Lac Apr 2010

INSTITUTE OF QUALITY
Lead Auditor / Auditor Course

For Quality Management Systems
ISO 9001:2008
Apr 2010
INTRODUCTION
Apr 2010 2
1
INTRODUCTION OF PARTICIPANTS
¾ Participants are requested to find a partner each.
¾ You are expected to find out professional information about

your partner in 2 minutes. Also enquire his / her key
expected learning from the programme.
¾ Please record your findings. Write down your name and the
details collected from your partner
¾ Each participant would in turn introduce his partner to the

group and his key expected learning.
¾ Hand over your recorded findings to the tutors.
Duration : 30 Minutes
Apr 2010 3
COURSE FORMAT
¾ FOR A DURATION OF FIVE DAYS
¾ COVERS THE REQUIREMENTS OF IRCA / NABET
¾ ENABLES SUCCESSFUL CANDIDATES TO REGISTER
¾ INCLUDES CLASSROOM SESSIONS, SYNDICATE

WORKSHOPS, ROLE PLAY EXERCISES
¾ EXTENSIVE EXAMPLES AND CASE STUDIES BASED ON

INDUSTRY SITUATIONS
Apr 2010 4
2
COURSE LEARNING OBJECTIVES
• PURPOSE OF QUALITY MANAGEMENT SYSTEM & 8 QUALITY MANAGEMENT
PRINCIPLES
• STANDARDS – ISO 9000, ISO 9001, ISO 9004, ISO 19011 & THEIR
INTERRELATIONSHIPS.
• INTERPRETATION OF ISO 9001 IN CONTEXT TO THE AUDIT
• ROLES AND RESPONSIBILITIES OF AUDITORS AND LEAD AUDITORS.
• PLAN AND CONDUCT AN AUDIT, GATHER OBJECTIVE EVIDENCE VIA VARIOUS
METHODS AND DETERMINE CONFORMITY TO THE REQUIREMENTS
• AUDIT REPORT WRITING
• AUDIT FOLLOW UP – EVALUATING THE EFFECTIVENESS OF CORRECTIVE
ACTION IMPLEMENTATION
• CERTIFICATION AND ACCREDITATION PROCESSES
• AUDITOR CERTIFICATION AND ROLE OF IRCA / NABET
Apr 2010 5
COURSE PROGRAMME
¾ BLEND OF LECTURES, INTERACTIVE WORKSHOPS AND

PRESENTATIONS
¾ ROLE PLAY ON OPENING AND CLOSING MEETINGS
¾ INCLUDES PRE-COURSE MATERIAL AND

COURSE MATERIAL
¾ CONTINUOUS ASSESSMENT OF PARTICIPANTS
¾ COURSE EXAMINATION
Apr 2010 6
3
DELEGATE RESPONSIBILITIES
¾ COURSE IS INTENSIVE, HENCE FULL ATTENTION AND
DILIGENCE IS REQUIRED
¾ TIME SCHEDULES ARE IMPORTANT
¾ BE ALERT, INTERACTIVE AND CO-OPERATIVE
¾ TAKING NOTES
¾ USE OF MOBILE PHONES PROHIBITED
¾ DELEGATES APPEAL AND COMPLAINT
Apr 2010 7
EVALUATION PROCESS & CRITERIA

• CONTINUOUS ASSESSMENT
• SKILL BASED PRACTICAL WORK
¾ TUTOR MARKED
¾ PRESENTATION / ROLE PLAY
¾ QUIZZES
DAILY ASSESSMENT
– CONTRIBUTION, QUESTIONING, COMMUNICATION,
REPORTING, PARTICIPATION IN TEAM
– PERSONAL ATTRIBUTES: ATTITUDE,
MANNER,SUITABILITY AS AUDITOR
– ATTENDANCE, PUNCTUALITY AND PARTICIPATION
¾ RESITTING THE EXAMINATION OR THE COURSE
• WRITTEN EXAMINATION
Apr 2010 8
4
ISSUE OF CERTIFICATES
¾ SUCCESSSFUL COMPLETION CERTIFICATE
WHEN THE DELEGATE HAS PASSSED BOTH THE
WRITTEN EXAMINATION AND CONTINUOUS
ASSESSMENT
¾ ATTENDANCE CERTIFICATE
WHEN THE DELEGATE HAS NOT PASSSED THE WRITTEN
EXAMINATION BUT SATISFIES THE CONTINUOUS
ASSESSMENT AND ATTENDANCE REQUIREMENT
¾ LETTER OF ATTENDANCE
WHEN THE DELEGATE IS NOT MEETING ANY OF THE
ABOVE BUT SATISFIES ATTENDANCE REQUIREMENT
ONLY
Apr 2010 9
SECTION – 1
Introduction to QMS
Apr 2010 10
5
Learning Objectives
By the end of the session successful students will

be able to :
• Explain the purpose and business benefits of a quality

management system.
• Explain the 8 principles of quality management.
• Explain the process approach to management systems.
Apr 2010 11
Certification
and
Streamlining recognition
the systems
Purpose of Benefits
to stake
QMS holders
Improvement
in
performance Enhanced
market
standing
Apr 2010 12
6
BENEFITS OF QUALITY MANAGEMENT
¾ CUSTOMER CONFIDENCE
¾ CONSISTENCY IN QUALITY
¾ REDUCTION IN WASTE AND REWORK
¾ EMPLOYEE PARTICIPATION
¾ REDUCTION IN LIABILITIES
¾ IMPROVEMENT IN PROFIT
¾ CONTINUAL IMPROVEMENT
Apr 2010 13
Activity on understanding QMPs

Group exercise :Relate the following QMPS with
organizations with the attribute most identifiable to them
Process Approach
Factual decision
making
Customer Focus
Continual improvement
Systems Approach
Supplier relationship
Involvement of people
Leadership
Duration = 15 min.
Apr 2010 14
7
PRINCIPLES OF QUALITY
MANAGEMENT
¾ TO LEAD AND OPERATE AN ORGANIZATION
SUCCESSFULLY, IT IS NECESSARY TO DIRECT AND
CONTROL IT IN A SYSTEMATIC AND
TRANSPARENT MANNER
¾ MANAGING AN ORGANIZATION ENCOMPASSES

QUALITY MANAGEMENT AMONGST OTHER
MANAGEMENT DISCIPLINES
¾ EIGHT QUALITY MANAGEMENT PRINCIPLES HAVE BEEN

IDENTIFIED AND THEY FORM THE BASIS OF ISO 9001 :
2008 STANDARD
Apr 2010 15
MANAGEMENT
• QUALITY MANAGEMENT QUALITY MANAGEMENT
PRINCIPLE 1 PRINCIPLE 2
• “CUSTOMER FOCUSED “LEADERSHIP”
ORGANIZATION”
LEADERS ESTABLISH UNITY OF PURPOSE
• ORGANIZATIONS DEPEND ON THEIR
AND DIRECTION OF THE ORGANIZATION.
CUSTOMERS AND THEREFORE
THEY CREATE THE INTERNAL ENVIRONMENT
SHOULD UNDERSTAND CURRENT
IN WHICH PEOPLE CAN BECOME FULLY
AND FUTURE CUSTOMER NEEDS,
INVOLVED IN ACHIEVING THE
MEET CUSTOMER REQUIREMENTS
AND STRIVE TO EXCEED CUSTOMER ORGANIZATION’S OBJECTIVE
EXPECTATIONS.
Apr 2010 16
8
MANAGEMENT
• “INVOLVEMENT OF PEOPLE” “PROCESS APPROACH”
• PEOPLE OF ALL LEVELS ARE THE A DESIRED RESULT IS ACHIEVED MORE

ESSENCE OF AN ORGANIZATION EFFICIENTLY WHEN RELATED
AND THEIR FULL INVOLVEMENT RESOURCES AND ACTIVITIES ARE
ENABLES THEIR ABILITIES TO BE MANAGED AS A PROCESS
USED FOR THE ORGANISATION’S
BENEFIT
Apr 2010 17
MANAGEMENT
• “SYSTEM APPROACH TO “CONTINUAL IMPROVEMENT”
MANAGEMENT”
• IDENTIFYING, UNDERSTANDING CONTINUAL IMPROVEMENT SHOULD BE
AND MANAGING A SYSTEM OF A PERMANENT OBJECTIVE OF THE
INTERRELATED PROCESSES FOR ORGANIZATION
A GIVEN OBJECTIVE IMPROVES
THE EFFECTIVENESS AND
EFFICIENCY OF THE
ORGANIZATION
Apr 2010 18
9
MANAGEMENT

• “FACTUAL APPROACH TO “MUTUALLY BENEFICIAL
DECISION MAKING” SUPPLIER RELATIONSHIP”
• EFFECTIVE DECISIONS ARE AN ORGANISATION AND ITS

BASED ON THE ANALYSIS OF SUPPLIERS ARE INTERDEPENDENT
DATA AND INFORMATION AND A MUTUALLY BENEFICIAL
RELATIONSHIP ENHANCES THE
ABILITY OF BOTH TO CREATE VALUE
Apr 2010 19
PDCA APPROACH
¾ CONCEPT INTRODUCED BY DR.SHEWHART IN

EARLY 40’S
¾ POPULARIZED BY DR. DEMING IN THE 1950’S
¾ BECAME KNOWN AS DEMING CYCLE
¾ PDCA STANDS FOR PLAN, DO, CHECK AND ACT
¾ PDCA CYCLE CAN BE APPLIED AT ALL LEVELS WITHIN

THE ORGANIZATION
Apr 2010 20
10
PDCA Cycle
PDCA cycle can be applied at all levels within the organization
Apr 2010 21
Activity on PDCA
Group exercise
• Apply Plan, Do, Check and Act on

common activities like
• Making Tea
• Organizing a Picnic
• Home budgeting
• Reaching Place of work
Duration = 30 min.
Apr 2010 22
11
PROCESS
SET OF INTERRELATED OR INTERACTING ACTIVITIES WHICH

TRANSFORM INPUTS INTO OUTPUTS (ISO 9000-2008)
¾ OUTPUTS FROM ONE PROCESS ARE TYPICALLY INPUTS

INTO OTHER PROCESSES,
¾ PROCESSES MAY BE INTERRELATED OR

INDEPENDENT,
¾ OVERALL AIM IS TO ADD VALUE BY PLANNING AND

CONTROLLING PROCESSES
Apr 2010 23
BASIC PROCESS MODEL

CON TROL / P R OC ED UR ES
MA N AG EM ENT DESIRED
CU STOM ER CU STOM ER
PROCESS ACTIVITIES
SATISFA C TIO N
INP U T
OUTPU TS
EN ABLER S
(RESU LTS)
MO N ITO R ING M EASU REM EN TS
Apr 2010 24
12
PRODUCT
¾ THE RESULT OF A PROCESS (ISO 9000-2008)
¾ 4 GENERIC PRODUCT CATEGORIES
HARDWARE TANGIBLE PRODUCTS
PROCESSED MATERIAL
SOFTWARE
SERVICE
¾ MOST PRODUCTS ARE COMBINATION OF THESE

Apr 2010 25
PROCESS
AN ACTIVITY USING RESOURCES, AND MANAGED IN ORDER TO
ENABLE THE TRANSFORMATION OF INPUTS INTO OUTPUTS,
CAN BE CONSIDERED AS A PROCESS. OFTEN, THE OUTPUT
FROM ONE PROCESS DIRECTLY FORMS THE INPUT TO THE
NEXT PROCESS
PROCESS APPROACH
THE APPLICATION OF A SYSTEM OF PROCESSES WITHIN
AN ORGANIZATION, TOGETHER WITH THE IDENTIFICATION
AND INTERACTIONS OF THESE PROCESSES AND THEIR
MANAGEMENT, CAN BE REFERRED AS THE PROCESS
APPROACH
Apr 2010 26
13
DOCUMENTING A PROCESS
• DOCUMENTING A PROCESS INVOLVES :
• IDENTIFY THE PROCESS OWNER
• IDENTIFY INPUTS AND EXPECTED OUTPUTS / RESULTS
• DEFINE THE CHARACTERISTICS OF INPUTS AND OUTPUTS
• DEFINE THE BOUNDARIES OF THE PROCESS
• DETERMINE THE ACTIVITIES AND THE SEQUENCE
• IDENTIFY RESOURCES AND RESPONSIBILITIES
• DETERMINE THE CRITERIA AND METHODS TO ENSURE THE
OPERATION AND CONTROL ARE EFFECTIVE (SOPs AND
CHECKING POINTS)
• DETERMINE PROCESS PERFORMANCE MEASURES
Apr 2010 27
QMS PROCESSES
QMS TYPICALLY INCLUDES PROCESSES FOR
¾MANAGEMENT ACTIVITIES
¾PROVISION OF RESOURCES
¾PRODUCT REALIZATION
¾MEASUREMENT
Processes are not restricted to production

or service delivery activities only
Apr 2010 28
14
PROCUREMENT PROCESS
• Procure material as per
• Actions on vendor related required specs and at
quality problem required date
• Improvement project with • Improve quality of incoming
vendor material
• Improve turn over
• Training needs of dept.
• Optimise inventory
Personnel & vendors
• Cost reduction
P • Timely payment of vendors
A D
• Review of pending payments beyond
agreed time
• Review incoming material go rate C • Vendor selection and
w.r.t. goal (item wise) evaluation
• Chronic vendor problems • Cost reduction project
allotment
• Cost reduction achievement review
• Procure products as per drg
• Status of inventory item wise &
and tech specs.
reduction of prod. Lead Time. (item
wise) • Periodic process audit and
periodic Rating
• Review of matl. With Material
Requirement Planning % (MRP) • Processing of bill/invoice
delivery adherance • Inventory management
• Review inspection cycle time • Disposal of receipt rejection
incoming (itemwise SRV)
Apr 2010 29
EVALUATING A PROCESS WITHIN THE QMS

INCLUDES AUDIT OF :
PROCESS INPUTS, OUTPUTS & RESULTS
PROCESS MEASURES, LINKAGE WITH QUALITY OBJECTIVES
& MEASURES FOR CONTINUAL IMPROVEMENT
THROUGH THE 4 BASIC QUESTIONS

IS THE PROCESS IDENTIFIED & APPROPRIATELY DEFINED ?
ARE RESPONSIBILITIES ASSIGNED ?
ARE THE PROCEDURES IMPLEMENTED & MAINTAINED ?
IS THE PROCESS EFFECTIVE IN ACHIEVING THE REQUIRED
RESULTS?
PROCESSES MAY OR MAY NOT BE DEFINED BY
DOCUMENTATION
Apr 2010 30
15
Activity on understanding and documenting
Process Approach
Team exercise
Identify the inter-linkages of a tutor given

Process of an organization with the other
relevant processes
Present on Flip Charts
Duration = 30 min.
Apr 2010 31
Raw
Material
Storage Planning
Procurement Any
other
Process
process
Incoming
Inspection Production
Processes
Apr 2010 32
16
SECTION – 2
Apr 2010 33
Learning Objective
• By the end of the session successful students

will be able to :
¾ Explain the purpose, content & inter-

relationship of ISO 9000, ISO 9001 & ISO 9004
Apr 2010 34
17
Session 2a
Purpose, content & inter – relationship
of ISO 9000 family of Standards
Apr 2010 35
Activity on identifying the Purpose of

