Internal Audit Analysis Template

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					                   Quality System Procedure
                      INTERNAL AUDIT
                           QSP8.2.2



                        [Company name / Logo]




The signatures below certify that this procedure has been reviewed and accepted, and demonstrates that the
signatories are aware of all the requirements contained herein and are committed to ensuring their provision.

                    Signature                           Position                            Date


     Prepared by



     Reviewed by



     Approved by




COMPANY PROPRIETARY INFORMATION
This document is an uncontrolled copy of a controlled document held by the Quality Management System. Prior to use,
ensure this document is the most recent revision by checking the Master Document List. To request changes, submit a
Document Change Request to the Document Control Representative.
                                                                                                                                     ISO 9001:2008 Quality Manual



Contents

1. Introduction & Purpose ............................................................................................................................................ 5

2. References ............................................................................................................................................................... 5

3. Terms & Definitions ................................................................................................................................................. 5

4. Application & Scope ................................................................................................................................................. 5

5. Requirements........................................................................................................................................................... 6

6. Audit Process ........................................................................................................................................................... 6

   6.1 Audit Planning ............................................................................................................................................................ 6
     6.1.1 Audit Team Evaluation & Selection ..................................................................................................................... 6
   6.2 Audit Preparation....................................................................................................................................................... 7
   6.3 On-site Audit .............................................................................................................................................................. 7
   6.4 Wrap-up Meeting....................................................................................................................................................... 7
   6.5 Follow-up ................................................................................................................................................................... 7
   6.6 Reporting ................................................................................................................................................................... 7
   6.7 Review ........................................................................................................................................................................ 8
   6.8 Records ...................................................................................................................................................................... 8
   6.9 Audit Process Matrix .................................................................................................................................................. 9
   6.10 Audit Process Map ................................................................................................................................................. 11




Document: QSP8.2.2                                                                                                                                                  Page 4 of 11
                                                                                       ISO 9001:2008 Quality Manual



1. Introduction & Purpose
The purpose of this procedure is to define Your Company’s process for undertaking internal audits in order to assess
the effectiveness of the application of ISO 9001:2008 and also to define the responsibilities for planning, and
conducting audits, reporting results and retaining associated records.



2. References
 Reference            Title

 8.2.2                Quality System Manual

 QF8.2.2-1            Internal Audit Schedule

 QF8.2.2-2            Internal Audit Plan

 QF8.2.2-3            Internal Audit Assignment

 QF8.2.2-4            Internal Audit & Gap Analysis Checklist

 QF8.2.2-5            Internal Audit Report

 QF8.2.2-6            Internal Audit Feedback




3. Terms & Definitions
Opportunity for Improvement a situation/condition of the QMS that may be weak, cumbersome, redundant, overly
complex, or in some other manner, may, in the opinion of the auditor, offer an opportunity for an organization to
improve its current status.
Minor Non-conformance is a non-conformity that, based on the judgment of the auditor, is not likely to result in the
failure of the QMS or reduce its ability to assure a controlled process.
Major Non-conformance the absence, omission or total breakdown of a system to meet a specified requirement.
A number of minor non-conformities against one requirement can represent a total breakdown of the system and thus
be considered a major non-conformity.
Preventive action is taken when we anticipate a potential problem and take action to eliminate the possible causes to
prevent the occurrence a non-conformance.
Corrective action is taken upon detection of a non-conformance to prevent it from happening again; we act to
‘prevent’ a repeat of a detected non-conformance.



4. Application & Scope
The scope of this procedure is focused on assessing the effectiveness of Your Company’s quality management system.
Where such processes are found to be deficient, the audit will lead to improvement in those processes.
By applying the principles of auditing, outlined by ISO 19011:2002, Your Company ensures that all internal audits are
conducted with due professional care, integrity and independence. All conclusions derived from the audit are based
upon objective and traceable evidence.




Document: QSP8.2.2                                                                                        Page 5 of 11
                                                                                                 ISO 9001:2008 Quality Manual



6.10 Audit Process Map

Quality Management                    Audit Team                   Responsible Manager                     Top Management
  Representative




Audit Considerations
• ISO 9001 requirements
• Customer complaint
• QMS requirements
• Quality objectives/policy
• Corrective actions
• Statutory/legal requirements
• Management decisions
• Concerns raised by 3rd parties
• Results of 3rd party audits
• Employee concerns
• Management Review concerns

Additional Considerations
• Status
• Importance
• Frequency




 Establish Audit Schedule
                                     Document Review
  and Prepare Audit Plan




                                   Prepare Audit Checklist




                                       Conduct Audit




                                                             YES
                                           Non-
                                        compliances                Initiate Corrective Actions
                                          found?




                                                 NO

                                                                     Close-out Corrective
  Review Audit Findings            Prepare Audit Report                    Actions



                                                 UPDATE


  Recommendations for                Verify Close-out at
      Improvement                    Follow-up Meeting



                                                                                                            Management Review




Document: QSP8.2.2                                                                                                Page 11 of 11

				
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