An internal audit is a formal laboratory activity that must be performed in accordance with a documented procedure and on a regular schedule. Laboratories may choose to conduct a full laboratory audit annually or biannually, or to audit parts of their system every month.
The internal audits should also ensure that the defined management system fulfils the requirements of ISO/ IEC 17025:2005 or ISO 15189:2012 or ISO/IEC 17043:2010 or ISO Guide 34:2009.
The audit should also ensure whether or not the requirements of the CAB’s quality manual and related documents are applied at all levels of work.
The non-conformities found during the internal audit should give valuable information for the improvement of the CAB’s management system and technical competence, which is to be used as a input to management reviews.
The quality manager may delegate the task of performing audits to personnel who are having sufficient technical knowledge with respect to the operations of the CAB, trained specifically in audit techniques and process. The auditors shall also understand requirements of ISO/IEC 17025:2005 or ISO 15189:2012 or ISO/IEC 17043:2010 or ISO Guide 34:2009 (whichever is applicable) and NABL accreditation requirements.
The audit program may include horizontal audit / vertical audit + (wherever feasible) so that all the sections/ departments are audited for every aspect/ clause of the management system and relevant standard.
Horizontal Audit – This examines one element in a process on more than one item. It is a detailed check of a particular aspect of the documentation and implementation of the management system.
Vertical Audit – This examines one sample looking at all of the inputs, operations and activities required to produce the output (result). It is a detailed check that all elements associated with the tests are implemented.
An audit timetable should be developed by each auditor in conjunction with their auditee to ensure the smooth and systematic progress of the audit.
The auditor will use the management system documents as reference (quality manual, system procedures, test methods, work instructions, records etc.), and compare what is actually happening with what these quality system documents state should happen.
The corrective actions procedure may need to be followed to reveal the root causes of some problems and to implement effective corrective actions.
The effectiveness of corrective actions should be checked by the quality manager as soon as possible after the agreed time limit has elapsed and clear/ close the non-conformity.