Sigma Labs Inc (SASI)

[GetRich1day]

I'll piggyback on Jackle's Value of Independence by saying that is why I've been a proponent of SGLB. It's because of their printer agnostic quality control and they have been a market leader way before most were seriously thinking about independent quality assurance. Organizations like the FDA pretty much require it and I believe that they will have quality standards whose language will change to must have objective evidence of compliance. The AM big boys know it and are trying to be ready before the language requires it. IMHO

See this article concerning FDA Quality Regulations
https://www.odtmag.com/issues/2017-02-01/view_columns/the-form-fit-and-function-of-the-quality-role/48676

Each manufacturer shall establish procedures for quality audits and conduct such audits to assure the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system. Quality audits shall be conducted by individuals who do not have direct responsibility for the matters being audited.

Subsequent sections of 21 CFR Part 820 support the need to have an independent, qualified, quality organization.

See this article
https://share.ansi.org/shared%20documents/standards%20activities/amsc/amsc_roadmap_february_2017.pdf

America Makes & ANSI AMSC Standardization Roadmap for Additive ManufacturingPage 104 of 2022.2.1.4AM Process-Specific Metal Powder SpecificationsCurrently, most manufacturers of AM equipment also offer metal powder for purchase. In fact, they provide data containing representative final material properties for parts created using both their equipment and powder. However, there is a need for a specification to procure and accept metal powder so that compliance can be independently verified.

Certification: Third-party attestation related to products, processes, or persons that conveys assurance that specified requirements have been demonstrated.10A formal definitional distinction therefore is that certification describes something done by a third party independent of the person or organization that provides the product, as well as the user or customer of the product.
Validation is defined in ISO 9000:2015 as: confirmation, through the provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled.