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  • Agenda 2016

Technical Sessions

Please take a look at the line up below for the past conference to see the quality of the technical program....

Day 1

Keynote: A New Era for the ISO 9001:2015 Standard

7:30 AM – 8:00 AM Continental Breakfast
8:00 AM – 8:10 AM Opening Remarks
Lorri Hunt, Chair, 2016 ISO 9000 World Conference

8:15 AM – 9:00 AM; Session #ISO-011
It's Déjà Vu! ISO 9001:2015 Revision Documentation vs. Auditability
Lorri Hunt, Lead U.S. Delegate to ISO TC176/SC2; President, Lorri Hunt & Associates, Inc.

ISO 9001:2015 brings a change in perspective for users by no longer requiring documented procedures. It provides organizations even more flexibility in determining what documented information it requires than in past versions. This has been something users have asked for in the past; now that they have it, many are concerned about what to do. Even more stressful to the user is not knowing how the change in requirements will be audited.

This session will focus on setting the stage for an organization to own its Quality Management System's documentation and remind users that they have gone through this kind of change and survived. It will help the organization use risk-based thinking to make a determination of when documented information is necessary. Finally, it will provide tips on how the organization can audit as well as be audited with minimal documented information.

9:00 AM – 9:45 AM; Session #ISO-012
Status Update on the Role of Registrars After the ISO 9001:2015 Revision
Randy Dougherty, Vice President, ANSI-ASQ National Accreditation Board

This presentation will explain the evolution of the global accreditation system for conformity assessment, including accreditation for certification to ISO 9001. It will explain the International Laboratory Accreditation Cooperation Multi-lateral Mutual Recognition Arrangement (ILAC MRA) and International Accreditation Forum Multi-lateral Mutual Recognition Arrangement (IAF MLA), and how these help facilitate trade globally and reduce technical barriers to trade. The system uses the international standards known as the CASCO tool box, the ISO/IEC conformity assessment standards.

ISO/IEC 17011, the standard for accreditation bodies, is currently in revision; the presentation will include information on the status of the revision. ISO/IEC 17021-1, the standard for management systems CBs, was published in June 2015; the presentation will report on the status of transition by CBs. The latest revisions to ISO 9001 and ISO 14001 were both published in September 2015; the presentation will report on the status of the three year transition.

9:45 AM – 10:15 AM; Refreshment Break

Plenary: What You Need to Know About the
ISO 9001:2015 Standard

10:15 AM – 11:00 AM; Session #ISO-021
Integrating Management Systems – A Journey
Craig Williams, The Convener for ISO/TC176/SC1/WG1; Vice President of Quality, Johnson Controls Power Solutions

This presentation will give the audience an opportunity to explore the challenges and benefits of integratingmanagement systems. The speaker will be sharing the experiences of such a journey that is being taken by a large global diversified industrial company. There are many challenges along the way in going from a regionally based or decentralized company to a more centralized and standardized organization while integrating its management systems. However, the benefits and synergies achieved in the long run are the prize for the effort. Some of the aspects of the journey that will be discussed are:

  • Addressing the need and desire to change
  • Developing one operating system
  • Understanding where standardization makes sense
  • Impacts on a large and diversified organization
  • Maturity models versus compliance alone
  • The next steps along the path

11:00 AM – 11:55 AM; Session #ISO-022
ISO 9001:2015 Revision - Panel Discussion
Panel Lead Lorri Hunt, Lead U.S. Delegate to ISO TC176/SC2; President, Lorri Hunt & Associates, Inc.

Panel Members:
  • Alan Daniels, Vice Chairman, US ISO TAG 176; Regulatory and Quality Systems Oversight (RQSO) QMS Strategy, Integration and Industry Standards Management, The Boeing Company
  • Randy Dougherty, Vice President, ANSIASQ National Accreditation Board
  • Jose Dominguez, Director, Plexus International, Mexico, ISO International Organization for Standardization TC176/SC2 Head of Delegation, INLAC
  • Jack West, Past Chair, US TAG to ISO TC 176 (19972005) and the Lead Delegate from the U.S. to the International Standards Organization; Advisor, Silver Fox Advisors
  • Craig Williams, The Convener for ISO/TC176/SC1/WG1; Vice President of Quality, Johnson Controls Power Solutions

12:00 PM – 1:00 PM; Networking Luncheon

Concurrent Session
1:00 PM – 1:35 PM; Session #ISO-031
Keeping Internal Audits Fresh
William Houser, Eagle Force, Inc.

All ISO based standards require that internal audits be performed periodically to ensure that the management system complies with requirements of the respective standard. Most internal audit systems start out strong, but then run out of steam as the same basic internal audit approach continues to be used over and over. When internal audits follow the identical process over and over, the internal auditors tend to become bored, those being audited tend to view the ordeal as a waste of time, and management interest tends to fade away. Consequently, in many organizations internal audits deteriorate to an obligation necessary to meet the requirements of the standard rather than a value adding process. To keep internal audits fresh, the audit process must be examined. 

1:35 PM – 2:10 PM; Session #ISO-032
Value Added Auditing
William Kovacich, Caterpillar, Inc.

