Category: ISO

How Do You Prepare for an ISO 9001 Certification?

By The Pro QC Quality Assurance Team What is ISO 9001:2015? If you want to indicate that your organization has a functional quality management system, ISO 9001:2015 is the certification you need. The official ISO.org website says the steps a company takes to demonstrate its ability to consistently provide quality products and services that meet customer and applicable regulatory requirements, combined with the company’s aim to enhance customer satisfaction through the effective application of the system, are the core tenets of the certification. ISO 9001:2015 is applicable to any organization of any size – whether it offers manufactured goods of …

Five Things You Should Know About ISO 13485

By The Pro QC Quality Assurance Team 1. Why ISO 13485? ISO 13485 is the global international standard for establishment and maintenance of a documented quality management system in the medical device industry. If a manufacturer has implemented ISO 13485, it will have a foundation upon which to certify for regional medical device regulations such as the EU Medical Device Directive (MDD), the EY Medical Device Regulation (MDR), US FDA 21 CFR 820, as well as other regulations that demonstrate a commitment toward the quality and safety of medical devices. 2. COVID-19 highlights sanitation requirements. Manufacturers of medical devices and …