When the concept of introducing ISO 9001 to the hospital setting first arose, concerns popped up that the quality management system would be a tough sell for the healthcare industry. As more hospitals look into using ISO 9001, however, it has become clear that hospital leadership—who often come from non-healthcare backgrounds—have frequently encountered the concept, with positive results.
St. Luke's Hospital in Maumee, OH, has been ISO-certified since 2004. The hospital is Joint Commission- and DNV-accredited, and expects to continue DNV-NIAHO accreditation in the next few months with a DNV deemed status survey.
Cheryl Roush, CPHQ, organizational quality manager at St. Luke's, has become the hospital's resident ISO expert—a learning experience that has sold her on the concept as an important one for healthcare organizations to pursue. It's not easy to take the first step, however.
"It's a little intimidating," says Roush.
Coincidentally, a local community college near the hospital offered an ISO-based quality assurance program, offering classes that provided background and basics on ISO concepts.
"Even the terminology is a little scary, but everyone is doing a really good job inter-relating the concepts," says Roush.
Darrel J. Scott, senior vice president of regulatory and legal affairs with DNV Healthcare Inc., points out that thus far, ISO certification has been handled by certified hospitals using existing staff.
"It should be noted that every hospital accredited by DNV (large and small) has become ISO 9001-compliant within its first year in the DNV program and has done so without the addition of any new staff," says Scott.
The ISO 9001 process targets certain areas to a more intense degree than facilities may have encountered in the past (e.g., calibration of equipment and documentation control).
"Your document control is going to be a big [change]," says Roush. "Joint Commission requires that clinical processes are written, but a lot of other areas, like finance, didn't have documentation [requirements]."
Updating and tightening document control has been an ongoing process. A central location on the hospital's intranet site has been developed to house all documentation, and each department has a section where it now stores its own policies.
A numbering system is now in place to help keep forms current and cycle out older versions. This was developed by a committee that established a specific sequence: the first three numbers identify whether the document is organizational, patient care, forms, etc., and the second three numbers are department specific, using cost center numbers. Beyond that, departments are allowed to customize their numbering system to meet their needs.
"I recommend hospitals have one repository for documents," says Roush. "We have a procedure on document control, highlighting the approval process, the numbering system…everything is controlled on the intranet."
This is also a tightly controlled repository—only Roush is able to go in and make changes, though staff can access the documents for printing and distribution.