A brief introduction of internal auditing of quality management systems.

1. ABN 95 844 017 962
kanriconsulting@adam.com.au

2. 
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ISO 9001
System which is implemented to
ensure customer requirements are
met.
Roots are MIL-Q-9858 Quality
Program Requirements in 1959.
Elements
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Management
Resources
Services and Products
Monitoring
PDCA
Customer Focus
Leadership
Involvement of People
Process Approach
Systems Approach
Continuous Improvement
Factual Decision Making
Mutually Beneficial Relationships
(c) Ewan Pettigrew
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3. Customer Focus
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9000 - Fundamentals &
Vocabulary
Leadership
9001 - Requirements for a QMS
9000:2000 Fundamentals and
Involvement of People
Vocabulary
9004 - Guidelines for Performance
Improvement
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9100 - Aerospace
To support we use
10012 - Measurement
10013 - Guidelines for
documentation
19011 - Audits
Process Approach (Input Output
Resources Controls)
Process Approach
Systems Approach
Continuous Improvement
Factual Decision Making
Mutually Beneficial Relationships
(c) Ewan Pettigrew
3

4. Customer Focus

Demonstrates that we can provide
product of consistent quality to the
Leadership
customer whilst meeting the
customer’s specifications.
Involvement of People
Process Approach
Systems Approach
Continuous Improvement
Factual Decision Making
Mutually Beneficial Relationships
(c) Ewan Pettigrew
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5. 
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ISO 9001:2008
Clause 1
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Clause 2
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Product Realisation
Clause 8
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Leadership
Involvement of People
Process Approach
Systems Approach
Continuous Improvement
Resource Management
Clause 7
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Management Responsibility
Clause 6
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QMS
Clause 5
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Terms and Definitions
Clause 4
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Normative Reference
Clause 3
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Scope
Customer Focus
Measurement, Analysis, and Improvement
Factual Decision Making
Mutually Beneficial Relationships
(c) Ewan Pettigrew
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6. 
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4. Quality Management System Control of Documents, Control of
Records (this means we need a quality
manual amongst other things).
5. Management Responsibility management commitment,
management Representative (Quality
Manager), Customer
Focus Management Review, quality
policy, planning
Customer Focus
Leadership
Involvement of People
Process Approach
Systems Approach
Continuous Improvement
Factual Decision Making
Mutually Beneficial Relationships
(c) Ewan Pettigrew
6

7. 
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6. Resource Management - provision
of resources, human resources,
infrastructure, work environment,
7.Product Realisation - planning of
product, customer related processes,
design and development, purchasing
8. Measurement Analysis and
Improvement - monitoring and
measurement (internal audit), control
of non conforming product,
improvement (CI, corrective action,
preventative action), we also need to
measure instructions for all
processes.
Customer Focus
Leadership
Involvement of People
Process Approach
Systems Approach
Continuous Improvement
Factual Decision Making
Mutually Beneficial Relationships
(c) Ewan Pettigrew
7

8. 
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Must be registered by external
organisation.
Once registered, requires external
audits.
Internal audits, or first party audits
conducted by organisation.
2nd party audits - customers
(external).
3rd party audits - registration or
certification external.
Customer Focus
Leadership
Involvement of People
Process Approach
Systems Approach
Continuous Improvement
Factual Decision Making
Mutually Beneficial Relationships
(c) Ewan Pettigrew
8

9. 
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Purpose to improve performance of
the organisation for the customer.
We use ISO 19011 as guidance.
Work to enterprise audit schedule
Auditors to come from all parts of the
organisation
Only shows that what was audited was
free from non conformities.
Auditing processes
Ethical
Conduct
Evidence
Based
Approach
Auditing
Fair
Presentation
Principles
Independence
Due
Professional
Care
Outputs Non conformances ->
Corrective Actions
内部監査
(c) Ewan Pettigrew
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10. 
Flow for audits.
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Initiate the Audit
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Conduct Document Review
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Appoint the audit team leader
Define objectives, scope and criteria
Determine the feasibility of the audit
Select the audit team
Review relevant management system
documents, reports and records
Determine adequacy in respect to audit criteria
Prepare for the On-Site Audit
Activities
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Prepare the Audit Plan
Assign Work to the Audit Team
Prepare Work Documents
Prepare Audit Checklists
Initiate the Audit
Conduct Document Review
Prepare for the On Site Audit Activities
Conduct On Site Audit Activities
Prepare, Approve, and Distribute the Audit
Report
Complete the Audit
Conduct the Audit Follow Up
(c) Ewan Pettigrew
内部監査
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11. 
Conduct On-Site Audit Activities
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Prepare, Approve, and Distribute the
Audit Report
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Prepare the Audit Report
Approve and Distribute the Audit Report
Conduct Document Review
Prepare for the On Site Audit Activities
Conduct On Site Audit Activities
Complete the Audit
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Conduct Opening Meeting
Communicate During the Audit
Collect and Verify information
Generate Audit Findings
Prepare Audit Conclusions
Conduct Closing Meeting
Initiate the Audit
Do not distribute information to any other
parties.
Conduct Audit Follow-Up
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Follow up corrective, preventative, or
improvement actions.
Prepare, Approve, and Distribute the Audit
Report
Complete the Audit
Conduct the Audit Follow Up
内部監査
(c) Ewan Pettigrew
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12. 
Contents of the Audit Plan
◦ The audit objectives;
◦ The audit criteria and any reference
documents;
◦ The audit scope, including
identification of the organizational
and functional units and processes
to be audited;
◦ The dates and places where the
on-site audit activities are to be
conducted;
◦ The expected time and duration of
on-site audit activities, including
meetings with the auditee’s
management and audit team
meetings;
◦ The roles and responsibilities of
the audit team members and
accompanying persons;
Initiate the Audit
Conduct Document Review
Prepare for the On Site Audit Activities
Conduct On Site Audit Activities
Prepare, Approve, and Distribute the Audit
Report
Complete the Audit
Conduct the Audit Follow Up
内部監査
(c) Ewan Pettigrew
12

13. ◦ The allocation of appropriate
resources to critical areas of the
audit.
◦ The audit plan should also cover
the following, as appropriate:
◦ Identification of the auditee’s
representative for the audit;
◦ The working and reporting
language of the audit where this is
different from the language of the
auditor and/or the auditee;
◦ The audit report topics;
◦ Logistic arrangements (travel, onsite facilities, etc.);
◦ Matters related to confidentiality;
◦ Any audit follow-up actions.
Initiate the Audit
Conduct Document Review
Prepare for the On Site Audit Activities
Conduct On Site Audit Activities
Prepare, Approve, and Distribute the Audit
Report
Complete the Audit
Conduct the Audit Follow Up
内部監査
(c) Ewan Pettigrew
13

14. 
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Records management
Audit plans
Audit reports
Non conformity reports
Corrective and preventative
action reports
Audit follow up reports
Audit Plans
Audit Follow
Up Reports
Audit Reports
Records
Management
Corrective
and
Preventative
Action
Reports
Non
Conformity
Reports
内部監査
(c) Ewan Pettigrew
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