Did You Know Your Third-Party Accredited Test Lab Must Comply with Standards Too?
Independent testing laboratories become accredited under International Standards Organization ISO 17025, just as most manufacturers today accredit their organizations using ISO 9000-9001 or other applicable standards.
The third-party test lab accreditation program requires that a testing lab be evaluated by compliance auditors, a process that can take days, or even weeks, as auditors scrutinize every detail of every standard for which the test lab is seeking accreditation. The audit process involves observing every step of the testing and reporting process, and includes reviewing documentation, inspecting the test equipment and its calibration, questioning the test engineers, evaluating the facility itself, checking the current version of the software, as well as reading through minutes of managers’ meetings, training manuals and responses to customers inquiries. This rigorous review and inspection provide a thorough evaluation of the test lab’s systems and processes and helps to ensure that the quality of its evaluations meets the requirements of the applicable standards.
The process of obtaining accreditation is complex and challenging. However, test labs that have been accredited to ISO 17025 are most likely to provide their manufacturing customers with the highest-quality testing by knowledgeable and experienced test engineers. Test lab customers can also ask to see the test lab’s Certificate of Accreditation which can be thirty pages or longer as it lists each test in a standard for which the test lab has been accredited.
Why Would a Test Lab Want to Put Its Employees Through So Much Pressure?
First off, the test lab wants to be a high-quality, first-rate lab that does every aspect of the testing and reporting process accurately with results that are reliable and repeatable, so their customers’ products work well out in the field.
Secondly, certification provides manufacturing customers with assurances that their lab will provide the highest quality testing and reporting to the latest requirements of each appropriate standard for each country in which they sell their product.
The Accreditation Process
The first step for a test lab is to check the background of the various accreditation bodies such as ANAB, NVLAP,A2LA, and others to make sure they are reputable and that they have the technical expertise to provide the accreditation the lab needs. Then they hire one of the accreditation bodies.
Next, they make sure the accrediting body understands the scope of the audit they want, so they receive accreditation for standards in all the different types of industries they test for and in all the different countries they test for, and for all the different types of testing they do, such as EMC, FCC, ISED, environmental, wireless, and product safety. The number of standards that a test lab is accredited for determines how long the audit will take and how much it will cost.
Although the accreditation bodies’ processes vary somewhat, they all evaluate your lab on an annual basis according to the ISO Quality Standard 17025. However, accreditation bodies may differ in the scope of what they cover each year. For example, an accreditation body may give a very comprehensive evaluation every other year, which can take two full weeks or more, and on the odd years provide a surveillance audit consisting of a shorter spot-check taking around four days to complete, depending on whether or not you have scope updates or additions.
The test lab is normally not informed as to what details will be checked, so it must make sure that every section of its quality system is in perfect condition, which includes contracts review, quoting process, testing, calibration, reports, etc.
Preparing for an Audit
The best way to prepare for an upcoming audit is to always keep your facility, test equipment, test procedures, report procedures, etc., top-notch. To do this, you designate a quality control engineer whose job is to scrutinize every aspect that could possibly be evaluated by the auditors. If the engineer finds something that is not up to standard, they immediately make the necessary changes. Following are some examples:
Monitoring Standards
Test labs constantly monitor standards agencies and industry publications to be informed when new standards are introduced and when they will be enforced, and also when the current version of a standard is being updated. When the lab purchases a new standard or a new version of a standard, they need to add it to their directory of standards. Before an audit, the lab must verify that its standards directory is current and that nothing has been omitted, as the auditor will be checking this information. You never want to test to an outdated standard (unless a customer has a specific reason for needing to test to that standard, which is rare).
Training and Teaching
Test labs are continuously training and teaching test engineers on the intricacies of accurately setting up and testing for standards of each specific product industry. This training must be recorded in each employee’s training manual, showing every type of test they are qualified to perform. If the laboratory tests for many different product industries, the engineers increasingly become more knowledgeable at testing a wider variety of products. Before an audit, we verify that the training records for each employee list all the capabilities of that employee, as auditors will look at their individual training manuals. No one wants their product tested by an engineer who has not been properly trained on how to set up and perform that specific test.
