Does Advanced Tubular Technologies Supply VTube ISO Validation for VTube Software?

Advanced Tubular Technologies (ATT) is not allowed to claim ISO-based (ISO 17025, AS9100, IATF, etc.) software validation compliance.

Why ISO-based software validation is required for customer laboratories.

In the case of ISO 17025, the standard applies to an entity that operates a testing or calibration laboratory and produces measurement results for its parts. Since ATT does not operate customer labs or measure customer parts for part qualification, customers are responsible for ISO-based validation.

How VTube software touches ISO 17025 from the customer side.

ISO 17025:2017 Section 7.11 specifically addresses management of data and information systems, including software validation. It requires that:

• Software used in laboratories should be validated before use.
• Changes to software should be authorized and documented. (See our VTube Update articles.)
• Software should be protected against tampering.  (See VTube's User Access Control - UAC system.)

So, VTube customers who are ISO-based accredited must validate VTube-LASER as part of their compliance.

What ATT can do as a software developer in relation to ISO-based validation.

Rather than claiming validation compliance, we can support customer compliance efforts by:

• Maintaining rigorous version control and change documentation  (See our VTube Update articles.)
• Offering verification artifacts — reference measurements with known results that customers can use to validate your software in their environment.  (See the cylindrical test bars in our store.)
• Documenting algorithms and calculation methods so customers can demonstrate they understand what the software does. (See the technical section of our knowledge base.)

Conclusion: The accurate answer

For any customer or prospect that asks, "Is VTube-LASER software certified to be ISO-based compliant for software validation?", the accurate answer is: 

ISO-based software validation applies to laboratories that use the software. Even though ATT cannot validate VTube for customers, we are willing to support your lab's compliance by providing documented methods and version-controlled releases that satisfy the specification requirements.”

What about AS9100?

AS9100 (Rev D) is the aerospace quality management standard built on ISO 9001.

In the context of software validation in customer facilities, VTube software touches AS9100 on the customer side.

AS9100 Section 7.1.5 addresses monitoring and measurement resources in a manner similar to ISO 17025's traceability requirements. 

VTube-LASER customers who are AS9100 certified must ensure that measurement tools are suitable for their intended purpose. 

When AS9100 requires that "software used to measure product must be validated," that requirement is placed on the organization performing the measurement. Customers are the ones operating under the certification; they produce the measurement results and are therefore responsible for validating every tool in that process, including software.

Advanced Tubular can support customer validation efforts. See the “What ATT can do” section above.