1. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
Effective Internal Audit Planning:
ISO 9000 Users Group - ASQ Section 509,
Wednesday, January 20, 2010
By David Collingham, CQA/CQE
Audit practices that add the most value!

2. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
Outline
• Definitions of Key Audit Terms
• Types of Audits
• Nonconformance Types
• ISO 9001:2008 Internal Audit Requirement
• CommonNCR’sissuedbyRegistrarsrelatedtoAudits
• Miss-Conceptions About Auditing
• What does the Industry and Product/Process have to do with Planning an Audit?
• How much do I invest in Auditing?
• Why do we Audit?
• First Party Audit Process Steps
• Planning Audits
• Typical Audit Schedules and Forms
Effective Internal Auditor Planning

3. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
Definitions of Key Audit Terms
• Effective - producing or capable of producing an intended result or
having a striking effect
• Planning - the act or process of drawing up plans or layouts for some
project or enterprise
• Audit - a methodical examination or review of a condition or situation
Effective Internal Auditor Planning

4. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
•First Party
When a Company uses an internal person to perform an Audit on itself.
•Second Party
When a Company uses an internal person to perform an Audit
on its Supplier or an other organization.
•Third Party
When a Company is Audited by a third party independent of the
Company’sCustomer.
Audit Types
Effective Internal Auditor Planning

5. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
Nonconformance Types
•Major
When the Quality System exhibits a void where an element of the
system has not been documented, implemented or is not effective.
In addition, the nonconformance does risk the shipment or delivery
of nonconforming material to the Customer
•Minor
When the Quality System is documented, implemented and effective, but
has exhibited a random nonconformance. The nonconformance does not
risk the shipment or delivery of nonconforming material to the Customer
•Comment
When an Auditor identifies an improvement opportunity that is not
a major or minor
Effective Internal Auditor Planning

6. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
ISO 9001:2008 Key Elements
Key
Value-adding activities
Information flow
Continual Improvement of
the Quality Management System
Customers
Customers
Requirements
Satisfaction
Management
Responsibility
Resource
Management
Measurement,
Analysis and
Improvement
Product
Realization Product
OutputInput
4.0
5.0
6.0
7.0
8.0
Effective Internal Auditor Planning

7. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
ISO 9001:2008 Internal Audit Requirement
Measurement,
Analysis and
Improvement
8.2.2 - Internal Audit
The organization shall conduct internal audits at planned intervals to determine whether the quality
management system:
a) conforms to the planned arrangements, to the requirements of this ISO Standard and to the quality
management system requirements established by the organization, and
b) is effectively implemented and maintained.
The audit program shall be planned, taking into consideration the status and importance of the processes and
areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and
methods shall be defined. The selection of the auditors and conduct of audits shall ensure objectivity and
impartiality of the audit process. Auditors shall not audit their own work.
8.0
Effective Internal Auditor Planning

8. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
CommonNCR’sissuedbyRegistrarsrelatedtoAudits
• Audit Plan/Schedule does not address all elements (major paragraphs)
of the ISO 9001:2008 standard
• Audit Plan/Schedule does not address multiple facility locations, work
shifts (shift 1, 2 & 3) or scope of business/registration
• Audit plan/schedule is not approved
• Audits are not completed as scheduled
• Audits are performed by personnel who audited their own work
• Audit results do not have written signature or electronic signature by
Auditor with date
• Audits were not conducted in an effective manner
• Auditor(s) received no internal auditor training
Effective Internal Auditor Planning

9. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
Miss-Conceptions About Auditing
• There needs to be 35 Internal Audits performed for ISO 9001:2008 (i.e.4.1-4.2.2,
4.23, 4.24, 5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 6.1, 6.2, 6.3, 6.4, 7.1, 7.2, 7.3, 7.4, 7.4.3, 7.5.1, 7.5.2, 7.5.3, 7.5.4, 7.5.5, 7.5.6,
7.6, 8.1, 8.2.1, 8.2.2, 8.2.3, 8.2.4, 8.3, 8.4, 8.5.1, 8.5.2, 8.5.3)
• I can not conduct 1 audit of the ISO 9001:2008 QMS each year
• We must use an outside contractor to perform our audits
• All the ISO 9001:2008 elements need to be audited every year
• Ifyoudon’tspend2-5 hours on each audit, then you are not doing your job
• The Auditor must prepare a checklist list using his or her own questions in
order to perform an effective audit
• I can use typed audit checklists with typed in results with typed in names and
dates (no written or electronic signature)
• If the Audit Report does not weight 3 pounds, then it must not have been
performed correctly
• Wecan’tusethereceptionistorfinancepersontoconductaudits,because
she/he does not know what we do
Effective Internal Auditor Planning

10. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
What does the Industry and Product/Process have to do with
planning an Audit?
• Critical, High Risk and High Exposure Industries/Products/Processes:
Effective Internal Auditor Planning

11. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
•High Risk
•High Complexity
•Critical to End Mission
•High Maintenance
•High Failure/Reject Rate
Appraisal/
Prevention
Investment;
Audits
High $
Risk Level
1 2 3 4 5 6 7 8 9 10
High
How much do I invest in Auditing?
Effective Internal Auditor Planning
(*) Graph
not to scale
Point 2
Point 1
Industry/Product/Process
•Low Risk
•Low Complexity
•Not Critical to End Mission
•Low Maintenance
•Low Failure/Reject Rate

12. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
Why do we Audit?
• Provides Senior Management an independent examination of business
processes
• To identify improvement opportunities in processes/products/services
• Proactive approach to prevent/reduce the risk of producing defective
product/services
• To identify needs for training, tools/fixtures, methods, etc.
• Enhances communication and training
• Provides a means for operator feedback
Effective Internal Auditor Planning

13. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
•Audit Process Steps:
A - Prepare Audit Schedule and Obtain Management Approval
B - Schedule the Audit(s)
C - Obtain Audit Requirements
D - Examine prior Audit Results and Corrective Actions
E - Prepare Audit Check List(s) and Any Other Support Questions
F - Conduct Audit Investigation
G - Record Audit Finds and Obtain Auditee Acknowledgment
H - Prepare Audit Report
I - Obtain Corrective Action(s)
J - Follow-Up On Corrective Action(s)
First Party Audit Process Steps
Effective Internal Auditor Planning

14. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
Effective Internal Auditor Planning
Planning Audits
• What is the budget for conducting audits? Hours? Dollars?
• How many audits do we need to do?
• HowI’mIgoingtobevalue-added?
• What does Senior Management feel is critical to the business success?
• Gain a clear understanding of what is expected from conducting the audits?
• If we spend money from the Overhead Budget for conducting audits, what is
expected for the investment?
• What are the critical processes/products that need to be examined?
• What does our past internal audit results tell us to focus on?
• Do we have any new areas/processes/staffing/equipment/vendors that requires
more focus than other areas?
• What facility locations, functions, processes/products and work shifts need to
be included in the schedule?
• What is the best time to conduct the audits? High Volume? Low Volume?
Before Lunch? After Lunch? At the end of work shift? Etc.

15. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
Effective Internal Auditor Planning
Approved By: Jim Brown Date: 01/14/10
Example 1
Planning Audits
(continued)

16. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
•s
Effective Internal Auditor Planning
Approved By: Jim Brown Date: 01/14/10
Example 1
Planning Audits
(continued)

17. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
Effective Internal Auditor Planning
Approved By: Jim Brown Date: 01/14/10
Example 1
Planning Audits
(continued)

18. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
•s
Effective Internal Auditor Planning
Approved By: Jim Brown Date: 01/14/10
Example 1
Planning Audits
(continued)

19. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
Planning Audits
(continued)
Effective Internal Auditor Planning
Approved By: Jim Brown Date: 01/14/10
Example 1

20. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
Typical Audit Schedules and Forms
Effective Internal Auditor Planning
•AUDIT FORMS & RECORDS
Procedure
Schedule

21. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
Typical Audit Schedules and Forms
(continued)
Effective Internal Auditor Planning
•AUDIT FORMS & RECORDS
Audit Summary Audit Checklist

22. IQR-TRG-012010 Rev. A
All Copy Rights Reserved by IQR.
Jan. 20, 2010
www.IQRCORP.com
By David Collingham, CQE/CQA
International Quality Registrars Corp.
Typical Audit Schedules and Forms
(continued)
Effective Internal Auditor Planning
•AUDIT FORMS & RECORDS
Audit Summary
Example