According to the standard, the laboratory quality manager is responsible for ensuring that the laboratory's quality management system is implemented and maintained effectively.
Regarding internal audits, ISO 15189:2012 requires that the laboratory perform regular internal audits to assess the effectiveness of its quality management system. However, the standard does not specify who should perform these audits.
In general, it is recommended that internal audits are conducted by individuals who are independent of the area being audited. This helps to ensure that the audit is objective and unbiased. Therefore, it may not be ideal for the laboratory quality manager to perform internal audits in his or her own lab.
However, if the laboratory has limited resources and it is not possible to have an independent auditor perform the internal audit, the laboratory quality manager may perform the audit. In this case, it is important that the laboratory quality manager demonstrates objectivity and impartiality in conducting the audit.
Ultimately, the decision of whether the laboratory quality manager should perform internal audits in his or her own lab should be based on the specific circumstances of the laboratory and should be made in accordance with the principles of ISO 15189:2012.
Comments
According to the standard, the laboratory quality manager is responsible for ensuring that the laboratory's quality management system is implemented and maintained effectively.
Regarding internal audits, ISO 15189:2012 requires that the laboratory perform regular internal audits to assess the effectiveness of its quality management system. However, the standard does not specify who should perform these audits.
In general, it is recommended that internal audits are conducted by individuals who are independent of the area being audited. This helps to ensure that the audit is objective and unbiased. Therefore, it may not be ideal for the laboratory quality manager to perform internal audits in his or her own lab.
However, if the laboratory has limited resources and it is not possible to have an independent auditor perform the internal audit, the laboratory quality manager may perform the audit. In this case, it is important that the laboratory quality manager demonstrates objectivity and impartiality in conducting the audit.
Ultimately, the decision of whether the laboratory quality manager should perform internal audits in his or her own lab should be based on the specific circumstances of the laboratory and should be made in accordance with the principles of ISO 15189:2012.
THE STANDARD DID NOT EXCLUDE THE MANAGER FROM CARRYING OUT AUDIT. IT IS THE OBJECTIVITY OF THE AUDIT THAT MATTERS.