March 11-12, 2019,  Hyatt Regency San Antonio Riverwalk, San Antonio, TX USA

The World’s Leading Conference on ISO 9001 & Related Standards

Reflecting on Implications of Technological Changes and ISO Compliance Assessments

Norma Antunano, Norma, Systems Lead, Faculty, Consulting Firm, University of Phoenix and Michigan, Austin, TX, USA

Keywords: Organizational Dransformation, Risk Management, Digitalization

Industry: All

Level: Intermediate


The presentation provides an overview of how the rapid advances of technology have been disrupting businesses, product and service designs, operations, customer service, and large supply chain transformations as organizations are expecting: a) to improve time to market and its service delivery, b) maintain or improve its product quality and reliability, and c) to optimize their cost structures to remain competitive. Some of the technological changes causing disruption, including for regulated sectors like healthcare are cloud computing, digitalization of processes and information systems. These technologies have been adapted by variety of enterprise throughout the world, and are currently advancing into more mature stage of their life cycles. In addition, 3D printing and robotics are already disrupting, creating opportunities for innovative business models while unfavorably impacting traditional business models when a new business model shows better value than the traditional business model. Moreover, the advances of Communication and Internet Protocols, the increasing acceptance of open source for software development; the use of artificial intelligence for analysis and decision making, assessments, research, predictions and discoveries continue in the rise. At the same time, cyber security threads and concerns continue in the rise. More conservative entities including those overseeing public well-being, health and public safety (homeland security, aviation, public health) are cautiously shifting part of their technological infrastructure to complement or increase their capabilities.

The named technologies are forming Internet of Things ecosystems in one or more verticals. Most organizations become part of more than one vertical as they interact with partners, suppliers and customers. This causes confusion about how to best adapt an organization to the fast changing environment. Organizations face difficulties managing ongoing risks with ongoing change and disruption. The changes of this nature can impact organization s values, vision, its core competencies, and possibly its sustainability. Simultaneous technological changes are gradually adopted, but in parallel new changes continue emerging.

Researchers across the world predict that manufacturing and variety of functions including those known as back office or shared services will continue decreasing as further digitization continues. In this presentation, we will review implications on how the practices, methods, and approaches to assess ISO 9000 compliance will need to change to adapt to the rise of autonomous systems, digitalization and automation. Skills to assess compliance to ISO9000 may need change or expand. The A case study will help to illustrate a situational analysis and alternatives to become prepared for changes of the nature described.

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A Step-by-Step Guide to ISO 9001:2015 Transition

ISO 9001:2015
Management Training

“ISO 9001 is used by millions of people and organisations around the world and the upcoming 2015 revision will have a big impact on those who work with the standard.

The impact of this revision will be similar to, if not greater than the 2000 edition, which was a major change for accreditation bodies, certification bodies, training organisations, implementing organisations, procurement organisations, consultants and customers.”

An excerpt from IRCA Resources on “ISO 9001: IRCA Supporting the 2015 Revision”, October 2013