What is ISO (International Organization for Standardization)?

ISO Definition

What is ISO

The International Organization for Standardization (ISO) is an international nongovernmental organization made up of national standards bodies; it develops and publishes a wide range of proprietary, industrial, and commercial standards and is comprised of representatives from various national standards organizations. ISO has a membership of 165 national standards bodies. Source: https://www.iso.org/about-us.html

ISO compliance refers to the creation of, and adherence to, policies, processes, and procedures. ISO standards include ISO 9000, ISO 9001, ISO 13485, and ISO 14971.

Example ISO Standards:

  • ISO 9000 Family: Quality Management
  • ISO 13485: Medical Devices
  • ISO/IEC 17025: Testing and Calibration Laboratories
  • ISO 20121: Sustainable Events
  • ISO 22000: Food Safety Management
  • ISO 26000: Social Responsibility
  • ISO/IEC 27001: Information Security Management
  • ISO 14971: Risk Management
  • ISO 3166: Country Codes


Although the process of getting certified can be time-consuming and costly, many businesses decide to pursue ISO certification for one or more of the following reasons:

  • Industry regulations – In order to market and sell products in certain countries, businesses become ISO certified to better align with the requirements set forth by the FDA, European Commission, and other regulatory bodies
  • Improved consistency and quality – Certification can help companies implement the necessary measures to ensure consistency across manufacturing processes and ultimately deliver safe and effective products
  • Customer satisfaction – Compliance with ISO standards can also help businesses quickly resolve customer issues and increase customer retention and revenue


ISO certification involves having an independent third-party organization provide assurance that a product or service meets the requirements of a particular ISO standard. Although the process will vary based on the type of standard and certifying body, the following steps are required.

  1. Implement a quality management system (QMS)
    A QMS provides the framework to help companies carry out processes in a systematic manner. It also provides a roadmap for meeting ISO and other quality standards.  The implementation of a QMS typically starts with a company’s overarching business goals and objectives which translate into policies, processes, and standard operating procedures (SOPs).

As you develop a QMS, keep these key elements in mind:

  • Quality policy and objectives
  • Quality manual
  • Organizational structure and responsibilities
  • Internal processes
  • Customer satisfaction
  • Continuous improvement
  • Document control
  • Enterprise quality management system (eQMS) software

Enterprise cloud-based solutions like Arena QMS connect product and quality records in a single system to help organizations easily manage corrective and preventive actions (CAPAs), customer complaints, SOPs, employee training records, and other processes that are essential for demonstrating compliance with ISO standards.

  1. Verify the effectiveness of your QMS
    Once the QMS is implemented, ensure that employees across the organization are properly trained on new polices and procedures. Conduct routine internal audits to ensure that processes are being followed as stated in documentation. Finally, identify any deficiencies and adjust as needed.
  2. Register your QMS with an ISO certifying body
    When selecting a third-party certification body, it is important to verify that the organization uses ISO’s Committee on Conformity Assessment (CASCO) standards. Also ensure that the organization is accredited. Once the certifying body is selected, submit the necessary QMS documentation for review. Upon review, the third-party organization will also perform an on-site audit to confirm that processes are being followed as documented.

The entire certification process can range from three to six months, depending on the size and complexity of your business.


What are the three standardizing agencies?

The three largest and most well-established such organizations are the International Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), and the International Telecommunication Union (ITU), which have each existed for more than 50 years (founded in 1947, 1906, and 1865).

*Source: https://en.wikipedia.org

Which international organizations develop international standards?

The International Organization for Standardization (ISO) is a global network of national standards organizations that creates and publishes a range of proprietary, industrial, and commercial standards. Since its inception in 1946, ISO has produced over 20,000 international standards and related papers.

*Source: https://www.investopedia.com

What is the purpose of the International Standardization Organization?

The ISO plays an important role in facilitating global trade by providing common standards across different countries. The standards are intended to ensure safe, reliable, and high-quality products.

*Source: https://www.investopedia.com


  • ISO standards are intended to ensure companies develop safe, effective, and high-quality products.
  • Many businesses pursue ISO certification to better align with various industry regulations, drive consistency and quality, and enhance customer satisfaction.
  • Manufacturers must implement a quality management system (QMS) as part of the ISO certification process.
  • Enterprise quality management system (eQMS) solutions help organizations easily manage corrective and preventive actions (CAPAs), customer complaints, SOPs, employee trainings, and other processes that are essential for demonstrating ISO compliance.


FDA and ISO audits are necessary for medical device companies, yet can be difficult and nerve-wracking. This article shared five tips to help prepare for an audit and pass one with confidence.