ISO 19011:2018 Changes and “What is this Risk-Based Audit stuff I hear so much about?”

Date: January 23, 2020

Location: Best Western – Royal Plaza, Marlborough, MA

Dinner Meeting Agenda:

6:00-6:30 PM – Meet New Member Leaders and Networking

6:30-7:15 PM – Dinner

7:15-7:30 PM – Section Business

7:30-8:30 PM – Dinner Presentation

The main differences in ISO 19011:2018 compared to the second edition are:

  1. Addition of the risk-based approach to the principles of auditing;
  2. Expansion of the guidance on managing an audit programme, including audit programme risk;
  3. Expansion of the guidance on conducting an audit, particularly the section on audit planning;
  4. Expansion of the generic competence requirements for auditors;
  5. Expansion of Annex A to provide guidance on auditing (new) concepts, such as organization context, leadership and commitment, virtual audits, compliance, and supply chain.

Today’s topic will briefly cover some of these changes, but will concentrate on Risk-Based auditing and planning.

‍Together, we will plan an audit using these techniques and concepts introduced and discussed in Annex A.

Bring your ideas and be ready to participate and make this workshop something you can take back to your workplace.

Presenter: Barbara Butrym

Barbara has more than 35 years’ experience as a quality professional, many of them as a trainer/consultant. She started out in aerospace/defense/automotive, and then added medical device and commercial manufacturing.  She was a teacher in the Worcester Public Schools and brings that training expertise into the manufacturing environment. She worked as Quality Manager and VP of Quality before starting BQA, a consulting and training company in 1991. She has brought many companies to successful ISO 9001, TS16949, ISO 13485, AS9100, and ISO17025 registrations. She is a trainer at Quality & Productivity Solutions, specializing in Medical Device Regulations, Defense topics, quality system implementation, problem solving, FMEA/Risk, and auditing, etc.  She is certified to teach Exemplar Lead Auditor for ISO 9001 and ISO 13485. She has a Lean Six Sigma Black Belt and several ASQ certifications, including CQA.

Barbara is a contract Quality System auditor for NQA. She is on the ASQ Worcester executive committee and is a past chair. Barbara was elected to and serves on the Board of Directors, Central Mass, and Divisional Rehabilitation Center of “Life Skills, Inc.”