Large, multisite organizations many times function as small, independent businesses within the larger enterprise. The result is often an autonomous approach to QMS deployment and suboptimal knowledge sharing within the broader organization. This “siloed” approach can be mitigated through a centrally coordinated team comprised of—or in close collaboration with—internal subject matter experts in various QMS processes. This team facilitates deployment of a single, comprehensive Quality Management System consisting of best practices observed throughout the enterprise. Furthermore, the team assesses the effective implementation of the Quality Management System, and through its experience, brings value to the audit program by propagating these best practices as they are developed. Attendees will learn how Caterpillar improves quality performance and adherence to its Quality Management System through an internal—but independent—2nd party audit group. 

2:10 PM – 2:45 PM; Session #ISO-033
Incorporating Lean & Six Sigma Into Your ISO 9001 Auditing Program
Scott Smith, SWS Lean Training and Consulting, LLC

The presentation explores how you can use Lean & Six Sigma tools to both identify quality issues during the planning and execution of the quality audit and also use additional tools to remove issues after identification. The presentation also explains how a robust lean management system will aid in preventing issues. The attendee will learn fundamentals of Lean & Six Sigma and how to apply the tools in the planning, execution, and follow up to the ISO 9001 audit. This presentation will review the following concepts: audit planning, PDCA, identifying waste during an audit, Value Stream Mapping, SIPOC, 8 Wastes, SPC, removing waste (Corrective and Preventative Actions), Ishikawa Diagram (fishbone), FMEA, SMED, Heijunka, and Poka Yoke. This presentation is geared towards auditors from novice to lead auditors.

2:45 PM – 3:15 PM; Refreshment Break

Transitioning to the ISO 9001:2015 Standard

Concurrent Session
1:00 PM – 1:35 PM; Session #ISO-041

Implementing ISO 9001:2015 Changes
Patsy Brown, Lennox Industries

As the Quality Director for the Lennox Industries manufacturing plant in Stuttgart, AR, Patsy is responsible for leading the implementation of the ISO 9001:2015 changes. In this presentation, She will describe the approach they are taking to ensure compliance with the requirements of the new standard. The presenter will review the following:
  • Overview of the facility, products, management system
  • Coordination with the registrar for the "upgrade" audit
  • Identification of the Implementation Team
  • Training Plan
  • Progress toward execution

1:35 PM – 2:10 PM; Session #ISO-042
Transitioning to ISO 9001:2015 - Lessons Learned
Charli Hoialmen, Diversified Management Systems, Inc.

This presentation will present two case studies of organizations that were among the very first to undergo a conformance audit to the ISO 9001:2015 Standard, transitioning from ISO 9001:2008, and the lessons we learned from the audits. We will discuss how we converted their existing systems to meet the criteria of the new standard, presenting the challenges we encountered, and changes to the existing systems that were necessary to achieve conformance. The case studies will present the perspective of the organization, both positive and negative, and whether they thought these changes would be of benefit for their organization. We will also present the perspective of the auditor on the interpretation of the standard, including those areas that we did not define satisfactorily and those we did well.

2:10 PM – 2:45 PM; Session #ISO-043
One Case of Implementing ISO 9001:2015
M. M. Christensen, MSME, P.E. Retired, TQM Systems

This presentation will be a case study from a small business implementing ISO 9001:2015. Some of the issues that did not go well and some of the things that went well will be discussed. This company employs about 20 people and is seeking certification as both a system improvement project and to aid in marketing the company. The organization had some documents that had been developed over several years. They were patterned after ISO 9001:2008. With the ISO 9001:2015 version published, they needed to revise the system to comply with the 2015 version. This presentation will point out the changes needed. Some process changes may be necessary, and these will also be mentioned. When system benefits are directly attributed to the use of ISO 9001:2015, these will be pointed out as part of the return on investment. The company is seeking to become certified for the first time; this is not a transition implementation. Where appropriate, some ideas from another company's implementation will be noted when different views are of value.

2:45 PM – 3:15 PM; Refreshment Break

ISO 9001:2015 Standard and Risk-Based Thinking

Concurrent Session
1:00 PM – 1:35 PM; Session #ISO-051
Comprehensive Risk- Based Thinking

ISO 9001:2015 Clause 6.1, "Actions to address risks and opportunities," is among the biggest changes to the standard, but it is far from specific as to the scope of the risks and opportunities an organization should consider. The current paradigm is that risks relate to negative outcomes such as poor quality, and many of ISO 9001:2008's provisions already cover those risks. This paradigm can blind an organization to the far greater risk of failure to identify and exploit an opportunity to (1) exploit or adapt to a new technology or (2) remove waste or “muda” from a supply chain. What we don't do right can therefore, be far costlier than what we do wrong.

1:35 PM – 2:10 PM; Session #ISO-052
Struggling Against Nature - Preventing Human Error in the New ISO 9001:2015 Standard
Matt Leiphart, Cavendish Scott

"To err is human," and now the new ISO 9001:2015 requires us to take this truth headon in section 8.5.1. Quality problems caused by human error have existed since the invention of the wheel. Now quality professionals can no longer attribute "human error" as a cause that cannot be eliminated. Methods exist to prevent human error, and many of them were present in the old version of ISO 9001, and these methods will be carried into the new version of the standard. Through an exploration of key aspects of the new ISO 9001 standard and reallife examples, this presentation will display best practices for eliminating human error using a hierarchy of controls present in other sections of the ISO 9001 standard.

