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Keshav Ram Singhal

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Thursday, September 27, 2012

Document and Record in ISO 9001:2008 QMS



ISO 9000:2005 Standard on ‘Quality management systems – Fundamentals and vocabulary’ has defined document and record (please see definitions in 3.7.2 and 3.7.6). According to ISO 9000:2005 Standard, a document is defined as ‘information (meaningful data) and its supporting medium. In simple terms, we can say that a document provides guidance and/or direction for performing a work, making a decision or rendering judgement. A document may be written, video tape, physical sample, sample drawing, computer programme or otherwise. According to ISO 9000:2005 Standard, a record is defined as a document stating results achieved or providing evidence of activities performed. Records are a special types of documents (please see clause 4.2.3 – ISO 9001:2008 QMS Standard). Accordingly, we may construe the following:
- All documents are not records.
- All records are documents.


People generally confuse with document and record. To make the difference clear between document (other than record) and record, following will provide you the clear difference:
- A document (other than record) is a live paper, while a record is a dead paper.
- A document (other than record) mentions how to carry out an activity, while a record mentions how the activity is carried out.
- Documents (other than records) are subject to change, records are evidence of the activity performed and not subject to change.
- Documents (other than records) are approved and issued (or released) by designated authorities before issue. Records are generated and approved after the activity is over by designated authorities.
- Retention period of documents (other than records) generally are not mentioned as these are live paper, however we can specify the retention period of records.
- The changes in documents (other than records) are identified by Revision number/Issue number. Records are identified by format numbers.

Clause 4.2.3 of ISO 9001:2008 QMS Standard mentions requirements for control of documents and clause 4.2.4 of ISO 9001:2008 QMS Standard mentions requirements for control of records.

With best wishes,

Keshav Ram Singhal

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2 comments:

itsurmachan said...

Documents can be revised/amended, but records is changed is called manipulated

Raj said...

Hi Keshav, great post! What you think about Asian countries, how can they elevate the proper benefit is ISO 9001:2008.