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

Ready to learn more about working with us?

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ISO Certification Resources

HIPAA and GDPR’s impact on Medical Devices

The European Union’s General Data Protection Regulation (GDPR), which was put into effect on May 25, 2018, is often considered to be one of world’s toughest laws when it comes to privacy and security. The regulations lay down privacy and security standards, imposing obligations on any/ all organizations having an impact on the people of EU, whether related to targeting or collecting data.

QSR and ISO 13485 Harmonization: Enforcement, the Ultimate Question

A couple of weeks ago I had the pleasure of moderating one of the Food and Drug Law Institute’s (FDLI) Law over Lunch Sessions. I spent my lunch hour with industry folks and lawyers discussing the forthcoming Quality System Regulation and ISO 13485 Harmonization. One topic emerged as the front-runner of what was on everyone’s mind: how is the FDA actually going to conduct enforcement for this? Can we expect to see a major change in FDA enforcement?