ISO/IEC 27001 and the Value of Certified Life Sciences Services Providers

Davor Milosevic, Quality Assurance Manager, IQVIA Quality Compliance

With data being one of the most valuable assets that an organization owns, information security management is an essential business practice. Protection of confidential data, particularly personal data with the introduction of GDPR in 2018, is critical for compliance and a business’ trust and reputation.

As highly risk-averse as the Life Sciences industry is, it is safe to say that most Life Sciences organizations will have some form of controls in place to manage information security. However, the degree of information protection and the delivery of real benefits to the market are incumbent on the effectiveness by which these controls are organized and monitored. ISO 27001 certification is the gold standard in demonstrating that effectiveness.

What is ISO 27001?

ISO 27001 is a security standard that outlines the suggested requirements for building, monitoring and improving an information security management system (ISMS). An ISMS is a set of policies for protecting and managing an enterprise’s sensitive information, e.g., financial data, intellectual property, customer details and employee records.

The ISO/IEC 27001:2013 international information security standard outlines the suggested requirements for building, monitoring and improving an ISMS. Its ISMS is built on a holistic, tailored approach to protecting and managing an enterprise’s sensitive information.

As a risk-driven standard, ISO 27001 focuses on helping organization’s build a culture of security, reducing the likelihood of security incidents and supporting the ability to meet additional compliance requirements. (Source: A-LIGN The ISO 27001 Certification Process)

Why is it important for Life Sciences organizations?

ISO 27001 can help Life Sciences organizations fully assess the risk to the privacy of their information assets, including patient and product data, through the implementation of security controls that mitigate information security risk. This is critical when proprietary, confidential data is being accessed or managed by a third-party provider.

Those providers that have been ISO 27001 certified have demonstrated that they can identify risk, assess their potential implications and put in controls to limit damaged caused by information risk incidents. Through a systematic security framework, the provider and its customer’s company data and information remain secure.

In addition to helping organizations ensure their security risks are managed, the adherence to a globally recognized best practice standard protects their corporate reputation and demonstrates credibility and trust with the industry, customers and partner organizations.

Key Benefits of ISO 27001 Certification

Unlike written standards that provide generalized guidance that isn’t applicable to the unique risks and assets of a particular organization, ISO 27001 helps organizations implement controls specific to its unique profile. Key benefits of this approach include:

  • Data and platform integrity – protection from data breaches
  • Protection of privacy such as patient data
  • Client confidence that information is protected
  • Better transparency of potential information risk
  • Cost savings through reduction of information security incidents
  • Alignment with customer requirements
  • Improved status as a preferred Life Sciences organization
  • Protect reputation and demonstrate credibility and trust

What does it take to get certified?

While the benefits are many, the process of achieving ISO 27001 certification is intensive. After implementing the standard’s requirements, organizations seeking certification must undergo multiple audits by an accreditation body. In the initial audit, the auditor ensures that the applicant’s ISMS has been developed in accordance with the standard. The applicant is expected to present evidence of all key aspects of the ISMS.

If the organization passes the initial stage, the auditor will conduct a more detailed examination, including analyzing the organization’s policies and procedures, and conduct an on-site investigation to assess how the ISMS is actually working in practice. This includes staff interviews and deep document reviews.

To maintain certification, companies must go through an annual external review process and 3-year recertification during which they must demonstrate continual improvement in the ISMS. When a new revision of the standard is published by ISO, certified providers must transition to the new version to retain compliance. The rigorous nature of ISO 27001 certification validates their ongoing commitment to maintaining confidentiality, integrity, availability and privacy of customer data.

IQVIA Quality Compliance is Certified and Committed

ISO 27001 certification is a good indication that a technology solution provider is taking security seriously. It reflects that the provider houses a robust infrastructure built to store and process data in a safe and secure manner. IQVIA Quality Compliance recently achieved certification, making it one of only a few quality management solution (QMS) providers in the world who are currently ISO 27001:2013 certified. Our customers can be confident in IQVIA’s ongoing commitment to information security management and protection of their most precious asset – their data.

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