ISO Certifications and 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.

Q: Why is Compliance with ISO 17100 is an essential requirement for language service providers (LSPs) working with life sciences clients?

A: All clinical research clients require certified translations, which is an industry requirement. During audits and regulatory health authority inspections, clinical research clients (whether pharmaceutical companies or CROs) must prove that translations have been carried out by fully qualified linguists, and that the translation has been reviewed by a second independent translator. ISO 17100 compliance gives our clinical research and other regulated clients the guarantee that our translations are endorsed by a standardized process which allows certification. The application of this standard affects the whole company, but especially the customer service and production department, on one side, as it establishes the mandatory steps in the translation process, from management of client requests to delivery and post-production activities. It also has an important impact on the vendor management team, as the minimal education/training requirements of translators and revisers are defined. Our linguist requirements not only comply with this standard, they actually exceed the requirements.

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. Click To Tweet

Q: Does Welocalize Life Sciences have any industry-specific certifications? If so, what and why?

A: Yes, in addition to ISO 17100, Welocalize Life Sciences holds ISO 13485 certification. This certification puts a higher emphasis on risk assessment of all processes related to labelling of medical devices following scales of probability and severity of the potential risk. It also puts a higher emphasis on corrective actions, as they are mandatory following a client complaint (unless a valid justification is documented in writing explaining why a corrective action is not necessary). Also, it makes it mandatory to comply with all the medical device regulations, which may affect the labeling and therefore have an impact on the translations.

Q: What about ISO 9001? It isn’t specific to language services or a particular industry, so why should it matter?

A: ISO 9001 certification ensures a framework which ensures a continual improvement process based on plan-do-check-act cycle. This is important for highly regulated industries such as pharma clients, where issue management and resolution is of the upmost importance, including management of corrective actions and assessment of their efficacy. The new version, ISO 9001:2015 puts a higher focus on risk assessment, on one side, and on management involvement.

Q: What is the value of an organization that practices a risk-based, process-driven thinking throughout its organization?

A: Risk-based thinking is important to be able to detect in a proactive way potential problems before they occur and launch preventive actions. Welocalize Life Sciences schedules periodic meetings involving key roles from several departments to assess potential risks in processes and then make decisions on how to mitigate the risk, especially in relation to patient-facing materials, and enable the delivery of the highest quality to life sciences clients.

ISO compliance is not limited to the Quality team, but every member of the company has to be suitably trained on the ISO requirements relevant for their job position and work in an ISO compliant way on a day-to-day basis. The Quality team is responsible for ensuring that the procedures and processes that employees use in their daily work are consistent with ISO requirements. We help the team to achieve this through the maintenance of suitable documentation in the QMS and detecting and helping to solve any deviations.”

At Welocalize Life Sciences, our regulated clients audit us on a regular basis. Having ISO certifications, and implementing the system requirements across all levels of the organization, allows us to be able to meet their requirements by having fully documented processes and a continual improvement system.

Ultimately, the goal is the same for both clients and their vendors — customer satisfaction, and consistent, conforming (quality) goods or services.

Here are three upcoming opportunities to meet our team and discuss the benefit of risk-based, process driven thinking and the role it plays to enable clinical trial and vendor/client success:

  • 15-16 May | Outsourcing in Clinical Trials Europe (Barcelona, Spain) – Booth 25
  • 4-7 June | BIO International Convention (Boston, MA) – Booth 1352
  • 24-28 June | DIA Annual Meeting (Boston, MA) – Booth 2351