DURA TRUE® IS PROUDLY CERTIFIED ISO 9001:2008 AND CGMP
You might be wondering why all the fuss about ISO 9001:2008 and cGMP certification? Well, to be frank, it’s another way that DuraTrue® has set itself apart from the competition. ISO 9001:2008 and cGMP certification is something that hasn’t yet been achieved by many other American manufacturers of eLiquid. By being the first to reach this level of excellence, we’ve positioned ourselves to lead the industry into the future.
ISO 9001:2008 certification is an international standard for quality management. Certification requires practices to meet policy. But, this isn’t as simple as it seems! It often takes businesses years to meet the ISO 9001:2008 standard.
To become certified, a business must develop their quality management system to meet the ISO 9001:2008 standard, then pass rigorous third-party audits by an accredited registrar! These audits search for inconsistencies in policies and practices and force a business to continually improve their quality management system.
A registrar is a third party organization that is accredited to audit a business’s conformance to the ISO 9001:2008 standard.
Good Manufacturing Practices, or cGMP, are practices and the systems required to be adopted in pharmaceutical manufacturing, quality control, diagnostics, foods, pharmaceutical products, medical devices and tobacco products as regulated by the FDA. It’s important to note that electronic cigarettes and eLiquid are not regulated by the FDA yet, so cGMP isn’t currently required for manufacturers of eLiquid. However, the FDA has announced that they do intend to use the tobacco regulations for electronic cigarettes in the near future.
By implementing Good Manufacturing Practices and having them audited through our ISO 9001:2008 certification, DuraTrue® we’re two steps ahead. When the time comes for FDA regulation, we’re prepared. This is our way of showing our customers that all of our manufacturing processes are good enough to meet the highest standards of the FDA.
In many industries, cGMPs are required by the FDA (or other international regulatory bodies). Interestingly enough, any company can claim that they follow GMP standards. There’s no audit process or inspection that a company must submit to before they can claim they follow cGMP standards. In order to prove to our customers that we don’t just claim to follow cGMP’s. Dura True® had our cGMP’s audited as part of our ISO 9001:2008 certification.