliant area?

To evaluate the effectiveness of the quality management system

To investigate adverse audit findings and schedule corrective action

To verify the implementation of corrective actions (correct)

To ensure management of the audited organization investigates and takes follow-up action

What is the primary purpose of a comprehensive system of planned and periodic audits?

To evaluate the effectiveness of the audit team

To verify compliance with all aspects of the quality assurance program (correct)

To provide training to audit personnel

To identify areas for improvement in the quality management system

What is a critical component of an audit plan?

Determining the audit scope and requirements Signup and view all the answers

What is a key requirement for audit team members?

They must have experience and training commensurate with the scope and complexity of the audit Signup and view all the answers

What is the purpose of procedures and checklists in an audit?

To adequately cover the program elements being assessed Signup and view all the answers

What should be included in an audit report?

A statement of effectiveness, including the audit scope, auditors, persons contacted, and results Signup and view all the answers

What should be done with conditions requiring prompt corrective action?

They should be reported immediately to management of the audited organization Signup and view all the answers

What is the role of the Lead Auditor in an audit?

To organize and direct the audit Signup and view all the answers

What is the primary consideration for determining the frequency of internal audits in an organization?

The importance of the processes concerned Signup and view all the answers

What is the primary responsibility of auditors in an internal audit?

To ensure the impartiality of the audit process Signup and view all the answers

What should be reported to relevant management after an internal audit?

The results of the audit, including opportunities for improvement Signup and view all the answers

What is the purpose of retaining documented information as evidence of the implementation of the audit programme and the audit results?

To provide evidence of compliance to QMS standards and requirements Signup and view all the answers

What is the primary goal of taking corrective action after an internal audit?

To prevent recurrence of the nonconformity Signup and view all the answers

What should be considered when planning and establishing an audit programme?

The importance of the processes concerned, customer feedback, and the results of previous audits Signup and view all the answers

Study Notes

Internal Audit

Internal audits are conducted at planned intervals to provide information on whether the quality management system conforms to the organization's own requirements and the requirements of ISO 9001.
The audits also determine whether the quality management system is effectively implemented and maintained.

Audit Program

The organization plans, establishes, implements, and maintains an audit program, including the frequency, methods, responsibilities, planning requirements, and reporting.
The audit program takes into consideration the importance of the processes concerned, customer feedback, changes affecting the organization, and the results of previous audits.

Audit Criteria and Scope

The organization defines the audit criteria and scope for each audit.
The audit scope includes the evaluation of performance indicators to determine whether the quality management system is effectively implemented and maintained.

Auditor Selection and Conduct

The organization selects auditors and conducts audits to ensure objectivity and the impartiality of the audit process.
Auditors have experience and training commensurate with the scope, complexity, and nature of the audit, and have no direct responsibility in the areas being audited.
Auditors have sufficient authority and organizational freedom to make the audit process meaningful and effective.

Reporting and Corrective Actions

The organization ensures that the results of the audits are reported to relevant management.
The organization takes appropriate correction and corrective actions without undue delay.
Audit results are documented and reviewed by management having responsibility in the area audited.

Audit Records and Follow-up

The organization retains documented information as evidence of the implementation of the audit program and the audit results.
Follow-up action, including re-audit of deficient areas, is taken where indicated.
Measures exist to ensure management of the audited organization or activity investigates adverse audit findings, schedules corrective action, and notifies the appropriate organization in writing of action taken or planned.

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Description

This quiz assesses knowledge of internal audits, quality management systems, and performance evaluation according to ISO 9001 standard Section 9.2. It covers the planning, implementation, and maintenance of audit programs and their role in evaluating quality management systems.