Professional Documents
Culture Documents
Name:
Department:
Email:
Locations Sampled:
AUDIT DATE
(RANGE)
Audit Scope/Criteria:
(area(s) being audited, applicable clauses from ISO 9001, applicable Administrative Directive
requirements, state or federal regulations, etc.)
FINDINGS
Internal Audit
Report #
FINDING
NC # & CA #
Audit Summary:
System Strength:
Minor
NC#
CA#
AUDITOR COMMENTS
MAJOR
EXPECTATION DEFINED
Comment
Recorded
Documented
CLAUSE
Proven
TYPE OF
EXPECTATION
Minor
System Weakness:
Comment
292315831.xls
TO
MAJOR
Relationship with
ISO 9001:2008
CONTROLLED
COPY
Revision: 02
18/05/2015
1 of 16
5.4 Planning
292315831.xls
MAJOR
FINDING
Minor
AUDITOR COMMENTS
Comment
EXPECTATION DEFINED
Recorded
Documented
Relationship with
ISO 9001:2008
Proven
TYPE OF
EXPECTATION
CLAUSE
NC # & CA #
NC#
CA#
How are responsibilities & authorities estblished within the organization? Does
it have an ORG chart?
Did the organization appoint an Management Representative?
What kind of responsibilities & authority does the Management Representative
has in achieving the following:
- establish, implement & maintain processes needed for effective QMS
- report to management on the performance of the QMS & any improvements
necessary
- promote awareness of customer requirements throughout the organization
What kind of communication channels are established regarding the
effectiveness of the QMS?
Revision: 02
18/05/2015
2 of 16
6.3 Infrastructure
6.4 Work Environment
292315831.xls
MAJOR
FINDING
Minor
AUDITOR COMMENTS
Comment
Recorded
EXPECTATION DEFINED
Proven
Relationship with
ISO 9001:2008
TYPE OF
EXPECTATION
Documented
CLAUSE
NC # & CA #
NC#
CA#
Are the resources needed to implement, maintain & continually improve the
effectiveness of the QMS & its processes determined & being provided?
Are resources needed to enhance customer satisfaction determined & being
provided?
Revision: 02
18/05/2015
3 of 16
7.3 Design
7.3.1 Design & development
planning
Does the organization has established plan & controls for design &
development?
Does the design & development plan identify the design changes?
Does the design & development plan identify reviews, verifications &
validations required at each stage?
Does the design & development plan identify the roles, responsibilities &
authority?
Does the design plan establish effective communication plan?
Are the design outputs reviewed & verified to meet design inputs?
Are the design outputs approved prior to release?
Does the design outputs show appropriate information for purchasing,
production and/or service, as applicable?
Does the design outputs provide appropriate reference to product acceptance
criteria?
Does the design outputs specify the characteristics of the product that are
essential for its safe & proper use?
292315831.xls
Revision: 02
18/05/2015
MAJOR
FINDING
Minor
AUDITOR COMMENTS
Comment
Recorded
EXPECTATION DEFINED
Proven
Relationship with
ISO 9001:2008
TYPE OF
EXPECTATION
Documented
CLAUSE
NC # & CA #
NC#
CA#
4 of 16
7.4 Purchasing
What type and extent of controls does the organization has over its suppliers?
Does the organization has controls established for any outsourced processes
or products?
Is supplier evaluation criteria established? How often are suppliers evaluated?
Are records maintained on supplier evaluations?
Does the purchaing information describe the product/service to be purchased?
Does the purchasing information describe the following:
- requirements for approval of product/service, procedures, processes and
equipment?
- requirements for qualification of personnel?
- requirements of Quality Management System? (such as a purchasing
procedure or policies)
How does the organization verify the adequecy of the purchasing requirements
prior to communicating them to supplier?
What kind of inspection or other activities are established to verify that the
purchased product meets the purchasing requirements?
If product verification is carried out at supplier's premises, how does the
organization verify the arrangements & method of product release?
Does the organization have any special processes where the output of the
process cannot be verified by subsequent monitoring or measurement?If so,
how does the organization address the following:
- validation of such processes to achieve planned results
- defined criteria for review and approval of those processes
- approval of equipment or personnel related to those processes
- use of methods and procedures for those processes
- any requirements for records
- revalidation of those processes when changes occur to those processes
Are proper records maintained including records of revalidation of any such
processes?