2:10 PM – 2:45 PM; Session #ISO-053
Don't Toss Out Good Preventive Action Practices
Denise Robitaille, Robitaille Associates

The ISO 9001 requirements pertaining to preventive action would get a lot more attention if people grasped the very simple fact that this is all about managing risk—which is really about managing the consequences of change. Whenever we change something, even for the better, there are consequences— ripples across the waters through which we navigate our Quality Management Systems. The new ISO 9001 standard has done away with the term "preventive action." It has been replaced with the concept of "riskbased thinking." While the focus on risk is a great move towards more effective activities, there are many organizations who experienced benefit from the now defunct preventive action requirements.This session will discuss how to migrate the best preventive action practices into the new riskbased thinking culture.

2:45 PM – 3:15 PM; Refreshment Break

In-Depth Session: ISO 9001:2015 Standard Overview 

Concurrent Session
5:00 PM – 7:00 PM; Session #ISO-061
Step By Step Guide to ISO 9001:2015 Standard
Jack West, Past Chair of the US TAG to ISO TC176 and the U.S. Lead Delegate; Advisor, Silver Fox Advisor; and Charlie Cianfrani, US Expert Representative to the ISO/TC 176

The International Organization for Standardization has recently published an update to the ISO 9001 standard. The title of this publication is ISO 9001:2015 Quality Management Systems – Requirements. This Standard has been widely recognized and embraced throughout the world with over 1,000,000 organizations independently certified as compliant with its requirements.

The 2015 publication is a major update to the Standard, the first since the 2000 edition. It incorporates a new structure, old requirements are restated in new ways and others, to some organizations, will be perceived as new requirements. There are also many nuances in the current edition that organizations will need to consider when contemplating what changes, if any, are required to their Quality Management System (QMS) to ensure compliance with ISO 9001:2015 requirements.

This latest edition is very important to many organizations for several reasons. First, customers may continue to require demonstration of compliance with its requirements. More importantly, it provides a model to enhance internal process effectiveness while also enhancing customer satisfaction. And most importantly, the processes it requires have been widely recognized as value adding to organizational achievement of its objectives. This session is focused on providing an overview of the Standard to enable quality professionals and all other personnel of the organization to understand what the Standard says and what it means. It also will provide insight into approaches for achieving effective compliance as the organization transitions processes to ensure compliance with the ISO 9001 requirements. This session will cover the following key aspects of ISO 9001:2015:

  • When will migration from ISO 9001:2008 be required
  • The implications of the “new” footprint for users, i.e., Annex SL
  • Understanding the concepts of “the organization and its context,” “the needs and expectations of interested parties,” and how to “determine the scope of the Quality Management System”
  • The change in wording from documents and records to "documented information" and the implications of this change
  • Risk based thinking requirements and the interaction with corrective action and preventive action
  • New requirements for top management leadership and the competence and awareness of staff
  • Internal audit and certification audit implications

The session is presented by Jack West or Charlie Cianfrani, who have directly participated internationally in actually writing both ISO 9001 and ISO 9004 since 1990.

Using the ISO 9001:2015 Standard for Transforming Businesses

Concurrent Session
3:15 PM – 3:50 PM; Session #ISO-071
Useful Tips and Helpful Hints for Sustaining Results
Jd Marhevko, Accuride Corporation

This is a high-level session on how to utilize Hoshin Kanri at the organizational level. Participants will develop an understanding of Hoshin Kanri and review a Lean Systems Plan (LMS) charter that can be tailored to their organization structure via a provided model. The session will help attendees visualize, articulate, and execute a plan to meet their organizational goals and objectives; and to share an LSS approach that enables cross- functional team alignment both horizontally and vertically.

3:50 PM – 4:25 PM; Session #ISO-072
Getting the Context Right: Using Simple SWOT Analysis to Address ISO 9001:2015 Standard
Colin Gray, Cavendish Scott, Inc.

SWOT, which stands for Strengths, Weaknesses, Opportunities, and Threats, is an analytical framework that can help your company face its greatest challenges and find its most promising new markets. SWOT is a simple approach to address internal and external issues and it has been tried and tested millions of times and is recognized as being straight forward enough for those entering the corporate world for the first time. This presentation revisits this established technique and explains how it can be used in any organization as a method to address this ISO requirement. It explains why this is important and how it will help with quality. It outlines the difficulties, constraints, and the limitations it has, and how different approaches (yes more acronyms) can be used in different situations and in different types of organization - especially the differences between larger and smaller organizations.

4:25 PM – 5:00 PM; Session #ISO-073
ISO 9001:2015's Lessons for Leadership

With the revised standards, there are new requirements for greater leadership involvement in the management system, which must be evident not only in the organization’s processes, but in its policies, objectives, and overarching strategic direction. Recognizing that an effective Quality Management System cannot be achieved without the commitment of the organization’s leadership, ISO has codified this requirement into seven broad areas. Points to be discussed include: Responsibility, Policy, Objectives, Integration, Compliance, Operational Awareness, and Authorities. Participants will have an understanding of what leadership looks like through the eyes of an auditor, ways to weave quality through various levels of the organization.

