ISO 9001 Quality management systems – Requirements (2000)

Clause 4.2.4 of ISO 9001 has only one short paragraph on control of records:

4.2.4 Control of records

Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

In my experience the key aspect of this statement is “readily identifiable and retrievable”.  This is almost never addressed in Quality Management Systems.

The most effective system that works is based on the “bleedin’ obvious”.  In this blog I am going to attempt to point out the “bleedin’ obvious” to you.  I am not setting out to give you a solution but more to set you on the right path.