292315831.xls
MAJOR
FINDING
Minor
AUDITOR COMMENTS
Comment
Recorded
EXPECTATION DEFINED
Proven
Relationship with
ISO 9001:2008
TYPE OF
EXPECTATION
Documented
CLAUSE
NC # & CA #
NC#
CA#
Does the organization has the available information that describes the
characteristics of the product/service?
Does the organization have the necessary work instruction needed to carryout
production and service provsion?
Does the organization use suitable equipment for carrying out production and
service provision?
Does the organization use & maintain measuring & monitoring equipment
where needed?
How does the organization control the release, delivery and post-delivery
activities?
Revision: 02
18/05/2015
5 of 16
292315831.xls
MAJOR
FINDING
Minor
AUDITOR COMMENTS
NC # & CA #
NC#
CA#
EXPECTATION DEFINED
Comment
Recorded
Proven
Relationship with
ISO 9001:2008
TYPE OF
EXPECTATION
Documented
CLAUSE
Does the organization use monitoring & measuring devices to prove evidence
of conformity?
Does the organization establish processes to enable performance of
monitoring & measuring activities that are consistent with the monitoring &
measuring requirments?
Does the organization identify the calibration needs for these measuring &
monitoring devices?
Does the organization establish the criteria & frequency of calibration for these
measuring & monitoring devices?
Are the calibration requirements/methods traceable to a known International or
national standard?
If there is no known standard, how does the organization perform calibration of
such devices?
Are the measuring or monitoring equipment adjusted or re-adjusted as
necessary?
What kind of controls are in place to safegaurd adjustments that would
invalidate the measurement result?
How can the calibration status of these devices be identified? (Is there a
calibration log or a calibration sticker on these devices?)
How are these calibrated devices protected from damage and deterioration
during handling, maintenance and storage?
Are the calibration results verified & recorded? Are the records properly
maintained?
When a device is found to be out-of calibration, how does the organization
assess & record the validity of the previous measuring results?
How type of actions does the organization take on any equipment or product
when a out-of-calibration situation occurs with the measuring device that is
used?
When using computer software as part of the measuring & monitoring
activities, is the ability of this application confirmed prior to initial use and
reconfirmed as necessary?
How does the organizaton demonstrate the following:
- conformity of product/service
- conformity to Quality Management System
- continually improve the effectiveness of the Quality Management System
What methods does the organization use to collect customer perception? How
does it use that information?
Does the organization has an internal audit procedure?
Does the Internal audit procedure define roles, responsibilities & authority for
planning, conducting audits, & reporting audit results?
Are internal audits conducted at planned intervals to determine the
effectiveness of the QMS?
Does the internal audit criteria include status, importance & results of previous
audits of the audit area?
Does the audits define the following: Audit criteria, scope, audit frequency &
audit methods?
Are the audits conducted in a manner that ensures impartiality and objectivity?
Are the audit records properly maintained?
Does the audit area take appropriate actions in a timely manner when
nonconformities are identified?
Does follow-up activities of the audit include verification of actions? Are the
results of these verification recorded?
Revision: 02
18/05/2015
6 of 16
NC # & CA #
NC#
CA#
What methods does the organization have in place to measure & monitor their
processes?
Does the organization take necessary corrective actions when its processes
are found not to achieve planned results?
Does the organization collect & analyze appropriate data to demonstrate the
suitability & effectiveness of the QMS?
How does the organization utilize this data to evaluate continual improvement
in the effectiveness of the QMS?
Does the organization collect and analyze data in relation to the follwoing:
- Customer satisfaction
- conformity of product/service requirements
- characteristics and trends of processes & products
- suppliers
8.5 Improvement
8.5.1 Continual Improvement
292315831.xls
FINDING
MAJOR
AUDITOR COMMENTS
Minor
EXPECTATION DEFINED
Comment
Recorded
Proven
Relationship with
ISO 9001:2008
TYPE OF
EXPECTATION
Documented
CLAUSE
Does the organization use Quality policy, objectives, audit results, analysis of
data, management reviews, corrective and preventive actions to continually
improve the effectiveness of the QMS?
