The September 2015 PD meeting will be held on Thursday, September 24th. Please REGISTER to confirm your attendance.
ISO/FDIS 9001:2015 – What to Expect in the Next Revision
By Mona Elkhatib
The world’s most recognized management system standard with over 1 million certifications, ISO 9001, has been under revision. The final draft international standard (FDIS) was released July 9, 2015. The expected publish date is September 2015. The changes will be significant for all sizes and types of organizations and you are encouraged to come explore the changes and get a head start with the transition.
Participants will develop an understanding of:
- Background to the ISO 9001 development and revision time line
- What are the key changes
- New structure
- New content
- Risk based approach
- Quality management principles
- How will the changes affect you?
- What are the transition timelines?
ASQ Dallas Section Mentoring Program
By John Jennings
The tutorial will be the kick-off for the revised ASQ Dallas Section Mentoring program. The topic will cover the program structure, Management, Implementation, and Evaluation Plan. It will also talk to local networking venues and:
- Educate the Mentee about section offerings
- Provide members with value to reinforce and maintain section membership
- Provide value for stakeholders
- Provide mentor services to members
- Opportunity for mutual sharing and learning
- Recertification Unit for Mentors
- Define Knowledge Management
Mona Elkhatib has over 15 years of experience in Process Improvements, Quality
Management Systems and Assurance, Regulatory Compliance, Training and Auditing.
Areas of Expertise: Mona’s expertise is in design and development of ISO recognized Quality Management Systems organizations in a manner to fit the organization’s needs and improve the efficiency of their current processes, while maintaining regulatory compliance. She has strong background in ISO 13485 Medical Devices system requirements including regulatory requirements such as FDA QSR, and Health Canada MDR.
Scope of Experience: Mona has designed, developed and assisted in implementation of ISO recognized Quality Management Systems for over 50 organizations. She has worked in various industry sectors including oil and gas, metal fabrication, electronics, plastics, health care, and medical equipment and diagnostics.
Education and Training: Mona holds a Master of Science degree in Biomedical Engineering from the University of Texas Southwestern / The University of Texas at Arlington and a Bachelor of Science degree in Industrial Engineering from The University of Texas at Arlington.
Relevant Assignments: In her role as a Lead Auditor for the accredited registrars, Mona audited over 500 companies from both the manufacturing and service sectors. She trained and witnessed auditors and reviewed the audit packages to issue ISO 13485 certifications to the organizations. In her role as a Trainer, she delivered ISO 9001, ISO 13485 lead auditor classes, on-site (customized) and in a public setting. Finally, in her role as an Advisor she designed and developed ISO 9001 and ISO 13485 compliant management systems for over 50 organizations.
John W. Jennings III.
John left the US Air Force in 1970, after serving four years. Thereafter, John gained thirty-five years of experience in manufacturing as a Quality Technician, QA Engineer, Reliability Engineer, QMS Auditor, QA Manager, Quality System Manager and Director of Performance Excellence. He continued his formal education part time and graduated from UTD (University Of Texas at Dallas) with a BSEE in Telecommunications (1992) and a MS in Engineering Sciences from UTD in Electronic Manufacturing (1996).
John taught Applied TQM (Total Quality Management) and SPC (Statistical Process Control) for Richland College’s Continuing Education classes for 2 years until they discontinued the program. He has taught refresher classes for the Dallas/Ft. Worth ASQ Section for CMQ/OE, CQT, CQIA, CQI, and CQE.
John is the Quality Assurance Manager for Bowhead Manufacturing, a part of UIC Government Services Division and the Bowhead Family of Companies, part of the Ukpeaġvik Iñupiat Corporation, an Alaska Native Corporation.
John has served as a senior examiner for the Texas Award for Performance Excellence, a member of the Board of Governors for Quality Texas and as a member of the board of examiners for Malcolm Baldridge National Quality Award. He is an ASQ Fellow and currently holds ASQ certifications as CQE, CRE, CSQE, CQA, CBA, CMI, CQT, CMQ/OE, CSSGB, and CSSBB. He is an Exemplar Global Certified QMS Lead Auditor and is certified by NARTE (The National Association of Radio and Telecommunications Engineers, Inc.) as an ESDC (ESD Control) Engineer.