RESOURCES

Since 1991 QSC Group has provided senior level quality, environmental and regulatory consulting services to our client organizations. We have assisted more than 240 companies with all areas of compliance with the various standards such as ISO 9001, ISO 13485, ISO 14001, AS9100 and more. We have achieved unmatched success in our commitment to excellence and unparalleled attention to our customers’ needs. 
QSC Group’s consultants provide every level of quality system services including internal audits, management reviews, corrective actions, complaint handling, deviation management, gap assessments, training, risk management, change control, design and development, documentation systems and record management systems. Trust QSC Group to ensure success with your quality assurance, environmental management and regulatory compliance needs.

We provide quality management services and training including:

ISO 9001:2008
ISO 13485:2003
FDA GMP – 21 CFR 820
AS9100D (2009)
ISO 19770-1
ISO 14001:2004
ISO 27001:2005
ITAR Compliance and Registration
201 CMR 17.00 Protection of Personal Information (Massachusetts Regulation)

Helpful Industry Links:

Achieve Global / Zenger-Miller
American Society for Quality (ASQ)
Association of the Advancement of Medical Instrumentation (AAMI)
British Standards Institution (BSI)
Bureau Veritas
Food and Drug Administration (FDA)
International Organization for Standardization (ISO)
International Traffic in Arms Regulations (ITAR)
Intertek
ITAK
Massachusetts Medical Device Development Center (M2D2)
National Quality Assurance (NQA) 
NEMKO 
Perry Johnson