Sunday, March 21, 2021; 8 AM - 5 PM
Lorri Hunt, President, Lorri Hunt & Associates, Inc., Kansas City, MO, USA
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.
Lorri Hunt has been implementing and auditing quality management systems to ISO 9001 in diverse organizations since 1994. She is an active member of the U. S. Technical Advisory Group to ISO Technical Committee 176 (ISO TC176). She is currently serving as an expert from ISO TC176/SC2 to participate on revision of Annex L, the source document that provides identical text and definitions from the ISO Directives. She was a co-convener for ISO 9001:2015, TS9002, and The Small and Medium Enterprise Handbook for Implementing ISO 9001:2015. She also served as the International Deputy Task Group Leader for the ISO 9001:2008 amendment and as the convener for ISO 10007 Configuration Management. As the head of delegation for ISO TC176/SC2 from
2009-2018. She was responsible for overseeing the development of consensus positions for the United States related to ISO 9001 and ISO 9004. She is also a member of US TAG to PC 302 Guidelines for Auditing Management Systems. Lorri is most often recognized for using her extensive experience in standards development and auditing to assist organizations in implementing ISO 9001 using a common sense approach. She is the president of Lorri Hunt & Associates Inc. Lorri frequently contributes to quality publications and journals and is a co-author to The ISO 9001:2015 Handbook – A Practical Guide to Implementation. She is a frequent speaker at conferences all over the world and an Exemplar Global certified lead auditor.
WHO SHOULD ATTEND
This workshop is highly recommended for anyone who is working with ISO 9001 Quality Management Standards, QA Managers, Practitioners, and Executives, and other decision makers who are involved with continuous improvement in their organizations.