6:00 PM – 7:00 PM; Networking Reception

2016 Revisions of the AS9100 Aviation, Space, and Defense Quality Standard

Concurrent Session
3:15 PM – 3:50 PM; Session #ISO-081
AS9100:2016 Revision: The Key Changes and How to Apply Them
Alan Daniels, The Boeing Company; and Buddy Cressionnie, Lockheed Martin Aeronautics

This presentation will provide participants with an inside look into the changes  in the 2016 revisions of the AS9100 aviation, space, and defense quality standard. The presentation will also offer an opportunity to look inside the International Aerospace Quality Group (IAQG), its strategy, the most current trends and developments, and discuss how a closed loop system works for a Quality Management System and the benefits it brings. This is a good time and opportunity to reinvigorate your organization's Quality Management System and ensure that it aligns with the strategic direction of the organization.

3:50 PM – 4:25 PM; Session #ISO-082
New Aerospace Counterfeit Parts Standards and Certification

Dale K. Gordon, ANAB

Counterfeit electronic parts pose a significant risk to performance, reliability, and safety. There is concern about this situation in the aerospace industry and now standards are in place to address this problem. One standard intended to be used by buyers of electronic components is AS5553 “Counterfeit Electronic Parts: Avoidance, Detection, Mitigation and Disposition.” The standard was developed by members from the US Government, Military, and Commercial Aerospace Companies. This presentation will give the attendee an understanding of the Counterfeit Electronic Parts standards, the certification scheme in place for AS5553, and how the standards link with the ISO & AS9100 series of standards.

4:30 PM – 5:30 PM; Session #ISO-091
ISO 9000 Speed Networking
Brian Clark, Praxis 8 LLC

Last year, the number one request from attendees according to our survey was networking. Space is limited so please sign up in advance. Speed networking will be in a round robin model, facilitating the meeting of individuals with similar goals, and the opportunity to exchange information in a structured environment. Each attendee is guaranteed to meet more people than they would in a traditional networking session. Sometimes individuals with a propensity for mastering the concepts of quality management, Six Sigma, and SPC may have less propensity for social interaction.

Whether you are an introvert or extrovert, starting out your career in the quality field or a seasoned professional, you will enjoy this format for meeting other professionals. Typically, participants are randomly paired and a signal is given for a three minute discussion. This is enough time for introductions and to gain a quick impression. You’ll be amazed at the results from a short confab with someone you’ve never met in this quick and simple networking setup. Meaningful conversations, clients, projects, jobs, and friendships can develop from connections started at a speed networking session!

Day 2

Plenary: Key Trends in Certification and Auditing

7:30 AM – 8:00 AM Continental Breakfast
Concurrent Session
8:00 AM – 8:05 AM Opening Remarks

8:05 AM – 8:40 AM; Session #ISO-101
Why You Should Care That Your Certification Body is Accredited
John J. Knappenberger, ANSI/ASQ National Accreditation Board

The ANSI/ASQ National Accreditation Board (ANAB) accredits certification bodies, testing and calibration laboratories, forensic test agencies, inspection bodies, police crime units, reference material producers, and proficiency testing providers. The presenter will explain how you wouldn’t want to be treated by a doctor who isn’t board certified in her specialty, or send your child to a college that isn’t accredited. Like medical and educational accrediting bodies, ANAB conducts audits to make sure our customers follow international standards and are competent to do their work. The work ANAB does helps facilitate international trade, and eliminate the expense of redundant audits and tests. While the work of ANAB is important, it does not operate in a vacuum. The presenter will give examples of how they contributed to the good of a greater whole.

8:40 AM – 9:15 AM; Session #ISO-102
Leveling the Playing Field With Your Certification Body
Jose Dominguez, Plexus Mexico

Understanding the rules always provides for a more level playing field  This include the rules for your certification body.  This presentation will highlight specific elements of ISO/IEC 17021-1 that are relevant for a client of a Certification Body.  It will help you understand the requirements that the certification bodies must follow, including certification activities such as application, quotation, contracting, establishment.

This session will provide  a better understanding of the relevance of ISO/IEC 17021-1 during their third party audits, resulting in better management of the certification activities.nt of the audit program, deployment of the audit program, and certification activities. This will help certified organizations understand why the certification bodies take certain approaches.  Relevant information from ISO/CASCO and IAF will be discussed during the session. 

9:15 AM – 9:50 AM; Session #ISO-103
Implementation Focused on Results Rather than Pleasing Certification Body Auditors
Denise Robitaille, Robitaille Associates

With the recent release of ISO 9001:2015, organizations are asking: “What will the 
auditors being looking for?" They are focusing their energies on pleasing the CB auditors. The auditability question should be secondary. This session will discuss the need to implement revisions to ISO 9001:2015 with a goal of improvement and value. It's possible and highly likely that a system that is established and implemented to reach its goals, create value, and experience improvement will logically produce results that will satisfy an auditor.