ISO 9000 Series of Standards
• Read section 0.1 of ISO 9000:2005 of Pre-

course reading material
• In your syndicate groups discuss and list

down the purpose of ISO 9000 series of
Standards for an organization
Duration = 20 min.
Apr 2010 36
18
ISO 9000 Family
ISO 9000:2005 – Quality Management Systems - Fundamentals And

Vocabulary
ISO 9001:2008 – Quality Management Systems - Requirements
ISO 9004:2009 – Managing for Sustained success of an organization – a

quality management approach
ISO 19011 : 2002 – Guidelines On Quality And / Or Environmental Management

Systems Auditing
Apr 2010 37
IS O 9 0 0 4
ISO 9001 Perspective
Quality of product and customer
satisfaction (effectiveness)
I SO 90 0 1
ISO 9004 Perspective

Wider focus on quality management than ISO 9001.
Addresses the needs and expectations of all relevant
Interested parties.
Systematic and continual improvement of the
organization's overall performance.
Apr 2010 38
19
ISO 9001 & 9004 : Relationship diagram
Apr 2010 O 39
Auditing Standards (Guidelines)
Guideline Standards originally published by ISO

Quality Management
•
1 1
ISO 10011-1:1990 Guidelines for auditing quality systems -- Part 1: Auditing
• 19 0
ISO 10011-2:1991 Guidelines for auditing quality systems -- Part 2: Qualification criteria for
quality systems auditors
O
•
y I S
ISO 10011-3:1991 Guidelines for auditing quality systems -- Part 3: Management of audit
db
programmes
s ede
Environmental Management
er
• up
ISO 14010:1996 Guidelines for environmental auditing -- General principles
s
•
N owmanagement
ISO 14011:1996
environmental
Guidelines for environmental auditing -- Audit procedures -- Auditing of
systems
• ISO 14012:1996 Guidelines for environmental auditing -- Qualification criteria for
environmental auditors
Apr 2010 40
20
ISO 19011:2002
• Guidelines for Quality and/or Environmental Management
Systems auditing
• Published in October 2002 jointly ISO/TC 176, Quality
management and Quality Assurance and ISO/TC 207
Environmental Management
• Replaced ISO 10011-1:1990, ISO 10011-2:1991, ISO 10111-
3:1991, ISO 14010:1996,14011:1996,ISO 14012:1996 and
combined all aspects into generic guidelines
• The standard is intended to act as a guide to all auditors,
including those who audit internally within their own
organization.
• Can be applied to Management systems other than QMS
and EMS
Apr 2010 41
NATIONAL ISO 9000 SERIES 1987 ISO 9000

STANDARDS 9001 9002 9003 ISO 9004
EN EN 29000
29001 29002 29003 EN 29004
ISO 9000 SERIES 1994 ISO 9000-1, 9000-2

9001 9002 9003 ISO 9004-1, 9004-2, 9004-3
ISO 9001 : 2000 ISO 9004 : 2000
ISO 9000 : 2005

ISO 9001 : 2008
ISO 9004 : 2009
(CONTRACTUAL) (NON-CONTRACTUAL)
Apr 2010 42
21
How is ISO Standard Revised
¾ International organization for standardization (ISO)
is a federation of national standards bodies
¾ ISO works through technical committees.
(TC–176 has the responsibility to issue and update
ISO 9000 standards )
¾ TC – 176 is supported by Sub Committees and
Working Groups (WG)
¾ The standard progresses from Preliminary Working
Draft (PWD) Î Committee Draft (CD) Î Draft
International Standard (DIS) Î Finalized Draft
International Standard (FDIS) Î Published
International Standard
¾ The standard is published only after positive votes
from members
Apr 2010 43
Activity on identifying differences between Auditable

Standard (AS) & Guidance Documents (GD)
Standard AS/ GD Why?
ISO 9000
ISO 9001
ISO 9004
ISO 19011
Identify the auditable standards & the guidance documents from the table
Discuss the rationale for this distinction in your syndicate group

Duration = 20 min.
Apr 2010 44
22
Auditable Standards /
Guidance Documents
¾ Auditable standard - ISO 9001:2008
Requirements for a QMS as specified
Audits are carried out against the
requirements of ISO 9001. ISO 9001:2008
Requirements
¾ Guidance documents
ISO 9000 - fundamentals & vocabulary
ISO 9004 - Managing for Sustained
success of an organization – a quality
management approach
“Notes” under requirement specified in
ISO 9001 standard
Apr 2010 45
Legal compliance vs conformance to ISO 9001(1)

¾ The statutory & regulatory requirements
applicable to products, as specified by
the controlling authorities are to be
complied under all circumstances.
– Euro norms for the automobile
vehicles
Examples
– Safety for medical equipments

– Intrinsically safe equipment in gas
dangerous zone
– FDA regulations for food products
& medicines
Apr 2010 46
23
Legal compliance vs conformance to ISO 9001(2)
Vendor
Customer driven selection by
corporate
Conformance
to QMS
standard
Voluntary decision Market image

& entry into
new markets
Apr 2010 47
Session 2b
QMS Terminology
Apr 2010 48
24
Activity on vocabulary
• Match the key phrases of the

definitions with the vocabulary
in the table provided within
your respective teams
• List your points of doubt on the
flip charts
Duration = 30 min.
Apr 2010 49
Definition Terminology Definition

1. Quality A. Information and its supporting medium
2. Grade B. ………….. increasing the ability to fulfill quality requirements
3. Customer Satisfaction C. ……. who directs and controls an organization, at the highest level
4. Quality Policy D. Document specifying the quality management system of an organization
5. Quality Objectives E. …..inherent characteristics fulfills requirements
6. Top Management F. ……… aimed for, related to quality
7. Quality Management G. Document specifying .. procedure and associated resources …… a specific
project, product, process or contract
8. Quality Control H. Extent to which planned activities are realized and planned results achieved
9. Quality Assurance I. Management system to direct and control an organization ….
10. Quality Planning J. Co-ordinated activities to direct and control an Organization ……
11. Quality Improvement K. The non – fulfillment of a requirement
12. Quality Management L. Document stating results achieved or providing evidence ……
Systems
13. Conformity M. Part of quality management focused on providing confidence …...
14. Non – Conformity N. Overall intentions and direction of an organization…….
15. Defect O. Category or rank given …. having the same functional use
16. Document P. Relationship between the result achieved and resources used
17. Quality Plan Q. Customer’s perception ……customer’s requirements have been fulfilled
18. Quality Manual R. The non – fulfillment of a requirement, related to an intended or specified use
19. Record S. Part of quality management focused on Fulfilling quality requirements
20. Effectiveness T. Part of quality management, focused on setting quality objectives and specifying
necessary operational process and related resources to fulfill the quality objectives
21. Efficiency U. The fulfillment of a requirement
Apr 2010 50
25
QUALITY
DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS
FULFILLS REQUIREMENTS
GRADE
CATEGORY OR RANK GIVEN TO DIFFERENT QUALITY
REQUIREMENTS FOR PRODUCTS, PROCESSES OR SYSTEMS HAVING
THE SAME FUNCTIONAL USE
CUSTOMER SATISFACTION
CUSTOMER’S PERCEPTION OF THE DEGREE TO WHICH
THE CUSTOMER’S REQUIREMENTS HAVE BEEN FULFILLED
Apr 2010 51
QUALITY POLICY
OVERALL INTENTIONS AND DIRECTION OF AN ORGANIZATION
RELATED TO QUALITY, AS FORMALLY EXPRESSED BY TOP
MANAGEMENT
QUALITY OBJECTIVES
SOMETHING SOUGHT OR AIMED FOR, RELATED TO QUALITY
Apr 2010 52
26
TOP MANAGEMENT
PERSON OR GROUP OF PEOPLE WHO

DIRECTS AND CONTROLS AN ORGANIZATION,
AT THE HIGHEST LEVEL
Apr 2010 53
QUALITY MANAGEMENT
CO-ORDINATED ACTIVITIES TO DIRECT AND CONTROL AN
ORGANIZATION WITH REGARD TO QUALITY
QUALITY CONTROL
PART OF QUALITY MANAGEMENT FOCUSED ON
FULFILLING QUALITY REQUIREMENTS
QUALITY ASSURANCE
PART OF QUALITY MANAGEMENT FOCUSED ON PROVIDING
CONFIDENCE THAT QUALITY REQUIREMENTS WILL BE FULFILLED
Apr 2010 54
27
QUALITY PLANNING
PART OF QUALITY MANAGEMENT, FOCUSED ON SETTING
QUALITY OBJECTIVES AND SPECIFYING NECESSARY
OPERATIONAL PROCESS AND RELATED RESOURCES TO
FULFILL THE QUALITY OBJECTIVES
QUALITY IMPROVEMENT
PART OF QUALITY MANAGEMENT, FOCUSED ON INCREASING
THE ABILITY TO FULFIL QUALITY REQUIREMENTS
Apr 2010 55
QUALITY MANAGEMENT SYSTEMS
MANAGEMENT SYSTEM TO DIRECT AND CONTROL AN

ORGANIZATION WITH REGARD TO QUALITY
Apr 2010 56
28
CONFORMITY
THE FULFILLMENT OF A REQUIREMENT
NON – CONFORMITY
THE NON – FULFILLMENT OF A REQUIREMENT
DEFECT
THE NON – FULFILLMENT OF A REQUIREMENT, RELATED TO AN
INTENDED OR SPECIFIED USE
Apr 2010 57
DOCUMENT
INFORMATION AND ITS SUPPORTING MEDIUM
QUALITY PLAN
DOCUMENT SPECIFYING WHICH PROCEDURE AND ASSOCIATED
RESOURCES SHALL BE APPLIED BY WHOM AND WHEN TO A
SPECIFIC PROJECT, PRODUCT, PROCESS OR CONTRACT
QUALITY MANUAL
DOCUMENT SPECIFYING THE QUALITY MANAGEMENT SYSTEM OF AN
ORGANIZATION
RECORD
DOCUMENT STATING RESULTS ACHIEVED OR PROVIDING EVIDENCE
OF ACTIVITIES PERFORMED
Apr 2010 58
29
EFFECTIVENESS
EXTENT TO WHICH PLANNED ACTIVITIES ARE REALIZED AND
PLANNED RESULTS ACHIEVED
EFFICIENCY
RELATIONSHIP BETWEEN THE RESULT ACHIEVED AND RESOURCES

USED
Apr 2010 59
Session 2c
ISO 9001: 2008 QMS Requirements
Apr 2010 60
30
Continual improvement of
the quality management system
Management
responsibility
Customers
Measurement,
Resource
Customers management
analysis and Satisfaction
improvement
Output
Input Product Product
Requirements Realization
Value adding activities
Information flow
Apr 2010 61
1. Scope and general

2. Normative references
3. Terms & definitions Clauses
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis and improvement
Apr 2010 62
31
Scope of ISO 9001
General
¾ This international standard specifies requirements for a quality
management system where an organization
Needs to demonstrate its ability to consistently provide product
that meets customer and applicable statutory & regulatory
requirements, and
Aims to enhance customer satisfaction through the application
of the system, including processes for continual improvement
of the system and the assurance of conformity to customer and
applicable statutory & regulatory requirements.
Note : 1a in this international standard, the term “product” applies only to
the product intended for, or required by, a customer
..............................
Apr 2010 63
Scope of ISO 9001

Application
¾ All requirements of this international standard are generic

and are intended to be applicable to all organizations
regardless of type, size and the product provided
¾ Where any requirements of the standard cannot be applied

due to the nature of an organization and its products, this
can be considered for exclusion.
¾ Exclusions are limited to requirements stated in clause 7.
¾ Permissible exclusions are those that do not affect the

organization’s ability or responsibility to provide product
that meets customer and applicable statutory & regulatory
requirements
Apr 2010 64
32
Justification of Exclusions
¾ When an organization limits the
application of the requirements of
the ISO 9001: 2008, this must be
detailed and justified in the
organization’s quality manual.
¾ This must also be clear in any other

publicly available document, such
as certification/registration
document or marketing material
Apr 2010 65
Most Likely Exclusions

¾ Within clause 7 (product realization), the following are the
most likely requirements, though not the only ones.
7.5.4
7.3 Design & Customer
development Most Likely property
Exclusions
7.6 Control
7.5.3 of monitoring
Identification & &
traceability measuring
(traceability may devices.
not be applicable)
Apr 2010 66
33
Scope of Audit
• Extent and Boundaries

¾Product
¾Physical location
¾Organizational units
¾Activities/ Processes
Apr 2010 67
Activity on Understanding ISO 9001

Requirements
• Refer to E01 of Work Book & Case

Study
Total Duration = 90 min.

Individual Work = 30 min; Group Work= 30 min; Feedback from Exercise = 30 min
Apr 2010 68
34
4.0 Quality
Management System
4.1 General Requirements
4.2 Documentation Requirement
4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Records
Apr 2010 69
4.1 General Requirements

Organization shall establish, document, implement, maintain and continually improve the
effectiveness of a quality management system.
The organization shall:
a. Determine the processes needed for quality management systems, and its application.
b. Determine the sequence and interaction of these processes.
c. Determine criteria and methods needed to ensure that both the operation and control of
these processes are effective.
d. Ensure the availability of resources and information necessary to support these
processes.
e. Monitor, measure where applicable and analyze these processes.
f. Implement actions necessary to achieve planned results and continual improvements of
these processes.
These processes shall be managed by the organization in accordance with the requirements
of this international standard.
Where an organization chooses to outsource any process, then control the outsourced
processes.
Note : processes needed for the quality management systems referred to above, should include
processes for management activities, provision of resources, product realization and
measurement analysis & improvement
Apr 2010 70
35
5.0 Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.5 Responsibility, Authority And Communication
5.6 Management Review
Apr 2010 71
6.0 Resource Management
Training
6.1 Provision of Resources
6.2 Human Resources
6.3 Infrastructure
6.4 Work Environment
Work Environment
Apr 2010 72
36
7.0 Product Realization
7.1 Planning of Product Realization

7.2 Customer – Related Processes
7.3 Design And Development
7.4 Purchasing
7.5 Production & Service Provision
7.6 Control of Monitoring & Measuring Devices
Apr 2010 73
7.5 Production &

Service Provision
7.5.1 Control of Production &
Service Provision
7.5.2 Validation of Processes For

Production & Service
Provision
7.5.3 Identification & Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
Apr 2010 74
37
8.0 Measurement, Analysis
& Improvement
8.1 General
8.2 Monitoring & Measurement
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5 Improvement
Apr 2010 75
8.2 Monitoring & Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring & Measurement of Processes
8.2.4 Monitoring & Measurement of Product
Apr 2010 76
38
Activity on identifying relationship between Quality
Management Principles (QMPs) & ISO 9001
• In your syndicate groups identify the

allocated QMPs to the relevant clauses
& sub clauses and list down in the flip
chart
Total Duration = 60 min.
Apr 2010 77
RELATIONSHIP BETWEEN THE QMPs AND ISO 9001

ISO 9001
P1 P2 P3 P4 P5 P6 P7 P8
Clauses
4.1
4.2
5.1
5.2
5.3
5.4.1
5.4.2
5.5.1
5.5.2
5.5.3
5.6
6.1
6.2
6.3
6.4
7.1
7.2
7.3
7.4
7.5
7.5.4
7.6
8.1
8.2.1
8.2.3
8.2.4
8.3
8.4
8.5.1
8.5.2
8.5.3
The above relationship are indicative - not exhaustive
LEGEND
P1 Customer Focus P5 System Approach
P2 Leadership P6 Continual Improvement
Apr 2010 P3 People Involvement P7 Fact Based Approach 78
P4 Process approach P8 Supplier Relationship
39
Session 2d
Documentation for QMS
Apr 2010 79
Documentation
Requirements
ISO 9001: 2008 requires

