B 131 ISO 9001:2015 Transitioning & Implementation 2016

Overview

Learn how to navigate the changes and understand the impact of the ISO 9001:2015 revisions on you and your organization. Leave the course with a formal, documented, detailed plan specific to your needs so you can meet the new requirements and provide the evidence to prove it.

Learn the specific differences between ISO 9001:2008 and ISO 9001:2015 and the rationale for these changes as well as the new requirements of ISO 9001:2015 including

specific methods for top management to demonstrate accountability for the Quality Management System,
steps needed to address “Risks and Opportunities” (Risk Based Thinking) and
“Organizational Knowledge”.

Leave with an understanding of the alignment requirements between the Quality Management System and the business objectives of the organization and the specific requirements for documented information and how to resolve the differences between ISO 9001:2008 and ISO 9001:2015. You'll define the context of your organization to meet this new stated requirement and learn specific methodologies for the identification of the needs and expectations of interested parties.

Gain an understanding of the steps an organization must take to update their current QMS to meet the requirements of ISO 9001:2015 and attain the related benefits and achieve value for your organization while decreasing the emphasis on documentation.

Learn methodologies for incorporating the needs of customers and interested parties into the processes that make up your organization's QMS.

Learning Objectives

Identify the differences between the two standards
Identify the clause alignment between the two standards
Given your organization, write an organizational Context that includes internal and external issues
Given your organization, determine Interested Parties and their requirements
Given your organization, determine Risks and Opportunities
Given your organization, identify knowledge that needs to be retained and maintained
Given your organization, identify the linkage between Context, Interested Parties, Risks, Opportunities and the processes within the QMS

Who Should Attend

Current users of ISO 9001:2008 who plan to implement ISO 9001:2015. Management at all levels, Quality personnel and others who need to understand the requirements of ISO 9001:2015. Personnel that need to develop a specific list of steps their organization will need to take to comply with the new requirements

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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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