ISO 17025 Quality Manual Template
Thursday, October 19, 2006
Internal audits
Internal audits are a critical requirement of ISO 17025:2005. The purpose of an internal audit for a lab is to verify that its operations continue to comply with the requirements of the management system. Section 4.14 of ISO 17025 specifies that internal audits are conducted “in accordance with a predetermined schedule and procedures” and “carried out by trained and qualified personnel.” No further information is provided by the standard on how to achieve an effective internal audit. Therefore, it is up to the lab to determine the procedure that best fits its needs.
Predetermined Schedule and Procedure
ISO 17025 does not specify the procedure to be used for a lab audit. However, other documents provide more specific guidance. APLAC provides a technical document on internal audits that can be found at www.aplac.org and is quite helpful. The important steps of an audit are planning, investigation, analysis, reporting, corrective action, and follow-up to determine the effectiveness of the corrective action. The investigation process involves gathering objective evidence by asking questions, observing activities, and examining facilities and records. The quality manager is responsible for planning and organizing audits.
The schedule for audits is determined by the lab. ISO 17025 suggests that an internal audit be completed within a year, but the suggestion is only a note. Notes are recommendations, rather than requirements. In fact it may make more sense for a lab to divide the audit into sections that can be periodically conducted throughout the year. Management may request an audit in addition to scheduled audits.
Trained and Qualified Personnel
Personnel must have sufficient technical knowledge of the operations that they are auditing and be trained in auditing techniques. Because a lab’s internal auditor is responsible for examining various aspects associated with equipment, the performance of tests/calibrations, and the issuing of results, it is required that the training and qualifications of the internal auditor be identified, documented, and evaluated. As a result, section 5.2 of ISO 17025 (e.g., formulation of goals, policy and procedure for identifying training needs, evaluation of the effectiveness of training administered, etc.) is applicable to the person designated as a lab’s internal auditor. Labs are expected to maintain records to demonstrate compliance with sections 5.2.1-5.2.5 as related to their internal auditor. The lab determines what training the internal auditor must have to perform a proper audit.
In addition, personnel are to be “independent of the activity to be audited,” but only “whenever resources permit.” If there is no alternative and it is not possible to have the audit conducted by independent personnel, then it must be demonstrated that an effective audit has been conducted. However, labs greatly benefit from a review by a trained individual independent of the testing performed. Thus, smaller labs choose to hire a consultant to conduct these audits.
Audit Findings
All audit findings must be recorded and prepared promptly so that the report is submitted to the facility as soon as possible. Nonconformities identified during an audit must be noted and the appropriate corrective action and the time frame for corrective action agreed upon with the lab. The auditor must check the effectiveness of corrective action as soon as possible after the agreed-upon time frame. Internal audit findings are an important part of the discussion at management review meetings.
Conclusion
ISO 17025 requires internal audits to verify that lab operations continue to comply with the requirements of the management system. It is up to the lab to put procedures in place to ensure an effective internal audit. These procedures result in an audit report that is an important tool for the lab and upper management to ensure that the lab complies with the management system.
Predetermined Schedule and Procedure
ISO 17025 does not specify the procedure to be used for a lab audit. However, other documents provide more specific guidance. APLAC provides a technical document on internal audits that can be found at www.aplac.org and is quite helpful. The important steps of an audit are planning, investigation, analysis, reporting, corrective action, and follow-up to determine the effectiveness of the corrective action. The investigation process involves gathering objective evidence by asking questions, observing activities, and examining facilities and records. The quality manager is responsible for planning and organizing audits.
The schedule for audits is determined by the lab. ISO 17025 suggests that an internal audit be completed within a year, but the suggestion is only a note. Notes are recommendations, rather than requirements. In fact it may make more sense for a lab to divide the audit into sections that can be periodically conducted throughout the year. Management may request an audit in addition to scheduled audits.
Trained and Qualified Personnel
Personnel must have sufficient technical knowledge of the operations that they are auditing and be trained in auditing techniques. Because a lab’s internal auditor is responsible for examining various aspects associated with equipment, the performance of tests/calibrations, and the issuing of results, it is required that the training and qualifications of the internal auditor be identified, documented, and evaluated. As a result, section 5.2 of ISO 17025 (e.g., formulation of goals, policy and procedure for identifying training needs, evaluation of the effectiveness of training administered, etc.) is applicable to the person designated as a lab’s internal auditor. Labs are expected to maintain records to demonstrate compliance with sections 5.2.1-5.2.5 as related to their internal auditor. The lab determines what training the internal auditor must have to perform a proper audit.
In addition, personnel are to be “independent of the activity to be audited,” but only “whenever resources permit.” If there is no alternative and it is not possible to have the audit conducted by independent personnel, then it must be demonstrated that an effective audit has been conducted. However, labs greatly benefit from a review by a trained individual independent of the testing performed. Thus, smaller labs choose to hire a consultant to conduct these audits.
Audit Findings
All audit findings must be recorded and prepared promptly so that the report is submitted to the facility as soon as possible. Nonconformities identified during an audit must be noted and the appropriate corrective action and the time frame for corrective action agreed upon with the lab. The auditor must check the effectiveness of corrective action as soon as possible after the agreed-upon time frame. Internal audit findings are an important part of the discussion at management review meetings.
Conclusion
ISO 17025 requires internal audits to verify that lab operations continue to comply with the requirements of the management system. It is up to the lab to put procedures in place to ensure an effective internal audit. These procedures result in an audit report that is an important tool for the lab and upper management to ensure that the lab complies with the management system.
