Has anyone been directly involved with or implemented an ISO9001-2000 system in the healthcare field? If so please share some the steps that were critical in setting up and certifying such a system. My core background with ISO has been limited to mfg. My goal is to migrate into the healthcare environment and provide the benefits of ISO to this industry.
My belief is there is great benefit in the effective implementation of a robust system and this area is virtually a new market. Any links to information on the web or personal experiences would be a great benefit. Thank you in advance.
We have helped a couple of NHS organisations to retain 9K compliance under the Yr2000 revision. The first was a new registration for which we used a “process approach” well in advance of the new standard, and the second was an Accident and Emergency department which had a “lapsed” narrative system which we tranformed into a set of process descriptions.
They refer to it as their Clinical Governance system rather than as a quality system, and they use it to define and improve their processes. In both cases certification tends to be less important than understanding and communicating how they operate - the benefit is in seeing the flow of processes, and identifying responsiblities and interfaces.
ISO 9001:2000 - A New Paradigm for Healthcare is the first book of its kind published for use by healthcare organizations to implement a sustainable management system. This hands-on book details the information needed by the healthcare organization for everything from writing the Quality Manual to the Self Assessment of the organization for readiness for the certification survey.