SERVICES

Quality System Implementation




  • Implement a new quality system for ISO 9001, ISO 13485, IATF 16949, AS9100D, ISO 14001, ISO 45001, ICH Q8, ICH Q9, ICH Q10
  • Simplify it to make it process-oriented
  • Transition from 9001 to other standards (e.g., IATF, 13485)
  • Can lead regulatory submission documentation preparation for medical devices and in vitro medical devices (for EU and US markets)
  • Set up to do virtual sessions


What sets SG Consulting apart from other implementers?


  • 100% success with 3rd party audits for over 50 implementations
  • Unique ability to design a quality system that is compliant and promotes continuous improvement. The Quality System helps identify opportunities for improvements
  • Most clients recover majority if not all costs of implementation within a year of implementation
  • Mentor employees and helps them own the quality system


What sets SG Consulting apart from other practitioners?


  • Over $750 MM in savings/growth over 1000 projects mentored
  • Can conduct a training or complete a project 
  • Can expect up to 10x returns for Green Belt trainings/projects and up to 30x returns on Black Belt trainings/projects
  • Can conduct training or complete a project in the areas of Lean Six Sigma, Kaizen, APQP, PPAP, 8D, Root Cause Analysis
  • Mentored over 1000 projects and completed over 50 Green Belt/Black Belt/RCA projects
  • Result-oriented ($$$) projects and trainings

Audits

  • Can help with internal audits, supplier audits or gap assessments
  • Areas of expertise include ISO 9001, ISO 13485, IATF 16949, AS9100D, ISO 14001, ISO 45001, ICH Q8, ICH Q9, ICH Q10
  • Set up for virtual audits or on-site audits

What sets SG Consulting apart from other auditors?


  • Experience of over 750 audit days across multiple standards
  • Audit style is catered to help clients improve their quality system (and not to count how many nonconformances can be found!)
  • Make recommendations and share best practices from multiple industries and companies


What sets SG Consulting from other trainers?


  • Training is customized for your company
  • Real-data used for continuous improvement trainings (such as LSS, 8D)
  • Experience with over 200 trainings done
  • Trainee engagement and involvement are a hallmark of our training (never has anyone fallen asleep in any training!)

Training

  • We cover training in a number of areas
  • ISO standards
  • Lead Auditor
  • Lean Six Sigma (Yellow Belt, Green Belt, Black Belt, Champion)
  • Production Part Approval Process (PPAP) / Advanced Product Quality Planning (APQP)
  • 8D/Root Cause Analysis
  • Set up for virtual and on-site trainings