• Documented statements of quality policy and
quality objectives.
• A quality manual.
• Documented procedures & records required
by the standard.
• Documents needed by the organization to
ensure effective planning, operation and
control of its processes.
Apr 2010 80
40
Activity on Documentation
• Read through 4.2.1 of ISO 9001:2008
in your syndicate groups
• What differences would you expect
to see in the documentation of
¾ A large scale industry
¾ A small scale industry
• What in your opinion are the reasons
for these differences ?
• Tutor lead discussion
Duration 10 mins
Apr 2010 81
Areas of differences
• Degree of Formality
¾ Content
¾ Number
¾ Issue procedures
• Hierarchy of documents
• Document numbering system
• Style of presentation
• Medium
• Distribution of responsibilities
for document approval
Apr 2010 82
41
Typical Quality Management System
Documentation Hierarchy
Source: lS/lSO/TR 10013:2001
Apr 2010 83
A Typical Quality Manual
1. Title and scope

2. Table of contents Quality
l
Manua
3. Review, approval and revision
4. Quality policy and objectives
5. Organization, responsibility and authority
6. References
7. Quality management system description
8. Appendices
Apr 2010 84
42
Structure of a typical Documented procedure
• Text
• Flow charts,
• Tables
• A combination of the
above,
• Or any other suitable
method
Apr 2010 85
Content of a typical Documented procedure

• Title
• Purpose
• Scope
• Responsibility and authority •
•
Xm
mm xmx
xm mx
• Xm xm mx
mx m mx
Xm mm mm
• Description of activities •
• mm mx
X,x
xm xmm
mm m
m
xm mx
m
xm mxm
mm
xm
xm
mx
mx
m
mm mm
mx
xm
m
• Xm m
mx m m x m m mx
Xm m mm m
• Records mx xm xm
m xm m
xm xm
xm xm
xm mm
xm mx
mx m
m
• Appendices
• Review, approval and revision
• Identification of changes
Apr 2010 86
43
Work Instructions
• The structure, format and level of detail

used in the work instructions should be
tailored to the needs of the organization’s
personnel and depends on the complexity
of the work
Apr 2010 87
Value of Documentation
¾ Enables communication of intent and consistency of action

¾ Definition of roles for members
¾ Enhancement of understanding
¾ Control and measurement
¾ System becomes auditable
¾ Evaluation of the effectiveness and continuing
suitability of QMS
¾ Information useful for training and competence building
¾ Provides confidence in the QMS
¾ Helps in continual improvement
¾ Provides repeatability and traceability
Apr 2010 88
44
SECTION – 3
Auditing QMS
Apr 2010 89
Section – 3
• LEARNING OBJECTIVES:
• By the end of the section, successful students will be able to
:
¾ Understand the Audit process
¾ Explain the role of auditor to plan, conduct, report and

follow up a QMS audit in accordance with ISO 19011
¾ Understand audit responsibilities
¾ Develop the skills required to plan, prepare, conduct and

report on audits
¾ Understand the certification / registration and

accreditation processes
¾ IRCA / NABET Schemes for Auditor certification
45
Section – 3
Sessions
¾ Accreditation certificate and auditor certification (3 a)
¾ Role of IRCA / NRBPT and Auditor certification (3 b)
¾ Introduction to Auditing (3 c)
¾ Auditor responsibilities (3 d)
¾ Audit Programmes (3 e)
¾ Planning of Audits (3 f)
Checklists (3 g)
¾ Conducting Audits
Opening meeting (3 h)
Onsite auditing and audit skills (3 i)
Closing meeting (3 j)
¾ Audit reporting (3 k)
¾ Audit follow up (3 l)
Learning Objective – Session 3
• By the end of the session, successful students

will be able to :
¾ Explain the role of an auditor to plan,

conduct, report and follow up a quality
management system audit in accordance with
ISO 19011.
Apr 2010 92
46
SESSION 3a
CERTIFICATION AND
ACCREDITATION
¾ CERTIFICATION
¾ ACCREDITATION
¾ REGISTRATION SCHEME FOR LEAD AUDITORS / AUDITORS
¾ PRINCIPLES OF AUDITING
¾ CONFIDENTIALITY
¾ CONFLICT OF INTEREST
Apr 2010 93
ACCREDITATION
BOARD
APPLICATION FOR AUDIT AND SURVEILLANCE

ACCREDITATION BY ACCREDITATION BOARD
CERTIFICATION BODY (CB)
APPLICATION FOR AUDIT AND

CERTIFICATION SURVEILLANCE BY CB
ORGANIZATION
Apr 2010 94
47
CONFORMITY ASSESSMENT IN UK
DTI
UKAS IRCA/CQI
NAMAS QUALITY MANAGEMENT TRAINING REGISTRATION

LABORATORY SYSTEM CERTIFICATION COURSES
ACCREDITATION BODIES AUDITOR
LEAD AUDITOR
PRINCIPAL
DTI : DEPARTMENT OF TRADE AND INDUSTRY AUDITOR
NAMAS : NATIONAL MEASUREMENT ACCREDITATION SCHEME
PROVISIONAL
UKAS : UNITED KINGDOM ACCREDITATION SERVICES AUDITOR
IRCA : INTERNATIONAL REGISTER OF CERTIFICATED AUDITORS INTERNAL

AUDITOR
CQI : CHARTERED QUALITY INSTITUTE
Apr 2010 95
CONFORMITY ASSESSMENT IN INDIA

Quality Council of India
Secretariat
NABCB NABET NABH NABL

National National National National
Accreditation Accreditation Accreditation Accreditation Board
Board for Board for Board for for Testing &
Certification Education & Hospitals & Health Calibration
Bodies Training services Laboratories
QIES
NBQP
Quality Information &
National Board for
Enquiry Services
Quality Promotion
Apr 2010 96
48
ACCREDITATION
ACCREDITATION OFFERS ASSURANCE TO

THE CERTIFICATION PROCESS
REFERENCE STANDARD FOR ACCREDITATION

EN 45012 / ISO 17021
Apr 2010 97
CERTIFICATION
• CREDIBILITY OF QUALITY SYSTEM

CERTIFICATION DEPENDS ON
) IMPARTIALITY
) WELL DEFINED SCOPE
) MAINTENANCE OF THE CERTIFICATE
) COMPETENCE OF THE AUDITORS
) CONSISTENCY OF APPROACH
Apr 2010 98
49
BENEFITS OF A CERTIFIED QMS
• CUSTOMER CONFIDENCE
• ENHANCED CREDIBILITY
• NATIONAL AND INTERNAL RECOGNITION
• ACCEPTANCE IN GLOBAL MARKET
• FACILITY OF INDEPENDENT EVALUATION AND

FEEDBACK
• REDUCES NEED FOR MULTIPLE AGENCY /

MULTIPLE PURCHASER EVALUATION
Apr 2010 99
SESSION 3b
ROLE OF IRCA / NABET
AND
AUDITOR CERTIFICATION REQUIREMENTS
Apr 2010 100
50
INTERNATIONAL REGISTRATION SCHEME FOR
AUDITORS OF QUALITY SYSTEM
) THE BEST KNOWN & WIDELY USED METHOD TO
DEMONSTRATE AUDITOR COMPETENCE
) INTERNATIONAL AUDITOR AND PERSONNEL

CERTIFICATION ASSOCIATION (IPC)
) IRCA (UK,) EARA(UK), NABET (INDIA), RAB (USA) ARE

MEMBERS OF IPC
) AUDITOR REGISTRATION IS CARRIED OUT BY SELECT

MEMBERS OF IPC
Apr 2010 101
REGISTRATION AS AUDITOR /
LEAD AUDITOR
DEPENDS UPON
) EDUCATIONAL QUALIFICATION
) WORK EXPERIENCE
) AUDIT EXPERIENCE
) 40 HOURS OF AUDITORS TRAINING
) AUDITOR COMPETENCE
Apr 2010 102
51
COMPETENCE AND EVALUATION
OF AUDITORS
A COMPETENT AUDITOR
GENERIC KNOWLEDGE & SKILLS
SPECIFIC KNOWLEDGE & SKILLS
EDUCATION, WORK EXPERIENCE, TRAINING
& AUDIT EXPERIENCE
AUDITOR EVALUATION
Apr 2010 103
A COMPETENT AUDITOR
¾ DEMONSTRATES PERSONAL ATTRIBUTES

¾ DEMONSTRATES ABILITY TO APPLY THE KNOWLEDGE &
SKILLS TO CONDUCT SUCCESSFUL AUDITS & ACHIEVE
THE AUDIT OBJECTIVES
¾ GAINS COMPETENCE THROUGH
EDUCATION
WORK EXPERIENCE
AUDIT TRAINING
AUDIT EXPERIENCE
Apr 2010 104
52
PERSONAL ATTRIBUTES
¾ ETHICAL
¾ OPEN-MINDED
¾ DIPLOMATIC
¾ OBSERVANT
¾ PERCEPTIVE
¾ VERSATILE
¾ TENACIOUS
¾ DECISIVE
¾ SELF RELIANT
Apr 2010 105

FOR AUDITORS
¾ AUDIT PRINCIPLES, PROCEDURES & TECHNIQUES
¾ MANAGEMENT SYSTEM & REFERENCE DOCUMENTS
¾ ORGANIZATIONAL SITUATIONS
¾ APPLICABLE LAWS, REGULATIONS & OTHER

REQUIREMENTS
Ref : ISO 19011: 2002 Section 7.3.1
Apr 2010 106
53
SPECIFIC KNOWLEDGE & SKILLS
FOR QMS AUDITORS
QUALITY RELATED METHODS AND TECHNIQUES
¾ QUALITY TERMINOLOGY
¾ QUALITY MANAGEMENT PRINCIPLES & THEIR APPLICATION
¾ QUALITY MANAGEMENT TOOLS
PROCESSES AND PRODUCTS INCLUDING SERVICES

¾ SECTOR SPECIFIC TERMINOLOGY
¾ TECHNICAL CHARACTERISTICS OF PROCESSES & PRODUCTS
Ref : ISO 19011: 2002 Section 7.3.3
Apr 2010 107

OF LEAD AUDITORS
ABILITY TO
¾ PLAN THE AUDIT & MAKE EFFECTIVE USE OF RESOURCES
¾ REPRESENT THE AUDIT TEAM
¾ ORGANIZE & DIRECT THE TEAM
¾ DIRECT & GUIDE AUDITORS IN TRAINING
¾ LEAD AUDIT TEAM TO REACH AUDIT CONCLUSIONS
¾ PREVENT / RESOLVE CONFLICTS
¾ PREPARE AUDIT REPORT
Apr 2010 108
54
AND AUDIT EXPERIENCE OF AUDITORS
¾ EDUCATION TO PROVIDE GENERIC & SPECIFIC

KNOWLEDGE & SKILLS
¾ WORK EXPERIENCE TO CONTRIBUTE TO THE
DEVELOPMENT OF KNOWLEDGE & SKILLS IN
QUALITY MANAGEMENT FIELD
¾ COMPLETION OF AUDITOR TRAINING
¾ AUDIT EXPERIENCE UNDER THE GUIDANCE OF
A COMPETENT LEAD AUDITOR
Apr 2010 109

AND AUDIT EXPERIENCE OF LEAD AUDITORS
¾ SHOULD HAVE ACQUIRED ADDITIONAL AUDIT

EXPERIENCE TO DEVELOP THE REQUIRED
KNOWLEDGE AND SKILLS
¾ THE ADDITIONAL EXPERIENCE IS FROM ACTING IN

THE ROLE OF AN AUDIT TEAM LEADER UNDER THE
GUIDANCE OF ANOTHER COMPETENT AUDIT TEAM
LEADER
Apr 2010 110
55
LEVELS OF EDUCATION, WORK EXPERIENCE,
AUDITOR TRAINING & AUDIT EXPERIENCE
¾ APPROPRIATE FOR AUDITORS CONDUCTING

CERTIFICATION OR SIMILAR AUDITS.
¾ HIGHER OR LOWER LEVELS ARE APPROPRIATE

DEPENDING ON THE AUDIT PROGRAMME
¾ Ref TABLE 1 of ISO 19011
Apr 2010 111
Table 1 – Example of levels of education, work experience, auditor training

training and
audit experience for auditors conducting certification or similar
similar audits
Auditor in both Audit team
Parameter Auditor
disciplines leader
Education Secondary education Same as for Auditor Same as for Auditor
Total work experience 5 years Same as for Auditor Same as for Auditor
Work experience in At least 2 years of the total 2 years in the second Same as for Auditor
quality or environmental 5 years discipline
management field
Auditor training 40 h. of Audit training 24 h. of training in the 2nd Same as for Auditor
discipline
Audit experience Four complete audits for a Three complete audits for a Three complete audits
total of at least 20 days of total of at least 15 days of for a total of at least 15
audit experience as an audit experience in the 2nd days of audit experience
auditor– in- training under discipline under the direction acting in the role of an
the direction & guidance of & guidance of an auditor audit team leader under
an auditor competent as competent as an audit leader the direction & guidance
an audit team leader in the 2nd discipline . of an auditor competent
The audits should be The audits should be as an audit team leader.
completed within the last 3 completed within the last two
consecutive years consecutive years.
(Contd..)
Apr 2010 O 112
56
MAINTENANCE & IMPROVEMENT OF
COMPETENCE OF AUDITOR
¾ CONTINUAL PROFESSIONAL DEVELOPMENT
¾ MAINTENANCE OF AUDITING ABILITY
Apr 2010 113
AUDITOR COMPETENCE EVALUATION
¾ INITIAL EVALUATION OF AUDITORS WHO WISH

TO BECOME AUDITORS
¾ AS PART OF THE AUDIT TEAM SELECTION
PROCESS
¾ CONTINUAL EVALUATION OF AUDITOR
PERFORMANCE TO IDENTIFY NEEDS FOR
MAINTENANCE & IMPROVEMENT OF
KNOWLEDGE & SKILLS
Apr 2010 O 114
57
RELATIONSHIP BETWEEN THE STAGES OF EVALUATION
Development of Competence
Criteria
not met Continual Evaluation of
Initial Evaluation Performance
Criteria met
Criteria met
Criteria not met
Auditor
Not Selected Maintenance &

Improvement of
Audit Team Selection Competence
Auditing
Apr 2010 O 115
COMPETENCE EVALUATION PROCESS

¾ IDENTIFY PERSONAL ATTRIBUTES, KNOWLEDGE & SKILLS
¾ SET EVALUATION CRITERIA (WORK EXPERIENCE, EDUCATION,

NUMBER OF AUDITS, HOURS OF AUDIT TRAINING)
¾ SELECT APPROPRIATE EVALUATION METHODS (REVIEW OF

RECORDS, FEEDBACK, INTERVIEW, OBSERVATION, TESTING,
POST AUDIT REVIEW)
¾ CONDUCT EVALUATION
Apr 2010 O 116
58
CONFLICT OF INTEREST
¾ AUDITORS SHOULD ENSURE THAT THERE IS NO

