what Is QMS Internal Audit?
QMS stands for Quality Management System. ISO 9000:2015 (Quality Management System – Fundamentals and Vocabulary) defines an internal audit as a systematic, independent, and documented process that obtains audit evidence and objectively evaluates it to determine the extent to which the audit criteria fulfillment occurs. The primary objectives of conducting in QMS internal audit is to ensure compliance with regulations, continuous improvement, risk mitigation, and maintaining or enhancing the quality of products or services delivered by the organization. Additionally, QMS internal audit provides valuable insights for enhancing overall organizational performance.
purpose Of QMS Internal Audit:
The QMS (Quality Management System) international standard’s demand to conduct internal audits at planned intervals (most commonly followed 1 year internal) to conforms
- Organization’s requirements for QMS (Quality Management System);
- Requirements of the QMS (Quality Management System) International Standard like ISO/IEC 17025, ISO/IEC 17020, ISO 9001 etc.
- QMS (Quality Management System) is effectively implemented and maintained.
Organization is able to select its own internal audit lead and team members so commonly organization’s qualified staffs conduct internal audit. An effective internal audit can
- Provide opportunity for employees to receive training and develop their skills
- Identify the improvement areas
- Identify potential risks and opportunities for risk mitigation
- Provide information to support management reviews of the QMS
Internal audit is one of the tools for continual improvement. Conducting a successful QMS audit involves several key steps. Here are some general guidelines that can be followed.
scope and objectives of QMS Internal Audit:
The auditors need to have a clear understanding of the objectives and the scope of the audit. A clearly defining scope and the objectives will help on focusing our efforts and ensure that we can cover all relevant areas of the QMS. Once the audit task will be allocated; the auditor must take information as necessary by gathering documentation and studying as appropriate and even by preliminary discussion with the appropriate auditee to develop an understanding of the audit target area.
Develop an audit program: Develop a detailed audit plan that includes
Make an audit team: At the time of making audit team, we should consider the required competency of the auditors by focusing on audit scope and objective. This will help to build a perfect competent audit team. Without a good audit team, objectives of the audit might be fail.
- Make audit detailed schedule: Make audit schedule based on the audit scope, area (related department), and assign auditors as per their expertise on different field. After making, the schedule circulate the audit schedule to auditee management.
- Develop Checklist: There should be detailed checklist as per the required standard. (If we want to conduct audit as per ISO/IEC 17025: 2017 then each clause of this standard must have to address on checklist, separate checklist for each testing standard might be developed).
- Detailed plan of action: The auditor must have plan how to obtain information and evidence by question. Such as where to start the audit, who to talk first, where to go next, who to talk to next, How / Where to observe the process, how / where to test the system etc. Thus a plan of action can be developed.
Conduct the QMS Internal Audit:
Conduct the audit according to the audit schedule. There are two types of audit
Vertical Audit
Conducting a vertical audit involves assessing compliance with relevant clauses through the random selection of test reports, certificates, reported test results, or calibration results.
Horizontal Audit
Horizontal audit is conducted by assessing compliance to relevant clauses across the standard or activities within the declared scope of audit.
Generally, auditors utilize both types of audits in the auditing process. Additionally, they conduct test witnessing alongside the two aforementioned audit types, specifically for technical audits. Auditor should assess the technical competency of the auditees as well the as the applicable calluses of the standard during test witnessing.
Auditors should collect objective evidence by documenting the findings, ask open-ended questions and avoid leading questions that could bias the results. It’s also necessary to verify that the process adheres not only to the specifications or relevant procedures but also to the general requirements for process management and improvement outlined in the internal standard. Auditor’s task is to verify that the defined system elements exist, implemented and effective.
paperwork that may be examined by an auditor
- Quality Procedure / Work instruction
- Quality plans
- Project Plans
- Test Data
- Specifications
- Drawing
- Contracts/ Orders
- Meeting Minutes of Management Review
- Failure Reports
- Vendor performance data
- Verification Results
- Design Review Meeting minutes
- Equipment Calibration
- Equipment Traceability
- Equipment Maintenance
- Training Details
- Previous Audit Findings etc.
Analyze the findings:
After completion of internal audit, auditors will group the findings, opportunities for improvement into categories such as process-related issues, documentation-related issues, human resource-related issues, etc. This will help to identify the areas of improvement and prioritize them based on their impact on the organization’s quality performance. During writing the audit report, evaluate the severity and frequency of each non-conformance and prioritize them based on their impact on the QMS. Auditor should issue Internal Audit report to top management so that management can focus on the area for improvement.
Take corrective actions plan:
Do proper root cause analysis for each findings and take corrective action accordingly. The involvement of the relevant stakeholders in the corrective action process and track progress towards resolution is very important so assign responsibility for implementing the corrective action consequently. Set timelines for implementing the corrective action and ensure that they are realistic and achievable. Monitor the progress of implementing the corrective action and report on it periodically which will help to track the effectiveness of the corrective action and make adjustments if necessary. This may involve conducting a follow-up audit or reviewing documentation.
Overall, internal audit is an important tool for ensuring that a Quality Management System is effective, efficient, and continually improving. By identifying risk, opportunities for improvement and verifying compliance with standards and regulations. Internal audits also help organizations meet customer requirements, reduce risk, and improve operation performance.
