B 132 Risk Based Thinking for ISO 9001 2016

Overview

Learn about the risk and opportunity management requirements in the ISO 9001:2015 revision as well as the implications these requirements have for your organization. Learn what “Risk Based Thinking” means and what an effective Risk Management Program looks like.

Learning Objectives

Identify and manage risks and opportunities associated with the requirement contained in ISO 9001:2015
Determine risks and opportunities important to customers and other interested parties
Learn risk and opportunity reporting requirements embedded in Management Review process
Identify needs and expectations of interested parties
Understand steps needed to implement risk and opportunity management
Identify risks that may arise from decreased emphasis on documents and records
Select appropriate Risk Management tools that will meet your organization’s needs

Who Should Attend

Managers, Management Representatives, Engineers and anyone who will be using ISO 9001:2015 and need to understand the risk and opportunity management requirements contained within the standard, and how to implement them.

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Important: All attendees are required to bring their own copy of the ASQ/ANSI/ISO 9001:2015: Quality Management Systems - Requirements to this training.

Instructor Chuck Mignosa

Instructor Bio

Mr. Mignosa has over 30 years of diversified experience in high technology, aerospace, telecommunications, food processing and biomedical device industries. He is an RAB/QSA Certified Lead Auditor Trainer (Certificate No. LA576).

He has 25 years of experience in IBM holding patents in solid lubricants. He was the Project Manager in charge of implementing quality systems. He is a certified course developer and has developed many customized courses; some examples are Total Quality Management, Continuous Flow Manufacturing, Customer Driven Quality, Statistical Design and Analysis of Experiments, Team Building, Six Sigma, and Communication Skills. He also was involved with IBM’s Six Sigma projects which were designed after Motorola’s program.

He has delivered courses in Management Development, Team Building, Organizational Excellence, Conflict Resolution, the Stephen Covey 7 Habits of Highly Effective People and Principle Centered Leadership, along with many other topics.

After leaving IBM he worked as an independent consultant. He has consulted for and done training with such companies as IBM, SanDisk, Owens Corning, Heinz USA, Siemens Automotive, General Mills, Connors Peripherals, HP, ADAC Labs, and many more. He has been an adjunct instructor with the University of Notre Dame, Nova University and the University of Nevada Las Vegas.

He spent 3 years as the Director of Quality for Cholestech Corporation where he brought them into FDA compliance and registered to ISO9001, and ISO 13485.

He spent 2 years as VP of Quality at P-COM, a telecommunications equipment development company where he reduced out of box failures from 30% to less than 1%.

Mr. Mignosa is President and CEO of Business Systems Architects, L.L.C. His teams specialize in the design and implementation of business and quality management systems, organizational excellence, continuous improvement Lean/Six Sigma, and strategic planning. His partners include H. James Harrington of the Harrington Institute and Jerry Mairani of the Institute of Performance Improvement.

In addition to a B.S. in Chemistry from San Jose State University, Mr. Mignosa has completed graduate work in Statistics at Stanford, a Masters in Systems Engineering at Systems Research Institute in New York and Management training with IBM. He is a senior member of ASQ, and is a certified Master Black Belt Trainer.

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Course Times

8:00 a.m - 5:00 p.m.

Lunch Break: 12:00 - 1:00 p.m.

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Course Details

Prerequisites: Copy of ISO 9001:2015 Standard

Hardware: N/A | Software: N/A

Required Materials:

- Proof of online Payment

- Pencil and Paper, laptop/tablet if you prefer

- If you are an ASQ member, a current-dated ASQ Membership ID

- Valid ID(s): sites may require US citizens to provide a Driver's License or a State-Issued ID; if you are not a US citizen you must bring 2 valid forms of identification

Learning Method: Lectures, teams, hands on approach, and discussions

Class Time: 8 hours

Class Size: 25 max. participants

Facilities: Room with PC projector, whiteboard, etc.

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