CONFLICT OF INTEREST DURING THE AUDIT.
¾ CONFLICT OF INTEREST CAN OCCUR IF AN AUDITOR

IS AN INTERESTED PARTY OF THE ORGANIZATION.
¾ CONFLICT OF INTEREST CAN ALSO OCCUR IF

AUDITOR OR HIS ORGANIZATION HAS PROVIDED
ADVICE, GUIDANCE OR CONSULTANCY DURING THE
RECENT PAST TO THE AUDITEE ORGANIZATION.
Apr 2010 117
WITNESSING OF AUDITORS
) COVERAGE OF THE STANDARD
) KEEPING TO THE PROGRAMME
) KNOWLEDGE OF THE CLIENT’S QUALITY SYSTEM
) RELEVANCE OF AUDITOR’S EXPERIENCE
) QUESTIONING SKILLS
) PROCESS OF SAMPLE SELECTION
) HANDLING UNFORESEEN OR DIFFICULT SITUATIONS
) RAISING NCRs
) NUMBER OF COMPANY STAFF INTERVIEWED
Apr 2010 118
59
SESSION 3c
INTRODUCTION TO AUDITING
¾ WHY AND WHAT OF AUDITS
¾ AUDIT TERMINOLOGY
¾ TYPES OF AUDITS
¾ STAGES OF AUDITS
¾ PROCESS APPROACH TO AUDITS
Apr 2010 119
WHY AUDIT?
• TO DETERMINE THE HEALTH OF THE UNIT
• TO CHECK COMPLIANCE TO A STANDARD

AND / OR CONTRACTUAL REQUIREMENTS
• TO DETERMINE THE EFFECTIVENESS OF THE

QUALITY SYSTEM
• TO IDENTIFY AND PRIORITISE AREAS FOR

IMPROVEMENT
• TO ASSESS AN EXISTING OR A POTENTIAL

SUPPLIER
• TO CHECK READINESS FOR CERTIFICATION

Apr 2010 120
60
PRINCIPLES OF
AUDITING
¾ ETHICAL CONDUCT (TRUST, INTEGRITY, CONFIDENTIALITY,
DISCRETION)
¾ FAIR PRESENTATION (TRUTHFUL & ACCURATE REPORTING)
¾ DUE PROFESSIONAL CARE (DILIGENCE & JUDGMENT IN
AUDITING)
¾ INDEPENDENCE (INDEPENDENT, FREE FORM BIAS & CONFLICT
OF INTEREST OBJECTIVES)
¾ EVIDENCE BASED APPROACH (RELIABLE & REPRODUCIBLE
AUDIT CONCLUSIONS BASED ON VERIFIABLE EVIDENCE &
APPROPRIATE SAMPLING)
Apr 2010 121
AUDIT TERMINOLOGY
AUDIT
SYSTEMATIC, INDEPENDENT AND DOCUMENTED PROCESS FOR
OBTAINING AUDIT EVIDENCE AND EVALUATING IT
OBJECTIVELY TO DETERMINE THE EXTENT TO WHICH AUDIT
CRITERIA ARE FULFILLED
AUDIT EVIDENCE
RECORDS, STATEMENTS OF FACT OR
OTHER INFORMATION WHICH ARE RELEVANT TO
THE AUDIT CRITERIA AND VERIFIABLE.
AUDIT CRITERIA
SET OF POLICIES, PROCEDURES OR REQUIREMENTS,
USED AS REFERENCE
Apr 2010 122
61
AUDIT FINDINGS
RESULTS OF THE EVALUATION OF COLLECTED

AUDIT EVIDENCE AGAINST AUDIT CRITERIA
AUDIT CONCLUSION
OUTCOME OF AN AUDIT PROVIDED BY THE AUDIT
TEAM AFTER CONSIDERATION OF THE AUDIT
OBJECTIVES & ALL AUDIT FINDINGS
Apr 2010 123
AUDIT PROGRAMME
SET OF ONE OR MORE AUDIT PLANNED FOR A
SPECIFIC TIME FRAME & DIRECTED TOWARDS A
SPECIFIC PURPOSE
AUDIT PLAN
DESCRIPTION OF THE ACTIVITIES &
ARRANGEMENTS FOR AN AUDIT
AUDIT SCOPE
EXTENT & BOUNDARIES OF AN AUDIT
Apr 2010 124
62
TYPES OF AUDIT
• INTERNAL AUDITS
FIRST PARTY AUDIT
AN AUDIT PERFORMED WITHIN AN ORGANIZATION BY THE
ORGANIZATION’S OWN AUDITING RESOURCES.
• EXTERNAL AUDIT
SECOND PARTY AUDIT
AN AUDIT OF CONTRACTORS / SUPPLIERS UNDERTAKEN BY
OR ON BEHALF OF A PURCHASING ORGANIZATION. THIS
MAY INCLUDE THE AUDIT OF COMPANIES OR DIVISIONS
SUPPLYING GOODS OR SERVICES TO OTHERS WITHIN THE
SAME GROUP. (ALSO REFERRED TO AS SUPPLIER AUDIT)
THIRD PARTY AUDIT

AN AUDIT OF AN ORGANIZATION PERFORMED BY A BODY
THAT IS INDEPENDENT OF THE ORGANIZATION BEING
AUDITED CERTIFICATION BODY OR REGISTRAR.)
Apr 2010 125
First, Second and Third party audits

Auditor roles
• Common
¾ To conduct audit in a professional and unbaised manner
¾ Finding evidence against defined criteria
¾ Determining effectiveness of processes and systems
• Varying
¾ First party –to determine opportunities for improvements
Can give suggestions in the reports
¾ Second party –to determine capability of auditee’s systems to supply
products / services
Can mutually agree on improvements specific to contract
¾ Third Party –to determine capability to meet and enhance satisfaction of
all customers
Apr 2010 O 126
63
Auditee roles
• Common
¾ To provide for time and resources for the audit to be conducted
• Varying Objectives
¾ First party
To develop internal audit criteria and ensure its implementation
To plan and schedule audits based on importance of activities
To provide competent and independent internal auditors
To take follow up actions on internal audit reports and review
findings in management review
¾ Second and third party
To agree on audit dates, audit plans and auditors
To provide guides during audits
To agree on improvement actions if non conformances are raised
To take follow up actions and report to audit client
Apr 2010 O 127

Audit Client role
Common
¾ To establish and inform to auditee and auditors
Audit criteria which may include statutory / regulatory requirements
Expectations from audits
Audit procedure and manner of reporting
• Varying
¾ First party – Top Management is Audit Client
To review audit findings during management review and take decisions for improvements
¾ Second party
To inform auditee of any contract specific audit criteria
To receive a specific evaluation report from the audit team in respect of the terms of
contract and / or regulatory requirements
To base business decisions on the report findings
¾ Third Party –
To receive a report from the audit team with recommendations
To inform decisions on certification or approval as relevant
Apr 2010 O 128
64
STAGES OF AUDIT
INITIATING THE AUDIT
STAGE 1 AUDIT
STAGE 2 AUDIT
ONSITE AUDIT ACTIVITIES
REPORTING ON THE AUDIT
AUDIT COMPLETION
AUDIT FOLLOW UP
Apr 2010 129
STAGE 1 AUDIT
The stage 1 audit shall be performed
• to audit the client's management system documentation
• to evaluate the client's location and site-specific conditions
• to determine the preparedness for the stage 2 audit;
• to review the client's status and understanding regarding
requirements of the standard,
• to collect necessary information regarding the scope, processes and
location(s) of the client, and related statutory and regulatory aspects
• to review and agree with the client the allocation of resources for
stage 2 audit
• to evaluate if the internal audits and management review are being
planned and performed,
• to estimate the client is ready for the stage 2 audit.
Apr 2010 130
65
STAGE 2 AUDIT
To evaluate on site, the implementation, including
effectiveness, of the client's management system which
includes
• evidence about conformity to all requirements of ISO 9001
• performance monitoring, measuring, reporting and reviewing against
key quality objectives and
• targets
• compliance to regulatory requirements related to product
• operational control of the client's processes;
• internal auditing and management review;
• management responsibility
• links among all of the above
Apr 2010 131
TYPICAL STAGES OF AUDIT

I. DOCUMENTATION REVIEW
REVIEW OF RELEVANT MANAGEMENT SYSTEM
STAGE DOCUMENTS AND RECORDS, IF REQUIRED, AND
1 DETERMINATION OF THEIR ADEQUACY
II. VERIFICATION OF PREPAREDENESS OF AUDITEE (OFF SITE +
ON SITE)
III. ON-SITE AUDIT

CONDUCTING OPENING MEETING
COLLECTING AND VERIFYING INFORMATION
(COLLECTING AUDIT EVIDENCE)
IDENTIFYING AUDIT FINDINGS STAGE
2
COMMUNICATION DURING THE AUDIT
AUDIT CONCLUSIONS
PREPARATION FOR CLOSING MEETING
CONDUCTING CLOSING MEETING
Apr 2010 132
66
AUDITING QMS DOCUMENTATION
¾ USE CHECK LIST / MATRIX.
¾ CAN BE DONE OFF-SITE BUT ON-SITE REVIEW PREFERRED.
¾ SHOULD COVER ALL THE LEVELS OF QUALITY SYSTEM

DOCUMENTS; MAY BE RESTRICTED TO QUALITY MANUAL,
INITIALLY, IN THIRD PARTY AUDITS FOR CONFIDENTIALITY
REASONS.
¾ LOOK FOR CLARITY IN UNDERSTANDING AND

INTERACTION OF THE PROCESSES ALSO.
¾ RAISE NON-CONFORMANCE REPORTS, WHERE REQUIRED
Apr 2010 133
PURPOSE OF DOCUMENT AUDIT
• TO ENSURE THAT THE QMS DOCUMENTATION PROVIDES

ADEQUATE CONFIDENCE AND PROVIDES SCOPE FOR
CONTINUAL IMPROVEMENT
• TO HELP IN PLANNING FOR ON-SITE AUDIT
• TO IDENTIFY SHORT-COMINGS AND INADEQUACIES IN THE

QMS AND THE QMS DOCUMENTATION
• TO IDENTIFY THE LOGISTICS DURING THE ON-SITE AUDIT
• TO TAKE INTO CONSIDERATION THE SIZE, NATURE AND

COMPLEXITY OF ORGANIZATION
• BASED ON THE SCOPE OF THE AUDIT
Apr 2010 134
67
D OCUM EN TATI ON REV I EW M ATRI X
I SO 9001 REQUI REM EN TS D OCUM EN TATI ON TH AT AD D RESSES TH I S

RQUI REM EN T
QUAI TY M AN UAL PROCED URE OTH ERS

5.1 M AN AGEM EN T
COM M I TM EN T
5.2 CUSTOM ER FOCUS
5.3 QUALI TY POLI CY
5.4 PLAN N I N G
5.5 RESPON SI BI LI TY,
AUTH ORI TY AN D
COM M UN I CATI ON
Apr 2010 135

O
PROCESS APPROACH TO AUDITING

AUDIT PLAN
• includes all activities applicable to the scope of
audit and ISO 9001
• enables audit trails to be established from top
level policy to all relevant functions and levels
• enables links to be established between policy,
objectives, targets, monitoring and
• continual improvement.
• reflects the structure, sequence and
interrelationship of processes
• is sufficiently flexible
• enables objective evidence to be gathered to
verify activities and results.
• reflects the organization's goals and priorities.
Apr 2010 O 136
68
PROCESS APPROACH TO AUDITING
Conducting the audit
Verify that
• the purpose, inputs, outputs, controls and resources for each
process are clear.
• links are established between processes and high level and local
quality objectives.
• outputs are compared with purpose, desired outcomes and
specific quality objectives of the process.
• steps in the process and associated responsibilities are
determined, where necessary.
• inter relating processes are identified and process measures are
identified.
• evidence of continual improvement is available
• needs of internal and external customers are clear.
Apr 2010 O 137
SESSION 3d
AUDIT RESPONSIBILITIES
• Roles and responsibilities of the auditor, auditee, client, lead
auditor, guides and observers, in accordance with ISO
19011.
• Management responsibilities of the Lead Auditor
• Effective communication with the auditee
• Auditor confidentiality.
• The IRCA code of conduct

Apr 2010 138
69
WHO ARE INVOLVED IN AN AUDIT
• AUDITOR : A PERSON WITH THE

COMPETENCE TO CONDUCT
AN AUDIT
• AUDITEE : ORGANIZATION BEING

AUDITED
• AUDIT CLIENT : ORGANIZATION OR PERSON

REQUESTING AN AUDIT
Apr 2010 139
WHO ARE INVOLVED IN AN AUDIT (Continued)
• AUDITOR :
A PERSON WHO IS COMPETENT AND IS AUTHORISED TO
PERFORM ALL OR ANY PORTION OF QUALITY SYSTEM AUDIT
• LEAD AUDITOR :
AN AUDITOR WHO IS COMPETENT AND IS AUTHORIZED TO
MANAGE A QUALITY SYSTEM AUDIT
Apr 2010 140
70
WHO ARE INVOLVED IN AN AUDIT (Continued)
¾ AUDIT TEAM : ONE OR MORE AUDITORS

CONDUCTING AN AUDIT
SUPPORTED IF NEEDED BY
TECHNICAL EXPERTS
¾ TECHNICAL EXPERT : A PERSON WHO PROVIDES

SPECIFIC KNOWLEDGE OR
EXPERTISE TO THE AUDIT
TEAM: Does not act as auditor
Apr 2010 141
ROLE OF LEAD AUDITOR
• LEAD THE THE TEAM OF AUDITORS

• REPRESENT THE AUDIT CLIENT (CERTIFICATION
BODY)
• MANAGE THE AUDIT ACTIVITIES
• REPORT AUDIT FINDINGS TO AUDIT CLIENT
Apr 2010 142
71
MANAGEMENT RESPONSIBILITIES OF
LEAD AUDITOR
¾ NEGOTIATE THE AUDIT SCOPE
¾ SELECTION OF AUDIT TEAM
¾ DIRECT THE AUDIT TEAM MEMBERS
¾ PLANNING THE AUDIT & MAKE EFFECTIVE USE OF
RESOURCES
¾ REPRESENTING THE AUDIT TEAM
¾ MANAGING THE AUDIT
¾ REVIEW OF AUDIT TEAM’S WORK
¾ PREVENT & RESOLVE CONFLICTS
¾ TO LEAD THE AUDIT TEAM TO REACH AUDIT
CONCLUSIONS
¾ PREPARATION OF THE REPORT
¾ CONTROL OF THE OPENING AND CLOSING
MEETINGS
¾ SUBMISSION OF THE REPORT
Apr 2010 143
ROLE OF AUDITOR
¾ COMMUNICATING AUDIT REQUIREMENTS TO THE AUDITEE

