Consider These Clauses When Conducting Your Laboratory’s Internal Audit
Achieving 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.
The Most Important ISO/IEC 17025 Clauses to Consider
Here is a brief summary of the ten clauses in
ISO/IEC 17025 to consider when seeking testing laboratory accreditation.
7.2.1: Validation of Methods
This clause has multiple parts, all of which cover the selection, verification, and validation of methods. Laboratories not only have to select methods appropriate for their customer’s needs but must also have the appropriate documentation and records to show verification and validation of those methods.
Additionally, 188.8.131.52 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.
8.8: Internal Auditing
An internal audit needs to confirm that a testing laboratory’s management system and activities are in compliance with ISO/IEC 17025. The language in this section is broad so as to allow laboratories to determine the frequency and depth of the audits, depending on the laboratory’s needs and risk tolerance. Once the internal audit plan is decided, records of implementation are required.
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.
7.8: Reporting of Results
This section details the requirements for reporting lab results. There are many variables regarding these reports, depending on the customer contract, the type of laboratory activities performed, and the methods used. Organizations must take an attentive and individualized approach to applying the requirements of this section.
One area commonly missed in this section is 184.108.40.206, 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.
7.7: Ensuring the Validity of Results
This section specifies that the laboratory must document procedures intended to continuously monitor the validity of test results and the required elements of the procedures that must be included. The laboratory must collect and analyze data from monitoring activities to evaluate and potentially improve their activities. This section also states that laboratories must compare their actual performance and results against that of other laboratories, referred to as proficiency testing. This section frequently uses phrases such as “where appropriate” and “where available.” For some laboratories, specific elements of these requirements will not be applicable, but the laboratory should be prepared to account for why that is the case.
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.
7.5: Technical Records
The focus of this section is the traceability and reproducibility of results. All laboratory activities must have technical records that are detailed enough to reproduce the exact process that initially produced them. This means that many factors will need to be consistently and diligently recorded, and that both original records and their amendments must be retained. Commonly cited deficiencies in this area include failing to record relevant environmental conditions such as temperature and humidity, or simply omitting data on when the test was performed and who performed it.
6.6: Externally Provided Products and Services
It is impossible to completely control what goes on outside your testing laboratory, but the quality of externally provided products and services is still within your control. This section requires that laboratories determine the suitability of externally provided products and services in a way that supports compliance. It requires that the testing laboratory create, document, and maintain procedures, evaluation criteria, and communication methods.
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.
6.2.5: Personnel Procedures and Records
This clause requires that laboratories have procedures for various activities related to the competence, training, and monitoring of personnel, as well as for retaining records of those activities. There is a list of specific topics that need to be addressed, either in one procedure or individual procedures. All relevant personnel must adhere to these procedures and records of implementation must be maintained in all cases as objective evidence the procedures are being followed.
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.
6.2.2: Documented Competencies and Supporting Records
The standard states that that several elements of competencies must be documented, including education, training, and experience. Each position category that has an influence on laboratory results must have a documented level of competency. Additionally, it is important to keep in mind that 6.2.5 a), discussed previously, requires that the laboratory maintain a procedure for determining competence requirements, an area commonly missed.
8.9.2: Management Review Inputs
This clause contains a list of 15 items that must be recorded as part of a management review, all of which the laboratory must take care to cover and record. This section may be removed from the list in the next year or so as laboratories undergoing certification renewal must work in advance to get their management review process in order and conduct these reviews with records showing each input.
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.
Based on our data, this section of the standard is the one that has most frequently proven to challenge electronics testing laboratories. In the most recent version of the standard, the term “equipment” is used to refer to all types of laboratory resources, including measuring equipment, reference standards, reference materials, reagents, consumables, and more. This section requires procedures for all equipment, including, but not limited to, accessibility, maintenance, storage, calibration, and record-keeping. It lists the specific equipment records that laboratories must maintain for all the equipment in their facility which can influence the activities listed on their scope of accreditation.
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).
Taking Corrective Action and Avoiding Deficiencies
All deficiencies found during an assessment must be addressed by conducting a root cause analysis, taking corrective action, and providing objective evidence that the deficiency has been corrected. By going back to the problem, asking the right questions, and thoroughly investigating it, you can determine what caused the issue and potentially eliminate the risk of non-conformity recurrence.
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.
Once accredited, your lab may advertise its accreditation, giving you a competitive advantage and instilling confidence in your test results and product quality—not only with customers but also with shareholders and other industry professionals. Frequently promote your accreditation to acknowledge the hard work put into achieving accredited status. If you have any questions about the process, you can always contact your accreditation body to discuss any references to your accreditation that you wish to publish.