I am reinstating the Los Angeles ISO Users Group. I thought of letting you know the existence and first meeting, scheduled for February 10th from 8 AM to 10 AM.

The meeting will take place at the
Long Beach Marriott
4700 Airport Plaza Drive
Long Beach, CA 90815 Phone: 1 562-425-5210

For directions, link http://marriott.com/property/mapAndNearbyAirports.mi?marshaCode=LGBLB

For the first session, I will be the main presenter, talking about the current state of the ISO 9000 Certification process, some lessons learned from the avalanche of transition audits done during the last quarter of 2003, to transition organizations to the ISO 9001:2000 Standard.
Also, I am going to present some material on the official ISO interpretation Documents and some ISO endorsed Guidance Documents.

I also plan to introduce the attendees to the Elsmar Cove Forums. I might even try a live demo from the conference room. Keep your eyes open on the 10th in the AM, folks.

While attendance is free, due to limited seating, you need to “register” to attend. In order to register, just email me or Christine Denton Christine.denton@dnv.com your intention to attend.

We appreciate the notice!

As an FYI: You can put this on the Public Calendar and it will show on the main forums page.

I also plan to introduce the attendees to the Elsmar Cove Forums. I might even try a live demo from the conference room. Keep your eyes open on the 10th in the AM, folks.
Good idea Sidney. I'd love to be there, but the trip would be a bit on the expensive side from over here.;)

The 10th in the AM, PST, right?... Ok, I'm nine hours ahead of you, so I'll be far into the PM by then, and hopefully at home. I'll see if i can be around.

...and good luck

/Claes

I'm sorry I can't be there to participate Sid...I now live in Arkansas and I'll be on the road (for one of your competitors).

I put it on the calendar. I may have 'Chat' integrated by then.

User Group Meetings are Great!

I attend one held here in Pheonix every other month. I have met alot of people in every kind of industry. They are very helpful and can be used for C.E.'s Wish I could be there!
Paula

Thanks,

Here in the Southern California region, we have had numerous Users Groups over the years. Unfortunately, some groups were created and maintained to support a commercial agenda and faded over time.

I hope that, this group will be sustainable and disseminate useful information, once again.

I sure miss the group we had in Georgia, organized by Georgia Tech. When we were first starting down the ISO road, they were a very valuable source of information and support. Unfortunately, they faded away. There is no telling how much time and aggravation the group saved us, and the price was right!

Craig H.

Craig,

The User Network Meetings hosted by Georgia Tech in Northwest Georgia are still going strong! Unfortunately, it's a long drive for you from Sandersville. I'm not sure about plans down your way, but I'll find out. Here's the lineup in my region: http://www.edi.gatech.edu/Quality/eventsfree.cfm?id=428. The meetings rotate between Dalton, Cartersville, and Rome, and of course they're all free.

By the way, would you be interested in speaking at one of them?