¾ CONDUCTING AUDIT
¾ DOCUMENTING OBSERVATIONS WITH EVIDENCE
¾ VERIFYING THE EFFECTIVENESS OF THE QUALITY SYSTEM
¾ REPORTING RESULTS TO THE LEAD AUDITOR
¾ CO-OPERATING WITH AND ASSISTING LEAD AUDITOR
Apr 2010 144
72
ROLE OF AUDITEE
• PRE - AUDIT
• DURING THE AUDIT
• POST AUDIT
Apr 2010 145
ROLE OF AUDITEE
• PRE - AUDIT
1. SELECT AUDITING AGENCY, BASED ON EXPERIENCE,
ACCREDITATION IN COUNTRIES OF INTEREST AND
REPUTATION.
2. LIASE WITH AUDITING / CERTIFYING AGENCY TO PROVIDE
REQUIRED INFORMATION (VERBAL AND WRITTEN)
3. AGREE ON SCOPE FOR AUDIT AND THE NOMINATED TEAM.
4. AGREE ON SUITABLE DATES FOR THE AUDIT ACTIVITY AND
SITES TO BE VISITED.
5. AGREE TO PROVIDE LOGISTIC ASSISTANCE DURING AUDIT
6. DECIDE ON THOSE WHO WILL ATTEND THE OPENING AND
CLOSING MEETINGS
7. INFORM ALL STAFF REGARDING THE AUDIT
Apr 2010 146
O
73
ROLE OF AUDITEE
• DURING THE AUDIT
1. PROVIDE OFFICE FACILITIES FOR OPENING AND CLOSING MEETINGS,
AND ALSO FOR LIASION MEETINGS OF AUDITORS
2. PROVIDE GUIDES
3. SEEK CLARIFICATIONS, IN CASE OBSERVATIONS, ATTRIBUTIONS OR
EXPLANATIONS OF THE AUDITORS ARE NOT CLEARLY UNDERSTOOD
4. ENSURE RELEVANT PEOPLE FROM MANAGEMENT ARE PUNCTUAL FOR
ALL MEETINGS
5. INFORM MANAGEMENT OF ANY MAJOR NON-CONFORMITY OBSERVED
BY THE AUDITORS
6. COOPERATE WITH THE AUDITORS, AGREE TO NON-CONFORMITIES AND
COMMIT TO TIMELY CORRECTIVE ACTIONS
Apr 2010 147
ROLE OF AUDITEE
• POST – AUDIT
1. IDENTIFY CAUSES FOR THE NON-CONFORMITY.
2. IDENTIFY THE CORRECTIVE ACTION ON THE CAUSES OF THE

NON-CONFORMITY.
3. PROPOSE TIME-BOUND CORRECTIVE ACTIONS, AND SEEK

AGREEMENT WITH AUDITORS (IN CASE REQUIRED).
4. IMPLEMENT THE CORRECTIVE ACTION
5. VERIFY THE EFFECTIVENESS OF THE ACTIONS, THROUGH

INTERNAL AUDITS, INFORM AUDITORS ABOUT SATISFACTORY
COMPLETION OF CORRECTIVE ACTIONS
Apr 2010 O 148
74
ROLES & RESPONSIBILITIES OF GUIDES
¾ SHOULD ASSIST THE AUDIT TEAM
¾ SHOULD ACT ON REQUEST OF THE LEAD AUDITOR
OTHER RESPONSIBILITIES :
¾ ESTABLISH CONTACTS &TIMINGS FOR INTERVIEWS
¾ ARRANGE VISITS TO SPECIFIC SITES
¾ ENSURE RULES CONCERNING SAFETY ARE FOLLOWED BY
AUDITORS
¾ WITNESS THE AUDIT ON BEHALF OF AUDITEE IF REQUIRED
¾ PROVIDE CLARIFICATION OR ASSIST IN COLLECTING
INFORMATION
GUIDES & OBSERVERS MAY ACCOMPANY THE

AUDIT TEAM BUT ARE NOT PART OF IT
Apr 2010 149
GUIDE TO THE GUIDE

¾ MUST HAVE GOOD KNOWLEDGE ON THE STANDARD
¾ MUST HAVE GOOD KNOWLEDGE OF QMS, IN THE AREA OF AUDIT
¾ MUST HAVE OVERALL UNDERSTANDING OF QMS OF THE COMPANY
¾ MUST BE TACTFUL AND COURTEOUS
¾ ACKNOWLEDGE NOT KNOWING AN ANSWER
¾ MUST BUILD RAPPORT WITH AUDITOR
¾ WITNESS TO THE OBSERVATION
¾ MUST BE BRIEF AND PRECISE
¾ SHOULD HELP THE AUDITOR IN FACILITIES
¾ NOT TO ARGUE WITH THE AUDITOR
¾ NOT TO VOLUNTEER OPINIONS
• AUDITORS SHOULD FIND THE NON-CONFORMANCES; IT IS NOT FOR
THE GUIDES TO PROVIDE THEM
Apr 2010 150
75
COMMUNICATION WITH AUDITEE
DURING AUDITS, TEAM LEADER SHOULD COMMUNICATE

TO THE AUDITEE
• PROGRESS & CONCERNS
• EVIDENCE SUGGESTING SIGNIFICANT RISKS
• ISSUES OUTSIDE AUDIT SCOPE
WHERE AUDIT OBJECTIVES ARE UNATTAINABLE

• REPORT REASONS TO AUDITEE & CLIENT
• RECONFIRM / MODIFY AUDIT PLAN
• CHANGE AUDIT OBJECTIVES, SCOPE OR TERMINATE AUDIT
Apr 2010 151
CONFIDENTIALITY
¾ AUDITORS HAVE TO ENSURE THAT THE
INFORMATION RECEIVED OR REVIEWED BY ANY
MEANS DURING THE AUDIT SHALL NOT BE
DISCLOSED TO ANY PARTY OR PERSON NOT
RELATED TO THE AUDIT UNLESS AGREED TO BY
THE PARTIES CONCERNED.
¾ THIS IS ESSENTIAL SINCE CONFIDENTIAL AND

SENSITIVE INFORMATION MAY BECOME
ACCESSIBLE TO THE AUDITORS DURING THE
AUDIT
Apr 2010 152
76
IRCA CODE OF CONDUCT
All certificated auditors are required to comply with the following code
of conduct:
• Act in a strictly trustworthy and un-biased manner
• To disclose to their employer any prior relatinship with the auditee
organization
• No to accept gifts, commissions, discounts or any other profits from
the organization audited or its representatives
• Not to disclose audit findings / other information gained during audit
to any external person
• Not to act in any way prejudicial to the interest & reputation of audit
organization and IRCA
• Cooperate fully in any formal enquiry procedure
Apr 2010 153
SESSION 3e
AUDIT PROGRAMME
SET OF ONE OR MORE AUDITS
PLANNED FOR A SPECIFIC TIME FRAME &
DIRECTED TOWARDS A SPECIFIC PURPOSE
Apr 2010 154
77
PROCESS FLOW FOR MANAGEMENT OF AN AUDIT
PROGRAMME
Authority for the audit
programme
Establishing the Audit Programme Plan

• Objectives
• Responsibilities
• Resources
• Procedures
Improving the Competence
Act Audit Implementing the Audit Programme
• Scheduling audits & Evaluation Do
Programme of auditors
• Evaluating Auditors
• Selecting audit team
• Directing audit activities Audit
Audit Activities
Activities
• Maintaining records
Monitoring & Reviewing Audit Programme

• Monitoring & reviewing Check
• Identifying needs for Corrective & Preventive action
• Identifying opportunities for implement
Apr 2010 155
AUDIT PROGRAMME : OBJECTIVES & EXTENT
BASED ON CONSIDERATION OF :
• MANAGEMENT PRIORITIES
• COMMERCIAL INTENTIONS
• MANAGEMENT SYSTEM REQUIREMENTS
• STATUTORY, REGULATORY & CONTRACTUAL REQUIREMENTS
• SUPPLIER EVALUATIONS
• CUSTOMER REQUIREMENTS
• NEEDS OF OTHER STAKEHOLDERS
• RISKS TO THE ORGANIZATION
Apr 2010 156

O
78
EXTENT OF AN AUDIT PROGRAMME
GOVERNED BY :
• SIZE, NATURE, COMPLEXITY OF THE ORGANIZATION
• SCOPE, OBJECTIVE & DURATION OF EACH AUDIT
• FREQUENCY OF AUDITS
• NUMBER, IMPORTANCE, LOCATIONS
• AUDIT CRITERIA
• PREVIOUS AUDIT CONCLUSIONS & REVIEW
• LANGUAGE, CULTURE & SOCIAL ISSUE
• SIGNIFICANT CHANGES IN THE ORGANIZATION
• CONCERNS OF INTERESTED PARTIES
Apr 2010 157

O
DEFINING THE AUDIT OBJECTIVES,

SCOPE AND CRITERIA
• AN INDIVIDUAL AUDIT IS BASED ON DOCUMENTED
OBJECTIVES, SCOPE & CRITERIA
• THE AUDIT OBJECTIVES DEFINE WHAT IS ACCOMPLISHED BY
THE AUDIT AND MAY INCLUDE
¾ DETERMINING EXTENT OF CONFORMITY OF THE AUDITEES
MANAGEMENT SYSTEM
¾ EVALUATING THE CAPABILITY OF MANAGEMENT SYSTEM TO
ENSURE COMPLIANCE TO STATUTORY, REGULATORY &
CONTRACTUAL REQUIREMENTS
¾ EVALUATING EFFECTIVENESS OF MANAGEMENT SYSTEM IN
MEETING ITS SPECIFIED OBJECTIVES
¾ IDENTIFICATION OF AIMS FOR POTENTIAL IMPROVEMENT OF THE
MANAGEMENT SYSTEM, BY AUDIT CLIENT
Apr 2010 158
O
79
FEASIBILITY OF THE AUDIT
• ADEQUATE INFORMATION FOR PLANNING THE AUDIT
• ADEQUATE CO-OPERATION FROM THE AUDITEE
• AVAILABILITY OF TIME AND ADEQUATE RESOURCES
Apr 2010 159

O
RESPONSIBILITIES FOR MANAGING

THE AUDIT PROGRAMME
• ESTABLISH THE OBJECTIVES & EXTENT OF THE AUDIT PROGRAMME
• ESTABLISH RESPONSIBILITIES, PROCEDURES
• ENSURE RESOURCES ARE PROVIDED
• ENSURE IMPLEMENTATION
• MAINTENANCE OF AUDIT PROGRAMME RECORDS
• MONITOR, REVIEW & IMPROVE THE AUDIT PROGRAMME
Apr 2010 160

O
80
AUDIT PROGRAMME RESOURCES
BASED ON :
• FINANCIAL RESOURCES NECESSARY TO
DEVELOP, IMPLEMENT, MANAGE & IMPROVE
AUDIT ACTIVITIES
• AUDIT TECHNIQUES
• AUDITOR COMPETENCE
• IMPROVEMENT OF AUDITOR PERFORMANCE
• EXTENT OF AUDIT PROGRAMME
• LOGISTICS
Apr 2010 161
O
AUDIT PROGRAMME PROCEDURES
• PLANNING & SCHEDULING AUDITS
• ASSURING COMPETENCE OF AUDITORS & LEAD AUDITORS

• SELECTING APPROPRIATE TEAM & ASSIGN RESPONSIBILITY
• CONDUCT AUDITS
• CONDUCT AUDIT FOLLOW UPS, IF APPLICABLE
• MAINTAIN RECORDS (AUDIT PLANS, REPORTS, NCRS)
• MONITOR PERFORMANCE & EFFECTIVENESS OF THE AUDIT
PROGRAM
• REPORTING
Apr 2010 162

O
81
AUDIT PROGRAMME MONITORING & REVIEW
THE ACTIVITIES INCLUDE :

• MONITOR AT APPROPRIATE
INTERVALS
¾ REVIEW TO ASSESS WHETHER

AUDIT OBJECTIVES ARE MET
¾ IDENTIFY OPPORTUNITIES OF
IMPROVEMENT
¾ REPORT TO TOP MANAGEMENT
Contd..
Apr 2010 163
O
AUDIT PROGRAMME MONITORING & REVIEW
PERFORMANCE INDICATORS TO MONITOR

CHARACTERISTICS :
• ABILITY OF TEAMS TO IMPLEMENT AUDIT

PLAN
• CONFORMITY WITH AUDIT PROGRAMME &

SCHEDULE
• FEEDBACK FROM AUDIT CLIENTS, AUDITEES

& AUDITORS.
Apr 2010 164

O
82
DEFINING THE AUDIT OBJECTIVES,
SCOPE AND CRITERIA (Continued)
AUDIT SCOPE
EXTENT AND BOUNDARIES
* BY AUDIT CLIENT & LEAD AUDITOR
AUDIT CRITERIA
REFERENCE AGAINST WHICH CONFORMITY IS
DETERMINED
* BY AUDIT CLIENT & LEAD AUDITOR
Apr 2010 165
OBJECTIVE / SCOPE OF AUDIT

¾ THIRD PARTY
AGREEMENT BETWEEN CERTIFICATION BODY AND AUDITEE
AUDITORS CONFIRM SCOPE WITH BUSINESS BROCHURES /
TENDERS
¾ SECOND PARTY
MAY BE COMPANY-WIDE OR CONTRACT-SPECIFIC
MAY BE SCHEDULED OR CIRCUMSTANCE-DRIVEN
¾ FIRST PARTY
COVERAGE OF ALL FUNCTIONS AND PROCESS
TO MEET QMS STANDARD AND DEMONSTRATE COMPLIANCE
Apr 2010 166
83
SCHEDULING OF AUDITS
¾THIRD PARTY AUDITS
PLANNED WELL IN ADVANCE
MUST COVER ALL ASPECTS OF THE QUALITY SYSTEM STANDARD
SHALL INCLUDE A 2 STAGE INITIAL AUDIT
SURVEILLANCE AUDIT IN THE 1ST AND 2ND YEARS
RE-CERTIFICATION AUDIT IN THE 3RD YEAR PRIOR TO
EXPIRATION OF CERTIFICATION
¾SECOND PARTY AUDITS

REQUIREMENTS OF CURRENT & PENDING CONTRACTS
VALUE OF CURRENT & PENDING CONTRACTS
DATE OF LAST AUDIT & FINDINGS OF PREVIOUS AUDIT
AVAILABLE RESOURCES
Apr 2010 167
O
SCHEDULING OF AUDITS (contd.)
¾ FIRST PARTY AUDITS
PLAN MUST BE AUTHORIZED.
SHOULD COVER ALL THE ACTIVITIES OF QUALITY

SYSTEM.
BASED ON THE NEEDS OF THE QUALITY SYSTEM

AND OF THE BUSINESS.
Apr 2010 168

O
84
SCHEDULING OF AUDITS (contd.)
¾ FIRST PARTY AUDIT

‘CALENDAR SCHEDULED’ AUDITS
RESULT OF PREVIOUS AUDITS
FOLLOWING LIKELY CHANGES IN
– MANAGEMENT
– ORGANIZATION
– POLICY
– TECHNIQUES / TECHNOLOGY
– QUALITY SYSTEM
‘EVENT LED’ AUDITS
Apr 2010 169

O
INTERNAL AUDIT SCHEDULE – YEAR 20XX
Audit Scheduled Corrective Action Response Accepted
Audit Performed & Reported Follow-up Action Required Audit Completed
Apr 2010 170

O
85
SESSION 3f
PLANNING OF AUDIT
• Pre-audit contacts
• Documentation Review
• Audit Scope, team competence and
selection of team
• On-site Audit Plan
Apr 2010 171
PLANNING & PREPARATION

• APPOINT THE AUDIT TEAM LEADER
• DEFINE AUDIT OBJECTIVES, SCOPE & CRITERIA
• DETERMINE FEASIBILITY OF THE AUDIT
• SELECT AUDIT TEAM
• ESTABLISH INITIAL CONTACT WITH THE AUDITEE
• CONDUCT DOCUMENT REVIEW
• PREPARE AUDIT PLAN (Strategy, sample, timings)
• ASSIGN WORK TO THE AUDIT TEAM
• PREPARE CHECKLIST, SAMPLING PLANS & OTHERS
• AUDIT TEAM BRIEFING
Apr 2010 172
86
GATHERING INFORMATION
¾ COMPANY’S PROFILE / MAN POWER

