PRESENTS

ISO 9001:2015
INTERNAL AUDITOR TRAINING

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 COURSE CONTENT
This course covers :-
 ISO 9001 Requirements – Risk Based
 Quality Audit
 Planning An Audit
 Responsibility & Authority
 Preparing For An Audit
 Site Audit
 Non-Conformity
 Corrective Action
 Post Audit Activities

ISO 9001:2015 INTERNAL AUDITOR TRAINING

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Scan and fill in E-attendance

ISO 9001:2015 INTERNAL AUDITOR TRAINING

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ISO 9001:2015
REQUIREMENTS

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 Ten Clauses – “Higher Level Structure”

1. Scope 6. Planning
2. Normative references 7. Support

3. Terms and definition 8. Operations

4. Context of organization 9. Performance Evaluation

5. Leadership 10. Improvement

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Basic of all ISO MSS Structure

ISO 9001:2015 INTERNAL AUDITOR TRAINING

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Ten Clauses – “Higher Level Structure”

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Clause 4. Context of The Organization

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Clause 5. Leadership

5.1 Leadership & Commitment

5.2 Quality Policy 5. Leadership

5.3 Organizational Roles,

Responsibilities & Authorities

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 Clause 6. Planning

6.1 Actions to address risks &

opportunities

6.2 Quality objectives & planning

To achieve them 6. Planning

6.3 Planning of changes

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 Clause 7. Support
Competence

7.2

Resources 7.1 7.3 Awareness

7. Support

Documented 7.5 7.4 Communication

Information

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 Clause 8. Operation
8.1 Operational Planning & Control
8.2 Determination of Market needs & interactions with
customers
8.3 Development of Goods & Services
8.4 Control of Externally provided goods and services
8.5 Production of goods and provision of services
8.6 Release of goods and services
8.7 Nonconforming goods & services

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Clause 9. Performance evaluation

Monitoring, measurement , analysis and

evaluation
9.1. 9.1.1.General, 9.1.2.customer satisfaction, 9.1.3. Analysis &
evaluation of data

9.2. Internal Audit

9.3. Management Review

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Clause 10. Improvement

10.1 Nonconformity and Corrective

Action

10.2 Improvement

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QUALITY AUDIT

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 DEFINITION
ISO 9000:2015 defines “Audit” as:

A systematic, independent and documented

process for obtaining audit evidence and
evaluating it objectively to determine the
extent to which audit criteria are fulfilled.

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 AUDIT OBJECTIVES
Objectives:

 Disclose evidence of nonconformity in quality management

system.
 Evaluate the need for corrective action or improvement.
 Assess readiness for external (2nd and/or 3rd party) audit.
 Stimulate maintenance and improvement of agreed practices.
 Maintain awareness of quality.
 Meeting requirements of Quality Management System.

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 Internal Audit Cycle
Management Review Selecting, training
INTERNAL AUDIT PROCEDURE
- Review audit findings &
- Define internal audit Define qualifying internal
policy audit objectives auditors
- Approve audit
program Plan audit

Follow-up
verification Appoint Pool
Audit Team of auditors
Report
audit Documentation
review and checklist
preparation
Corrective Nonconformity,
Action Observation,
Corrective action Audit Team
meeting
Perform Schedule
on-site audit audit

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PLANNING AN AUDIT

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 FACTORS TO CONSIDER
 Context of organization & interested parties’ needs
 Actions to address Risks and opportunities
 Scope of business activities
 Range of products/processes
 Boundary – physical size and location of various sites
 Any requirements by customers, statutory & regulatory or
certification body affecting the quality management system
 Organisation’s own policy(s) on internal audit
 Availability of experienced/potential Internal Auditors

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 GUIDELINES FOR APPOINTMENT
OF AUDITOR /AUDIT TEAM

 No Auditor shall audit his/her own area of work.