9:50 AM – 10:15 AM; Refreshment Break

Challenges & Opportunities in QMS Implementation

Concurrent Session
10:15 AM – 10:50 AM; Session #ISO-111
An Effective QMS is About People, Not Paper
Tim O'Hanlon, Ph.D. MBA FCQI, GE Healthcare Finnamore

GE has a legacy of innovation and leadership since 1878 - imagination at work. The National Health Service, in the UK faces severe financial pressures. As an early adopter of the ISO 9001:2015 standard, GE Healthcare Finnamore took the opportunity to challenge the value-adding attributes of its QMS. The presenter will explain how to engage and measure leadership involvement in the QMS, to align individual and team objectives with the overall strategy through the principles of Hoshin Kanri; to address risks and opportunities, operational, and strategic level; to measure hygiene factors every month and review them at board level; to map and share organizational learning; and to apply the requirements of ISO 9001:2015 throughout the design and deployment of the business operating model.

10:50 AM – 11:25 AM; Session #ISO-112
Face Challenges While Driving Continual Improvement
Susan Moore, Lockheed Martin Missiles and Fire Control

In the early 1980’s, a Lockheed Martin Product Oriented Survey identified several issues in facilities. The workforce failed to follow procedures and were weak in documentation control. This revealed systemic problems and limited employee involvement. By the mid 1980’s, the company initiated a process to drive a culture change. Employee involvement was encouraged. Greater emphasis was placed on Quality as the #1 priority. Teams were formed and their performance was closely monitored. Achievements were recognized. These teams were formed from natural work groups to empower employees to strive for continuous improvements. Teams were encouraged to report any/all compliance issues and take action to minimize the risk. The presenter will explain how these teams formed and worked together successfully.

11:25 AM – 12:00 PM; Session #ISO-113
How to Prepare Your Top Management for an Audit!
Dan Reid, Omnex Engineering and Management

Some companies pursue independent certification of their management system as a result of a customer expectation or contract requirement. Too often, however, top management views this as a "cosmetic" exercise that requires little additional effort for the "credential." Those who have to understand and implement the system requirements know better! Often these practitioners have little access to top management, or are unable to effectively convince them of the size of the task and the need for top management engagement. In this session, we will review some key information to help your top management team prepare for a successful interview by an auditor. Let us do the "heavy lifting" for you. The alternative can be seriously "career limiting"!

12:00 PM – 1:00 PM; Networking Luncheon

Streamlining Your QMS Application and Improving the Bottom Line

Concurrent Session
10:15 AM – 10:50 AM; Session #ISO-121
Get a Grip on Suppliers – The Impact Can Be Dramatic
Alan Lund, Core Business Management Solutions

Supplier Relationship Management (SRM) is “the discipline of strategically planning for, and managing, all interactions with third party organizations that supply goods and/or services to an organization in order to maximize the value of those interactions.” The goal of SRM is to streamline and make more effective the processes between an enterprise and its suppliers. This presentation will provide attendees with a strategy and the tools to analyze your suppliers and establish a plan to determine supplier viability. Key points to be presented and discussed include: Building a case for strategic supplier development and Six Steps for a Strategic Supplier Strategy: Establishing Commodity Matrix; Ensuring a unified front; Supplier Assessments; Review & Analysis; Implementing Changes; and Tools and Methods.

10:50 AM – 11:25 AM; Session #ISO-122
The Minus Principle™ The Most Profitable Formula in Business Least Used
Miriam Ochart, ASQ CSSBB, CQA, Lean Compliance Partners

How often when you reviewed your personal checking account have you been surprised, upset, or embarrassed about what you discover? Perhaps you found a subscription you did not cancel, a charge you did not authorize, expenses you forgot about, or something you forgot to return? These are not expenses; they are “waste" of your money. The same idea applies to business expenses. Not everything that businesses spend money on is actually necessary. Every business has unnecessary expenses that drain money every day: redundancies, returns, defects, and penalties. The presenter will explain how to use The Minus Principle™, and teach you how to reduce waste and increase profits. 

11:25 AM – 12:00 PM; Session #ISO-123
The QMS for a Government Agency Responsible for Highway Construction
Yuchao Chang, Taiwan National Expressway Engineering Bureau

With the responsibility of planning and construction of the freeway system in Taiwan, the Taiwan Area National Expressway Engineering Bureau (TANEEB) was constantly paying attention to the quality of the public construction projects. Starting with the setup of the standard operation procedures (SOP) for the efficient execution of the construction projects, the people in TANEEB gradually realized that management skills and standards are required for every department in the organization. For this reason, the ISO 9000 standard was chosen as a goal that the management system would be designed or modified to attain. The presenter will share his experience regarding the QMS and finally the upcoming ISO 9001:2015.

