Company Name
Division or Address
Division or Address
Internal Quality Audits
Doc. No.
Rev. No.
Date: 6/28/2016
Page 1 of x
ISO Procedure
Internal Quality Audits
Approved:
__________________________________________________
Name
title
Approved:
___________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Approved:
__________________________________________________
Name
title
Change Record
Rev
Date
A
Responsible
Person
Description of Change
Name
Initial Release
Distribution List
(list the departments that receive controlled copies)
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Division or Address
Division or Address
1.
2.
Internal Quality Audits
Doc. No.
Rev. No.
Date: 6/28/2016
Page 2 of x
Purpose
•
To ensure that the procedures in Quality Manual are being followed.
•
To determine the effectiveness of the procedures in controlling the quality
of <COMPANY>’s products
•
To identify the need to modify any of the above procedures.
Scope
All areas described in the ISO 9000 procedures, policies, and work instructions
affecting the quality of work are audited.
3.
Responsibilities
<Job title>:
•
initiates the audits and ensures they are conducted in an efficient manner.
•
delegates the authority to carry out specific audits in accordance with this
procedure.
<Team> comprised <departments> are responsible for forming an internal audit
team to audit ISO 9000 compliance.
The cognizant area Manager responds to audit findings and corrective actions.
4.
Procedure
4.1
The Audit Team
The audit team is composed of representatives from the following
departments: <departments>.
<Job title> selects auditors for the audits defined.
Auditors are selected from a function not directly involved in the audit.
Auditors have sufficient seniority in the company to reflect the
importance of the audit.
4.2
Training
Auditors are trained in auditing techniques and attend <training>. <Job
title> maintains <training record> in <location> for <length of time>.
Auditors are provided with auditing guidelines for completing the audit.
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Division or Address
Division or Address
4.3
Internal Quality Audits
Doc. No.
Rev. No.
Date: 6/28/2016
Page 3 of x
Audit Plan
Initially ISO 9000 procedures are audited <frequency>. This frequency is
adjusted for <activities>. The maximum interval between audits is
<interval>.
<Job title> creates the audit schedule. The audit schedule defines:
4.4
•
<attribute>
•
<attribute>
•
<attribute>
•
<attribute>
Carry Out Audit
Departments are notified of an upcoming audit by <notification>.
<Job title> briefs auditors on procedures and audit scope prior to the
audit. Auditors study the procedures prior to the audit.
During the audit, auditors ensure that procedures are being followed and
record their findings onto <name of report>.
<Job title> reviews the audit findings. Audit findings are reviewed with
the staff responsible for the procedures audited.
4.5
Corrective Action
Upon review of the audit, if an audit finding is legitimate, the corrective
action system is followed.
<Job title> has the final say in cases where the legitimacy of an audit
finding cannot be resolved.
<Job title> completes the <name of form> to initiate the corrective
action. The <name of form> is stored in <location> for <length of time>.
<Job title> verifies successful implementation of the corrective action.
The corrective action must be completed within <timeframe>.
Follow-up audits by <job title> within <timeframe> verify that the
corrective actions are being maintained.
4.6
Closing an Audit
Controlled Copy, Do Not Duplicate
For Internal Use Only
Company Name
Division or Address
Division or Address
Internal Quality Audits
Doc. No.
Rev. No.
Date: 6/28/2016
Page 4 of x
Audits are closed upon <criteria>.
<Job title> prepares a final audit report. <Job title> approves the final
audit report prior to distribution. The final audit report is distributed to
<name of departments>.
To close the audit, <job title> prepares <name of report>.
<Job title> maintains an audit history file that includes <items>.
<Job title> maintains an audit log stored <location>. The audit log
includes <items>.
4.7
Review and Evaluation
<Team, departments, job title> reviews audit results for <criteria>.
5.
Related Documentation
<Audit Plan>
<Audit report>
<Audit Log>
Management Responsibility
Corrective and Preventive Action
Quality Records
<list work instructions>
Controlled Copy, Do Not Duplicate
For Internal Use Only