by Beth Long

Implementing International Organization for Standardization (ISO 9001-2008) standards improves patient care. The application of globally accepted quality standards creates a healthcare environment that involves individuals at all levels within the organization and focuses on improving processes.

The walls between departments are removed and individuals working in other areas gain appreciation for the complexity of procedures required for consistent outcomes. Every service we provide in healthcare, from preparing a patient tray to administering a medication, is a process. Once we understand the ISO concepts of document and record control, internal auditing, and corrective and preventive action, we speak a common language and begin enhancing our services.

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Healthcare organizations that implement and maintain ISO standards demonstrate a commitment to quality care. Policies and procedures (documents) are written to describe processes and are used to train employees. Documents are controlled, and the most current versions are available for use. Employees have the expertise to access documents and participate in internal audits to validate that processes are performed as written. Non-conformances are identified and corrective action is communicated to the employee in the department, as well as to the governing body.

The implementation of ISO standards at Margaret R. Pardee Memorial Hospital in North Carolina has created tremendous change. Through internal audits, we identified the need to revise multiple procedures (cleaning patient rooms, recording dish washing machine temperatures, securing sample medications, procuring supplies after hours and evaluating contracts). In addition, we eliminated out-dated policies, procedures and forms, and now maintain control of documents via the intranet. Training is conducted using written procedures and is validated. Non-conformances are discussed across the organization and are tracked until resolved.

If you think you know what happens in your facility, just send a small team of ISO auditors into a department to audit a procedure and you'll probably be very surprised with the findings.

At the beginning of each audit, an introduction explains how the evaluation will be performed. The audit begins with auditors reviewing the written procedure for control, determining responsibility and validating training. By the conclusion, the auditee understands whether the process is performed as written or if corrective action is required. The auditor leaves with an appreciation for the complexity of the process and the expertise required to perform the procedure.

The commitment to become an ISO-certified facility required direction from our Board and dedication from our employees. Perhaps it is time to consider ISO for your organization.

Beth Long is the Compliance and Accreditation Officer at Pardee Hospital in Hendersonville, N.C.