12:00 PM – 1:00 PM; Networking Luncheon

Professional Networking Meetings & Round Table Discussions

Concurrent Session
10:15 AM – 12:00 PM; Session #ISO-131
User Group Meetings

Please join us to network with fellow practitioners who share common interests or career paths with you! Topics are grouped into two categories: (1) based on your area of interest, or (2) your career path. Note that these groups are not mutually exclusive and you may attend more than one group meeting, time permitting. Group seating is limited and will be assigned on a first-come, first-served basis.
  • Group 1: Internal auditing & Corrective Action
  • Group 2: Context of the Organization & Risk-Based Thinking
  • Group 3: System Improvement & Monitoring and Measuring Processes
  • Group 4: Documented Information & Integrated Systems
  • Group 5: Leadership/Management Involvement & Competence of Employees
Professionals Networking Meetings
For the following Quality Professionals, Environmental Professionals, and Safety Professionals:
  • Managers
  • Supervisors
  • Auditors
  • Engineers
  • Analysts
  • Trainers
  • Practitioners

12:00 PM – 1:00 PM; Networking Luncheon

Sector Specific Applications of the ISO 9001:2015 Standard

Concurrent Session
1:00 PM – 1:35 PM; Session #ISO-141
API and the Quality Journey of the Oil and Natural Gas Industry
Gerardo Uria, American Petroleum Institute

One of the American Petroleum Institute’s (API) defining and enduring roles since its founding on March 20, 1919, is to develop standards to promote the use of safe, interchangeable equipment, and proven, sound engineering practices throughout the oil and natural gas industry. In 1924, API published the first standards for the American oil industry. Today, API maintains more than 600 standards. This discussion will cover API’s ongoing efforts to improve quality performance within the oil and gas industry. It explores API’s Monogram program and how API’s Quality Management System standard, API Spec Q1, promotes standardization among oil and natural gas industry manufacturers. The discussion will review the adoption of the ISO 9001 requirements and what prompted the industry to develop API Spec Q1. 

1:35 PM – 2:10 PM; Session #ISO-142
The Revision of ISO/TS16949 - The Automotive Industry's Quality Standard

Scott Gray, AIAG

The International Automotive Task Force (IATF), the organization responsible for the automotive industry’s quality requirements standard, ISO/TS16949, has launched a project to revise the standard. This will be the first update to industry’s Quality Management System (QMS) standard since 2009. The IATF has confirmed that the new revision will incorporate the new high level structure and content of ISO 9001:2015 as boxed text. Are you interested to see how the requirements of ISO 9001:2015 will be carried over to the new requirements? Many questions with regard to the proposed revision will be addressed. Mr. Gray is directly involved with the rewrite project activities and will share the latest IATF updates and answer your questions about the revisions and the timeline.

2:10 PM – 2:45 PM; Session #ISO-143
Healthcare and the New ISO 9001:2015 Standard
M. M. Christensen, MSME, P.E. Retired, TQM Systems

This presentation will address how the ISO 9001:2015 can be applied in a healthcare organization. Those previously certified to ISO 9001:2008 will need to transition by September 2018 and beginning to transition soon will be helpful. Those not certified to ISO 9001, but want to be compliant or certified to ISO 9001:2015 will learn about the standard as it could be applied to a healthcare organization. Healthcare organizations could be hospitals, clinics, clinical labs, etc. The new standard has some changes that should make it more ‘readable’ to people in a service-type industry. The criteria are pretty much the same, so drastic changes should not be needed. Some examples of how the new standard’s requirements could be implemented will be discussed to be a high level guidance for healthcare.

2:45 PM – 3:15 PM; Refreshment Break

In-Depth Session: Management Review and the ISO 9001:2015 Standard

Concurrent Session
1:00 PM-2:45 PM; Session #ISO-151
Management Review: ISO 9001:2015 – Challenges and Opportunities
Denise Robitaille, Robitaille Associates

The revision to ISO 9001 is substantial, with a new structure, added and revised requirements, and introduction of new terms and concepts. Management review has been expanded, as well as leadership responsibility as it relates to the newly introduced “Context of the Organization.” Some enhancements that permeate the entire standard are focused directly (or through inference) at top management and its responsibilities. These include, among others, requirements relating to quality objectives, planning, risk, the role of the management representative, and the management review process.

This session will focus specifically on the management review process and all the inputs into the review. Getting top managers to pay attention to the management review process is a daunting task. Filled with “quality speak,” the reviews often fail to present data that managers need in a format that reflects appropriate consideration for the strategic and monetary impact of the issues being discussed.

The presentation will cover the new requirements found in ISO 9001:2015 and how a well-implemented management review can facilitate the transition process. It will discuss the values implicit in the review process that enhance the organization's ability to meet its goals.

It will include ISO 9001:2015 requirements as they relate to:
  • Management review as a dynamic, cyclical process
  • Preparing for the review
  • What information to include
  • Involvement of key players
  • Relation to quality objectives
  • Action items and other outputs
This is a great learning experience for QA managers, quality engineers and technicians, general managers, consultants, and auditors.

2:45 PM – 3:15 PM; Refreshment Break

Tools and Strategies for ISO 9001:2015 Standard Implementation

Concurrent Session
1:00 PM – 1:35 PM; Session #ISO-161
Using the Cloud to Deploy Quality Management Software Solutions

Paul Murcott, VERSE

This session will talk about the trends surrounding Cloud Computing—what it is, what to look for, and some of the benefits of deploying QMS in the cloud. We will talk about Software as a Service and how companies can leverage the latest methods of deployment for their QMS solution. We will review:
  • How Quality Management Systems can be deployed to the cloud as a cost-effective dedicated environment for your organization
  • Types of deployment of enterprise software
  • Benefits of Cloud-based technology
  • What to look for in cloud deployment
  • How QMS fits into the cloud computing scheme
  • How to go about selecting a solution, with cloud in mind