Craig
The other one...in north Georgia

~~~~~~~~~~~~~~~~~~~~~~~~~~~
Craig Cochran
Center for International Standards & Quality
Georgia Institute of Technology
craig.cochran@edi.gatech.edu

Hi Everybody, the LA ISO USERs Group is online and many people here are now aware of the Elsmar Forum website.

In a couple of hours I will post copy of the presentation file and picture.

Attached a couple pictures of the meeting and copy of my Powerpoint presentation file :D

Thanks, Sidney! I hope everyone here was on their best behaviour! :notme:

Unfortunately, I did not have much time to go over all the wonderful features of this website with the crowd, but I told them, in no uncertain terms, that this is the best source of information available on-line for "quality professionals". If you see a hike of new members signing up from So-Cal, this is the reason.

We had a lively session, this morning in Long Beach. Interesting discussions.

On the 9th of March, we will have the 2nd session of the Los Angeles ISO Users Group. From 8-10:30 AM. For location and directions, check above.

We will review the new Family of Aerospace Standards, such as AS9100, AS9110, AS9120, 9003, 9006, etc . . . We will talk about the deployment of such documents around the World and also the information in the OASIS database.

Due to limited seating, interested parties need to email a reservation request to christine.denton@dnv.com

Looking forward to see you there.

Hi Folks, please see attached the file used during the last presentation.

Mark your calendars for the April 13th meeting.

Sidney, I can't get your attachment to open in Powerpoint 2000. Is the file OK, or is it a "version" thing?

File can be opened as read only.

I can't get the file to open at all. What version of Powerpoint was it created in?

When? May 11, 2004 8 AM

Long Beach Marriott
4700 Airport Plaza Drive
Long Beach, CA 90815 Phone: 1 562-425-5210

For directions, link http://marriott.com/property/mapAnd...arshaCode=LGBLB

Korina Ortiz from www.regulatoryspecialists.com will present on the Medical Device Directive and ISO 13485

While attendance is free, due to limited seating, you need to “register” to attend. In order to register, just email Christine.denton@dnv.com your intention to attend.

Join us for the June 15th Los Angeles ISO Users Group session. *

Starting at 8AM

Long Beach Marriott
4700 Airport Plaza Drive
Long Beach, CA 90815 Phone: 1 562-425-5210

For directions, link http://marriott.com/property/mapAnd...arshaCode=LGBLB

While attendance is free, due to limited seating, you need to “register” to attend. In order to register, just email Christine.denton@dnv.com your intention to attend. Please let Christine know if you are interested in the ISO Users Group, the AS9100 Users Group, or both.


We are going to focus on an emerging aspect of ISO 9001:2000 – The Service Sector, with particular emphasis on two critical sectors HealthCare and Education., Jim Rivas from BVQi will provide us up-to-date information on this subject.

Jim Rivas Bio:

Jim Rivas has over 5 years experience working in the ISO Certification field. Jim currently holds the title of Business Development Manager at BVQi (NA), Inc. He is responsible for Marketing, Sales and Public Relations on the West Coast. Jim has received a certificate for successfully completing AS 9100 Lead Auditor Training through BV Training and Advisory, as well as ISO 9001:2000 Lead Auditor Training through CEEM Inc. He works closely with many accounts, such as Agilent Technologies, Expeditors International, Lawrence Livermore Labs and others, to ensure customer satisfaction before, during and after registration. Jim’s prior work experience includes development of software training programs and customer service. Jim also volunteers as Publicity Chair for the Sacramento ASQ Section-605. He has a bachelor’s degree in Marketing from California State University, Sacramento.

* Even though we normally meet during the second Tuesday of the Month, in June we will meet on the 3rd Tuesday, due to scheduling conflicts.

In June, we will start our AS9100 Users Group. There will be no presentations associated with AS9100 UG. People interested in AS9100 and related subjects will share their experiences and have a chance to ask questions about AS9100 to other professionals in the room

The AS9100 Users Group will take place on the same date and room as the ISO Users Group, from 10 AM to 11:30 AM

I apologize for the change of speaker and topic, but I just got informed that Mr. Rivas is no longer representing BVQi and is not available for next week’s presentation. We are very lucky and proud to have Muriel Sasaki speaking at the Users Group next Tuesday.

Muriel’s presentation is summarized in the following 2 paragraphs:

Is your internal audit program supporting your company's current business objectives? Come to learn, share, and discuss some rules for managing an internal audit program that will add value and stimulate participation and interest throughout the company.

Bring your company's quality policy, quality & business objectives/metrics, and internal audit schedule for your personal perusal during the discussion. This program will be most useful if the Quality Manager/Audit Team Leader and "Top Manager" attend together.
http://aims-online.com/art/mSasaki.jpg

Muriel T. Sasaki


ASQ Certified Quality Manager & Certified Quality Auditor


