Institute of Technology & Business Development

Institute of Technology & Business Development


ISO 9001:2015 Revisions, Implementation and Risk Management Training

This course covers the fundamentals of the changes to the ISO 9001 Standards and how it will affect your current Quality Management System. Included will be review and interpretation of the new ISO 9001:2015 Standard as well as application of techniques during audit scenarios. Risk Management will address the requirements of ISO 9001:2015 for the successful implementation of a Risk Management program.

Day One:

  • Review of the ISO 9001:2015 vs. ISO 9001:2008 changes
  • ISO 9001:2015 fundamentals, Definitions, purpose, types
  • ISO 9001:2015 requirements, Types of audits
  • 3rd party auditing process and certification requirements
  • Definitions of key words in ISO Standards
  • Review of Standard requirements and summary of key points
  • General requirements, Changes from old Standard and newly emphasized points
  • General review of 10 major categories
  • Quality management system
  • Management responsibility, Resource management
  • Product realization, Measurement, analysis and improvement changes
  • Type of findings, Minor non-compliances, Major non-compliances
  • Recommendations, Corrective actions/follow-up
  • Internal audit process

Day Two: 

  • Define Risk Management for manufacturing industry
  • How to implement a system for Risk Management
  • Workshops for actual Risk Management implementation
  • Analysis as part of management review
  • Tools for effective Risk Management
  • Fishbone, 5 Why and Paredo Analysis and other tools for RM
  • How Risk Management is used in ISO 9001:2015/AS 9100/ISO 13485/FDA Part 820 QMS Systems
  • Differences of RM for aerospace, manufacturing, general industries
  • Problem solving techniques for Risk Management
  • Background of FMEA/PFMEA, Tools in using FMEA/PFMEA
  • Who is involved in FMEA/RM process, How to construct a FMEA and use in design
  • PFMEA process for manufacturing
  • Applicability for different industries such as manufacturing, aerospace, automotive, medical
  • FMEA/RM benefits


Registration Form

Date: October 5 and 6, 2015

Schedule: 8:30am-4:30pm

Location: Downtown Campus, 185 Main Street, New Britain, CT 06051

Cost: $695