Reference model to illustrate how to take an active approach toward audit planning and execution in order to implement sustainable data analytics-enabled auditing for quality management system improvement (QMS) presented by Noriyoshi Fukumaru - Fukumaru Management Techno Corporation.

1. Maturity Model of Internal Audit
Fukumaru Management Techno representative director
Noriyoshi Fukumaru
©FMT NORIYOSHI FUKUMARU 1
Keynote 2
April 15

2. Question？
• Are your organization’s internal audits useful for improvement of
QMS ?
• Are your organization satisfied a competence of internal auditor ?
• Are your organization assessment the output of internal audits with
your organization’s performance ?
• Are your organization assessment a cost of internal audits ?
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3. Purpose of internal audit
The organization shall conduct internal audits at planned
intervals to determine whether the quality management system
a) conforms to the planned arrangement(see7.1),to the
requirements of this International Standard and to the quality
management system requirements established by the
organization
b) is effectively implemented and maintained
ISO9001:8.2.2
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4. Problems of internal audit process
• The audit results doesn't related to the quality management
system improvement.
• Auditor's ability is insufficient.
• The plan of audit doesn't consider process.
• Effectiveness of QMS is not evaluated.
• The organization’s overall performance is not evaluated.
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5. QMS of the organization
QMS of ISO9001
Objects of internal audit
QMS requirements that organization decided
Necessary minimum
requirements
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6. Elements of QMS
• Policy management
• Improvement management
• Marketing management
• Research and development
management
• Design management
• Production management
• Purchasing management
• Quality control
• Retail management
• Human capital management
• Standardization management
• Safety management
• Environment management
• Plant management
• Measurement equipment
management
• Stock control etc
Elements necessary for
business management
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7. Basis of process assessment
• Evaluate the performance appropriately on the site.
• Evaluate the resource, the activity, and the management of the
process.
• Is the organization acting as it is an established procedure?
• Is this procedure effective?
• Is this procedure efficient?
procedure procedure procedure
process
monitoring
resource
control
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8. View of process output
• Does the output that follows the procedure exist?
• Is not the mistake found in the output?
• Is the output effective compared with the target of the process?
• When the plan is not filled, is the improvement activity
implemented?
PROCESSOBJECT OUTPUT
Improvement
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9. Maturitylevelofinternalaudit
Time
Level 1
Level 2
Level 3
Level 4
Maturity Model of Internal Audit
Assessment of
process and
performance
for QMS
Assessment of
conformation
for QMS
Management
skills
Analysis skills of
process and
performance
Self-assessment
skills
Assessment of
effectively
and efficiency
for QMS
Assessment of
ability for
change of
business
environment
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10. Maturity Level 1
Assessment of conformation for QMS
• Viewpoint
Is the QMS conforms to the quality management system
requirements established by the organization ?
• Knowledge
quality control ，quality manual，ISO9000，ISO9001
• Skills
question，observation，assessment，record，report
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11. Maturity Level 2
Assessment of process and performance for QMS
• Viewpoint
Is the organization’s process and QMS effective？
• Knowledge
daily management，process，process approach，QC seven tools
• Skills
comparing quality performance with planed and performed process
or QMS
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12. Maturity Level 3
Assessment of effectively and efficiency for QMS
• Viewpoint
Is the planed and performed business process effectively and
efficiency ？
• Knowledge
policy management，quality management principles，process
assurance，process analysis，risk treatment methods，statistical quality
control，ISO9004
• Skills
technology、，assessment of strong-weakness for process and QMS
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13. Maturity Level 4
Assessment of ability for change of business environment
• Viewpoint
Is the organization’s ability equivalent to change of business
environment？
• Knowledge
customer value management ，self-assessment，JIS Q 9005:2014
（Quality management systems－Guideline for sustained success）
• Skills
analysis of self-assessment for process
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14. Acceleration System for MS internal auditor
Ex：N-MSAE（Association of Nippon Management System Audit
Engineers）
 Grade 1（2 days）・・・ Maturity Level 3
e-Learning + lecture + case study + test
 Grade 2（2 days）・・・ Maturity Level 2
e-Learning + lecture + case study + test
 Grade 3（2 days）・・・ Maturity Level 1
lecture + case study
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15. Thanks you！
Have ａ nice trip！
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