1:35 PM – 2:10 PM; Session #ISO-162
ISO 9001:2015 Quality Management System Software - GRC Framework?
Jeffrey Lewis, FCQI CQP, Safety In Your Hand

A growing number of credit rating agencies and investor services, such as Moody’s and Standard & Poor’s, and Institutional Shareholder Services, are ranking organizations on their Governance, Risk and Compliance (GRC) performance. GRC performance impacts an organization’s ability to attract capital, reduce losses and allocate capital to its highest and best use. ISO 9001:2015, the Standard; through its context 4.1 & 4.2 defines Governance, Risk based thinking (Risk) and regulatory & statutory (Compliance). This presentation will show how the attributes of ISO 9001 as a Standard can serve GRC for a basis for software buying Standardization and will satisfy both ISO 9001:2015 and GRC.

2:10 PM – 2:45 PM; Session #ISO-163
Pre-Emptive Six Sigma: Risk Management and Preventing Unintended Consequences
Janet Nelson, SSBB, J. Nelson Enterprise LLC/OQL Solutions

Pre-Emptive Six Sigma© is an approach tied best to the 'Risk' element of ISO 9001:2015. The session presents nine modified, and uniquely applied problem avoidance and decision making tools. At the end of this session the participants will be able to leverage the most powerful yet non-statistical, traditional problem solving tools, in a manner which can be used to avoid the negative, unintended consequences of a bad decision, or an incomplete or ill thought out set of actions. Additionally, attendees will be able to execute well thought out decisions that ensure they have a high probability to the uncovered unintended, negative consequences; to defend/show the considerations of a decision. Most importantly, attendees will learn how to avoid having to do after-the-fact 'fixing.'

2:45 PM – 3:15 PM; Refreshment Break

In-Depth Session: Risk-Based Thinking and the ISO 9001:2015 Standard

Concurrent Session
3:15 PM – 4:25 PM; Session #ISO-171
Understanding the Importance of Risk-Based Thinking for the ISO 9001:2015 Standard

Provision 6.1 of ISO 9001:2015, "Actions to address risks and opportunities," is perhaps the biggest change in the standard. This session’s purpose is to equip the attendees to anticipate the potential requirements, as well as to act beyond the requirements to ensure the competitiveness of his or her organization. Compliance with the letter of the standard is of little comfort if a competitor exceeds the requirements by, for example, cutting its cycle time 50 percent or more. Among this session’s most important takeaways is that a risk or opportunity can hide in plain view unless our workforce knows how to identify it.

The objective of this session is to provide participants with an introduction to risk management awareness aligned with ISO 9001:2015. If you’re from an organization that wants to raise its level of risk-based awareness across the enterprise then you should attend this session. Attendees will:
  • Have an understanding of the ISO 9000 series of standards and be aware of the development and application of the ISO 9000 family of standards
  • Understanding of ISO 9001:2015 and risk based thinking
  • Be able to discuss and understand hazard identification and risk assessment (HIRA) as well as the types of risk assessments and the application thereof in the workplace
  • Be able to discuss quality risk management and risk management methodology
  • Understand and be able to discuss various risk analysis tool

Avoiding Pitfalls and Maximizing Results with the ISO 9001:2015 Standard

Concurrent Session
3:15 PM – 3:50 PM; Session #ISO-181
Avoiding Misinterpretation Quicksand
John Guzik, Impact Management

After the release of ISO 9001:2015, organizations will spend a lot of time interpreting new or revised concepts and this bringing with it the risk of misinterpretation. Because the standard’s language is written with a degree of vagueness—to allow its application to any organization—it is essential that transition plans and training for implementers and auditors consider elements beyond the requirements themselves. To properly apply the standard’s requirements to your Quality Management System (QMS), three items must be considered for an effective approach to transition planning and training: the introduction, the annexes and ISO 9000:2015—Quality Management Systems—Fundamentals, and Vocabulary.

3:50 PM – 4:25 PM; Session #ISO-182
Using ISO 9000 Quality Management System as a Basis for the Baldrige Excellence Framework
Ron Schulingkamp, Sc.D., Fluor Federal Petroleum Operations Company, LLC; and Kerry Thornton, Federal Petroleum Operations Company

This presentation will provide the audience with a basic understanding of how the ISO 9000 Quality Management System (QMS) and ISO 14000 Environmental Management System (EMS) were used as the foundation for developing a “systems approach” in creating a high performing, sustainable and resilient organization using the Baldrige Excellence Framework. The Baldrige Excellence Framework is non-prescriptive and is a series of open-ended systems and process focused questions. It is designed to facilitate an understanding of organizational complexity and systems thinking. The Baldrige Excellence Framework promotes a risk-based systems perspective, that includes an appreciation for the organization as a “whole” to achieve ongoing high performance, sustainability, and resiliency. The presenter will use a case study to provide an example of the interrelationships between the ISO QMS and EMS and the Baldrige Excellence Framework.

4:25 PM – 5:00 PM; Session #ISO-183
Zen of Quality Assurance
R. J. Marks, PMP, CMQ/OE, Jacobs/TEIMS

CMC launched their Lean initiative in 2004 and has worked on embracing Lean thinking across the organization and throughout all value streams. Success has been extensive and significant, including achieving five record years of top and bottom line performance during that period, despite the global recession. By focusing on Lean’s underlying principles, we have avoided the trap of becoming entangled by the limitations of a tool and technique approach.

