Industry News

MassMEDIC & MassMEP ISO 13485 Collaborative Begins Certification

Massachusetts Medical Device Industry Council (Mass MEDIC) and Massachusetts Manufacturing Extension Partnership (MassMEP) launched the MassMEDIC/MassMEP ISO 13485 Collaborative in December, 2012. This project is funded by a Workforce Training Fund Program (WTFP) grant through the Commonwealth of Massachusetts, Executive Office of Labor and Workforce Development. The grant program is administered by the Commonwealth Corporation.

Eighteen people, representing the eight participating companies, began seven months of training in preparation of receiving ISO 13485 certification, the quality standard for manufacturing for the medical device industry. The WTFP has fully funded the training for the eight companies who want to obtain certification in order to retain or increase business with current medical device customers and initiate new business in that industry. Participating companies are:

• AdvanDX
• BJA Magnetics
• CBM Industries
• Mass Machine Inc.
• Metrigraphics LLC
• O.R.M. Inc.
• R-Technologies, Inc.
• Surface Solutions Laboratories

MassMEDIC president, Tom Sommer, spoke a bit about his organization and the assistance they provide to the state’s medical device-related industries before introducing Joanne Goldstein, Massachusetts’ Secretary of Labor and Workforce Development. Secretary Goldstein joined the group for part of their first session, explaining that she was thrilled that the collaborative format allowed eight companies to take advantage of grant funds to move toward ISO certification without having to shoulder the cost of doing so alone. She and her team are looking for ways to promote the grant program and encourage more businesses to get involved.

"This collaboration represents the use of the Workforce Training Fund at its finest," said Goldstein. "We are committed to providing training funds to small businesses and the consortium application allows them to aggregate their training needs and grow their workforce and business within the Commonwealth. We commend MassMEP for its success with collaboratives and work within manufacturers throughout the state. We are encouraging MassMEDIC to help us spread the word at how these funds add value to businesses and look forward to more consortia applications."

From left, Michael Prior, MassMEP Director – Business Development/NGM Programs; Joanne Goldstein, Massachusetts Secretary of Labor and Workforce Development; Tom Sommer, President of MassMEDIC

Robert Duncan, Senior Project Manager from Commonwealth Corporation, provided the group with a summary of available grants and training incentives being offered, including some for hiring veterans and people who have been unemployed for over six months. These programs are available to all Massachusetts manufacturers.

The MassMEP ISO Collaborative programs are designed to assist small to medium-sized manufacturers with the often overwhelming prospect of becoming ISO certified. During the ISO 13485 program, representatives from the eight companies will meet for one day each month as a group to work collaboratively, share ideas, and help one another create quality systems and teams.

Each company also has one on-site training day per month when Jim Saropolous, the ISO training resource for MassMEP, or one of his team, focuses on the specific needs of the individual company and application of the ISO standards to their unique business. At the end of the training, the participating companies are "tested" with mock audits and receive other pertinent assistance to ensure that they are prepared for the actual 13485 audits as they are scheduled.

"I noticed that the participating companies were interactive and enthusiastic about the program and that some of them have come back for more certification," said Emad Lababidi of AdvanDx. "This is a good sign!"

Dave Sylvestre, Quality Control Manager and ISO Representative at R-Technologies, also participated in the ISO 9001 Collaborative that concluded in September, 2012. His company passed their audit and received ISO 9001:2008 certification the following month.

"It was great to be a part of the ISO 9001 collaborative," said Sylvestre. "It was very educational. The trainers were diligent in making sure we understood what and how everything works. Everyone helped each other achieve the goals that their companies were striving for. I am really looking forward to experiencing this again with the ISO 13485 Collaborative."

As the group completed the first day of the MassMEDIC/Mass MEP ISO 13485 Collaborative program, Jim Veglas, President of CBM Industries offered, "We are pleased to be working with the consortium in regards to the ISO 13485 training. This grant is CBM’s fourth state grant and the first in working with a consortium of other Massachusetts based companies. I believe that by working together during the ISO 13485 training, all companies involved will benefit from the shared information regarding process control, quality, etc. We look forward to continuing to work with the training staff on location here at CBM as well as off site in the group!"

For more information about Mass MEP and other collaborative opportunities visit www.massmep.org

To learn more about Mass MEDIC please visit www.massmedic.com

If you are interested in Workforce Training Fund Grant Programs please visit www.mass.gov/wtfp