LOCATION / GEOGRAPHICAL SPREAD
¾ USE OF TELEPHONE / QUESTIONNAIRE /

QUALITY MANUAL
¾ ESTABLISH INITIAL CONTACT WITH THE

AUDITEE
¾ PRE-AUDIT VISIT / MEETING (as required)
Apr 2010 173
PURPOSE OF ESTABLISHING INITIAL

CONTACT WITH THE AUDITEE
¾ TO ESTABLISH COMMUNICATION CHANNELS WITH THE
AUDITEE REPRESENTATIVE
¾ TO CONFIRM AUTHORITY TO CONDUCT THE AUDIT
¾ TO PROVIDE INFORMATION ON TIMING & TEAM
COMPOSITION
¾ TO REQUEST ACCESS TO RELEVANT DOCUMENTS &
RECORDS
¾ TO DETERMINE THE SITE SAFETY RULES
¾ TO MAKE ARRANGEMENTS FOR THE AUDIT
¾ TO AGREE ON THE OBSERVERS & GUIDES
Apr 2010 174
87
PRE-AUDIT VISIT
¾ WHEN REQUIRED?
SIZE OR COMPLEXITY
GEOGRAPHICAL SPREAD
CONFIRM ‘SCOPE PROPOSED’ IS IN LINE WITH BUSINESS
¾ BENEFITS
TO CLARIFY THE AUDIT PROCESS TO THE AUDITEE
CHECK MATURITY OF QUALITY SYSTEM
ON-SITE DOCUMENTATION REVIEW POSSIBLE
Apr 2010 175
PRE-AUDIT VISIT (contd.)
¾ TYPICAL AGENDA
UNDERSTANDING THE PROCESSES NEEDED FOR QMS
(MAY OR MAY NOT BE DOCUMENTED).
EXPLAIN THE AUDIT PROCESS
INTRODUCTION WITH KEY PERSONNEL
CONFIRM SCOPE OF AUDIT
CONFIRM DATE/DETAILS OF AUDIT
IDENTIFY NEED FOR SPECIAL KNOWLEDGE
SHORT VISIT OF SITE TO HAVE A ‘FEEL’ OF THE COMPANY
ON-SITE DOCUMENTATION REVIEW
CLARIFY DOUBTS OF AUDITEE
Apr 2010 176
88
NOMINATE THE AUDIT TEAM
¾ INDEPENDENCE OF THE FUNCTION & TO AVOID

CONFLICT OF INTEREST
¾ ACCEPTABILITY TO THE AUDITEE
¾ LANGUAGE OF AUDIT & UNDERSTANDING OF AUDITEES

SOCIAL AND CULTURAL CHARACTERISTICS
¾ KNOWLEDGE OF BUSINESS
¾ STATUTORY, REGULATORY, CONTRACTUAL &

ACCREDITATION / CERTIFICATION REQUIREMENTS, AS
APPLICABLE
Apr 2010 177
NOMINATE THE AUDIT TEAM (Contd..)
CONSIDERATION TO BE GIVEN TO THE FOLLOWING :
¾ AUDIT OBJECTIVES, SCOPE, CRITERIA & ESTIMATED

DURATION OF THE AUDIT
¾ COMPETENCE NEEDED TO ACHIEVE AUDIT

OBJECTIVES
¾ WHETHER AUDIT IS JOINT OR COMBINED
¾ TECHNICAL EXPERTISE
(FAMILIARITY WITH INDUSTRY SECTOR)
¾ INTERPERSONAL SKILLS
Apr 2010 178
89
PREPARE WORK DOCUMENTS
¾ CHECKLISTS
¾ AUDIT SAMPLING PLANS
¾ FORMS FOR RECORDING
SUPPORTING EVIDENCE
AUDIT FINDINGS
RECORD OF MEETINGS
[ SAFEGUARD CONFIDENTIAL OR
PROPRIETORY INFORMATION AT ALL TIMES]
Apr 2010 179
PREPARING THE AUDIT PLAN
• AUDIT OBJECTIVES
• AUDIT CRITERIA
• AUDIT SCOPE
• DATES & PLACES OF ONSITE AUDIT
• EXPECTED TIME, DURATION INCLUDING
MEETINGS WITH AUDITEES MANAGEMENT &
AUDIT TEAM MEETINGS
• ROLES & RESPONSIBILITIES OF AUDIT TEAM
MEMBERS & TECHNICAL EXPERTS, IF ANY
Apr 2010 180
90
PREPARING THE AUDIT PLAN (continued)
¾ ALLOCATION OF APPROPRIATE RESOURCES
TO CRITICAL AREAS OF AUDIT
¾ OTHER POINTS COULD COVER, AS
APPROPRIATE
IDENTIFICATION OF AUDITEES
REPRESENTATIVE FOR THE AUDIT
LOGISTICS
MATTERS RELATED TO CONFIDENTIALITY
ANY AUDIT FOLLOW UP ACTIONS
Apr 2010 181
IAF Guidance on the Application of ISO 17021:2006

Guide for Process to Determine Auditor Time for Initial Audit
(Auditor Time Chart)
Number of Employees Auditor Time for Initial Number of Employees Auditor Time for Initial
Audit (auditor days) Audit (auditor days)
1 – 10 2 876 – 1175 13
11 – 25 3 1176 – 1550 14
26 – 45 4 1551 – 2025 15
46 – 65 5 2026 – 2675 16
66 – 85 6 2676 – 3450 17
86 – 125 7 3451 – 4350 18
126 – 175 8 4351 – 5450 19
176 – 275 9 5451 – 6800 20
276 – 425 10 6801 – 8500 21
426 – 625 11 8501 – 10700 22
626 - 875 12 > 10700 Follow Progression
above
1. “Employees” as referenced in the table refers to all individuals whose work activities support
the scope of the certification / registration as described by the quality management system
2. Minimum 90% of time shown in Auditor’s time chart should be spent on onsite audit
3. Surveillance time annually should be 1/3rd of the time spent on initial assessment.
4. Re-assessment time should be about 2/3rd of the time spent on initial assessment.
Apr 2010 182
O
91
AUDIT PLAN OF UCP Ltd. AT GURGAON PLANT
Lead Auditor - Mohan P
Auditor - Amardeep
Scope : The Audit is to the cover the processes of UCP Ltd against ISO 9001 : 2008
Purpose : The purpose of the audit is to assess the Quality Management System against ISO 9001
with eventual registration of the company to the above scope.
Day I
Time Auditors Area / Coverage Time Auditors Areas / Coverage
Activities Activities
0900 - Lead Opening
0930 Auditor + Meeting
hrs. Auditor
0930 - Lead CEO's Management Responsibility
1015 Auditor + office including Management
hrs Auditor Commitment, Resources,
Infrastructure, Customer
Focus, Quality Policy,
objectives and Deployment ,
QMS Planning, Management
Review, Responsibility &
Authority, continuous
improvement …
1015 - - Do- Interaction Internal Communication,
1115 with Internal Quality Audit,
hrs. Manage- Management Review,
ment Corrective & Preventive
Represen- Action……
tative
Apr 2010 183

O
Continued…..
Time Auditors Area / Coverage Time Auditor Areas / Coverage
Activities s Activities
1115 - Lead Marketing Customer Related processes, 1115 - Auditor Purchasing Selection, approval of suppliers,
1300 Auditor Related process of order procurement, 1300 Processes verification process at suppliers
hrs. Process (interactions with mfg.) hrs. premises, Inspection plans,
customer communication Requisition/ Indent making,
processes & customer Interaction Process with
satisfaction Measurement Inspection, Mfg. & other related
Processes corrective and processes….
preventive action (data, trend &
analysis, Root Cause analysis
etc.)….
1300 - 1400 Lunch / liaison meeting
1400 - Lead Productio Production related processes 1400 - Auditor Production Verification, validation,
1700 Auditor n related including Production Planning, 1700 related monitoring etc., control of NC,
hrs. processes Quality objectives & hrs. processes in work environment, resource
in the requirement of product, the Heat provision, quality objectives,
Machining provision of resources specific to treatment targets….
& the product, verification, operations
Welding validation, monitoring etc.,
operations control of nonconforming
product, corrective and
preventive action……
Apr 2010 184

O
92
Continued…..
Day II
Time Auditors Area / Activities Coverage Time Auditors Areas / Coverage
Activities
1000 - Lead Calibration Process Control of Monitoring & 1000 - Auditor Processes Infrastructure, linkage
1200 hrs. Auditor (Laboratory Measuring Devices though 1300 related to with production related
Instrument) External Calibration… hrs. maintenance processes, qualification
of personnel,
effectiveness of the
maintenance process
1200 - Lead Production processes Purchase Process on
1300 hrs Auditor related to Presentation Incoming material, process
of Products of storage, Preservation,
Packaging, Interaction
with Produc-tion, Mfg,
Quality objectives,
targets…
1300 - Lunch / Liaison
1400 hrs. Meeting
1400 - Lead Processes related to Monitoring & Measuring 1400 – Auditor Processes Human Resources,
1550 hrs Auditor Monitoring and Devices; Calibration done 1550 related to Competence,
measuring devices and inter-nally (Engg.), hrs. training and Awareness & Training,
processes related to Interaction Processes with competence Effectiveness of
Measure-ment Engg., Monitoring & building Training…
Measurement of processes
1530 - Lead Preparation for
1630 hrs. Auditor + Closing Meeting
Auditor
1630 - Closing Meeting
1730 hrs.
Apr 2010 185

O
EXERCISE E:02
Learning Objective : How to prepare On-Site
Audit Plan
Method : Refer 6.4 of ISO 19011 & the Quality
Manual to prepare Audit Plan
Time : 45 minutes for team work :
Prepare Audit Plan (team wise)
Feedback by Tutors after evaluation, followed
by common discussion
Apr 2010 186
93
Case Study CS-1
Learning Objective : How to conduct Documentation

Review
Method : Conduct Documentation Review of a Quality
Manual against ISO 9001:2008 requirements
Time : 45 minutes for individual review
30 minutes for consensus among teams
90 minutes for team presentation on flip charts
Apr 2010 187
SESSION 3g
CHECKLISTS
¾ CHECKLISTS – PREPARATION
¾ CHECKLISTS – USE, BENEFITS & LIMITATIONS
Apr 2010 188
94
CHECKLISTS - PREPARATION
ACTIVITY
¾ After this training programme, your company management
has asked you to conduct the audit of a Supplier of your
company. During the initial contact with the supplier, you
realize that there are no documented procedures for the
QMS of the supplier.
¾ WHAT CONSIDERATIONS WILL YOU GIVE WHILE

PLANNING THIS AUDIT? HOW WILL YOU PROCEED WITH
THE PLANNING OF THIS AUDIT?
¾ Each team to reflect for 15 minutes followed by open
house discussion (15 minutes)
Apr 2010 189
CHECKLISTS - PREPARATION
¾ PREPARED DURING AUDIT PLANNING AND

DOCUMENTATION REVIEW
¾ SHOULD BE IN LINE WITH OBJECTIVE / SCOPE OF THE

AUDIT
¾ SEPARATE CHECK LIST FOR PROCESSES COVERING

DIFFERENT WORK-AREA TO BE AUDITED
¾ TIME TO BE PROVIDED FOR AN AUDIT IN ACCORDANCE

WITH NUMBER OF ITEMS IN THE CHECK LIST.
¾ MAY BE LIST OF QUESTIONS OR LIST OF HEADINGS

(HEADINGS PREFERRED)
Apr 2010 190
95
CHECKLISTS - PREPARATION (Continued)
• BASIS OF PREPARATION
QUALITY POLICY AND QUALITY OBJECTIVES (FUNCTION AND
LEVELS)
ISO 9001 STANDARD
QMS DOCUMENTATION INCLUDING QMS PROCESS
DOCUMENTATION
MEASUREMENT, ANALYSIS AND IMPROVEMENT
CONTINUAL IMPROVEMENT (P - D - C - A)
STATUTORY AND REGULATORY REQUIREMENTS APPLICABLE
USE OF PERSONAL EXPERIENCE
• CHECKLIST MUST ENABLE THE AUDITOR TO PURSUE

AN EFFECTIVE AND PURPOSEFUL AUDIT TRAIL
Apr 2010 191
CHECKLISTS - BENEFITS
¾ HELPS TO ENSURE COVERAGE OF ENTIRE SCOPE IN TIME
¾ HELPS TO BALANCE AUDIT SAMPLE
¾ TOOL FOR PREPARATION OF AUDITOR
¾ CONTROLS THE ‘PACE’ OF AUDIT
¾ HELPS TO PRIORITISE CHECK POINTS
¾ RECORD OF ACTIVITIES EXAMINED
¾ BECOMES A BASE FOR IMPROVEMENT
Apr 2010 192
96
CHECKLISTS - LIMITATIONS
¾ MAY RESTRICT ENQUIRY BY AUDITOR
(Auditor should not become a slave or victim of the Checklist)
Apr 2010 193
Sample Audit Checklist Related to the Purchasing Process (The PDCA Approach to a Process Audit)
Sl. Checklist ISO Remarks Time

No. Clause
1. Ask for the overview of the Purchasing Process 7.4.1
2. Are there planned results identified in line with established objectives (from the Quality Policy) for 5.4.1 /
the Purchasing function 7.1
3. Understand the overall Process Sequence 4.1a
4. What are the processes identified in the Dept. / function to achieve planned results ( e.g. Selection 4.1a
of Suppliers, Evaluation of Performance of Suppliers, Release of Purchase Orders, Testing
Requirements by Suppliers etc. )
4a. What procedures / work instructions are available
4.1c/d
5 Check for sequencing of these processes 4.1b
5a. Check for process owners 4.1 f/d
6. Check for interaction of processes with inter or intra-functional processes ( e.s. - Check for testing 4.1b
by suppliers before dispatch
- Check approval of Transporters for RM etc.)
7. Check whether input & output & process performance measures are identified for the processes 4.1c
8. Check how processes are monitored & measured 4.1e
9. Are there targets to monitor 4.1c
9a. Analyse characteristics & trends of processes 8.4

9b. Review process performance
9c. Identify NC ( if any ) 8.2.3
10. What is the "Corrective Action" and /or preventive action mechanism 8.5
11. What records / evidence are there to show that product characteristics (if any) are in conformity 8.2.4 ,
with acceptance criteria 8.3
12. How is continual improvement of these process planned & implemented 8.5
Apr 2010 194

O 08 - 04
97
EXERCISE E:03
Learning Objective : How to prepare a Checklist

Method : Prepare Checklists for the two situations in the
Case Study / Workbook individually.
Time : 30 minutes : Individual work
15 minutes : Self Evaluation
15 minutes : Discussion
Self Evaluation by the participants in line with the
Marking Guidelines, followed by common discussion.
Apr 2010 195
SESSION 3h
OPENING MEETING
¾ OPENING MEETING
¾ PURPOSE OF OPENING MEETING
¾ OPENING MEETING – AGENDA
Apr 2010 196
98
OPENING MEETING
¾ FORMAL START OF THE ON-SITE AUDIT
¾ CHAIRED BY LEAD AUDITOR
¾ CONDUCTED AT AUDITEE ORGANIZATION’S PREMISES
¾ PROVIDES GENERAL RULES FOR CONDUCT OF AUDIT
¾ ENSURE AUDITEE MANAGEMENT TEAM PRESENT
¾ LANGUAGE AND CULTURE AND TIMING TO SUIT (ISO 19011)
¾ SHOULD BE SHORT
Apr 2010 197
PURPOSE OF OPENING MEETING
¾ TO CONFIRM THE AUDIT PLAN
¾ TO CLARIFY HOW THE AUDIT ACTIVITIES

WILL BE UNDERTAKEN
¾ TO ESTABLISH COMMUNICATIONS WITH

THE AUDITEE MANAGEMENT.
¾ TO PROVIDE OPPORTUNITY TO THE

AUDITEE TO SEEK CLARIFICATION
Apr 2010 198
99
OPENING MEETING - AGENDA
¾ INTRODUCTION OF PARTICIPANTS
¾ AUDIT OBJECTIVES, SCOPE & CRITERIA
¾ TIMETABLE
¾ CLOSING MEETING - TIME, INTERIM MEETING & OTHER
LATE CHANGES
¾ AUDIT BY SAMPLING
¾ EXPLAIN AUDIT PROCEDURE & DISCLAIMER
¾ AUDIT RESPONSIBILITIES
¾ FORMAL COMMUNICATION CHANNELS BETWEEN
AUDITOR & AUDITEE
Apr 2010 199
OPENING MEETING - AGENDA (contd.)

