During the DNV GL symposium, I overheard someone say that after four years of “doing” ISO, they can “kind of see” how leadership and management review can contribute to improvement. It is unfortunate that it has taken years for the benefits of ISO to be appreciated, but sadly it is a common observation and truth for many hospitals using the 9001 framework as part of their accreditation. Implementing, maintaining, and improving a management system is a journey, not a destination.

All of us have probably heard that by now. Leadership involvement and the management process of your management system is usually one of the last to mature.

Many of my conversations with hospitals are about how to help them with their management processes. I usually hear that their leadership is open to have some education but it needs to be about an hour, two hours at the most because they do not have the attention span to sit any longer. If this sounds familiar, rest assured you are not alone. Historically, leadership education is high level and generic about ISO 9001 to include “their” requirements. The management rep is usually the person who makes it all happen and ensures there is enough evidence to ensure leadership can show “evidence of its commitment” to the QMS.

The 2015 standard adds additional leadership requirements to the QMS. One of the requirements is to identify the context of the organization. The context of the organization is determined by looking at the external and internal issues that are relevant to the strategic direction and its purpose and that affects the ability of the QMS to achieve intended results. Conducting a risk assessment on the current state of leadership and management processes for hospitals with adhoc management processes would be appropriate. Use the outcome of the assessment to show leadership the risks to their accreditation. These risks to their accreditation are based on their current involvement level compared to the new leadership requirements. Hospitals that have chosen to switch to DNV GL for their accreditation have to maintain conformance to ISO 9001 even if they do not want to become certified to ISO. This ISO QMS requirement is not going away for hospitals that use DNV GL.

ISO 9001 surveyors expect to see a QMS maturing each year, including the management processes. Several hospitals received findings last year written against leadership that put them in jeopardy of losing their accreditation. Being honest about the issues that affect your QMS will help you to mitigate risk and possibly get the positive attention of leadership to help mature your QMS.

Bio:

Eric is a Certified Enterprise Risk Manager (CERM©), and a Senior Advisor with BlueSynergy Associates. BlueSynergy Associates maximize innovation, experience and customer perspective to reduce risk and make hospitals a safer environment. He advises and instructs hospitals in quality, risk, and environmental management systems. Eric was a Project Lead and Senior Consultant in the largest ISO 9001 implementation in healthcare at the Veterans Administration. He is a certified Lead Auditor in quality management systems by Exemplar Global. He can be reached by email at eschulze@bluesynergyassociates.com or by calling toll free at 844-424-7825