 Familiarity of Auditors towards area to be audited.
 Competence
 Language and communication skills

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 AUDIT PLAN / SCHEDULE

ISO
Date Time Audit Scope Auditors Auditee
Clause

Prepared By: Approved By:

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 ANNUAL AUDIT PLAN
NO AUDIT SCOPE JAN FEB MAR APR MAY JUNE

1 SALES
2 PRODUCTION
3 QA
4 WAREHOUSE
5 PURCHASING
6 HR
7 PRODUCT DESIGN
8 DOCUMENT CONTROL
9 TOP MANAGEMENT
10 CAR / PAR

Prepared By:

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 AUDIT SCHEDULE
Date Time Audit Scope Auditors Auditee

2-2-07 9.00AM SALES ALAN TAM JACKY C

PRODUCTION JACKY C ELINA
QA ARON K LEON LAI
WAREHOUSE LEON LAI EMMA
PURCHASING EDISON C ALAN TAM
HR GIGI L ROCKY
3-3-07 9.00AM PRODUCT DESIGN LUCY L ARON K
DOCUMENT CONTROL ELINA EDISON C
TOP MANAGEMENT EMMA LUCY L
CAR / PAR ROCKY GIGI L

Prepared By:

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 Internal Audit Cycle
Selecting, training
Management Review
INTERNAL AUDIT PROCEDURE &
- Review audit findings qualifying internal
Define
- Define internal audit auditors
policy audit objectives
Plan audit
- Approve audit program

Follow-up
verification Appoint Pool
Audit Team
of auditors
Report
audit Documentation
review and checklist
preparation
Corrective Nonconformity,
Action Observation,
Corrective action Audit Team
meeting

Perform Schedule
on-site audit audit

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RESPONSIBILITY &
AUTHORITY

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 LEAD AUDITOR
 Perform opening meeting.
 Manage all phases of an audit.
 Select and appoint Audit Team.
 Liaise with Auditee.
 Plan and schedule the audit.
 Conduct and lead the audit.
 Final authority on decisions regarding audit findings.
 Conduct closing meeting.
 Present the audit findings.
 Prepare, verify and submit audit report.

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 AUDITOR
 Co-operate and support Lead Auditor.

 Perform audit assignments and conduct on site audit.

 Prepare working / supporting documents.

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 Internal Audit Cycle

INTERNAL AUDIT PROCEDURE Selecting, training

Management Review &
- Review audit findings Define qualifying internal
- Define internal audit
audit objectives auditors
policy Plan audit
- Approve audit program
Follow-up
verification Appoint
Audit Team Pool
of auditors
Report
audit Documentation
review &
checklist
Corrective Nonconformity, preparation
Action Observation,
Corrective action
Audit Team
meeting
Perform Schedule
on-site audit audit

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PREPARING FOR
AN AUDIT

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 Prepare Audit Checklist
Auditor should pick up and note on the audit checklists
those important and essential points which could contribute
to achieving the objectives stated in the documents.

 As an aid to audit planning and time keeping.

 To maintain continuity of audit.
 To ensure thoroughness of audit.
 To provide ease of reference to relevant documents.
 For recording the audit findings.

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 Internal Audit Cycle
Management Review INTERNAL AUDIT PROCEDURE Selecting, training
- Review audit findings &
- Define internal audit Define qualifying
policy audit objectives internal
- Approve audit program Plan audit auditors

Follow-up
verification Appoint Pool
Audit Team of auditors
Report
audit Documentation
review and checklist
preparation
Corrective Nonconformity,
Action Observation,
Corrective action Audit Team
meeting
Perform Schedule
on-site audit audit

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SITE AUDIT

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THE AUDIT PROCESS
OBSERVE
(Memerhati)

CHECK ASK
(Memeriksa) (Bertanya)

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 Objective Evidence
Audit Evidence must be objective such as:
 Documented info (Records) such as minutes of review,
process control sheets, labels, conformity certificates etc.
 Documented info (Documents) such as specifications,
documented procedures and instructions, reference or
workmanship standards etc.
 Physical conditions of infrastructure such as instruments,
equipment, machines, storage areas for parts/products etc.
 Communicated answer to Auditor’s questions during an
audit, especially for top management.
 Observations by Auditor on the state of an area or activities
performed and the state of an area under audit.

