The Value of Risk-Based, Process-Driven Thinking

The life sciences industry operates in a world of regulations. These regulations govern the manufacturing and distribution of pharmaceuticals and medical devices to help protect their safety and efficacy, the patients that use them, and the people who produce them. For life sciences companies, compliance with the myriad of regulations established by HIPPA, EMA, IRBs, FDA, GCP, among others, is a daily endeavor. Compliance, quality, and safety are all reasons to consider the ISO certifications of your vendors. Specifically, what is the presence or absence of ISO certifications, as well as how do your vendors demonstrate adherence?

ISO certifications should be considered because they ensure that vendors have a documented Quality Management System (QMS). However, beyond ISO standards, your vendor’s compliance points to an organization that values risk-based thinking and a process-driven approach—all of which are important in highly regulated industries.

 The New Era of Global Compliance for Language Service Providers

According to International Standards Organization, international standards give world-class specifications for products, services, and systems, to ensure quality, safety and efficiency. ISO has published 22,150 international standards and related documents, covering almost every industry, from technology to food safety, to agriculture and healthcare.

Hugo Riu, Quality and Training Director at Welocalize Life Sciences, shares what ISO certifications the company holds, why they are relevant to life sciences companies, and how a risk-based, process-driven approach is important.

Read the full interview here.