What is ISO Compliance?

ISO Compliance Definition

ISO compliance is following the requirements of the ISO standards, focusing on decisions that create policies, processes, and procedures that adhere to the specifications set forth within the ISO. When companies are considered ISO compliant, that means all the standards of the International Organization for Standardization have been met. There are thousands of standards that serve as the framework for companies and organizations to standardize business practices. Increasing an organization’s external reputation and making improvements to the business operations are two benefits of ISO compliance. ISO standards include ISO 9000, ISO 9001, ISO 13485, and ISO 14971.

What is a ISO Compliance


Why is it important to be ISO certified?

ISO certification provides companies the framework to streamline productivity, ensure consistency and safety of products, improve customer satisfaction, and expand business into global markets.

There are various ISO standards that companies can follow and each offers different benefits to the manufacturer and its customers.

*Source: https://blog.swantonweld.com/why-iso-certification-is-important

What does it mean to be ISO compliant?

ISO compliance means adhering to the requirements of ISO standards without the formalized certification and recertification process. For example, organizations may choose to follow guidelines for establishing a quality management system as outlined in ISO 9001. Unlike ISO 9001 certification which requires a series of audits, ISO compliance focuses on using the standards as a way to make decisions regarding policies, procedures, and processes so that they align with the specifications.

*Source: https://smallbusiness.chron.com/iso-compliant-61481.html

What is the purpose of an ISO audit?

An ISO audit is designed to:

  • Ensure your quality management system (QMS) complies with the appicable ISO standard
  • Ensure your organization takes the appropriate actions to meet your quality objectives
  • Ensure processes are running according to the way they are designed
  • Identify any existing nonconformities and ensure plans are in place to properly address them

*Source: https://www.qmsuk.com/iso-standards/iso-9001/audit

Who needs ISO certification?

Although it is not necessarily a requirement, ISO certification benefits a wide range of companies, especially those that are involved in manufacturing or service-based industries. Adherence to the ISO standards enables these organizations to maximize operational efficiency and enhance customer satisfaction.

*Source: https://www.iso-9001-checklist.co.uk/is-ISO-9001-a-legal-requirement.htm

What is the difference between ISO Compliance and ISO Certification?

ISO certification means that a third party has independently validated that an organization conforms to a set of standards established by the International Organization for Standardization (ISO).

ISO compliance means that companies adhere to the requirements of ISO standards without the formal certification and recertification processes.

To date, the ISO has developed over 22,000 international standards covering multiple industries and topics. One group of these standards, the ISO 9000 family of quality management standards, aims to help organizations deliver better products and services that are safer, more secure and more resilient, as well as environmentally friendly.

Source: https://reciprocity.com/resources/iso-compliance-vs-certification-whats-the-difference/

Best Practices

An FDA or ISO audit is a necessary and potentially difficult part of doing business for any medical device manufacturer. Get 5 tips to pass your FDA or ISO audit with confidence.