The definition of the documented information is combined from several characteristics that affect the documented information and its functionality such as identification, relevance, media, etc. All those properties must be defined and applied when designing, releasing, and updating documented information. The ISO 9001 Standard requirements are very clear:
- When creating and updating documented information, the organization shall ensure that identification and description of this documented information are defined and clear. The identification and description may include characteristics like title, date, author, or reference number.
- For each type of documented information, the appropriate format will be determined and maintained.
- For each type of documented information, the appropriate media will be determined and maintained.
- When creating and updating documented information, the organization shall apply reviews and approval needed for the suitability and adequacy of this documented information.
Identification and Description of Documents
Any documented information (internal or external) must be identified and represented with words (described) in order to make the use and function of this document clear. A document must have a name, catalogue number, or other means of identification. This is done through defining elements that can identify, describe it, and submit it to the control. Anyone in the organization that picks up the document will know where to assign it. The ISO 9001:2015 Standard requires the determination of a method for identification of documents. The following example for identification of documented information is quite basic but will hold in an audit. The organization maintains the next operational hierarchy of documentations:
- Documented procedure that describes a process
- Work instructions that specify how activities will be performed
- Forms that document activities and deliver evidences
Let us assume that the organization manages a process for receiving customer orders. This documented procedure is numbered and identified: PR-004—Receiving Customer Order. This caption will appear on top of the documentation that describes or displays the procedure:
- PR: stands for procedure
- 004: the three digits represent the process in the workflow
- Receiving Customer Order: the name of the procedure
On the documented procedure (whether it is a diagram or a text that describes the procedure), references to lower work instructions will appear. Let us go one tier below to the work instruction. Take a look at the following number: WI-004-002: Entering Customer Order into the ERP system.
- WI: stands for “work instruction”
- 004: the first three digits represent the process
- 002: the second three digits represent the subprocess
- Entering Customer Order into the ERP system: the name of the procedure
And to it I add form FO-004-002-003: List of Open Orders
- FO: stands for form
- 004: the first three digits represent the process related to this form
- 002: the second three digits represent the subprocess related to this form
- 003: represents the third form related to this subprocess
- List of Open Orders: the name of the form
Together, they combine an identification number, maintain the interrelation between each other, but most importantly they provide identification of the documents. This kind of identification must be applied to documented information when creating or updating a document.
Identification of Records
Although the standard neglects the differentiation between documentations and records and refers to records as documented information, I would like to relate to the records because I feel that records do have special properties. Records like documents must be identified. A record must have a name, catalogue number, or other means of identification: an element that identifies it. Normally, it inherits the identification of its related document. Anyone in the organization that stumbles upon it will know where to assign it. But important is who performed the activity. As stated before, a record is an evidence of performance. Each record must have the identity of the person that filled it or at least the function that is responsible for it. The classic way is the name, date, and a signature on the record. The identification of the person will be clear and understood. A digital signature counts as well.
This webpage contains only a fragment of the chapter 7.5 – Documented Information from the book: ISO 9001: 2015 – A Complete Guide to Quality Management Systems published by:
Why choose the book ISO 9001:2015?
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