5:00 PM – 5:10 PM Closing Remarks
Lorri Hunt, Chair, 2016 ISO 9000 World Conference



The New ISO 9001:2015 Standard: Implement, Audit, and Transition

8:00 AM – 5:00 PM; 0.8 CEU
By Lorri Hunt, Chair, 2016 ISO 9000 World Conference; Lead U.S. Delegate to ISO TC176/SC2; President, Lorri Hunt & Associates, Inc.

With the publication of ISO 9001:2015, organizations now face the next steps of implementing, learning toaudit, and transition to a new certification. This workshop will blend these different concepts so that organizations not only will learn how to understand the requirements so they can be implemented, but how to audit to the requirements when there is no specific documented information requirement.

The workshop will include:
  • Tips on how to conduct gap analysis
  • Tools for developing plans for managing the transition
  • Clause-by-clause review of ISO 9001:2015
  • Information on how to implement and audit ISO 9001:2015
  • How to determine when documented information is needed
  • How to audit when minimal documentation is available
This workshop is structured to provide the needed information for an organization to transition with confidence.

Who Should Attend
This workshop is highly recommended for anyone who is working with ISO 9001 quality management standards, QA managers, practitioners, executives, and other decision makers who are involved with continuous improvement in their organizations.


This workshop will be presented by Lorri Hunt, who has participated as an international expert for the ISO 9001:2015 revision.

Ms. Hunt has been implementing Quality Management systems in diverse organizations such as Honeywell, the Department of Energy, and small businesses since 1994. She is an active member of the U. S. Technical Advisory Group to ISO Technical Committee 176. She currently serves as the head of delegation for ISO TC176/SC2. In this role, she is responsible for overseeing the development of consensus positions for the United States related to ISO 9001 and 9004. She is a United States expert and co-convener for the group responsible for ISO 9001:2015, TS9002, and The Small Enterprise Handbook for ISO 9001:2015. She also served as the international Deputy Task Group Leader to the ISO 9001:2008 Amendment.

Lorri frequently contributes to quality publications and journals and is a co-author to The Insiders' Guide to ISO 9001:2008. She is also a frequent speaker at conferences all over the world and an Exemplar certified lead auditor.

Lorri is most often recognized for using her experience to assist organizations in implementing ISO 9001 using a common sense approach. She is the president of Lorri Hunt and Associates, Inc.

Workshop registration fee is $645 if you register by February 12, 2016; $695 after this date. The fee includes course materials, a certificate, and lunch. Please note that space is limited.

AS9100:2016 Series Revision for Aerospace: Understanding the Changes & How to Apply Them

8:00 AM – 5:00 PM; 0.8 CEU
Alan Daniels, Process and Systems Manager, The Boeing Company; and L.L. “Buddy” Cressionnie, Sr. Manager, Quality & Mission Success Processes, Lockheed Martin Aeronautics

This workshop will provide participants with an inside look into the changes in the 2016 revisions of AS9100, AS9110, AS9120, and AS9115 aviation, space, and defense quality standards, as well as the ISO 9001:2015 used as its foundation.

The entire AS9100 standard will be reviewed and tips will be provided on how to conduct assessments and what to look for as you conduct the gap analysis. This is a good time and opportunity to reinvigorate your organization's Quality Management System and ensure that it aligns with the strategic directio
n of the organization. 
The workshop will also offer an opportunity to look inside the International Aerospace Quality Group (IAQG), its strategy, the most current trends and developments, and discuss how a closed loop system works for a Quality Management System and the benefits it brings.

Whether you have an established Quality Management System or are just getting started, this workshop will provide you with the knowledge to confidently implement a Quality Management System, as well as those interested in the advance skill levels associated with the AS9100, AS9110 and AS9120 quality management standards.

Who Should Attend
Aviation, Space, and Defense Quality and Project Managers, and AS9100 Internal and External Quality Auditors with Introductory to advanced skill level of AS9100 knowledge.

Alan Daniels is currently the International Aerospace Quality Group (IAQG) Requirements Team Leader representing Quality Management Systems (QMS) standards AS9100, AS9110, AS9120, and AS9101 internationally. He is also the leader of the 9100 Writing Team and is the Vice-Chair and voting member of ISO/TC 176 that writes the ISO Quality Management System.

Buddy Cressionnie is currently an International and Americas IAQG 9100 Team lead for maintaining and revising the AS9100 standard. He is a voting member of the Technical Advisory Group (TAG) to ISO/TC 176, and is the Aviation, Space, & Defense Sector Liaison to the US TAG.

Workshop registration fee is $645 if you register by February 12, 2016; $695 after this date. The fee includes course materials, a certificate, and lunch. Please note that space is limited.


PowerPoint submission deadline: 

January 31, 2020

Deadline for hotel reservation:

February 24, 2020

Speakers’ Orientation Meeting:
Sunday, March 22, 2020
6 PM-7 PM

Please click the link below to download the Speaker Instructions

Government Organizations


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(*) based on previous conference attendance

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