What is Documented Information????

Documented Information is a new terms used in the High Level Structure of the ISO management system standards directed by ISO/IEC.  This means that the terms is transferred into each of the management standards, ISO 9001, AS 9100, IATF 16949, ISO 14001 and ISO 45001.  Effectively, this new term has replaced the previous requirement for document control in 4.2.3 and and record control in 4.2.4.  Section 7.5 of the latest standards highlights the requirements for documented information.

In summary, the same rules apply as before with less specificity.  You still need to identify each document uniquely.   You still need to ensure that the current version of a document is used (control of changes and protection).  They still need to be reviewed and approved for suitability and adequacy.  There is still no mention of requiring a master list or a specific numbering scheme as many think.  There is still no requirement to stamp every hard copy uncontrolled or invalid after 24 hours.  Yes, these are methods to control documents, however they are not required.

There are many acceptable simplified ways to control documents which do not require document change forms or logs or wet signatures or stamps or watermarks or PDF conversions.  We can help you understand what the standard requires.

Whatever methods you derive to control documents, they must be suitable for your organization and stand the test of an audit.  Often the more complicated, the more risk of failure.

 

Also, the only mention of record control is in retention and disposition of documented information.  The most important thing to remember when reading the standard, is that if the standard refers to maintaining documented information it is referring to document control, if it refers to retaining documented information it means record control.  It does not say specifically that you have to document a record retention period, however most customers require this and you need to demonstrate that you address the retention and disposition of records in your system.

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