Strategic Planning and Organizational Context


Often the quality organizations are forced to focus on compliance or being the “quality police”. This workshop will give you practical skills and conversations to promote the view of the quality organization on facilitating the strategic planning for your organization. This will help you change the perception of the quality group to bring value to the business instead of slowing you down.

In this session we will focus on how the planning process which is inherent in the process approach that is the core of the quality management system brings value to your organization and leverage the risk based approach that makes preventive action a ‘normal’ part of the business. We will move through the purposes of each part of the quality management system (management, development, operations and improvement) to help you realize the value proposition that these bring to your organization.

Mark Swanson (ASQ CMQ/OE, CQE, CBA) is the President and lead consultant of Quality and Regulatory Expert Partners (QRx Partners); a group focused on helping small to mid-sized companies have the same regulatory and quality systems knowledge as the large medical device companies. Mark has more than 20 years of experience in the medical device industry including all quality roles. He is a senior member of ASQ, corporate AAMI member (serving on several AAMI and ISO standards committees) and a RAPS member.

Mark has spent the last six years as an active member of ISO Technical Committee 210 (TC210), Working Group 1 (WG1) working on the revision of ISO 13485:2003 that was published on March 1, 2016, was the project co-lead for the guidebook on ISO 13485 and has also participated with ISO TC176, WG24 on ISO 9000 and 9001:2015. He continues to contribute work in Working Group 6 working on the guidance for post-market surveillance and the US TAG and IWA31 for risk management. This work includes discussions regarding the impact of changes in the ISO quality management system standards, the integration of various standards and how to effectively integrate these various international standards and other regulations into a single management system.