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

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.

IEC 62304: Medical Device Software Life-Cycle Processes

The Food and Drug Administration (FDA) utilizes regulatory standards developed by non-governmental organizations as regulatory criteria for medical devices, these are referred to as recognized consensus standards [1]. Examples of some of the organizations that develop these standards are: International Organization for Standardization (ISO) standards, American Society for Testing and Materials (ASTM) standards, American National Standards Institute (ANSI) standards, International Electrotechnical Commission (IEC) standards, etc. The IEC is an organization that develops standards to standardize the electrical and electronic fields [2].

Recognized Consensus Standards

Under FDA compliance, to bring a medical device to market, there are a multitude of regulations that need to be accounted for and followed. Many of these regulations fall under the Code of Federal Regulations (CFR), however, others are known as recognized consensus standards. These recognized consensus standards are adopted from the International Organization for Standards (ISO), Clinical & Laboratory Standards Institute (CLSI), American Society for Testing and Materials (ASTM), American National Standards Institute (ANSI), Association for the Advancement of Medical Instruments (AAMI), International Electrotechnical Commission (IEC), or other Standards Development Organizations (SDOs). These standards can either be voluntary or required via being ‘incorporated by reference’ into the regulation (CFR) [1].

The Digitalization of Quality Management Systems

One blessing that occurred in the recent years is the rapid digitalization of business functions. It’s hard to imagine a time before the use of video calling or instant messaging to reach teammates or clients from across the world almost immediately.

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