We're a big charity hospital that provides medical and surgery care for patients. Lately, the management gave us a commitment to establish ISO 9001:2015 as a step for publishing Quality Culture in our Foundation. I am the responsible person to establish the QMS from scratch. I established ISO 9001:2008 in industrial companies, but it's the first time for me to establish it in a big healthcare foundation currently. I am not afraid of starting, but we need your advice for the start point, we need professional advice and learn important of first and next steps, we need to get the real scoop on the difficulties and challenges of implementation. Could you please help us sending us guidelines?
Implementing ISO 9001 in hospitals is a challenging task. The best way to approach it is to set it as a project, meaning to determine what needs to be done, who will do it and what are the deadlines. First thing that should be done is to conduct GAP analysis and determine to what extent your organization is already compliant with the standard a nd what documents and processes need to be established to achieve the full compliance.
QMS in hospitals differs from the QMSs i other industries so it needs extra caution. ISO organization published IWA 1 - Quality Management Systems - Guidelines for process improvements in health service organizations and I suggest you to use this document for implementation of the ISO 9001 in your organization. For more information, see:
- Would hospitals benefit from ISO 9001? https://advisera.com/9001academy/blog/2015/07/21/would-hospitals-benefit-from-iso-9001/