Q: Is there a published ISO standard for good documentation practices (e.g., crossing out an error with a single line and initialing and dating; striking through a blank space)?
A: Your question has two parts:
1) Is there a standard?
2) Does it cover the specific practice you cited?
The answers are “yes” and “no.” 🙂
About a decade ago, the ISO Technical Committee (TC) 176 on Quality Management and Quality Assurance started work on a documentation standard. There was (and still is) much confusion in the world about what kind of documents were expected and what should go into them. Of course, most didn’t want to take the time and energy to understand the purpose of documents, much less describe their practices in a site-specific manual. How sad. The output of the ISO/TC 176 work was a Technical Report: ISO/TR 10013:2001 – Guidelines for quality management system documentation. Frankly, however, I do not think it will address your question.
First of all, documents and records are often confused. Even though the ISO terms and definitions standard (ANSI/ISO/ASQ 9000:2005 Quality management systems — Fundamentals and vocabulary) parks them both under the word document, it is good practice to always think document=before, and record=after.
In other words, a document tells us what to do. A record tells us what was done. Many people, not understanding this principle, have actually tried to place records under configuration control!
The record-keeping practices you cited — crossing out an error and marking in a blank space — have their origin in the early military practices of the 1950s! Back then, there were no computers, internet or even ISO standards. There was also much more falsification of information back then, as we treated the workers with little or no respect.
The practices you cite were attempts to make sure that the data entered on a record wasn’t changed. Those practices just kind of hung on for half a century. In my 40 years in the quality profession, I have never seen these “rules” written down in an external document, like a regulation or standard or policy. Sure, individual organizations have required these practices through their local Standard Operating Procedures, but I am pretty sure they are not published in higher-level documents.
With automation and networking, records are becoming much more virtual. Paper records are becoming a thing of the past. Security and protection of those electronic records is a much bigger problem than when they were all on dead trees.
Follow-up from expert: Doing some further research (for an upcoming class), I discovered that ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories, contains a clause about records correction, 220.127.116.11. In general, the clause says all alterations must be visible (not erased, blacked out, or deleted), and all changes must be signed or initialed by the person making the change. Equivalent measures should be taken in the case of electronic records.
I don’t know why I didn’t think of this standard earlier, however, my earlier remarks about this coming from the 1950s practices B.C. (before computers) still stand.
The Audit Guy
Columbia Audit Resources
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