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In this phase an internal audit system will be established. To enable internal audits in the laboratory, the quality officer and at least one additional personnel member with technical knowledge need to be qualified as internal auditor and will therefore need to participate in an internal auditor course to become a certified ISO 15189 internal auditor. On the course list provided with this implementation plan also several courses for ISO 15189 internal auditor are included. Store the certificates in the personnel files of the appropriate personnel members and update their job descriptions accordingly. |
Activities related to Phase 3 - Assessment
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ISO 15189 requires that every element of the quality management system is audited once every 12 months. The laboratory supervisor must plan internal audits on a regular basis throughout the year (not all in one short period as this will burden the laboratory personnel too much). Communicate this plan to the persons that are going to be audited so that these persons can adapt their own planning for the days the audits are planned.
Note that auditors must not audit their own activities. E.g. the quality officer may not audit his/her quality activities. In this case, the additional personnel member may audit the activities of the quality officer.
If resources admit this, it is better to do audits in pairs, as one can completely focus on asking questions while the other is secretary, recording the answers
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Perform the audits and report the results and conclusions within 2 weeks to the laboratory manager or director who needs to draft an action plan containing SMART action points to solve the nonconformities/points for improvement found during the audit within 1 week. The nonconformities/points for improvement should be scored on a 4 point scale:
- No deviation from the standard was observed.
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Finding will have a negative effect on the quality management system in the long run when not solved (no direct threat to the quality management system).
>Follow-up: Include the observed finding in an action plan and implement action within 1 year.
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Finding has a negative effect on the quality management system.
>Follow-up: Observed deviations need to be solved within 4,5 months.
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Finding has a direct critical effect on the quality management system.
>Follow-up: Stop the regular work and first solve the observed deviation before continuing.
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Based on the findings recorded in the audit report the laboratory supervisor must make an action plan of the internal audit in which SMART activities are formulated to solve the nonconformities found in the internal audit. Make this plan within two weeks after issuing the audit report by the quality officer. The reason for this time limit is that nonconformities found during an audit need to be solved as quickly as possible, especially when the nonconformities have a serious negative effect on the processes of the laboratory.
The results of internal audits also need to be submitted to the management of the laboratory. This is generally done through the quarterly reports, so that audits are reviewed in the management review. The procedures in whcih deviations were found during the audit need extra attention in the subsequent audits to see if the corrective/preventive actions formulated in the action plan appropriately solved the deviation.
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Discuss the report and the action plan in a meeting to assign actions to specific staff members and to set deadlines. The lab manager should be part of this meeting.
The person writing the minutes (the quality officer) must subsequently include the action points from the action plan in the work meeting minutes so that the status of handling the action points will be assessed every staff meeting with the person assigned to handle the action point.
When action points exceed their deadlines it is up to the laboratory manager to use his/her authority to make sure that the person assigned to handle the action point will do this in the shortest amount of time possible.
Store the action plan in a file titled “Action Plans” under the tab “Internal and External Audits”.
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Standardize the complete procedure of internal auditing in your laboratory in an SOP.
Make sure that this SOP is read by all relevant personnel members.
