Audit Body of Knowledge

Quality Audit
body of knowledge
ISO 19011:2011
Edited & prepared by

ADEL YOUNIS
Quality & BD Consultant
PHD in TQM
Agenda
 CQA body of knowledge
 ISO 19011: 2011
 PDCA structure of the standard
 Case studies
 Workshops
 Quiz
Ex.1, auditor communication skills quiz
Certified quality auditor, BK
 Level - I : Auditing fundamentals
 Level - II : Audit Process
 Level - III : auditor competence
 Level - IV : Audit Management
 Level – V : Quality tools & techniques
Level – I Audit Fundamentals
Types of
Quality
Audit Conduct
of audit
Purpose &
scope of
R & R of
audit
Audit
participants
Criteria to
audit
against
Level – II Audit Process
Audit preparation
and planning
Audit performance
Audit reporting
Audit follow up &

closure
Level - III : auditor competence
On-site audit
Auditor Conflict
resource
characteristics resolution
management
Interviewing Communication
Team dynamics
techniques techniques
Level - IV : Audit Management
Audit programme Business &

management financial impact
Level – V : Quality tools & techniques
 Basic quality & problem solving tools
 Process improvement techniques
 Basic statistics
 Process variation
 Sampling methods
 Change control and configuration
management
 Verification and validation
 Risk management tools
ISO 19011:2011
1. Scope
2. Normative reference
3. Terms and definitions
4. Principals of audit
5. Managing an audit programme
5.1 - general
5.2 - objectives & extent
5.3 – responsibilities, resources and procedures
5.4 – implementation
5.5 – records
5.6 – monitoring & reviewing
ISO 19011:2011 – cont.
6. Audit activities
6.1- general
6.2 – initiating the audit
6.3 – conducting document review
6.4 – preparing on-site audit activities
6.5 – conducting on-site audit activities
6.6 – preparing, approving, and distribution
of audit report
6.7 – completing the audit
6.8 – conducting audit follow up
ISO 19011:2011 – cont. - 2
7. Competence and evaluation of auditors

7.1 – general
7.2 – personal attributes
7.3 – knowledge and skills
7.4 – education, work experience, training
and audit experience.
7.5 – maintenance and improvement of
competence
7.6 – auditor evaluation
PDCA structure of the standard
view the structure of the standard.

Structure of ISO 19011:2011
independ
ence
Evidence Due
based professional
approach care
Principals
of Audit
Ethical Fair
Conduct presentation
Video – 1.0
professional audit conducting
Types of QMS Audit
2nd party 3rd party

1st party audit
audit audit
Vendor / Registration
Internal audit audit
supplier audit
Surveillance
audit
Audit categories
 Desk Audit
 preliminary audit
 System Audit
 Conformance Audit
 Compliance Audit
 Process Audit
 Product Audit
 Department Audit
System Audits
are looking at a particular system
which includes multiple processes
and can spread across several
employees and departments. The
audit of your calibration system can
be consider a system audit.
Interaction chart lists your systems.
Conformance Audits
are audits to define system
requirements. These are global
in nature. For example a 3rd
party Audit for ISO system is a
conformance audit
Compliance Audit
is an audit to regulatory
requirements. This includes
government agency audits.
Process Audit
is a focused audit on a set of
processes within organization. It
examines adherence to
procedures and specifications
during production or service
activities
Product Audit
is a focus audit on the
product itself. This may be
an inspection activity or an
out of the box audit
Department Audit
is a focus audit on one department
that looks at the processes,
specifications, and systems in one
department only. It will look at the
different operations with in that
department. It will also examine
department organization and
training
Quiz - 2.0 / Video – 2.0
1) categorize type of audit in the

following video
2) try to count the total number of
NCs found during the video
Audit responsibility
 Client’sresponsibility
 Lead auditor responsibility
 Auditor responsibility
 Auditee responsibility
5.0 Managing audit programme
5.1 general
5.2 audit programme objectives and extent
5.3 audit programme responsibilities ,
resources, and procedures
5.4 audit programme implementation
5.5 audit programme records
5.6 audit programme monitoring and
review
6.0 audit activities
6. Audit activities
6.1- general
6.2 – initiating the audit
6.3 – conducting document review
6.4 – preparing on-site audit activities
6.5 – conducting on-site audit activities
6.6 – preparing, approving, and distribution
of audit report
6.7 – completing the audit
6.8 – conducting audit follow up
6.2.1 appointing audit team leader
Review Deliver the

documents audit report
Represent Assign team

audit team roles
Report NCs to Prepare the

auditee Make final audit plan
decisions
6.2.2 defining audit objectives, scope , and
criteria
Examples of audit objectives are:
Determining the extent of conformity of

