ISO 9000 & AUDITS WORLD CONFERENCE
Managing Change and Conformity to ISO 9001:2015
Presenter: Lorri Hunt, President, Lorri Hunt & Associates, Inc., Kansas City, MO, USA
Keywords: ISO 9001, Change Control, QMS Integrity
In today’s business environment, the one thing most organizations must deal with is change. Changes in expectations and requirements from customers, changes in statutory and regulatory requirements, changes in suppliers, changes in the availability of resources, and even changes to the standards they implement.
Organizations must also deal with how the change is implemented. Changes might be made permanently, or a change might be needed temporarily to manage a deviation to an existing process. Regardless of the length of time for the change, the change must be controlled.
Organizations must establish a quality management system that is flexible to manage the needed changes while at the same time allow them to keep meeting requirement. At times, users of ISO 9001:2015 can become frustrated with understanding the different types of change. This workshop will review the requirements in ISO 9001:2015 that are related to change and how to best implement them. 4.1 Context of the Organization 6.1.1 /
6.1.2 Risks and Opportunities 6.3 Planning of Changes 8.5.6 Control of Changes Discussion will include what are the differences between the types of change referenced in the standard. It will discuss how these requirements can actually be used when an organization is in transition by demonstrating that the integrity of the quality management system is being maintained even though a change is not fully implemented. In addition to the different requirements that require some level of controlling change, the workshop will review each clause of the standard and discuss how change might affect the requirement as well as how to control the change to maintain control. For example, the availability of resources is a key change that organizations are learning to manage. Due to low employment, the availability of employees is limited in many markets. The workshop will discuss how to ensure that employees, whether they be full-time or temporary, meet requirements to demonstrate competence. All of this change is happening when there are few or no resources added to ensure that customers remain satisfied. Let this workshop help you establish methods to help with the ongoing success of the organization as changes are made.