Organizational change specialist with 25+ years of experience in workplace modification projects involving production management, process and capital improvements, training and development, and implementation of quality assurance systems. In 1996, Ms. Sasaki established the Alliance for International Management Systems (AIMS), and has provided quality assurance training and consulting to manufacturers in Texas, Arizona, Nevada, and California. A highly effective trainer and project leader, she has developed easy-to-use forms and systems to help her clients reach earnings, quality, and productivity goals.

Her prior experience includes responsibilities as a Manufacturing Manager, Training and Development Manager, and Management Engineer at various Hughes Aircraft Divisions from 1979 - 1990.
* 1985-1990 Manufacturing Manager – Responsible for harness fabrication & installation for commercial & military spacecraft; member of Internal Audit and Process Improvement Teams. (Space & Communications Group – El Segundo, CA)
* 1982-1987 Manufacturing Training Manager – Responsible for manufacturing training programs to include workmanship certification; supervisor training and statistical techniques. Member of Value Engineering Teams. (Ground Systems Group – Fullerton, CA & Space & Communications Group – El Segundo, CA)
* 1979-1982 Member of the Technical Staff – Designed & tested training materials in support of various radar systems and ground support equipment; performed Management Engineering studies and implemented process improvements in manufacturing, warehouse, and office environments. Developed New Hire Orientation program used throughout Hughes Aircraft. (Ground Systems Group – Fullerton, CA)

BA Psychology - University of California, Santa Barbara (1976)
MBA - Drucker Center-Claremont Graduate School (1988)
ISO 9000 Lead Auditor Certificate (1995)
ASQ Certified Quality Auditor and Certified Quality Manager
International Standardized Testing Organization – Certificate of Achievement: ISO 9000:2000 (2001)

Professional Affiliations:
American Society for Quality – Los Angeles Section Chairperson
Society of Automotive Engineers (SAE)
Fellow, Institute for the Advancement of Engineering

The next session of the Los Angeles ISO Users Group will be held on July 13th from 8 to 10 AM.

Jim Bertsch has over sixteen years experience in developing and auditing
engineering, quality, and safety related standards for domestic and
international manufacturers. He is currently responsible for maintaining
three Solar Turbines Inc. business units under the ISO 9000:2000
certification as group manager in the Product Quality and Quality System
Certification group.

Solar has developed an on-line quality system that is process based and has
solved many of the traditional system problems. The presentation will
review the challenges that Solar faced during the transition and present
many of the solutions that have been successfully implemented. Solar Turbines was a Malcolm Baldrige Award winner in 1998.

The meeting will take place at the Long Beach Marriott
4700 Airport Plaza Drive
Long Beach, CA 90815 Phone: 1 562-425-5210

For directions, link http://marriott.com/property/mapAnd...arshaCode=LGBLB

While attendance is free, due to limited seating, you need to “register” to attend. In order to register, just email me or Christine Denton Christine.denton@dnv.com your intention to attend.

Put it on the calendar!

The next session of the Los Angeles ISO Users Group will be held on August 10th from 8 to 10 AM.

Organizations exporting equipment to the European market are faced with their regulatory requirements for product certification. Many regulated products have to attain CE-Mark prior to be being allowed in Europe. Two of the most demanding European Directives are the Pressure Equipment (PED) and ATEX directives. Roy Teather will explain the basic requirements for organizations that need to comply with such directives.

Roy Teather is the Business Development Manager for DNV’s North American Product Certification division. He is based in Houston, Texas and is responsible for DNV activities associated with European compliance to the many product Directives mandated under European law.

Roy brings to DNV more than 30 years Hazardous Area approval experience that started with a new range of underground mining equipment employing state of the art low power integrated circuits and protection techniques. Life long work experience has been gained in the design of instruments and instrument systems in military, aerospace, industrial, mining and oil related industries.

Mr. Teather is an ISO 9001, EN 13980 (ATEX) and PED auditor with formal qualifications in Electronics and Telecommunications.


The meeting will take place at the Long Beach Marriott
4700 Airport Plaza Drive
Long Beach, CA 90815 Phone: 1 562-425-5210

The next session of the Los Angeles ISO Users Group will be held on October 12th from 8 to 10 AM.

The meeting will take place at the Long Beach Marriott
4700 Airport Plaza Drive
Long Beach, CA 90815 Phone: 1 562-425-5210

For directions, link http://marriott.com/property/mapAnd...arshaCode=LGBLB

While attendance is free, due to limited seating, you need to “register” to attend. In order to register, just email me or Christine Denton Christine.denton@dnv.com your intention to attend.

Policies & Procedures Communication 101

Raymond E. Urgo

Description

