Sample Page
ISO 9001:2008 Quality System
Requirements Checklist

Sample Page
of the ISO 9001:2008 Requirements Checklist
included in the ISO 9001:2008 Quality Management System Model

Checklist to be used for documentation development. These 31 pages of the checklist provide easy identification of the requirements of ISO 9001:2008. In addition it can be used for an overview of the current status of the documentation development process including information about the recording of developed documents that address specific ISO 9001 requirements as well as documents that still must be developed.

M = the requirement is addressed in the manual
Procedures = procedure(s) that addresses the requirement
Y = yes, document addresses the requirement  
I = content of existing document should be improved 
N = still pending, not yet addressed
X = requirement not applicable for your organization, must not be addressed  


 Sample of page 3 of total 31 pages     

 

Requirements Checklist for ISO 9001:2008
For internal use only                                                                                                                                                        Page 3 of 31

Important: This checklist shall assist with the assessment of compliance with requirements of ISO 9001:2008. 

Review performed by: ___________________________________     Date: _________________________

Y = yes, I = improvement needed, N = no,  X = not applicable

 
ISO 9001 System Clauses / Requirements
                  

 
M

 
Procedures

 
Y

 
I

 
N

 
X

(continues 4.2.2 Quality Manual)

The manual shall include
a) - the scope of the quality management system 		           
    - details of any exclusions            
    - justification for any exclusions            
b) - documented procedures, or reference to them            
c) - a description of the interaction of the processes
       included in the quality management system 		           
 
4.2.3 Control of Documents
Documents required for the quality management system
- shall be controlled 		           
Records
- shall be controlled according to the requirements in  clause 4.2.4 		           
For the control of documents
- a documented procedure shall be established 		           
The documented procedure shall define the controls needed
a) - to approve documents for adequacy prior to issue 		           
b) - to review documents as necessary            
    - to update documents as necessary            
    - to re-approve documents as necessary            
c) - to identify changes of documents            
    - to identify current revision status of documents            
d) - to have applicable revisions of documents
      available at use 		           
e) - to maintain documents legible            
    - to maintain documents readily identifiable            
f) - to identify documents of external origin            
    - to control the distribution of external documents            
g) - to prevent unintended use of obsolete documents            
    - to properly identify obsolete documents that are
      retained for any purpose