chieving ISO/IEC 17025:2017 accreditation for your electronics testing laboratory can be an exhaustive and time-consuming process. But an outside evaluation based on internationally recognized standards can improve your organization’s overall competitive advantage. Accreditation not only showcases your organization’s commitment to quality work but also demonstrates the integrity of your personnel and supports the validity of your test results.
Whether your organization is seeking ISO/IEC 17025 accreditation for the first time or renewing your current accreditation, there are a few frequently overlooked or misunderstood sections of the ISO/IEC 17025 standard to pay close attention to. If you and your team members are aware of the common deficiencies most often experienced in connection with these sections, you’re better positioned to identify them through internal audits and address them before seeking accreditation from an outside accreditation body.
Testing laboratories should always conduct an internal audit to identify gaps or weaknesses in their systems and procedures to determine if additional resources are needed to ensure compliance. Sufficient records must be kept of the internal audit results and any follow-up actions taken. The outcome of the internal audit may help determine if your laboratory is, in fact, ready for an external assessment or if additional work is needed before applying for accreditation.
Additionally, 7.2.1.5 requires that laboratories verify that they are capable of performing a method before introducing it to their scope. Furthermore, when a method is revised by the issuing body, this verification must be repeated. The depth of this verification is to be determined by the laboratory. However, records must be maintained. This is commonly missed by laboratories adding new methods to their scope or updating existing methods consistent with standard revisions.
While ISO/IEC 17025 ultimately leaves it up to the laboratory to determine the frequency and depth of internal audits, it is important that laboratories adhere to their own internal procedures and plans. When it comes to internal audits, deficiencies are often cited against the laboratory’s own procedures rather than those described in ISO/IEC 17025.
One area commonly missed in this section is 7.8.2.2, which requires the laboratory to identify within the report any data that was supplied by the customer. Additionally, a disclaimer must be made on the report when data provided by the customer can impact the validity of results.
Regardless of the monitoring activities chosen by the laboratory, it is important that pre-defined criteria are determined, and that results are recorded in a way to easily detect and evaluate trends. Oftentimes, laboratories overlook these requirements, resulting in a deficiency. These steps are crucial in maintaining confidence and quality in a laboratory’s results.
Oftentimes, deficiencies are cited because a laboratory does not document or record the appropriate processes and criteria required by 6.6.2, parts a) through d). Furthermore, it is common for a laboratory to define its requirements for evaluating a supplier but then fail to include how the supplier will be re-evaluated and what actions will be taken based on this evaluation.
Similar to section 6.6 discussed previously, laboratories oftentimes fail to define the various processes and criteria required by this section. Clause 6.2.5 a) through f) requires that the laboratory maintain procedures and records for determining competence requirements as well as selection, training, supervision, authorization, and monitoring of personnel. It is common for a laboratory to miss one or more of these items in their personnel procedures or records.
Often cited deficiencies in this area include all 15 items required by 8.9.2 a) through o). Similar to internal audits discussed above, it is up to the laboratory to determine the frequency of their management reviews. However, the intervals shall be planned. It is important for the laboratory to follow its own internal procedures here as deficiencies are often cited for not adhering to planned schedules or processes.
The most commonly cited deficiencies in this area are related to equipment calibrations. When sending equipment out for calibration, it is imperative for the laboratory to be aware of specific calibration requirements (procedures, frequency ranges, etc.) outlined in a given test method. Other commonly cited deficiencies in this area include failing to record software and firmware versions in equipment records (6.4.13a), not labeling, coding, or otherwise identifying the calibration status of laboratory equipment so that it is clear to all personnel (6.4.8), and failing to maintain a maintenance plan and maintenance records for relevant equipment (6.4.13g).
In addition, implementing and maintaining a Quality Management System (QMS) can greatly reduce your risk of deficiencies. A QMS is where documented processes and procedures are kept and maintained so that personnel can reference them at any time, ensuring consistency and efficiency. It serves as a framework for all laboratory activities, reducing the likelihood of deficiencies, and offering a competitive advantage.
Another option to consider when seeking accreditation is training for you and your laboratory staff. Although it is not mandatory, training can be done early in the accreditation process to help personnel gain an understanding of the standard, the overall importance of accreditation, and the need for continuous competency improvement. Training can be done in-house or through a public venue, and a variety of options may be found through a simple internet search. There are also virtual course options that allow you to receive the training you and your team need while keeping costs low.
When in doubt, always refer to your copy of the ISO/IEC 17025:2017 standard. The accreditation process is thorough so it’s critical to pay close attention to each clause and perform corrective actions when deficiencies are found.