At the October 12th ISO Group meeting, Raymond E. Urgo, consultant, educator, and internationally recognized leader in Policies and Procedures (P&P) Communication will present an overview of this “undefined” discipline. Raymond will introduce his latest research, ideas, and teachings on this evolving discipline which he has been defining as one of its foremost leaders. He will present his four cornerstones to understanding P&P Communication as a discipline: P&P users, P&P practitioners, P&P information products, and the P&P development process. He will address the frequently and should-be asked questions to understanding this discipline. Topics include different approaches to developing, communicating, and managing P&P information; the benefits and values of P&P to users and their organizations; the relation of P&P Communication to Quality and other disciplines, the roles and opportunities of the P&P practitioner, and the evolving trends and available resources about the discipline. Be sure to attend this rarely presented and unique subject and by a foremost leader in this discipline.


BIO

Raymond E. Urgo is the principal of Los-Angeles-based Urgo & Associates, specializing in Policies and Procedures Communication. He is a consultant, educator, author, and coach on this specialty. His clients include the City of Los Angeles, Taco Bell, Kinko’s, Pacific Life, Zenith Insurance, Northrop Grumman, Kaiser Permanente, Toshiba America, and individuals in the Technical Communication and Quality professions. Raymond teaches policies and procedures in the Technical Communication Program at UCLA Extension where he designed and delivers the world’s first online course in P&P for a continuing education program. He founded and is the present manager of the Policies & Procedures Special Interest Group (SIG) which is the world’s largest (800+ members) and longest existing (11 years) group on this specialty. He served as the Assistant to two Presidents of the international Society for Technical Communication. Raymond holds the honorary rank of Associate Fellow in STC and is a recipient of the Society’s Distinguished Chapter Service Award for his contributions to the Los Angeles Chapter.

Due to several reasons, I had to discontinue the Los Angeles ISO USERS Group, but I am taking over as the chair for the ISO Clinics of the Orange County ASQ Chapter. The ISO Clinic will be branded as the So-Cal ISO USERS group, again under the auspices of the local ASQ Chapter.
Check ASQ Orange Empire - Section 0701 (http://www.asqorangeempire.org/)
I have been a member of that chapter for many years and the average attendance to the monthly dinner meetings is one of the best I have seen around the country. We have in average 60-70 people attending our dinner meetings. I have seen as many as 130, depending on the speaker/topics.

I am now looking for speakers/presenters to share their knowledge with the local members. The ISO clinic takes place every second Tuesday of the Month with the exception of July and December. The sessions go from 5:45 to 6:30 PM and speakers get a free dinnerhttp://elsmar.com/Forums/images/smilies/wink.gif.

So, fellow Covers residing or visiting Southern California, please contact me about your interest in presenting. Randy, Howste and other gipsy Covers. We are looking forward to have you guys as speakers.

Any topic related to Management and Product System Standards, Quality tools, any (and I hate to use the term) ISO related issue is welcome.

Any takers?
And spread the word.
http://elsmar.com/jpg/asq_section_0701.jpg

Sidney welcome to 0701 I had planned to drive up the road to attend your LA function but now that its come to the OC the drive just got shorter :applause:


Jeff

ASQ – Clinic # 1 – Southern California ISO User Group

May 10, 2005



Title & Abstract



Canadian CMDCAS Program for Medical Devices



In Canada, regulations require that certain medical devices be designed and manufactured under a registered quality management system (QMS) that meets the criteria of the international standard ISO 13485. To implement these regulations, which came into force on January 1, 2003, the Canadian Medical Devices Conformity Assessment System (CMDCAS) was developed by Health Canada's Therapeutic Products Directorate (http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/index_e.html)(TPD), in collaboration with the Standards Council of Canada (SCC). Korina will explain the CMDCAS ISO 13485:2003 certification requirement as part of product licensing for Canada , as well as the Structure of the Canadian Medical Device Regulation SOR 98/282 with amendments 190 and 173, GD 210 Medical Problem Reporting

By attending this information packed Clinic you will learn about…


Medical Devices Regulations - Schedule No. 1101 (SOR/98-282)
Medical Device Reporting as required under Health Canada
Information on GD 210- Audit questions document used by Registrars




Speaker Information



KORINA A. AKHONDZADEH



From 1996 to 2003 Korina worked with numerous Notified Bodies and held such positions as Business Development Director-TUV America; Area Manager-TUV Rheinland of North America; Auditor-Quality & Medical Technical Expert & Business Development Manager, Medical Devices Group-British Standard Institute (BSI). In all of her roles, Korina oversaw all new business development activities for certification services the Notified Bodies offered to non medical as well as medical companies. These services included: CE Marking under all medical directives, ISO 9001, ISO 13485, electrical safety testing, machinery testing, Pressure Vessels, EMC, and other international approval testing marks such as: GS, NRTL, GOST-R, NOM..



