His auditing credentials include: Certified Information System Auditor (CISA) by the Information Systems Audit and Control Association (ISACA), QMS Lead Auditor by the International Registrar of Certificated Auditors (IRCA), ASQ Certified Quality Auditor (CQA), Medical Device Lead Auditor (MDSAP: ISO 13485, FDA, Health Canada, MDR, etc.). Chris also has extensive experience consulting with standards such as ISO 9001, ISO 13485, AS9100, ISO 27001 and others.

He represented Canada on the ASQ Software Division’s regional council for seven years. And, Chris was awarded the prestigious International Quality Award - Feigenbaum Medal for outstanding achievement and recognition of his contribution to software quality improvement and work with the Canadian and European space agencies.

Chris is the co-author of the book “ISO 9001 Registration for Small and Medium Sized Software Enterprises” (McGill-Queens Press, 1995) and published the Masters thesis “An Analysis of the Differences in Software Project Management Practices Between Organizations Registered to ISO 9001 and Non-Registered Organizations” (Carleton University, 1998). Chris is based in Ottawa (Stittsville) Ontario. He is a co-founder of Orion Canada.

Mary is an experienced project manager and quality system leader with a particularly strong background in manufacturing, medical devices and service delivery.

She has worked within organizations registered to ISO 9001, ISO 13485, ISO 17025, and TS16949 standards where she has set up and managed quality systems, and led the corrective & preventive action, and audit functions. Mary has led internal audits, supplier audits, and represented organizations through successful third-party audits for the ISO 9001: 2015 requirements, ISO 13485:2016 requirements, and MDSAP. She is also skilled in risk assessment, process planning, project management, and environmental system management.

Mary graduated from Mechanical Engineering at Queen’s University and is a member of the Professional Engineers of Ontario. She is a member of the American Society for Quality. She is a certified quality auditor (CQA), and has earned course certificates for ISO 9001, ISO 13485:2016, MDSAP, Quality system audits, and Environmental system audits. Mary is a certified ISO 9001 Lead Auditor (PECB LA). She is based in Ottawa, Ontario.

Engineering, Project Management and Strategy Development, Stephen Davies brings a charismatic and dynamic quality to his work. Trying to both inspire people and to encourage conceptual thinking.

An active member of both the American Society for Quality (ASQ) and the Institute of Quality Assurance (IQA) he is always at the forefront of new developments, and is constantly aiming to research, publish articles and to deliver papers to conferences. In addition to his consultation role he also lectures at the Sprott Business School at Carleton University (Ottawa) and is a technology agent, representing Silicon foundries and design groups in North America.

Peter is a certified and active medical device auditor specializing in ISO 13485, ISO 14971, ISO/IEC 62304 and FDA pre-audits. Through his work with Notified Bodies, he has reviewed numerous technical files. He has prepared technical documentation packages for regulatory submissions as well as having professionally guided many companies on efficiently preparing their regulatory submissions. Peter has developed, worked with and evaluated software development methodologies, including procedures and documentation.

From 1986 to 2000 he worked in the Radiotherapy division of Philips Medical Systems (purchased by Elekta of Sweden) whose main products consist of a range of computer controlled linear accelerators for the treatment of cancer. After many years in the medical industry working in hospital environments, Peter became a consultant (Accredited Business Link & MHRA) in 2000. Since then, he has worked extensively in Scandinavia, Germany, Italy, Russia, USA and Great Britain, and for Orion clients in North America and Europe.
Peter contributes a very personal view of project processes, interpretation and implementation to any forum, together with a unique ability to focus a team on the objectives and goals that are required by the sponsor of the project. His leadership skills create focus, vision and motivation at all levels of a team.

With more than 20 years in quality, Daniel is an exceptional, senior Quality Management professional whose experience covers all sides of the quality industry. This includes implementing and maintaining business management systems from within world-class organizations, carrying out third-party audits for international registrars, and providing consulting and training services to client companies. Dan has worked as an Air Weapons Director & Computer Systems Analyst at the Department of National Defence (DND Canada), a Manager of Quality Assurance at Lockheed Martin Canada, Product Assurance Manager at Com Dev Space Systems, and a Quality Management Lead for the DND Land Software Engineering Center through ADGA Consulting Group. He has instructed hundreds through professional training courses on quality management standards and auditing. He holds a degree in Mathematics and is a certified Aerospace Industry Experienced Auditor (AIEA) and Probitas QMS Auditor.

Sheila has over 25 years of experience in the healthcare and regulatory & quality management fields, both nationally and internationally.  Her quality management and auditing credentials include: Certified Quality Auditor (CQA) with ASQ, Certified Manager of Quality/Organizational Excellence (CMQ-OE) with ASQ, CSertified Professional Healthcare Quality (CPHQ) with the US National Association for Healthcare Quality and ISO Lead Assessor (RAB/IRCA Accredited Training).

Ten years of regulatory and performance management experience with Canadian Blood Services has provided Sheila with expertise in conducting audits and operational assessments in such disciplines as blood and blood products collections (including stem cells and bone marrow), reference and testing laboratories and blood banks.
As an auditor, Sheila has conducted numerous multi-site audits in the pharmaceutical, biologics manufacturing and medical devices fields, both nationally and internationally.

As a consultant in the medical devices field Sheila has supported organizations in implementing corporate wide quality management systems and successfully achieving registration to ISO 13485:2003. Throughout her healthcare career, Sheila actively participated in the implementation of healthcare accreditation programs and standards in facilities throughout Canada and beyond (Saudi Arabia and the United Arab Emirates).

As a Quality & Risk Management professional, Sheila has held postings as the Director of Quality and Quality Specialist and successfully supported the implementation of strategic corporate Quality and Risk Management programs in healthcare facilities in both Saudi Arabia and the United Arab Emirates.

Sam is a quality professional with over 25 years of experience in Systems and Software Quality Assurance in the Aerospace, Software, Telecommunications, and Military fields. He is a consultant, trainer and certified auditor to several standards, including the latest version of the ISO 27001. Sam has worked with ISO 27001 since its inception over 15 years ago and is also familiar with BS 7799 – Information Security Management, CAN/CSA Q830 – Canadian Code for the Protection of Personal Information, and the new GDPR requirements (released by the European Economic Community on May 25th, 2018).

In addition to information security auditing and consulting, Sam also works with the CMMI assessment model, and he is a certified Aerospace Industry Experienced Auditor (AIEA), leading registration audits to the latest AS9100D Aerospace standards.

Having conducted over 600 Quality Management System audits in Canada, United States, Asia, South America, Europe and the Middle East, Sam has helped a remarkable number of organizations to improve their business processes. He is an ASQ Certified Software Quality Engineer (CSQE), Certified Quality Auditor (CQA), and certified Lead Auditor (AS9100, ISO 27001 and TL9000). He also develops and conducts Quality Management training programs, and continues to support the development of high reliability mission critical software systems.