A Case Study of Services

1. ©E.M.M.A. International Consulting Group, Inc. 1©E.M.M.A. International Consulting Group, Inc. 1
The Client X Project
A Case Study of Services

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Background
• Client X as a contract manufacturer for the Medical Device,
Automotive, Electronics and Telecommunications industries engaged
the services of E.M.M.A. International Consulting Group in the
Summer of 2014.
• Client X customers had been exerting immense pressure on the
organization to become ISO/TS 16949 & ISO 13485 certified. Of
course for customers in the Automotive industry, it was not a nice to
have, rather it was a requirement for Client X to obtain ISO/TS 16949
certification in order for them to gain any potential business from
Automotive companies.

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Background cont.
• As such, Client X engaged the services of E.M.M.A. International
Consulting Group, Inc. to completely revamp the business culture,
overhaul the Quality Management System, restructure the
organization into a corporate site in USA and an associated
manufacturing facility in Mexico, and obtain ISO 9001, ISO/TS 16949
& ISO 13485 certifications for both sites.

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Background cont.
• E.M.M.A. International Consulting Group, Inc. (hereafter E.M.M.A.)
was immediately faced with the following tasks:
• Assess Client X’s Quality Management System (QMS), its current state, and its
compliance with ISO 9001
• Perform a Gap Analysis to highlight the amount of work required to bring
Client X’s QMS in compliance with ISO 9001, ISO/TS 16949 & ISO 13485
• Assess Client X management team and organizational structure
• Assess Client X’s business culture
• Complete evaluation of Client X’s resources and infrastructure
• Development of project plan, strategy and path forward

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The Gap Analysis
• E.M.M.A. conducted its Gap Analysis of Client X’s QMS for both
facilities, whereby the E.M.M.A. team was able to:
• Gain full understanding of Client X’s operation and business culture
• Fully analyze Client X’s QMS
• Evaluate the resources and infrastructure for both locations
• Develop recommendations and strategy for path forward

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Organizational Restructuring
• E.M.M.A. specializes in the design and development of integrated
QMSs that comply with a multitude of international regulatory
requirements and/or ISO standards. Therefore, upon the completion
of the aforementioned Gap Analysis, E.M.M.A. presented the
appropriate recommendations and strategy to Client X’s CEO.
• With the abovementioned, the team of expert consultants at
E.M.M.A. determined that in an effort to comply with ISO 9001,
ISO/TS 16949 & ISO 13485 via the new integrated QMS, the
organizational structure had to be overhauled. As such, E.M.M.A.
guided Client X in establishing its new organizational structure and all
associated job descriptions, trainings, org chart modifications …etc.

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Organizational Restructuring cont.
• Inevitably, the major transformation occurred in the Quality
Assurance unit, whereby two groups were created. A Quality Systems
group, led by a Quality Systems Manager and a Manufacturing Quality
group, led by Manager of Manufacturing Quality. Additionally, a
newly created position of Director of Quality Assurance was
developed with aim to lead the global QA operation for corporate in
USA and in MX. Furthermore, the Quality Systems group was
organized in a way that positions it to govern global QA activities
across all facilities.

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QMS Development & Implementation
• The E.M.M.A. team of expert consultants developed the integrated
QMS, with all the necessary processes, procedures, work instructions
and forms. All of which is in compliance with ISO 9001, ISO/TS 16949
& ISO 13485. Moreover, E.M.M.A. provided training, mentoring and
coaching where necessary to help Client X during this
transformational journey.

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Audit Activities
• E.M.M.A. spearheaded and hosted all external audit activities for
Client X, which comprised of a total of 6 stage I & II audits for
corporate and for MX. All audits were successfully completed with
minor nonconformances identified. Currently, Client X has been
cleared to attain ISO 9001, ISO/TS 16949 & ISO 13485 certifications
for its integrated QMS.

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Overall Services Provided by E.M.M.A. to Client X
• Full & complete gap analysis
• Development of strategy & path forward
• Reengineering the organization via the new structure
• Creation of job descriptions
• Assistance in HR activities as pertains to job postings, recruitment and
interviewing
• Development of the new integrated QMS
• Development of Client X’s training program
• Development of Client X’s internal audit program

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Overall Services Provided by E.M.M.A. to Client X
cont.
• Extensive training sessions, 1:1 coaching & mentoring, and facilities-
wide training seminars
• Development of Client X’s Supplier Management program
• Deployment of an E.M.M.A. resource to serve as Client X’s interim
Director of QA
• Provide outsourcing services for the following roles:
• Automotive Quality Engineer
• Corporate Internal Auditor
• Supplier Quality Engineer

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Overall Services Provided by E.M.M.A. to Client X
cont.
• Deployment of several E.M.M.A. consultants to work on the activities
outlined herein
• Translation services for all new QMS documents to Spanish
• Assistance in the implementation of the new QMS
• Oversight of all external audit activities

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Contact E.M.M.A. for
additional information
Office Address:
27600 Farmington Rd. Suite 100
Farmington Hills, MI 48334
(P) 419-215-9108
(F) 248-479-0339