¾ LANGUAGE
¾ CONFIRMATION TO KEEP AUDITEE INFORMED OF AUDIT
PROGRESS
¾ RESOURCES & FACILITIES REQUIREMENT
¾ CONFIDENTIALITY
¾ RELEVANT WORK SAFETY, SECURITY PROCEDURES
¾ INTRODUCTION TO GUIDES
¾ REPORTING METHODS (NCRS, GRADINGS)
¾ TERMINATION OF AUDIT
¾ APPEAL SYSTEM ON THE CONDUCT OR CONCLUSIONS OF
THE AUDIT
¾ CLARIFY AUDITEES DOUBTS
Apr 2010 200
100
EXERCISE E:04
Learning Objective : How to conduct Opening Meeting
Method :
Refer 6.5.1 of ISO 19011
Role Play across two teams each playing role of Audit
team and management team and two teams play the role
of observer
Time : 30 minutes for team work : Preparation by all teams
for respective roles
15 minutes for role play
15 minutes for Feedback
Apr 2010 201
SESSION 3i
ON-SITE AUDITING & AUDIT SKILLS
¾ AUDITING
¾ COLLECTING INFORMATION FOR REACHING AUDIT
CONCLUSION
¾ COMMUNICATIONS DURING AUDIT
¾ PROCESS APPROACH TO AUDIT
¾ AUDIT OF MANAGEMENT COMMITMENT
¾ AUDITING SKILLS
Apr 2010 202
101
TASKS FOR 3RD PARTY
CERTIFICATION AUDIT
¾ EXAMINE AND VERIFY THE STRUCTURE, POLICIES,
PROCESSES, PROCEDURES, RECORDS AND RELATED
DOCUMENTS OF THE CLIENT RELEVANT TO THE
MANAGEMENT SYSTEM
¾ MEET REQUIREMENTS RELEVANT TO THE SCOPE OF
CERTIFICATION
¾ DETERMINE PROCESSES ARE ESTABLISHED,
IMPLEMENTED AND MAINTAINED EFFECTIVELY TO
PROVIDE A BASIS FOR CONFIDENCE IN THE CLIENT’S
MANAGEMENT SYSTEM
¾ COMMUNICATE TO THE CLIENT ANY INCONSISTENCIES
BETWEEN CLIENT’S POLICIES, OBJECTIVES AND
TARGETS AND THE RESULTS
Apr 2010 O 203
AUDITING
¾ EXISTENCE OF QUALITY MANAGEMENT SYSTEM
• CLEARLY DEFINED RESPONSIBILITIES AND AUTHORITIES
• ADEQUACY OF SYSTEM COMPONENTS/ELEMENTS
¾ OPERATION OF QUALITY SYSTEM

• UNDERSTANDING OF PROCESSES AND THEIR INTERACTIONS
• PROVISION OF ADEQUATE RESOURCES
¾ EFFECTIVENESS OF QUALITY SYSTEM

• ACHIEVEMENT OF DECLARED OBJECTIVES
• CORRECTIVE ACTION / CONTINUAL IMPROVEMENT
Apr 2010 204
102
AUDITING
¾ COVERAGE OF ENTIRE SCOPE

¾ NON-CONFORMANCE REPORTS (NCR)
¾ OBJECTIVITY OF NCRs AND WITNESSING BY AUDITEE
¾ IMMEDIATE INFORMATION TO COMPANY FOR MAJOR NCRs
¾ HOLDING OF REGULAR REVIEW MEETING WITH
TEAM MEMBERS
¾ HOLDING OF REGULAR LIAISON MEETING WITH AUDITEE
REPRESENTATIVE
¾ TO INFORM ALL AUDIT OBSERVATIONS TO THE AUDITEE
Apr 2010 205
PROCESS OF COLLECTING INFORMATION

FOR REACHING AUDIT CONCLUSIONS
- Interviews
Source of information - Observation of activities
- Review of Documents/Records
Collect by appropriate
sampling & verifying
Audit Evidence
Evaluate audit evidence
against audit criteria
Audit findings
Review audit findings
Audit conclusions
Apr 2010 206
103
SOURCE OF INFORMATION
• INTERVIEWS WITH EMPLOYEES & OTHERS

• OBSERVATION OF ACTIVITIES
• DOCUMENTS (POLICY, OBJECTIVES, PLANS,
PROCEDURES, STANDARDS, INSTRUCTIONS ETC.)
• RECORDS
• ANALYSIS OF DATA
• CUSTOMER FEEDBACK
• SUPPLIER RATINGS
Apr 2010 207
COMMUNICATION DURING AUDIT

1. WITHIN AN AUDIT TEAM
¾ EXCHANGE INFORMATION
¾ ASSESS AUDIT PROGRESS
¾ IF NEEDED REASSIGN WORK BETWEEN AUDIT TEAM
MEMBERS
2. WITH THE AUDITEE

¾ ANY CONCERNS TO THE AUDITEE (& CLIENT)
¾ PROGRESS OF THE AUDIT
¾ ANY SIGNIFICANT RISKS (SAFETY, ENVIRONMENT,
QUALITY) TO BE REPORTED IMMEDIATELY TO AUDITEE
(& CLIENT)
Apr 2010 208
104
¾ ANY CONCERN ABOUT AN ISSUE OUTSIDE THE AUDIT
SCOPE SHOULD BE NOTED AND REPORTED TO LEAD
AUDITOR (FOR POSSIBLE COMMUNICATION TO
AUDITEE / CLIENT)
¾ AUDIT EVIDENCE TO SUPPORT THAT AUDIT
OBJECTIVES ARE UNATTAINABLE
¾ ANY REASONS FOR MODIFICATION OF AUDIT PLAN,
OBJECTIVES, SCOPE OR TERMINATION OF AUDIT
[ ANY NEED FOR CHANGE IN AUDIT SCOPE DURING
AUDIT SHOULD BE REVIEWED WITH & APPROVED BY
AUDIT CLIENT & / AUDITEE
Apr 2010 209
¾ OBJECTIVE AND SCOPE OF THE AUDIT

¾ AUDIT PROGRAMME AND ASSIGNMENT OF RESPONSIBILITIES
¾ REVIEW OF CHECKLIST, WITHIN THE AUDIT TEAM
¾ REVIEW OF OBSERVATIONS
¾ CROSS FLOW OF INFORMATION TO AUDIT TEAM MEMBERS
¾ ADDITIONAL DOCUMENTS / REFERENCES IF REQUIRED
¾ ANY CORRECTIONS TO AUDIT PROGRAM
¾ STATUS OF AUDIT & ANY CONCERN AREA TO THE AUDITEE
¾ WHEN THE AUDIT OBJECTIVES ARE UNATTAINABLE, REPORT THE
REASON TO AUDITEE & DETERMINE APPROPRIATE ACTION
Apr 2010 210
105
AUDIT TRAILS
POLICY AND COMPANY LEVEL OBJECTIVES
DEPLOYED OBJECTIVES
PROCESS DOCUMENTATION
PROCESS INPUTS
RESOURCES
OPERATION OF PROCESS
CONTROL OF PROCESS
MONITORING AND MEASUREMENT
OUTPUTS
PERFORMANCE INDICATORS
DATA ANALYSIS
USE OF DATA FOR IMPROVEMENT
Apr 2010 211
PROCESS APPROACH TO AUDIT
¾ UNDERSTAND THE PROCESS TO BE AUDITED

(MAY OR MAY NOT BE DOCUMENTED)
¾ SCOPE AND RESPONSIBILITIES
¾ CHECK THAT PROCESS INPUTS & OUTPUTS ARE PROPERLY
IDENTIFIED AND SUIT THE PURPOSE
¾ INTERACTION WITH OTHER PROCESSES
¾ CHECK THE RESULT AND OUTCOMES
¾ VERIFY THE PROCESS MEASURABLES
¾ EVALUATE IF THE OBJECTIVES ARE ADDRESSED AND ACHIEVED
¾ ARE THE MEASURABLES LEADING TOWARDS CONTINUAL
IMPROVEMENT
Apr 2010 212
106
INTERVIEWS
¾ HELD WITH PERSONS FROM DIFFERENT LEVELS /FUNCTIONS
(ESPECIALLY WITHIN THE SCOPE OF AUDIT)
¾ SHOULD BE CONDUCTED DURING NORMAL WORK HOURS
AND NORMAL WORK PLACE
¾ PUT THE INTERVIEWED PERSON AT EASE PRIOR TO THE
INTERVIEW
¾ REASON FOR INTERVIEW AND NOTE TAKING EXPLAINED
¾ INITIATE BY ASKING DESCRIPTION OF THEIR WORK
¾ RESULTS SUMMARISED AND REVIEWED WITH THE PERSON
¾ QUESTIONS LEADING TO BIAS TO BE AVOIDED
¾ THANK FOR PARTICIPATION AND CO-OPERATION
Apr 2010 213
AUDIT OF MANAGEMENT COMMITMENT
• AUDITOR LOOKS FOR EVIDENCE OF TOP MANAGEMENT

COMMITMENT IN:
¾ ESTABLISHMENT OF QUALITY POLICY.
¾ ENSURING THAT THE OBJECTIVES ARE ESTABLISHED.
¾ COMMUNICATING WITHIN THE ORGANIZATION THE

IMPORTANCE OF MEETING CUSTOMER AND
STATUTORY / REGULATORY REQUIREMENTS.
¾ ENSURING AVAILABILITY OF RESOURCES.
¾ CONDUCTING MANAGEMENT REVIEW.
Apr 2010 214
107
AUDIT OF MANAGEMENT COMMITMENT (Continued)
¾ IDENTIFICATION OF TOP MANAGEMENT PERSONNEL

¾ DETAILED INTERVIEWS OF TOP MANAGEMENT PERSONNEL
¾ NOT A ONE PERSON AUDIT
¾ NOT A ONE PLACE AUDIT
¾ RECORDS MAY NOT BE SUFFICIENT EVIDENCE
¾ AUDITORS TO GIVE FEEDBACK TO LEAD AUDITOR
¾ LEAD AUDITOR TO CONCLUDE DURING CLOSING MEETING
¾ SHOULD FIND A PLACE IN THE AUDIT REPORT
TO CONCLUDE ON LACK OF TOP MANAGEMENT COMMITMENT,
COMPREHENSIVE AND HIGHER ORDER EVIDENCE IS REQUIRED.
Apr 2010 215
AUDITING SKILLS
¾TIME MANAGEMENT
¾FACT FINDING
¾REPORTING
Apr 2010 216
108
TIME MANAGEMENT
¾ PLANNING AND PREPARATION
¾ BE PUNCTUAL
¾ AVOID TIME WASTERS
INTRODUCTION / PRESENTATION
WALK ROUND THE PLANT
LUNCH / TEA / COFFEE
FALSE TRAILS
UNIMPORTANT ISSUES
FRIENDLY TALKS
TOP BRASS
Apr 2010 217
FACT FINDING
PURPOSE OF AN AUDIT IS TO FIND FACTS SUPPORTED
BY OBJECTIVE EVIDENCE, WHICH MAY BE:
¾ DOCUMENTS (Eg. POLICY, OBJECTIVES, PLANS, PROCEDURES
ETC.)
¾ RECORDS (MANY EXAMPLES POSSIBLE)
¾ DATA SUMMARIES, ANALYSIS, METRICS AND PERFORMANCE
INDICATORS
¾ REPORTS FROM OTHER SOURCES (Eg. CUSTOMER FEEDBACK,
VENDOR RATINGS ETC.)
¾ OBSERVATIONS OF ACTIVITIES
¾ OBSERVATION OF SURROUNDING WORK ENVIRONMENT AND
CONDITIONS
¾ SOMETIMES, EVEN STATEMENTS OF INFORMED PERSONS
Apr 2010 218
109
FACT FINDING METHODS
¾ READING • OBSERVATION
¾ COMMUNICATIONS • BODY LANGUAGE
¾ INTERVIEWING • QUESTIONING
¾ LISTENING • USE OF THOUGHT SPEED
¾ FIRST QUESTION • UNASKED QUESTIONS
¾ USE OF CHECK LIST • TO-AND- FRO CHECKING
¾ TAKE NOTES • SELECT SAMPLE YOURSELF
¾ SPOT CHECK DOCUMENTS
¾ RECORDS/SAMPLES
Apr 2010 219
COMMUNICATING WITH THE AUDITEE
¾ MESSAGE TO BE IN LINE WITH

