What is ISO (International Organization for Standardization)?

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ISO Definition

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

WHY ISO CERTIFICATION MATTERS

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 PROCESS

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.

2. 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.
3. 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.

Related Articles

• Delivering Safe, High-Quality Products
• Improving Compliance

External Resources

• ISO – About Us
• What Exactly Is ISO Certified? And Why Does It Matter?
• International Organization for Standardization
• International Organization for Standardization (ISO)

Related Terms

• ISO 9000
• ISO 13485
• ISO 14971
• FDA
• Current Good Manufacturing Practices (CGMPs)