In recent years there has been considerable discussion regarding the role of accreditation in health care and also how certification programs can be valuable to organizations receiving them. Certification is a process where an outside agency evaluates an organization and issues a report on that organization. These reports are intended to be shared with the public so potential customers can have confidence in the quality of care provided by the organization. Certification programs often go deeper into specific aspects of operation than accreditation does and are not intended to be visible to all patients.
Several certification programs have been created specifically for hospitals in the hope of giving patients a way to remove some of the unknowns inherent in deciding where to receive health care. One common certification program is ISO 9001, a quality management standard consisting of over 100 standards published by the International Organization for Standardization.
Achievement of these standards is not easy and requires a great deal of effort on the part of any organization receiving certification. The information, standards, procedures, and processes for an organization to achieve this are broken down into several steps with designated time periods within which they must be completed:
Preparation for Certification: Before a hospital can even apply for certification, its management performs an internal evaluation to determine whether it is ready to begin the process (ISO 9000 Step 1). This involves documenting policies and procedures that describe the way the organization operates as well as areas where improvement may be needed. It also includes identifying any new methodologies that will be used being implemented and the timeline for their adoption. If these policies and procedures are not in place, then they must be established prior to applying for certification.
Self Assessment: During this step (ISO 9000 Step 2), the hospital develops a self-assessment plan to confirm that ISO standards are relevant to its operations and address every area where the hospital is required to meet ISO standards. This plan also identifies areas where the hospital has unique practices that need to be documented. The self-assessment plan leads into the internal audit phase (ISO 9000 Step 3).
Internal Audit: Here, a third party assesses all documentation related to policies, procedures, and processes against the requirements of each standard relevant to that hospital. These audits are conducted by a team of specialists who examine the documents to make sure they are accurate and complete, including any necessary evidence that the requirements have been met (ISO 9000 Step 4).
Corrective Actions: The internal audit leads directly into corrective action plans (ISO 9000 Step 5), where additional information is added to areas that do not meet the standard. This process continues until all documentation matches the requirements of each relevant standard and the hospital is ready to move into its external audit (ISO 9000 Step 6).
External Audit: An external auditor examines and reviews every paper trail, procedure, record, and other objective evidence for each area that needs to be compliant with an ISO standard. This includes interviewing employees and managers to make sure the internal audit team’s findings are accurate (ISO 9000 Step 7).
Corrective Actions: These audits lead directly into another round of corrective action plans, which continue until all documentation matches ISO standards and the hospital is ready for a final assessment (ISO 9000 Step 8). The external auditor then draws conclusions about the hospital’s compliance based on all documentation, interviews, and other evidence.
Evidence of Compliance: This is the last step (ISO 9000 Step 9) in the certification process for hospitals, where a certificate is issued to any organization that has met ISO standards. Once certified, an organization must document its continuing effort to maintain these standards by completing a re-certification audit at least once every three years.
Issued faced in ISO Certification for Hospital
Lack of adoption of the ISO standard for healthcare is not due to lack of need, as many hospitals are still struggling with compliance with other health standards and regulations. For example, many hospitals are still awaiting formal approval from the government and lack initiatives to implement electronic health records systems.
“According to the Healthcare Financial Management Association’s 2015 survey of healthcare finance executives, a mere 5% of hospitals are expected to report operating in full compliance with ICD-10 by the Oct. 1 deadline.”
In contrast, many nonprofit and public health organizations have adopted the ISO 9001 standard due to its track record for establishing better management processes as well as a broader focus on organizational development. Generally, the ISO standards provide a solid platform from which organizations can build up their quality management systems and increase their focus on building processes that promote continual improvement rather than relying on more traditional compliance programs.
Cost of ISO Certification in Hospitals
The cost of certification is directly proportional to the size of the hospital. The larger the organization, the more resources needed for the audit and the more likely they are to have extra staff devoted to quality assurance. Smaller hospitals generally need less staff and incur smaller costs.
Some hospitals may find it less expensive to join a consortium of other hospitals, which share inspection services in order to reduce cost by spreading out their expenses; however, this does sacrifice some form of independence and control over the process.
Also refer: How to get ISO Certification
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