the auditee's management system, or
parts of it, with the audit criteria;
Evaluating the capability of the
management system to ensure compliance
with legislative and contractual requirements;
Evaluating the effectiveness of the
implemented management system in meeting
specified objectives;
Identifying areas of potential improvement of
the management system.
Audit scope
Physical location;
Organizational units;
Activities and processes to be
audited;
The duration of the audit, if
possible.
The audit criteria may include applicable:
Standards
Policies
Procedures
Regulations
Legislation
Management system requirements
Contract requirements
6.2.4 selecting the audit team
 Audit objectives, scope, criteria and estimated
duration of the audit;
 Whether the audit is a combined or joint audit;
 The overall competence of the audit team .
Statutory, regulatory, contractual and
accreditation/certification requirements.
 The ensure of the independence of the audit
team from the activities to be audited and to
avoid conflict of interest.
 The ability of the audit team members to interact
effectively with the auditee and to work together.
 The language of the audit, and an understanding
of the auditee’s particular social and cultural
characteristics.
Select suitable
auditors
Explain the
objectives(s) and scope
of the audit
Assign responsibilities
to every auditor
Provide information
Answer any questions
Check understanding
of the team
6.4.1 preparing the audit plan
Write audit checklists
Estimate resources Determine object and scope
Preparing
Contact the auditee Research
Includes
Form an audit team Make visit arrangements
Develop an audit plan

Ex.2 : judge the audit agenda represented
6.5.1 conducting opening meeting.
6.5.2 communication during audit.
Minimum of the lead auditor to

communicate with the auditee:-
 Make introductions
 Explain objectives and scope of audit
 Indicate the size of the audit team
6.5.5 generating audit findings
Conformation of meeting Writing a summary

objectives statement
Exchanging information Planning the closing

meeting
Writing nonconformity
statement
6.5.5 generating audit findings - II
Activities done on audit findings:

1) Review audit observations
2) Writing NC statement
What is observation?
 audit findings
results of the evaluation of the collected
audit evidence, against audit criteria
NOTE Audit findings can indicate either

conformity or nonconformity with audit
criteria or opportunities for improvement.
NC statement
 Purpose:
- Understanding of the NC
 Requirements:
- QMS standard / QMS documented information /
specification – regulation / code of practice / contract
/ management instructions
 Nature :
- Description of failure to meet requirements, with provision of
factual evidence
NC statement - II
 Evidence :
- Name and position of the interviewee
- Location
- Time
- Verbal statement
- Document identity and status
- Serial numbers
- Sample size.
Categorizing NCs
Minor This category applies

where a requirement of the ISO
9001 has not been fully addressed
or where there have been
Major This category applies
isolated failures in implementing
where a significant element
the QMS.
of the standard has not been
.
addressed. A breakdown in
implementing the QMS
would also constitute a major
nonconformance, as would Categorizing nonconformance is
failure to improve an not easy and it is possible for
unsatisfactory situation over experienced auditors to come to
a period of time different conclusions. It needs
considerable judgment on the
part of the auditor. It also requires
clearly defined criteria.
Ex. 3 assess the audit incidents
represented, categorize NCs in each
incident “if any”
6.5.7 conducting the close meeting
 Reintroduction of the audit team
 Review of the scope and purpose of the audit
 Brief review of how the audit was conducted
 Review of the audit criteria, namely, ISO 9001,
the organization's QMS documentation, and
other related documentation
 Review NCs level “major – minor – observations”
 Disclose the recommendations of the audit
team.
Preparing the audit report.
Acceptable audit report should include:
a) Audit objective
b) Audit scope and extent
c) Audit client
d) Audit team, leader and members
e) Date and place of on-site audit activities
f) Audit criteria
g) Audit findings
h) Audit conclusion
i) List of auditee representatives
j) Confirmation of achieving audit objectives
k) Any areas not covered during the audit and justifications
l) Any un-resolving diverging with the auditee
m) Recommendations for improvement
n) Statement of confidentiality
o) Distribution list
Competence and Evaluation of Auditors
– 7.2 personal attributes
a) Ethical, i.e. fair, truthful, sincere, honest
and discreet;
b) Open-minded, i.e. willing to consider
alternative ideas or points of view;
c) Diplomatic, i.e. tactful in dealing with
people;
d) Observant, i.e. actively aware of
physical surroundings and activities;
e) Perceptive, i.e. instinctively aware of and
able to understand situations;
f) Versatile, i.e. adjusts readily to different
situations;
g) Tenacious, i.e. persistent, focused on
achieving objectives;
h) Decisive, i.e. reaches timely conclusions
based on logical reasoning and analysis;
and
i) Self-reliant, i.e. acts and functions
independently while interacting effectively
with others.
Little advice
 Do not be biased
 Keep an open mind
 Do not be argumentive
 Be patient
 Remind the participant that the audit is for continuous
improvement
 Always state the facts
 Do not correct the person on the spot.
 Report accurately and clearly
 Be familiar with the procedure
Typical audit system - word file
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Quality Audit

Edited & prepared by

Audit follow up &

Audit programme Business &

7. Competence and evaluation of auditors

view the structure of the standard.

2nd party 3rd party

1) categorize type of audit in the

Review Deliver the

Represent Assign team

Report NCs to Prepare the

Examples of audit objectives are:

Determining the extent of conformity of

Estimate resources Determine object and scope

Form an audit team Make visit arrangements

Develop an audit plan

Minimum of the lead auditor to

Conformation of meeting Writing a summary

Exchanging information Planning the closing

Activities done on audit findings:

NOTE Audit findings can indicate either

Minor This category applies

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