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ISO 9001 Internal Audit Checklist

ISO 9001 Internal Audit Checklist

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Published by Amir Shahzad

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Published by: Amir Shahzad on Jun 19, 2012
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ISO 9001:2008Internal Auditor Checklist
Copyright ©2008 The 9000 Store
 
INTERNAL AUDIT CHECKLIST
ISO 9001:2008
©Copyright 2008 The 9000 Store Page
2 of 23
 
4 Quality Management System Observation/Comments Results4.1 General Requirements
Has your organization established amanagement system (QMS) givingconsideration to:a)
 
Identifying the processesneeded and the application of theprocesses throughout theorganization:b)
 
Determining the sequence andinteraction of the processes?c)
 
Determining the criteria andmethods for operation and controlof the processes?d)
 
Ensuring the availability of resources and information tosupport the processes?e)
 
Monitoring, measuring andanalyzing these processes?f)
 
Implementing actions to achieveplanned results and the continualimprovement?If your organization out sources anyprocesses that affects product conformity,are the outsourced process controlled andidentified?
Additional questions4.2 Documentation Requirements4.2.2 Quality Manual
Does your organization have a qualitymanual? Does it include the following:a)
 
The scope of your QMS and justifications and details of anyexclusionsb)
 
The documented procedures for theQMS or reference them?c)
 
A description of interactionsbetween the processes of the QMS?
Additional questions
 
INTERNAL AUDIT CHECKLIST
ISO 9001:2008
©Copyright 2008 The 9000 Store Page
3 of 23
 
4.2.3 Control of Documents
Does your organization have a formalprocedure regarding the control of documents for your organization:Does this procedure address the followingitems:a)
 
Are documents approved prior toissue?b)
 
Are documents reviewed andupdated as necessary and then re-approved?c)
 
Are changes and the current revisionstatus of documents identified?d)
 
Are relevant versions of applicabledocuments available at points of use?e)
 
Are documents legible and readilyidentifiable?f)
 
Are documents of external originidentified and their distributioncontrolled?g)
 
Is a mechanism in place to preventunintended use of obsoletedocuments: Are old documentsidentified if retained?
Additional questions4.2.4 Control of Quality Records
Does your organization have a formalprocedure for the control of quality records?Are quality records legible, readilyidentifiable and retrievable?Does the procedure describe identification,storage, protection, retrieval, retention time,and disposition of records?
Additional questions

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