Prior to working for Notified Bodies, Korina worked in the Medical Device Industry in Regulatory Affairs and Quality Assurance. In those positions, she was responsible for a variety of RA/QA functions including CGMP internal audits, Medical Device submissions and registrations, training, ISO implementation and CE Marking requirements. Korina holds a Bachelor’s degree in Public Relations and actively speaks on regulatory topics for various national as well as international organizations such as: RAPS, AMDM, SDRAM, USC. SDSU, and others.



Additionally, Korina is a member of ASQ and RAPS.

October 11th at 5:45 PM at the Crowne Plaza Irvine

Quality Standards in Aerospace Manufacturing –
Automated Web-Portal for AS9102 and AS9103 compliance



Current Situation



While viewpoints vary from wildly optimistic to a cynical fatalism, most of those in the know agree that US manufacturing is navigating a critical juncture. Markets with low labor costs have courted away much work traditionally performed by American companies. Pessimists say that the loss must be accepted as this business can not be regained. Others, though, aspire not only to slow the trend, but to reverse it, by focusing on the elimination of inefficiencies, continuous process improvement, and maximizing productivity through automation.



IAQG standards and guidelines provide an excellent framework that is aimed at assisting manufacturers stand up to this challenge. However, the implementation of standards such as AS9102 and AS9103 is often perceived as a labor-intensive and costly effort that outweighs the benefits.



The Opportunity



The net-inspect® system offers a solution that not only automates AS9102 and AS9103 processes, it also provides a portal through which customers and suppliers can connect to share any quality management related data from First Article Inspection to Manufacturing capability and process control, to supply chain quality. The objective is to reduce cost, improve process capability and ultimately improve the manufacturers’ bottom line.



The web-based, web-hosted infrastructure makes the solution easy to implement, and very affordable, independent of size and complexity of a company, whether it has 3 or 3,000 users. Current users of the system include Vought Aircraft, Airbus, Honeywell UK, Goodrich, PCC, to name a few.



The presentation includes a live demonstration of the net-inspect® AS9102 and AS9103 capability, and a discussion of the benefits.



The presentation will be delivered by Mike Dunlop, President and Owner of QPM Aerospace and Net-Inspect. (see Bio below)



_____________________________________________________________________________



Participant ‘Take-away’



§ Reduce the cost of quality and manufacturing through the elimination of waste, rework, and redundant inspection, using automated and integrated quality management processes

§ Use a web-based tool for real-time management of variation and capability of Key Characteristics (AS9103)

§ Collaborate with your suppliers through a web-based quality management portal, and achieve transparency of key processes such as First Article Inspection Reporting (AS9102), non-conformance processing, and internal supplier quality and capability tracking



_____________________________________________________________________________














MIKE DUNLOP

President and Owner, QPM Aerospace

President, net-inspect®









Mike Dunlop is a natural contrarian. As the president and owner of QPM Aerospace (a Bellevue, Washington based components supplier to such industry giants as Boeing, Lockheed, Northrop Grumman, Airbus and others), he has built his businesses and career by defying conventional wisdom.



In an age when many companies are sending manufacturing jobs oversees in an effort to lower operating costs, QPM is expanding in the US by adding highly-skilled US based labor; winning contracts due to its efficiency, quality and costs; and most importantly staying profitable. QPM Aerospace and net-inspect™ (a Dunlop complementary business which developed software to ensure parts are produced with zero defects by collecting and analyzing real-time data from the shop floor and presenting the results in real time via the internet) are case studies in innovation and illustrate Mr. Dunlop’s willingness to take risks and think differently.



Born in the UK, Mr. Dunlop came to the US in the early 1970s and is now a US citizen. Shortly after his arrival, he started a software consultancy company. A chance meeting with a client’s CEO led to a discussion about the company’s financials, or rather lack thereof. Mr. Dunlop offered to write a “turn-around” plan, which was ultimately presented to the company’s bank. The bank not only accepted the plan, but asked Mr. Dunlop to provide a similar service to other financially challenged businesses. This led to a 17-year practice in which Mr. Dunlop orchestrated large-scale financial turn-arounds for corporate clients. This experience was invaluable in helping QPM’s sales grow from $300,000 to $25 million in just 6 years. This remarkable growth earned QPM a 2002 award as number 67 of the top 100 fastest growing private companies in Washington State. QPM was one of a small number of manufacturing companies in this group.



Mr. Dunlop and his wife live in Bellevue, Washington and have two adult children. He is an avid squash player and is active in Puget Sound-based charities, most notably sitting on the council of the Pete Gross House, which is a housing facility for families undergoing treatment at the Seattle Cancer Care Alliance.