What ISO Certification Means for Your Business

by | Aug 7, 2023 | Compliance, FDA, ISO, Medical Devices, QMS, Quality, Quality Systems, Regulatory, Risk Management

The wonderful thing about Quality is that it is industry agnostic. While certain industries, such as medical device and automotive, do have “special” requirements, the foundation of a Quality Management System is the same industry to industry. Obtaining ISO certification can be more than just a badge of honor for your organization, more and more customers and regulatory bodies are requiring ISO certification, which is why it’s more critical now than ever to consider it for your business.

There is a huge breadth of ISO certifications available, each one tailored to a unique service, business, and industry. The most common is ISO 9001, the general Quality Management System standard. There is also ISO 13485 for medical devices, IATF 16949 for automotive, and ISO 17025 for calibration/testing houses, just to name a few!

All businesses in the automotive industry are required to be compliant with IATF 16949. This standard is a harmonization of various requirements across the entire automotive supply chain and defines the requirements of a QMS for all organizations in the automotive industry. Medical device organizations are in a similar boat with ISO 13485, most regulatory bodies now require compliance to the standard, with the FDA following suit sometime in the near future.

But what is the benefit if you are not legally required? ISO Certification does require resources and time, but the overall value outweighs any upfront costs of certification and maintenance. Being ISO certified demonstrates to your customers that they can trust your products, there are risk mitigations in place for any failures, and that there is a higher threshold for customer service. In today’s day and age, ISO certification is a highly competitive edge that all organizations should consider.

If you need support with ISO Certification, EMMA International can help! From setting up your QMS, to working with registrars to set up certification audits, and supporting maintenance of your certified system, the experts at EMMA have you covered!

Give us a call at 248-987-4497 or email info@emmainternational.com today to learn more!

Emma International

Emma International

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