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ISO/IEC 27000 Standards for Medical Devices & Pharma Companies

August 10, 20210

The ISO 27000 series is developed by IEC and consists of 46 different standards. These standards address businesses and third parties regarding their Information Security Management Systems (ISMS). In this series, the ISO/IEC 27000 standards address three essential elements of information security, i.e.,

  • People
  • Processes
  • Security

Although the basic elements of information security remain the same, ISO keeps modifying them in response to technological evolution.

The ISO 27000 Series

There are 46 standards mentioned in the ISOIEC 27000 series, with ISO 27001 being the first and the most important. The 2013 version of the standard tells organizations about the measures they should take for achieving information security and compliance. Because of this, only ISO 27001 can be audited and certified, as the remaining standards of the ISO 27000 series only further expand the ISO 27001 requirements.

Benefits of Having ISO 27001 Certification

Although the ISO 27001 certification is not mandatory for organizations, it can provide them with great benefits. Some of these benefits are:

Demonstration of Cyber-Safety

An ISO 27001 company can prove to its clients that it is severe regarding information security. That organization can also confirm that it has taken all the necessary cyber and information security measures across all of its physical systems and operational processes.

Proof of On-Going Commitment

Since ISO 27001 is auditable, its certification will work as a proof for a company of its ongoing commitment, maintenance, and improvement of its security systems. Also, with cybercriminals becoming more innovative, businesses now want their partners to have ISO 27001 certification.

Extensions of ISO 27001: ISO 2700x

While ISO 27001 provides grounds for a robust information security system, its extensions offer details for implementing such a system. For operations to run with the built-in flexibility, ISOIEC has ensured that no two systems should look alike in the ISO 2700x family. However, businesses can look for additional support while they fulfill these requirements.

Standards in ISO 27001 Extended Series

The standards in the ISO 2700X family include:

  • ISO 27002: Provides an overview of potential controls
  • ISO 27017 and ISO 27018: Provide details of cloud security measures
  • ISO 27701: Released in response to the GDPR.

Strategies for Showing Compliance to ISO 27001

Fulfilling the Requirements

To become compliant with ISO 27001, companies need to fulfill 114 requirements. These requirements cover

  • Use of nondisclosure agreements
  • Use of secure login procedures
  • A careful review of suppliers
  • Management and monitoring of third-party services.
Continuous Monitoring

While one-time audits can be helpful for organizations, there is still a continuous need for organizations to establish a system for constant monitoring. This will allow them to show better compliance to the ISO 27001.

Risk Assessment

One of the significant steps to show compliance to ISO 27001 is risk assessment. The outlines for this risk assessment procedure are provided in ISO 27005. With risk assessment, an organization can

  • Identify any addressable vulnerabilities
  • Identify areas where it has secured client and employee information
  • Maintain its ISO certification by risk-based cyber-security programs.

Note: Since businesses continuously change and evolve, they must update their cyber-security infrastructure to counter the constantly evolving cyber-threats.

Additional Support

Sometimes, risk assessments alone cannot reassure an organization about ISO 27001 compliance. In these situations, the companies should look for an alternative, such as

  • Quick supplier vetting
  • Continuous and automated monitoring procedures
  • Critical alerts, etc.

Alysidia Solutions are Prepared Complied with ISO/IEC 27000 Series

All Alysidia solutions for medical devices and pharmaceutical companies are compliant with ISO 27000 standard series. Solutions developed by Alysidia are prepared based on guidelines in these standards. Our solutions are cost-effective and better than many of those available in the market. Contact Alysidia today, and get a glimpse of our end-to-end security encryption system.


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