Healthcare internal audits are nothing new, however their relation to the ISO 9001: 2008 journey is relatively novel for healthcare providers in the U.S. Although many think of manufacturing when they hear ‘ISO 9001’, one of the major benefits of the standards is that they are applicable to all product and service categories, in all sectors, and to all sizes of organizations. The same principles that can guide and benefit a 20 hospital healthcare system can be applied to a two person operation.
ISO 9001 is oriented towards continual improvement and customer satisfaction. It is easy to see how that translates to healthcare:
- Enhanced Patient Safety
- Better Patient Care
- Reduced Risk
So it makes sense that healthcare organizations are embarking on the ISO 9001: 2008 journey. But this does not come without some anxiety. Healthcare folks are hardwired to read standards and regulations to the letter to determine if they are in compliance. When it comes time to plan the internal audit, many organizations are looking for something prescriptive.
The good news is there is more than one way to go about this. The standards can be interpreted in different ways and still be achieved. Once you have become familiar with the standards, keep it simple and don’t try to do ‘ALL’ and ‘EVERY’. Getting started can be as easy as picking a process.
For example, think of patient satisfaction as a process. How you manage patient satisfaction is how it ties back to your quality management system and ISO 9001. With regard to the chosen process determine:
- What is required?
- What questions will we ask?
- What will we ask to see?
- What happens when something goes wrong?
- What can we do to be better?
- Are we managing our patient satisfaction processes to achieve the results we want?
Remember that nonconformity is not failure – it is opportunity for improvement; a topic for discussion. When you find an issue, look across systems, processes and departments to see if it’s the same problem all across the board.
Healthcare internal audits are the most effective way to ensure your compliance, and they are a requirement of ISO 9001: 2008. But ISO reminds us that the purpose of striving for core process excellence is consistency, customer satisfaction, and continual improvement.
For more on the topic you can download this document: Practical tips from industry on optimizing healthcare internal audits.