Ten Mistakes of Risk Management in the context of ISO 9001 / ISO 13485

Risk Management (RM) has been increasingly emphasized in ISO standards, and indeed risk based thinking is encouraged. However, there is no requirement for a documented process for the same. Many wonder what is really meant by risk based thinking and in the absence of a requirement for procedures for Risk Management, how does one imbed this in the organization.

Borrowing from his book (Ten Mistakes of Risk Management), Rai Chowdhary presents the most frequently observed mistakes organizations make as they try to integrate RM into their QMS and SOPs. His unique insight on how to do this in an effective manner has helped organizations across the world.

Areas Covered in the Session :

  • The most frequent ten mistakes with respect to implementing RM in conformance with ISO standards
  • Embedding RM within the QMS – simply and effectively, while addressing multiple clauses in the standards (addressing Products, Processes, Supply Chain, and more)
  • Tips on developing easy to use SOPs and records for RM
  • One key element that the standards do not cover, and other training programs do not cover – but could save your company from disaster
  • Setting up controls to ensure RM implementation sustains over time
  • Interactive Q&A Session
Who Will Benefit:

  • Quality Departments (Managers, Auditors, Engineers, Associates)
  • Regulatory Departments
  • Compliance Departments
  • Program Managers
  • Operations Departments
  • Site Managers
  • Corporate Quality Departments
  • Production Departments
  • New Quality Assurance Managers
  • ISO 13485/9001 Implementation Team Members
  • Management Representatives
  • Project and Program Management Teams
  • Safety and Quality Auditors

FDB2010

Rai Chowdhary

Rai Chowdhary brings over 30 years of business and technical expertise from diverse industries to bear during his workshops. He has implemented Risk Management in several organizations, and coached thousands of participants in the approach. He has worked with / for world leaders such as Applied Materials, Dell, DuPont, Frito-Lay, Tokyo Electron, Samsung, Intermedics Orthopedics / Sulzermedica, Abbott Spine, Amedica, Edwards Life Sciences, Evenflo, Reckitt Benckiser, Ultradent, Siemens, GE, Philips, and more.

Rai holds certifications from ASQ as: Quality Auditor, Quality Engineer, Quality Manager / Operations Excellence, and Six Sigma. He has conducted several workshops (including Lead Auditor training) on a vast range of topics such as: ISO 9001, 13485, 14971, IEC 62366, AS 9100, 21 CFR 820, MDDEV, Risk Management, Lean, Six Sigma, etc. He is an award winning presenter, and top rated workshop leader. His book on The Ten Mistakes of Risk Management was first published in 2007; an updated version is expected soon.

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