What is Conformance Testing and Does My Company Need It?
Conformance testing is performed to validate that your verifier is in working order and outputting the correct results, ensuring conformance to ISO standard requirements. The quality control policies and/or industry’s application standard or barcode guidelines for your company will determine if conformance testing is necessary. For certain industries, such as medical device and pharmaceutical companies, conformance testing is required to prove that their equipment is functioning properly.
For routine verification performance checks, companies will perform a conformance testing using a NIST-traceable Conformance Test Calibration card to confirm verification results are within the acceptable tolerance range after calibration.
What does that mean and what does that entail?
To be ISO compliant, a verifier must be manufactured following the standards established in ISO/IEC 15416 and ISO/IEC 15415 for 1D and 2D barcodes, respectively. These standards outline a list of hardware and software requirements that must be followed to provide a level of standardization between verifier producers and maintain a consistent level of quality in verification results.
One component of the ISO standards is to confirm verification results are within an acceptable tolerance range listed in the ISO/IEC 15426-1 and ISO/IEC 15426-2 standards. This test can only be completed by using a NIST-traceable Conformance Test Calibration card. A conformance test calibration card has a calibration symbol as well as several other symbols with intentional errors on them. The card will list an overall grade and corresponding parameter grades for each symbol on the card. Within the ISO 15426 standards, an acceptable tolerance range for each quality parameter is established. A verifier is expected to be within the tolerance range for each quality parameter tested on the calibration card to be considered in conformance with the ISO standards.
What happens if the results are outside of the acceptable range?
If you are not receiving results within the tolerance range, a few small troubleshooting steps may fix the problem. Make sure:
-The unit is in focus.
-The camera and window are clean of dust and debris.
-The Grading Standard is set to ISO 15415/6 and the Aperture is set to “Auto 80%”
What is a validation protocol do I also need one?
A validation protocol is a comprehensive document that validates the software and hardware as a system to show proper installation, operation, and performance qualification. In heavily regulated industries, it is required to show equipment is installed properly and working as intended or perform thorough testing when a new piece of equipment is added to production.
Using photographically printed barcodes, a validation protocol exercises the features and functionality of the software and ensures the results are in accordance with the expected results. Consisting of hundreds of individual tests, a validation protocol provides step-by-step instructions to achieve this necessary validation and is available for every verifier model at Cognex.
What barcode verifier models are ISO compliant?
All verifiers manufactured at Cognex meet all requirements listed in the ISO/IEC 15415 and 15416 standards and are also tested for compliance before leaving the manufacturing facility for conformance against ISO/IEC 15426-1/15426-2. Cognex and Webscan barcode verifiers are delivered with a certificate of conformance.
For more information on the types of hardware and software requirement listed in the ISO 15426-1/15426-2 standards please refer to the Difference between barcode quality software and barcode verification, blog post.