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 Internal Audit Cycle
Management Review INTERNAL AUDIT PROCEDURE
- Review audit findings Selecting, training &
- Define internal audit Define qualifying internal
policy audit objectives auditors
- Approve audit program
Plan audit

Follow-up
verification Appoint
Audit Team Pool
of auditors
Report
audit Documentation
review & checklist
preparation
Corrective Non-conformity,
Action Observation,
Corrective action Audit Team
meeting

Perform Schedule
on-site audit audit

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NON-CONFORMITY

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 Definition

According to ISO 9000 :

The non-fulfillment of
Specified requirement.
NCR

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 Major Non-conformity

A non-conformity that has the

potential to result in very
serious consequences in
relation to achievement of
quality or effectiveness of the
quality management system.

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Minor Non-conformity

A non-conformity is
considered minor or non-
critical and unlikely to have
serious consequences.

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 Observation / OFI

It is not a non-conformity against the

standard or documented procedure but the
auditor’s opinion that the situation could be
improved upon.

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CORRECTIVE ACTION

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 Definition
According to ISO 9000:

Actions taken to eliminate the cause(s) of a detected non-

conformity. Such actions taken should be of preventive
nature to prevent the recurrence of similar
nonconformities.

Corrective actions are usually

initiated through the issue of
“Corrective Action Request (CAR)” or
“Non-Compliance Report (NCR)”.

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 Process for Corrective Action
• Investigate and determine the root cause(s) of non-
conformity.
• Analyze the causes such as man, machine, material,
method and environment etc.
• Select and implement appropriate corrections and
corrective actions to prevent recurrence of nonconformity.

• Apply control to ensure effectiveness of actions taken.

• Record actions taken and update
affected documents.

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ISO 9001:2015 INTERNAL AUDITOR TRAINING
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 001/15

Production Simon Lee

QP-02 KY Tan

Auditor to write up non- Production floor next to Blowing machine #2 found

conformity found during dirty (greasy). This might contaminate paper roll which Simon Lee
the audit put on top of the floor. This was against ISO clause
7.1.4 2-3-2015

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 001/15

Production Simon Lee

QP-02 KY Tan

Auditor to write up non- Production floor next to Blowing machine #2 found

conformity found during dirty (greasy). This might contaminate paper roll which Simon Lee
the audit put on top of the floor. This was against ISO clause
7.1.4 2-3-2015

Production supervisor to arrange worker to cleanup the KY Tan

greasy floor immediately
Auditee to propose correction to 15-03-15
solve the problem on the spot
It was found that the screw was loosen.
Auditee then to investigate the
root causes KY Tan

15-03-15
Auditee to propose corrective
action to prevent recurrence To include the screw condition check in the KY Tan
maintenance program.
15-03-15

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 001/15

Production Simon Lee

QP-02 KY Tan

Auditor to write up non- Production floor next to Blowing machine #2 found

conformity found during dirty (greasy). This might contaminate paper roll which Simon Lee
the audit put on top of the floor. This was against ISO clause
7.1.4 2-3-2015

Production supervisor to arrange worker to cleanup the KY Tan

greasy floor immediately
Auditee to propose correction to 15-03-15
solve the problem on the spot
It was found that the screw was loosen.
Auditee then to investigate the
root causes KY Tan

15-03-15
Auditee to propose corrective
action to prevent recurrence To include the screw condition check in the KY Tan
maintenance program.
15-03-15
Auditor to verify the effectiveness Production floor found was
of action taken cleaned up and the screw Simon Lee
condition check was
included in INTERNAL
ISO 9001:2015 the program
AUDITOR TRAINING 20-3-2015
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POST AUDIT
ACTIVITIES

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 Follow-up Verification
 A post-audit activity which is part of the corrective
action process.

 Within an agreed time-frame (usually 2-4 weeks).

 Involve the auditor/audit team arriving at audit site to

verify the effectiveness of corrective actions taken.

 Carry out in the presence of auditee.

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 THANK YOU

QUESTIONS & ANSWERS

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