American Society for Quality
Merrimack Valley Sec. 0102
PO Box 275
North Andover,  MA 01845-0275

Section Meeting

Thursday September 7, 2017

Are Your Internal Auditors Ready to Conduct Audits to ISO 13485:2016?

Summer activities are over and many of us find ourselves digging in and getting back to work.This evening we will help that process with the able guidance of Theresa McCarthy in a discussion on ISO 13485:2016, the Medical Devices QMS Regulatory Requirements Standard. This is current, this is important, so please encourage members of your audit team to attend
this presentation. Theresa recommends bringing a hard copy of your Quality Manual, ISO 13485 or other standard. If you are in a company with a different Quality Management System, or no formal Quality Management System, you are most welcome. Theresa has promised an interactive and instructive program that will benefit all.

Presentation Description:
Theresa will highlight changes to ISO 13485:2016 and touch briefly on the newly published EU Medical Device Directive (MDD). She will also include a discussion on 21 CFR 820 as it relates specifically to the ISO 13485:2016 updates. Theresa will lead the discussion with a slide presentation and provide the opportunity for you and your team to review your Quality Manual. Those with ISO 9001, AS 9100, or TL 9000 QMS’s or no formal QMS will benefit from the discussion. The program will be interactive and Theresa will encourage dialogue. She reminds us: “ISO means Equal, so we can learn from each other.”

Theresa McCarthy
Theresa McCarthy has been a long-term Senior Member of ASQMV as well as Past Chair of the ASQ Boston Section. She is a Global Exemplar Quality Management System Lead Auditor, ASQ Certified Quality Auditor, maintains a certificate for GMP/QS Requirements and Industry Practice from the Association for the Advancement of Medical Instrumentation (AAMI).
Theresa also teaches the Certified Quality Auditor (CQA) preparatory course. Theresa is a Pfizer employee and works in Compliance, Inspection Readiness, Quality Risk Management. Theresa conducts audits to ISO 13485:2016, 21 CFR 820 and 21 CFR 210/211.

Location (see map)
Holiday Inn Tewksbury –Andover
4 Highwood Dr
Tewksbury, MA 01876


5:30-6:00 Registration

6:00-7:00 Dinner and Networking

7:00-8:00 Program

Dixieland Buffet

Note: An alternate menu is available.  Please use the Contact the Organizer on the right side of the EventBrite registration page to let us know your choice if you require a vegetarian, gluten free or organic meal. 

Call for Speakers

ASQMV is looking for subject matter experts!

Have you ever thought about giving a presentation on something you do well?  Do you have a case study that would be of interest to our colleagues?  Do you know someone who would be a great speaker? Think about joining me to be part of our innovative programs planning for the upcoming year.  Any ideas or interests please contact ASQMV Programs Chair at, or just discuss your thoughts at one of our upcoming meetings.