ISO Standards Consulting

Have you lost a current or potential customer due to not having a particular ISO compatible Quality Management System (QMS)? Has a current customer informed you that without obtaining a particular ISO certification, you will be removed as an approved supplier? EMMA International can help provide the right ISO Certification Consulting Services for your organization.

We have assisted companies of all sizes who have faced these challenges. We will not only work with your organization, we will work with your current or potential customers as the trusted liaison until certification is obtained.

Trust us to provide the necessary trainings, cultural awareness workshops, and assist your organization in its journey towards certification. We specialize in designing, building and implementing integrated QMSs that are customizable to meet your compliance and business needs.

We can provide you with the consulting support you need to implement the desired QMS and attain certifications through 3rd party registrars.

We have the in-house expertise in:

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ISO 9001

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ISO 17025

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ISO 13485

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ISO 14971

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OHSAS 18001

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ISO 14001

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IATF 16949

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ISO 15189

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ISO 22000

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ISO Certification Resources

ISO 9001: An Overview

ISO 9001 is the international standard that specifies requirements for a quality management system (QMS) and is used to ensure that products and services meet quality and customer requirements. It is the most practiced standard in the ISO 9000 series. The first version of ISO 9001 was published in 1987 by the International Organization for Standardization with the most current version being released in September 2015.

What ISO Certification Means for Your Business

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.

Proposed EtO Rules for Sterilization and the Regulatory Impact

In April of this year, the FDA published two proposed regulations that, if finalized, would put limits on how much EtO can be used to sterilize products among other workplace/occupational hazard requirements. EtO, or ethylene oxide, is commonly used in the medical device industry to sterilize finished devices. Some examples of devices that are sterilized with EtO include gowns/drapes, heart valves, pacemakers, surgical drills, and catheters among many others.

EMMA International Consulting Group, Inc. Achieves ISO 9001:2015 Recertification

Bingham Farms, MI, July 13, 2023 –E.M.M.A. International Consulting Group, Inc. (EMMA International), a global leader in FDA compliance consulting, has achieved ISO 9001:2015 recertification for its quality management system (QMS). Obtaining ISO 9001:2015 recertification reinforces EMMA International’s commitment to continuing to be a global powerhouse in FDA compliance consulting by consistently meeting and exceeding the expectations of our clients.

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