The purpose of a QMS internal audit, is to determine the efficiency of the organisation’s Quality Management System (QMS), as well as its overall efficiency. Internal audits assess compliance with an organisations policies, procedures and internal systems, such as the Quality Management System (QMS). During the audit, it would be reviewed how an organisations processes are executed and maintained. The audit criteria would include ISO 9001, QMS documentation and any defined customer or relevant regulatory requirements.
Auditing is based on a set of principles, the goal of which is to make the audit an effective and efficient tool. An audit should provide objective data, on which the organisation can act to keep improving its quality. It also enables auditors to operate independently and reach similar outcomes when auditing under similar conditions. These principles are:
QMS internal audit, is the process for having an independent party observe and assess a process being carried out and identify areas of improvement. Following are the basic and most important steps for conducting an efficient and effective QMS Internal Audit.
The first and important step while planning audits, is to define the audit schedule, which provide an overview of when each procedure will be audited during an audit cycle. The Management Representative plans and supervises QMS internal audits. Audits are scheduled based on risk and an audit cycle is typically between 6 months and 3 years. Internal Audits are carried out by trained professional auditors, or do through outsourced internal audit by a third party. While selecting the auditors, it is important to ensure they are impartial to what is being audited. After the selection of the auditor, the audit schedule is disclosed and communicated to relevant stakeholders.
It is the duty of Management Representative to ensure that internal audit is based on documented policies, procedures, scopes, documents, records and the results of previous audits. Internal audits should be planned so that the auditors are able to prepare before the audit. The auditor can prepare an Internal Audit checklist, to guide them through the audit. An internal audit checklist can support you through the audit, but does not necessarily need to be followed. The auditor should always be flexible to adjust the direction taken, based of the information received during the audit.
This step is referred to as “Fieldwork”. After the planning, the QMS internal audit is put into action. During the audit, the auditor can gather information in a variety of ways, including reviewing records, speaking with personnel, evaluating key process data, and even assessing the process from start to finish. It is very important to try and reduce distractions and work cooperatively with auditors to make sure that the audit process runs as smooth as possible.
After conducting the audit, the auditor creates a report of all the findings and opportunities for improvement. These reports must be prepared with proper attention. The written report not only helps the process owners to work on the corrective actions, but also helps during follow ups.
Audit follow up is a crucial step in the audit process. After the issues are identified and resolved by corrective actions, it is important to have a follow up to check if the desired result is achieved or not. Based on the severity of the issue identified, follow-up actions may include analysing revised processes or supporting documents, interviewing employees, or re-auditing the procedures where the issues were identified in the first place.
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