RQMIS, Inc.

Consultant Listing

RQMIS, Inc.

RQMIS, Inc.

TAILORED SOLUTIONS FROM RQMIS, Inc. :
RQMIS listens to the needs of our clients and provide customized solutions to achieve their business objectives. Our support ranges from providing templates companies can use to customize for their company’s requirements to designing an entire quality system. RQMIS has been retained to and successfully completed the following projects in the past year:

Overall management of a company’s internal audit program
Manage/negotiate FDA Warning Letters
Conduct full Quality System audits for compliance with Medical Device, Pharmaceutical, Biologics and Tissue regulations
Design, implement and receive EN/ISO13485 certification on Quality Systems
Design process and forms to capture regulatory pathways and decisions to file premarket submission
Design reliability-verification protocols for design control activities
Develop and Training for Risk Management Program
RQMIS consultants provide both a depth of knowledge and experience that can be customized based upon a client’s needs. Examples of Quality System Consultants and Technical Writers that are available.
RQMIS Auditing Programs that include:
– Internal Audits to ensure meeting ISO 9001:2015; ISO 14001:2015; ISO 13485:2016 and IATF 16949
– Training and/or leading internal and supplier audit teams
– Performing Supplier Audits for supplier Selection Process
– Performing Supplier Audits for Supplier Qualification (ASL)
– Performing Supplier Audits for Risk Mitigation
– Parternering with Purchasing/Supplier Quality to determine Supplier Audit needs

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