Set Up and Perform Testing Properly
Each test engineer not only needs to be able to set up and perform a test properly but must also understand the details of the test standard and the basis for its particular requirements before they begin the actual testing. So, before an audit, each employee should have the knowledge required to understand and accurately answer any questions that an auditor may ask them. They need to know why they are setting up that test in that specific way and why they are testing that product in that specific way.
Test Equipment
Standards generally specify what test equipment is required to fully assess their requirements. After purchasing the specified equipment, the test lab is responsible for making sure it is working properly during testing, that the current software version number is recorded in the equipment database, and that the equipment is calibrated on a regular basis and is traceable to NIST. Test labs are able to do some calibrating themselves and some equipment gets serviced on-site by a third party, while some equipment has to be sent out to be calibrated, which can be time-consuming.
Facility Requirements
Many standards detail specific facility requirements, such as the layout of the room, the type of absorbing material used, and specific requirements to meet normal site attenuation. For example, test chambers are sometimes required to be of a specific height in order to raise and lower antennas, while others may need turntables in order to rotate the product being tested. The auditors check the facilities at each of the company’s locations for these issues.
Creating Reports
Standards specify exactly how a report is to be constructed, with photos showing the test setup, the testing that was performed, and the results of each test to verify the validity of the test results and the accuracy of the test report. Auditors check each detail of the report system and how test results are recorded as well as the test lab’s communication with customers post-testing to determine their satisfaction. If the customer does raise concerns about the testing, the auditors verify that the issues identified were addressed to the customer’s satisfaction. Finally, every detail of the test setup and the testing must be documented so it can be repeated at a later date if necessary.
Organization Chart
Auditors also check the test lab’s organization chart, making sure each employee knows which manager they are accountable to. Auditors also read the minutes of managers’ meetings to see that everyone follows through on any changes that need to be made. They review the test lab’s goals and priorities.
The Audit
The accrediting body appoints qualified auditors who will spend a few days to a few weeks at the test lab, depending on the number of standards for which the test lab is to be accredited. The auditors generally change from year to year. They begin by working with the lab’s quality control manager to see that all records have been kept and are up-to-date, as proper documentation is a huge part of the audit. They interview lab personnel for their knowledge and performance and to verify that they have the required experience with the test procedures, the test equipment, and the standards used.
Auditors will also decide if the lab is adequately staffed for the type and volume of testing currently undertaken, and that the laboratory has the necessary competencies related to the fulfillment of ISO/IEC 17025:2017 requirements. The specific accreditation body may also have additional accreditation requirements. As you can see, no stone is left unturned. Every possible aspect of testing and reporting is scrutinized.
Certificate of Accreditation
Once the auditors are satisfied that they have thoroughly checked every aspect of the lab’s testing and reporting qualifications, and the lab has been found to be:
- Technically competent and well organized in their approach to testing for all the standards on their scope of accreditation; and
- Their management quality system is well-defined and is being implemented to ensure they follow ISO/IEC 17025:2017 requirements,
they present the test lab with a Certificate of Accreditation, which also includes comments on competence, comments on conformity, and opportunities for improvement.
Conditional Approval Pending Satisfactory Nonconformity Corrective Action Response
If even the smallest detail is found lacking, the test lab is instead given a Conditional Approval Pending Satisfactory Nonconformity Corrective Action Response that gives the test lab 30 days to make the necessary changes. If all recommended changes have been made in the allotted time, the test lab then receives its Certificate of Accreditation.
Summary
Test labs work hard to make sure everything about their testing and reporting process is compliant at all times. Even when an auditor makes suggestions for improvement, no matter how minor, the test lab is appreciative of being notified so that it can quickly make the required improvements to maintain its compliance with the requirements of the standard.