a
Revision: 02
18/05/2015
7 of 16
292315831.xls
Revision: 02
18/05/2015
MAJOR
FINDING
Minor
AUDITOR COMMENTS
Comment
Recorded
EXPECTATION DEFINED
Proven
Relationship with
ISO 9001:2008
TYPE OF
EXPECTATION
Documented
CLAUSE
NC # & CA #
NC#
CA#
8 of 16
C/MR/01/02
Rev. Date: 18/05/2015
Name:
Department:
Email:
Locations Sampled:
AUDIT DATE
(RANGE)
Audit Scope/Criteria:
(area(s) being audited, applicable clauses from ISO 14001)
FINDINGS
Internal Audit
Report #
FINDING
NC # & CA #
Audit Summary:
System Strength:
Minor
292315831.xls COD-FRM-009
AUDITOR COMMENTS
MAJOR
EXPECTATION DEFINED
Comment
Recorded
Proven
Documented
TYPE OF
EXPECTATION
Minor
System Weakness:
Comment
Relationship with
ISO 14001:2004
TO
MAJOR
CLAUSE
CONTROLLED
COPY
NC#
CA#
Revision: 4
08/23/10
9 of 16
292315831.xls COD-FRM-009
Revision: 4
08/23/10
FINDING
MAJOR
AUDITOR COMMENTS
Minor
EXPECTATION DEFINED
Comment
Recorded
Proven
Relationship with
ISO 14001:2004
TYPE OF
EXPECTATION
Documented
CLAUSE
NC # & CA #
NC#
CA#
10 of 16
C/MR/01/02
Rev. Date: 18/05/2015
Name:
Department:
Email:
Locations Sampled:
AUDIT DATE
(RANGE)
Audit Scope/Criteria:
(area(s) being audited, applicable clauses from ISO 18001)
FINDINGS
Internal Audit
Report #
FINDING
NC # & CA #
Audit Summary:
System Strength:
Minor
292315831.xls COD-FRM-009
AUDITOR COMMENTS
MAJOR
EXPECTATION DEFINED
Comment
Recorded
Proven
Documented
TYPE OF
EXPECTATION
Minor
System Weakness:
Comment
Relationship with
ISO 18001:2007
TO
MAJOR
CLAUSE
CONTROLLED
COPY
NC#
CA#
Revision: 4
08/23/10
11 of 16
292315831.xls COD-FRM-009
Revision: 4
08/23/10
FINDING
MAJOR
AUDITOR COMMENTS
Minor
EXPECTATION DEFINED
Comment
Recorded
Proven
Relationship with
ISO 18001:2007
TYPE OF
EXPECTATION
Documented
CLAUSE
NC # & CA #
NC#
CA#
12 of 16
C/MR/01/02
Rev. Date: 18/05/2015
Name:
Department:
Email:
Locations Sampled:
AUDIT DATE
(RANGE)
Audit Scope/Criteria:
(area(s) being audited, applicable clauses from ISO/IEC 80079-34)
FINDINGS
Internal Audit
Report #
FINDING
NC # & CA #
Audit Summary:
System Strength:
Minor
292315831.xls COD-FRM-009
AUDITOR COMMENTS
MAJOR
EXPECTATION DEFINED
Comment
Recorded
Proven
Documented
TYPE OF
EXPECTATION
Minor
System Weakness:
Comment
Relationship with
ISO/IEC 80079-34
TO
MAJOR
CLAUSE
CONTROLLED
COPY
NC#
CA#
Revision: 4
08/23/10
13 of 16
292315831.xls COD-FRM-009
Revision: 4
08/23/10
FINDING
MAJOR
AUDITOR COMMENTS
Minor
EXPECTATION DEFINED
Comment
Recorded
Proven
Relationship with
ISO/IEC 80079-34
TYPE OF
EXPECTATION
Documented
CLAUSE
NC # & CA #
NC#
CA#
14 of 16
C/MR/01/02
Rev. Date: 18/05/2015
Name:
Department:
Email:
Locations Sampled:
AUDIT DATE
(RANGE)
Audit Scope/Criteria:
(area(s) being audited, applicable clauses from WELMEC Guide 8.6)
FINDINGS
Internal Audit
Report #
FINDING
NC # & CA #
Audit Summary:
System Strength:
Minor
292315831.xls COD-FRM-009
AUDITOR COMMENTS
Revision: 4
08/23/10
MAJOR
EXPECTATION DEFINED
Comment
Recorded
Proven
Documented
TYPE OF
EXPECTATION
Minor
System Weakness:
Comment
TO
MAJOR
CLAUSE
CONTROLLED
COPY
NC#
CA#
15 of 16
292315831.xls COD-FRM-009
Revision: 4
08/23/10
FINDING
MAJOR
AUDITOR COMMENTS
Minor
EXPECTATION DEFINED
Comment
Recorded
Proven
TYPE OF
EXPECTATION
Documented
CLAUSE
NC # & CA #
NC#
CA#
16 of 16