Making Sense of Documented Procedures in ISO 9001
A Common Sense Guide for Hospitals Using NIAHO/ISO 9001
Digging Through Policies & Procedures
December 11, 2013
This is the first in a series of quick lessons in the 6 required documented procedures of ISO 9001 – 1) Document Control, 2) Record Control, 3) Internal Audit, 4) Control of Non-conforming Product, 5) Corrective Action, and 6) Preventive Action. These lessons are for hospitals adopting ISO 9001 – usually as part of NIAHO based accreditation through DNV – or simply wanting to clean out the Augean Stables of their Policies & Procedures. These are designed to be 10 minute reads – introducing some concepts that I’ve found valuable.
Buried in documents – A Practical Guide to Shoveling Out
ISO is pretty straight forward about documents, they are required to be included in the quality management system “…documents, including records, determined by the organization to be necessary to ensure the effective planning, operations and control of its processes.” (Section 4.2.1) More specifically, in section 4.2.3 ISO 9001 requires a documented procedure to control documents including, 1) Approval prior to use, 2) Periodic review and updating, 3) Version control, 4) Availability of the current version in the workplace as required, 5) Identification and legibility of documents, 6) Identification and control of third party documents (user manuals and the like), and 7) To prevent the unintended use of obsolete documents.
In short, ISO requires pretty much what state and federal regulations require of most hospitals policies and procedures (P&Ps) with a few important differences. As a result, most hospitals undertaking ISO use their existing P&Ps as the foundation for operational documentation. This requires a few words of caution. First the P&P format is archaic in a process oriented system like ISO – requiring specific (and unique) policy identification with each procedure. In ISO, the concept is that documents describe steps in processes, and are essential to the “say what you do, do what you say” premise of ISO – thinking of a standard operating procedure (SOP) is a clearer construct.
Secondly, in most hospitals, P&Ps were allowed to grow unchecked – resulting in thousands of documents – often contradictory, redundant and unused. ISO will not tolerate such documents as control documents – ISO requires that you actually need to have a reason for a document, and will hold you accountable: 1) For proving that people follow the procedure that the document describes, 2) For proving the effectiveness of the underlying process, and 3) For having reasonable data to prove points 1&2. These requirements (in addition to the 7 requirements for document integrity listed in the first paragraph) really make unused, poorly written, contradictory and redundant P&Ps a liability.
The rest of this lesson looks at the practical steps to take in developing a lean and functional document system from the typical confused morass of P&Ps.
A Filter System to Focus Documents
I like to use a document filter – normally based on an Excel based management template – to filter the “wheat from the chaff”. The first set of filters looks at redundancy, contradiction and related criteria to eliminate and consolidate (I normally use 7-10 criteria depending on the site). Once I’ve narrowed the P&Ps down to rational documents, I risk rate them – based on factors including: 1) Three factors relating to patient care, 2) Frequency, 3) Cost, and 7 other factors to derive a risk score. When finished, you have P&Ps which both meet the criteria required by ISO, and are lean and focused on processes based on risk.
When this is completed I like to use a Word Template to move into the new document format. This combination allows for the development of a data base of changes, and a good audit trail to show how the old document system morphed into the new system. The paired use of Excel and Word allows for an easy numerical expression of total changes, as well as fast specific identification for individual P&Ps.
The availability of very high quality third party clinical documentation has expanded enormously in recent years, and I’m a big fan of its use – with a couple of caveats. First, I like third party documents that are available electronically. This way, documents are always up to date, and version control issues are greatly reduced. Secondly, I see increasing use of third party documents and order sets – available directly through the EMR. This is a huge advantage in: 1) Controlling documentation, 2) Ensuring up to date best practices, 3) Integrating training and competency directly back into the document system, and 4) Ensuring the seamless transition of documents into records. Rather than maintain mountains of P&Ps that are hard to access and very expense to maintain, simply adopt a third party standard, and integrate it directly into your document system.
A Vertical Look at Document Structure
Finally, I encourage taking a hard look at the span of policies. Most policies relate to specific processes, and may have many procedures related to adherence. As an example, an accounting department may have many procedures related to a single policy – e.g. “we will comply with GAAP standards”. It is typical that there are many procedures pointed at a single policy – an infinite number of sub-policies add nothing – and take up more time and money to develop and maintain. Similarly, I frequently see P&Ps written which simply duplicate the steps outlined in an order set – why bother. All that this does is add more cost, time, complication and opportunities for error.
As the ultimate test I ask people if anybody does (or should) train to a particular P&P. If the answer in no – what do you want it for? I have seen spectacular reductions in document burden happen – almost always concurrent with the increase in document utility.
As we will see in subsequent lessons, it is virtually impossible to have a functional process improvement effort without a functional and controlled P&P system. ISO is a documented quality management system – always start with getting the documents right.
Needing a filter to sort out the signal from the noise