To be in compliance with ISO 9001:2008, the organization must have some mandatory documents. These requirements are stated under various clauses of ISO 9001:2008. The documents required for ISO 9001 are listed below.
According to ISO 9000 (QMS Fundamentals and Vocabulary), A Document is defined as “Information and its supporting medium“. This is further explained in the notes to this definition.
The medium can be paper, magnetic, electronic or optical computer disk, photgraph or master sample or combination there of.
A set of documents is called as “Documentation”
The requirements of documentation for compliance with ISO 9001:2008 are as follows.
The following Clauses define the documentation requirements in the Quality Management System
The Quality Management System Shall Include the following documentation
(4.2.1 a) – A documented Statement of Quality Policy
( 4.2.1 a) – A documented Statement of Quality Objectives
(4.2.1 b) – Quality Manual
(4.2.1 d) – The documents including records which are to be determined by the organization as necessary for effectiveness of its QMS
(4.2.1 c) In addition to the above, the Standard identifies some documents and records which are identified under different sections of the standard
To meet the requirement of 4.2.1 c, we need to scan through the standard for further requirements. This will be found as follows.
( 4.2.3 ) A documented procedure to define the document control
(4.2.4 ) A documented Procedure to define the controls needed for various records
(8.2.2) A documented procedure to define the responsibilities and requirements regarding internal audit.
(8.3) A documented procedure to define the control of non-conforming product
(8.5.3) A documented procedure to define the requirements concerning the Corrective Action
(8.5.4) A documented procedure to define the requirements regarding Preventive Action.
To comply with these requirements, documented Procedure means that the procedure is established, Documented, implemented and Maintained.
The Documentation requirements can be covered in more than one document, and a single document may address one or more requirements.
All these documentation requirements may or may not be part of the Quality Manual. Where these are not part of the Quality Manual, The reference to these procedures must be provided in the Quality Manual.
Please note in addition to the requirements listed above, the organization may require some additional documents which may or may not be part of Quality Manual.
Originally posted 2011-04-19 16:42:00.