Maintaining the Integrity of ISO 9001: Drafters, Auditors, and Users

Industry: All Industries

Keywords: ISO 9001 Integrity

Level: All Levels

LinkedIn: https://www.linkedin.com/in/lorri-hunt-7b98373/

When looking into the future of the next revision to ISO 9001, there are alternative views on whether the standard needs revised to maintain its level of relevancy or whether the generic nature of the standard is flexible enough to address these changes. There is also the conversation that relates to when changes to ISO 9001 are desired to improve the way the standard is audited.

Based on these viewpoints, and a mandate from the ISO Technical Management Board that the text drafted to address climate change as part of the London Agreement be incorporated into all management system standards, which includes ISO 9001, there will be challenges in striking a balance that meets the needs of most of the users.After the publication of ISO 9001:2000, which was a major revision to the standard, studies on the transition to the revised standard were conducted. One of these studies included statements related to electronic documents and a skeptical viewpoint that this would be the norm in the future.

Some of the other changes in the workplace such as remote working could not be anticipated. Consideration must be given to maintaining the generic nature of the standard to make it easier to apply for all types and sizes of organizations.

This includes restraint in ensuring that the standard considers emerging trends in business but does this in the framework of changing requirements only when the current text is too prescriptive to allow this. For example, did the words electronic documents have to appear in the standard or were the requirements for documents in ISO 9001 flexible enough to address the change in how documents were delivered.

This session will discuss some of the emerging trends in business today and how the current standard addresses these.

It will review why words matter and how rewriting a sentence to mean the same thing can cause confusion to users. It will discuss how auditor competence is critical to the integrity of ISO 9001 and how companies can help drive improvement by keeping their ISO 9001 knowledge up-to-date.

Upcoming ISO 9001 Revision: Separate the Facts from Fiction

Industry: All Industries

Keywords: ISO TC176, ISO 9001 Revision, Scope of the Revision

Level: All Levels

LinkedIn: https://www.linkedin.com/in/lorri-hunt-7b98373/

A decision to begin the ISO 9001 revision process was made in July 2023. In anticipation of a revision, a design specification to be used for the potential revision was developed which has accelerated the revision process. Subsequent planning has been conducted to establish the working group responsible for the revision and the timeline for completing the work.

With the start of any revision process, there are discussions on what does this mean, how does it impact our organization, and what will be changed. This results in some information that is correct (fact) and some information that either is slightly incorrect or not correct (fiction). Since the last revision to ISO 9001, ISO Technical Committee 176 (ISO TC176), including the sub-committee that revises ISO 9001, has increased its communication tools to provide information that is directly accessible to any user.

This panel discussion will include a review of how to access this information and highlight the status of the ISO 9001 revision. It will include how to determine if something about the ISO 9001 revision is fact or whether it is an interpretation of the information. The session will also allow attendees to answer questions. Topics to be reviewed include:

• ISO TC176 Communication Platform
• Timetable for ISO 9001 Revision
• Scope of the Revision (amendment vs. revision).

The panel will also answer general questions from attendees on other relevant topics related to quality management systems in order to provide needed clarifications.

Discussions with Your Auditor

Having a discussion with your auditor is at times easier said than done,  Organizations that are being audited may lack confidence in understanding the requirements in a manner to present their viewpoint.  Some organizations are uneasy about potentially upsetting their auditor.  This session will review how to have a discussion with your auditor.  It will review resources that are available that provide valuable information.  While not official interpretations, documents such as the auditing practices group papers, which are available at no charge, can help you understand how a requirement might be audited to help you prepare.  This session helps strengthen the auditee's understanding of requirements while at the same time works to improve the working relationship with the auditor.

Lorri Hunt

President, Lorri Hunt & Associates, Inc., Kansas City, MO, USA

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 served as an expert from ISO TC176/SC2 to participate on revision of Annex SL, the source document that provides the high-level structure that includes identical text and definitions from the ISO Directives.

Lorri was recently appointed to the leadership team to the next revision to ISO 9001. 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 was 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.