In ISO 17025, there are a number of clauses that you must know and understand. Some of these important clauses include clauses 8.8, 7.2, 6.4, and 7.7 (and more). In this blog post, we will continue our ISO 17025 risk aversion blog series and discuss those 4 different clauses in the ISO standard which will help to ensure your compliance with all regulations is up to date for your lab management.
ISO 17025 clauses include items such as the standard’s organization, document control, and management of records. You can check out our previous blog post for more information on ISO standards in general to get a better idea of what we are talking about here today. Let’s jump right in.
ISO 17025 Clauses and Risk Aversion
Clause 8.8 (Formerly 4.14)
Clause 8.8 Internal Audits: This section covers laboratory internal audits. Deficiencies that have been identified in ISO 17025 Section 8.8 include the following:
- Internal auditing records were not available on the auditor's training and qualifications;
- The most recent internal audit did not evaluate testing procedures; and
- The most recent internal examination did not address A2LA's required norms (i.e. A2LA Advertising, Traceability, and Proficiency Testing regulations).
Deficiencies can result from a lack of understanding regarding what constitutes a full internal audit. Some test laboratories, for example, believe that completing the A2LA general checklist for the ISO 17025 standards is sufficient. This is only one aspect of an entire internal audit. A2LA rules and requirements, as well as laboratory compliance with their own testing procedures and management system, must all be checked. Furthermore, it's critical to adhere to the established audit timetable since shortcomings are frequently discovered when laboratories postpone their audits.
Finally, although ISO 17025 does not define what is required for an internal auditor's qualification, the laboratory itself must decide what qualifications it wants and must then document how its internal auditors fulfill those requirements.
Clause 7.2 (Formerly 5.4)
Clause 7.2: This clause addresses, in part, the selection and validation of testing procedures at a laboratory. The most frequent deficiencies that have been addressed in accordance with ISO 17025 Section 7.2 are:
- An internal procedure was not validated prior to implementation; and
- Information was kept in such a manner that neither protection nor confidentiality of data was maintained.
A lack of experience or knowledge, as well as problems with documentation or implementation, are all possible reasons for laboratory failures. These shortcomings frequently stem from the misinterpretation of ISO 17025 by laboratory experts or a failure to follow the relevant provisions. The way in which the laboratory fulfills the clause may be revisited to ensure thorough validation of internally-developed methods, as well as additional safeguards to guarantee that data is kept in a secure manner.
Clause 6.4 (Formerly 5.5)
Clause 6.4: The clause addresses equipment that is utilized in approved testing activities. Standard ISO 17025 Section 6.4 contains the following examples of lapses:
- Equipment was not thoroughly inspected before being put back in service (after calibration, repair, or maintenance);
- The equipment was not individually identified;
- Calibrated equipment was not labeled to indicate calibration status; and
- There was no maintenance strategy or plan in place for the equipment cited.
Maintain an eye on your laboratory's results over time to ensure that the quality of the analysis is maintained. When testing parameters begin to deviate from accepted standards, certain forms of mistakes can arise, such as invalid test data or incorrect equipment identification. This kind of mistake is commonly caused by lacking training for laboratory staff or shortcuts being taken in order to ensure that testing is performed quickly and efficiently.
Clause 7.7 (Formerly 5.9)
Clause 7.7: This clause addresses the validity of test and calibration findings. Deficiencies cited against ISO 17025 Section 7.7 include:
- There was no method for recording data from the quality control procedure that would allow trends to be seen; and
- The laboratory did not take part in interlaboratory comparisons or existing and accessible proficiency testing programs.
Laboratories frequently are unaware of commercially available proficiency testing programs that pertain to the kind of tests they execute, as well as the existence of appropriate inter-laboratory comparisons. As a result, these types of problems arise. In addition, while quality control data is generally recorded, the laboratory may be unable to demonstrate how the information is utilized to identify patterns. Because of this aspect of ISO 17025, small modifications to the specified procedure are generally required.
ISO 17025 Clause Pitfalls Checklist
ISO 17025 compliance is a must for any laboratory. Be sure to stay on top of these ISO 17025 Clauses pitfalls by following the checklist below:
- Ensure that you are audited at least once every three years;
- Make sure you have an internal auditor who meets ISO requirements;
- Utilize ISO 17025 as a guideline for developing new tests or calibrating existing ones;
- Keep accurate records of quality control data so trends can be seen over time;
- Participate in inter-laboratory comparisons and proficiency testing programs when possible.
QATrax software can help you stay on top of ISO 17025 clauses better than ever by streamlining your workflows from start to finish and supplying you with a dedicated LIMS (Laboratory Information Management System) team to help keep you compliant. Book a demo with us today to find out how at Traxstar.com/demo.