Based on ISO 19011, there are three types of audits: 1st party audit, 2nd party audit, and 3rd party audit. A 1st party audit refers to an internal audit, which is a key requirement in every management system standard. A 2nd party audit is conducted by an external interested party (e.g., a supplier). A 3rd party audit refers to certification and accreditation audits, and statutory or regulatory audits performed by authorized bodies.
Preparing for QMS Audits
IntellaQuest offers AuditQuest, an audit software that can be used for each type of audit mentioned above, including Quality Management System (QMS) internal and external audits.
Step 1 - Establish the Audit Program
The first step in preparing for a QMS audit involves defining the audit program. This includes determining the scope, objectives, and criteria, identifying the necessary resources, and setting a schedule.
AuditQuest allows the management of QMS internal and external audits within a single integrated platform and provides a dashboard that communicates the audit schedule across the organization, ensuring that all stakeholders are informed and aligned.
Step 2 - Plan the Audit
Developing a detailed audit plan is crucial. This plan should outline the QMS audit’s scope, objectives, timeline, and responsibilities.
AuditQuest can be customized to reflect the requirements of specific standards, including ISO 9001, ensuring that the audit setup meets the unique needs of the organization. Additionally, the compliance audit software provides timely alerts about upcoming audits sent to key stakeholders, helping maintain readiness and reducing the risk of overlooked details.
Step 3 - Select and Prepare the Audit Team
Selecting auditors with the appropriate skills and ensuring their independence is vital. Auditors should be prepared with the necessary information and resources to conduct the audit effectively.
AuditQuest features detailed auditor profiles, including their qualifications and expertise, ensuring the right auditors are chosen for the QMS audit.
Step 4 - Conduct the Audit
During the audit, it’s important to collect and verify information using appropriate techniques and to communicate effectively with the auditees.
AuditQuest provides a flexible configuration feature that enables utilizing pre-configured checklists and audit tools tailored to the organization’s requirements, ensuring a thorough and consistent audit process. The software also enables capturing findings and observations during the audit for accurate and timely reporting, ensuring that all relevant details are documented as they arise.
Step 5 - Report the Audit Findings
It is essential to clearly and concisely document the audit findings, including non-conformities and opportunities for improvement.
AuditQuest generates comprehensive audit reports with an executive summary, providing clarity and ensuring completeness of the documentation. The tracking feature of the audits software enables management of follow-up activities to address findings and track improvement actions, ensuring that issues are resolved promptly.
Step 6 - Follow Up on Audit Findings
Implementing corrective actions to address non-conformities and verifying their effectiveness is a key part of the audit process.
AuditQuest can be integrated with PRRQuest to manage corrective actions seamlessly within the system, addressing audit findings efficiently. Another useful application is CIPQuest, which integrates continuous improvement processes to enhance the QMS based on audit insights, fostering a culture of ongoing enhancement. KnowledgeQuest can be used to document and share lessons learned to prevent recurrence of issues and promote organizational learning.
Book a demo today to discover how AuditQuest can help your organization prepare for and manage QMS audits based on ISO 9001 and ISO 19011.
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