Quotations

“Change is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”                             
Charles Darwin

“Data is directional, Change is emotional”
Dan Feliciano (GE MBB)
“There is nothing more powerful than an idea whose time has come”
Victor Hugo
“Uncertainty and mystery are energies of life. Don't let them scare
you unduly, for they keep boredom at bay and spark creativity”                           
R.I. Fitzhenry
"Failure is simply the opportunity to begin again, this time more intelligently."
Henry Ford

"Never mistake knowledge for wisdom. One helps you make a living; the other helps you make a life."
Sandra Carey
"No great discovery was ever made without a bold guess."
Isaac Newton

"Control without action is simply a hobby."
Kauru Ishikawa

“ Problems breed problems and the lack of a disciplined method of openly attacking them breeds more problems."
Philip Crosby

“An old error is always more popular than a new truth."
German Proverb

"You can't do today's job with yesterday's methods and be in business tomorrow."
"We are what we repeatedly do. Excellence, then, is not an act, but a habit." 
Aristotle
“To achieve Quality there is no substitute for knowledge”
 Deming
 “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.”
William A. Foster
"Impossibilities are merely things which have not yet learnt"  Charles W. Chestnutt

QMS Implementation & Certification

Quality Management System (QMS)

William A. Foster once noted, “Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skilful execution; it represents the wise choice of many alternatives.”

Whether you need to establish your Quality System for a new facility, make an existing system more effective, demonstrate compliance to a regulatory or customer-imposed requirement, or prepare for registration to a standard to be recognized globally, our team of highly experienced professionals are available to support you and meet your deadlines and schedules, no matter how stringent that may be! 

We will provide a quick overview of how well you meet industry best practices for Quality Management Systems, and offer guidelines on how to reduce risks that could affect the quality of your processes, your eligibility for site registration and/or product licensing, as well as the quality of the services and products delivered to your customers.
 

Implementation Services

We design Quality Assurance and Regulatory Affairs programs in accordance with various recognized standards as applicable to your needs. We will deliver not only the processes, but also the required documentation and procedures to capture know-how and grant you certification. 


QMS SERVICES

  • Development and training based on ISO 9000, ISO 14000, AS 9000, ISO 14385, ISO/IEC 17025, TS 16949, EFQM ,CAMDCAS, CGMP, NHPD, JGMP, FDA 
  • Cost Of Quality and establishing proper metrics to measure QMS performance
  • Root-cause Analysis and Corrective and Preventive Action, including mistake proofing
  • Risk management for sustainability of operation
  • Supplier QMS evaluation and monitoring
  • Effective documentation and procedure writing

AUDITS

  • Gap analysis audits to establish the degree of compliance with the specific standard
  • Pre-assessment audits to ensure that any non-conformance is actioned
  • Full or partial internal audits to evaluate how effective QMS is and where to improve or deploy better
  • Subcontractor or supplier audits to evaluate supplier compliance to contractual QMS and technical/management requirements

Site and Product Licensing

21 CFR 820, Quality System Requirements, FDA
CAMDCAS, Canadian Medical Device Conformity Assessment, Health Canada
CGMP, NHPD, Health Canada
CE Marking, EU
JGMP, Japan Good Manufacturing Practices
Turkish Ministry Health regulations for medical devices