− PURPOSE
− AUDIENCE
− SITUATION
¾ USE OF SIMPLE LANGUAGE
¾ STRUCTURED / ORGANIZED MESSAGE
¾ IMPACT OF A MESSAGE IS
− 7 % VERBAL
− 38% VOCAL
− 55% BODY LANGUAGE
Apr 2010 220
110
QUESTIONING
¾ LEADING QUESTIONS LIKE
DO YOU?…………DON’T YOU ?
¾ CLOSED QUESTIONS LIKE
DO YOU……….. ?
CAN YOU ……… ?
WILL YOU ………. ?
¾ OPEN QUESTIONS LIKE THOSE
WHAT, WHEN, WHERE, WHO, WHY, HOW AND “SHOW
ME”
¾ ONE QUESTION AT A TIME
¾ QUESTIONS RELEVANT TO THE ACTIVITY BEING AUDITED.
Apr 2010 221
LISTENING
• BARRIERS TO LISTENING
¾ DECIDING IN ADVANCE THAT THE SUBJECT IS NOT INTERESTING
¾ EVALUATING THE SPEAKER
¾ BECOMING EMOTIONALLY INVOLVED
¾ LISTENING FOR FACTS, NOT IDEAS
¾ TAKING COPIOUS NOTES
¾ FAKING ATTENTION
¾ GETTING DISTRACTED
¾ AVOIDS DIFFICULT LISTENING
¾ FAILING TO CAPITALIZE ON “THOUGHT SPEED”
Apr 2010 222
111
THOUGHT SPEED
•AVERAGE PERSON SPEAKS ABOUT 120 WORDS PER MINUTE
WHILE BRAIN CAN PROCESS 450-500 WORDS PER MINUTE
A GOOD LISTENER USES THIS EXCESS CAPACITY TO:
¾ ANTICIPATE WHAT THE PERSON IS GOING TO SAY
¾ ANALYZE WHAT HE IS SAYING
¾ SUMMARISE WHAT HAS BEEN SAID
¾ MENTALLY FRAME THE NEXT QUESTION
¾ UNDERSTAND ANY EMPHASIS BEING MADE
¾ UNDERSTAND BODY LANGUAGE
Apr 2010 223
BODY LANGUAGE
¾EYE CONTACT
¾CLENCHED FISTS
¾CROSSED ARMS AND LEGS
¾HAND SHAKE
¾EYE MOVEMENT
¾DIRECTION OF FEET AND LEGS
¾CARE ABOUT PERSONAL SPACE
¾SILENCE AT THE END OF A QUESTION
Apr 2010 224
112
SESSION 3j
AUDIT REPORTING
¾ NON CONFORMANCE REPORTS (NCR)
¾ NCR GRADING AND IMPLICATIONS
¾ OPPORTUNITY FOR IMPROVEMENT & AUDIT CONCLUSION
¾ REPORTING
¾ SUMMARY STATEMENT
Apr 2010 225
OBJECTIVE EVIDENCE
DATA SUPPORTING THE EXISTENCE OR
VERIFIABILITY OF AN ENTITY NOTE.
OBJECTIVE EVIDENCE MAY BE OBTAINED
THROUGH OBSERVATION, MEASUREMENT,
TEST OR OTHER MEANS.
VERIFICATION
CONFIRMATION, THROUGH THE PROVISION OF
OBJECTIVE EVIDENCE, THAT SPECIFIED
REQUIREMENTS HAVE BEEN FULFILLED.
Apr 2010 226
113
SUBJECTIVE / OBJECTIVE OBSERVATION
(EXAMPLES)
SUBJECTIVE OBSERVATION
• THE TESTING OF WELDERS IS THE RESPONSIBILITY OF
THE PRODUCTION MANAGER WHEREAS IT WOULD BE
MORE SENSIBLE IF IT WERE THE RESPONSIBILITY OF THE
WELDING ENGINEER.
OBJECTIVE OBSERVATION
• AN UNQUALIFIED WELDER MR. A IS WORKING ON A
CONTRACT FOR WORK ORDER 0201 WHICH CALLS FOR A
WELDER TO BE QUALIFIED TO BS 4871.
Apr 2010 227
NON – CONFORMANCE REPORT (NCR)

OR
CORRECTIVE ACTION REQUEST (CAR)
• OBSERVATION
• ATTRIBUTION
• EXPLANATION
• CORRECTIVE ACTION PROPOSAL
• FOLLOW UP ACTIVITIES
Apr 2010 228
114
QMS AUDIT Incident Number
NONCONFORMITY REPORT
Company under Audit : Note Number
Area under review: ISO 9001: 2008 Clause Number
Category MAJOR / MINOR (DELETE ONE)

Observation :
Attribution
Explanation
Auditor : Acknowledged by :
Date : Date :
Comments / Agreed Action Target Date :
Signature :
Date :
Actions Taken
Signature :
Date :
NCR Closed Sample Audit OK Signature :

Date
Apr 2010 229
QMS AUDIT Incident Number

NONCONFORMITY REPORT
Company under Audit : UCP Ltd Note Number 1 / 12
Area under review : Clause Number 8.2.3 of ISO 9001:2008
Materials Section
Category MAJOR / MINOR (DELETE ONE)
Observation :
Stocks of a fast moving item (Headlight Rims), Part No. 05/1234 are not monitored daily.
Attribution
NCR against Clause 8.2.3 ISO 9001 : 2000 and Company Document No. QSP/ PUR / 7.4
Explanation
• Clause 8.2.3, ISO 9001 : 2000 requires the organization to apply suitable methods
to monitor the processes for its Quality Management Systems.
• Company Document No. QSP / PUR / 7.4 requires stocks of all fast moving items
to be monitored daily
Auditor : Y K Nayar Acknowledged by : Rajkumar
Date : 10th June, 2001 Date : 10th June, 2009
Comments / Agreed Action Target Date : 30, June 2001
• A daily Run Chart indicating the stock position of Headlight Rims is introduced
• Monitoring method for all fast moving items to be reviewed
• Materials Staff to be trained on revised procedures.
Signature : Rajkumar
Date : 12th June, 2009
Actions Taken
• Materials Staff trained on the revised methods of monitoring of fast moving items
on 29 June, 2001
• Procedures now implemented. Signature : Rajkumar
Date : 30th June, 2009
NCR Closed Sample Audit O.K. Signature : Y K Nayar
Date 6th July, 2001
Apr 2010 230
115
NCR GRADING
MAJOR NC
COMPLETE ABSENCE OF A STATEMENT OR PROCEDURE
TO MEET A REQUIREMENT OF THE STANDARD.
BREAKDOWN OR NON OBSERVANCE OF A SPECIFIED
REQUIREMENT.
MINOR NC
SINGLE OBSERVED LAPSE IN THE USE OF A DEFINED
PROCEDURE OR REQUIREMENT.
A NUMBER OF MINOR (NUMBER NOT SPECIFIED) NCs
AGAINST ONE PROCEDURE OR REQUIREMENT, AROUND
THE ORGANIZATION OR IN A SINGLE DEPARTMENT,
PROVING A BREAKDOWN, CAN BECOME A MAJOR NC.
Apr 2010 231
IMPLICATIONS OF NCR GRADING

MAJOR NC
RECOMMENDATION CANNOT BE MADE
CORRECTIVE ACTION GENERALLY REVIEWED BY AUDITEE
MANAGEMENT
CLOSURE OF NCR THROUGH FOLLOW UP VISIT
MINOR NC
RECOMMENDATION CANNOT BE MADE IF NON
CONFORMITY PERTAINS TO REQUIREMENT OF STANDARD
RECOMMENDATION CAN BE MADE AFTER CORRECTION
AND VERIFICATION
CLOSURE OF NCR IS POSSIBLE THROUGH DOCUMENTARY
EVIDENCE / FOLLOW UP VISIT / SURVEILLANCE AUDIT
Apr 2010 232
116
OPPORTUNITY FOR IMPROVEMENT
THE AUDIT TEAM MAY IDENTIFY

OPPORTUNITIES FOR IMPROVEMENT BUT
SHALL NOT RECOMMEND SPECIFIC
SOLUTIONS
Apr 2010 233
AUDIT CONCLUSIONS
¾ EXTENT OF CONFORMITY OF THE
MANAGEMENT SYSTEM WITH THE AUDIT
CRITERIA
¾ EFFECTIVE IMPLEMENTATION, MAINTENANCE
& IMPROVEMENT OF THE MANAGEMENT
SYSTEM
¾ CAPABILITY OF THE MANAGEMENT REVIEW
PROCESS TO ENSURE THE CONTINUING
SUITABILITY, ADEQUACY, EFFECTIVENESS &
IMPROVEMENT OF THE MANAGEMENT
SYSTEM
Apr 2010 234
117
EXERCISE E:05
Learning Objective : How to write Non Conformance
Reports
Method : Use the three incidents in the Case Study/
Workbook to identify possible Non Conformances in
relation to ISO 9001 requirements, individually.See
instructions in Workbook.
Time : 45 minutes : Individual work
20 minutes : Self Evaluation
25 minutes : Discussion
Self Evaluation by the participants in line with the Marking
Guidelines, followed by common discussion.
Apr 2010 235
Case Study CS-2

Learning Objective : How to conduct audit of
manufacturing functions
Method : Sequel to Case Study 1
Identify Non-conformances and Potential non
conformances in the 20 scenarios of the Case Study.
Time : 45 minutes for Individual work
Apr 2010 236
118
SUMMARY REPORT - CONTENT
THE SUMMARY REPORT SHOULD INCLUDE OR
REFER TO THE FOLLOWING :
¾ THE AUDIT OBJECTIVES

¾ THE AUDIT SCOPE (ORGANIZATIONAL & FUNCTIONAL
UNITS OR PROCESSES AUDITED AND THE TIME
PERIOD COVERED)
¾ AUDIT TEAM LEADERS & MEMBERS
¾ DATES & PLACES OF ONSITE AUDIT
¾ AUDIT CRITERIA
¾ THE AUDIT FINDINGS
¾ THE AUDIT CONCLUSIONS
Apr 2010 237
SUMMARY REPORT – CONTENT (Continued)

THE REPORT SHOULD INCLUDE OR REFER TO THE
FOLLOWING, AS APPROPRIATE
¾ THE AUDIT PLAN
¾ LIST OF AUDITEE REPRESENTATIVES
¾ A SUMMARY OF THE AUDIT PROCESS
¾ DISCLAIMER ANY AREAS NOT COVERED ALTHOUGH WITHIN
THE AUDIT SCOPE
¾ ANY UNSOLVED DIVERGING OPINIONS BETWEEN AUDIT TEAM
& AUDITEE
¾ RECOMMENDATIONS FOR IMPROVEMENT, IF SPECIFIED IN
AUDIT OBJECTIVES
¾ AGREED FOLLOW UP ACTION PLAN
¾ A STATEMENT OF THE CONFIDENTIAL NATURE OF THE
CONTENTS
¾ DISTRIBUTION LIST FOR THE AUDIT REPORT
Apr 2010 238
119
REPORTING
THE METHOD AND CONTENT OF REPORTING DEPENDS
ON THE TYPE OF AUDIT
¾ IN FIRST PARTY (INTERNAL) AUDITS, SUMMARY STATEMENTS
AND NCR WILL SUFFICE
¾ IN A SECOND PARTY (EXTERNAL) AUDIT, A FORMAL REPORT

STATING THE PURPOSE, SCOPE, CONTRACT, AUDIT TEAM,
LOCATION AUDITED, DOCUMENTS REFERRED, FINDINGS,
CONCLUSIONS AND POSSIBLE FOLLOW-UP ACTIONS ARE
REQUIRED
¾ IN A THIRD PARTY OR CERTIFICATION AUDIT, A FORMAL

REPORT AS PER SECOND PARTY & FURTHER STATING THE
CONCLUSIONS REACHED BY THE AUDIT TEAM, IN TERMS OF
RECOMMENDATION, ARE REQUIRED.
Apr 2010 239
SUMMARY STATEMENT
(Audit Report)
This Company has a quality system which is well documented and generally in compliance with the requirements of
ISO 9001. However, the systems and procedures have not been fully implemented in the contract, planning and
product shipment areas. The audit found 33 deficiencies
• Particular concern is felt for :
(a) interaction of processes between laboratory & engineering section regarding control of monitoring & measuring
devices.
(B) lack of quality awareness on the part of project and senior management personnel.
(C) although there are systems of collecting data in production & customer related processes, the analysis and
utilizations of these data towards continual improvement is not evident.
(D) quality objectives for some important sections/functions i.e. Heat treatment section and Machine shop have
not been established.
• No significant problems were found in systems for design & purchasing processes.
• There is a need for more frequent review of the quality management systems and related process documents.
• It will therefore be necessary for the company to undertake corrective action on the deficiencies raised and for a
further audit to be carried out to verify that it had been taken before the company can be awarded a certificate.
Corrective action should be effected within three months from today.
Apr 2010 240
120
Case Study CS-3
Learning Objective : How to conduct audit of Service
functions
Method : Identify Non conformances, potential non
conformances and Statement against 20 scenarios related
to Quality Manual
Time : 45 minutes for individual review
30 minutes for preparation for Role play
45 minutes for Role Play
15 minutes for Feedback on Role Play
Apr 2010 241
EXERCISE E:06
Learning Objective : How to write Summary Audit Reports

Method : Refer 6.6 of ISO 19011. Use Audit findings of CS-
1, CS-2 and CS-3 for writing an Audit Summary Report
Time : 45 minutes for preparing the Summary Report,
team-wise
30 minutes for evaluation and feedback
Apr 2010 242
121
SESSION 3k
CLOSING MEETING
¾ PURPOSE OF CLOSING
MEETING
¾ CLOSING MEETING –
PREPARATION
¾ CLOSING MEETING –
AGENDA
Apr 2010 243
CLOSING MEETING
¾ FORMAL END OF THE ON-SITE AUDIT
¾ CONDUCTED AT AUDITEE ORGANIZATION

PREMISES
¾ SENIOR MANAGEMENT OF AUDITEE

ORGANIZATION PRESENT
Apr 2010 244
122
PURPOSE OF CLOSING MEETING
¾ A CLOSING MEETING IS HELD TO PRESENT AUDIT

FINDINGS AND CONCLUSIONS
¾ IT IS TO BE ENSURED THAT THE AUDIT FINDINGS ARE

UNDERSTOOD AND ACKNOWLEDGED BY THE AUDITEE
¾ A CORRECTIVE ACTION PLAN IS TO BE AGREED UPON,

IF APPROPRIATE
¾ TO CLARIFY AUDITEE’S DOUBTS
¾ DISCUSS AND RESOLVE ANY DIVERGING OPINIONS. IF

NOT, RECORD IT
Apr 2010 245
CLOSING MEETING - PREPARATION
AUDIT TEAM MEETS BEFORE CLOSING MEETING

TO:
¾ REVIEW ALL THE NON – CONFORMANCES
¾ CATEGORISE NCRs AS MAJOR/MINOR, IF APPLICABLE
¾ PREPARE A SUMMARY REPORT
¾ PREPARE AGENDA FOR THE CLOSING MEETING
Apr 2010 246
123
EXERCISE E:07
Learning Objective : How to conduct Closing Meeting
Method : Sequel to Case Study 3 : Role Play across two
teams, playing role of the Audit team and the
Management team respectively
Time : 45 minutes for team work : Preparation by all 4
teams for their respective roles (Refer 6.5.7 of
ISO 19011)
30 minutes for Role play
30 minutes for Feedback
Apr 2010 247
CLOSING MEETING – AGENDA

¾ INTRODUCTION
¾ THANKS FOR ASSISTANCE AND HOSPITALITY
¾ RE-STATE OBJECTIVE AND SCOPE OF THE AUDIT
¾ DISCLAIMER FOR SAMPLE AUDIT
¾ EMPHASIS ON NEGATIVE REPORTING
¾ PRESENT THE FINDINGS
¾ EXPLAIN THE CONCLUSION/RECOMMENDATIONS
¾ EXPLAIN THE SURVEILLANCE
Apr 2010 248
124
CLOSING MEETING – AGENDA (Continued)
¾ RECONFIRM CONFIDENTIALITY
¾ DIVERGING OPINIONS
¾ CLARIFY AUDITEE’S DOUBTS
¾ HAND OVER COPY OF THE REPORT
¾ ASK FOR CORRECTIVE ACTION PLAN / COMMITMENT
¾ RECORD ATTENDANCE AND PROCEEDINGS
¾ IF SPECIFIED BY AUDIT OBJECTIVES, MAKE
RECOMMENDATIONS FOR IMPROVEMENT BUT
EMPHASISE THAT RECOMMENDATIONS ARE NOT
BINDING
Apr 2010 249
SESSION 3L
AUDIT FOLLOW-UP
¾ PURPOSE FOR CORRECTIVE ACTION
¾ EVALUATION OF CORRECTIVE AND

PREVENTIVE ACTION
¾ SURVELLIANCE AUDIT
Apr 2010 250
125
AUDIT FOLLOW-UP
(Ref. ISO 9000 : 2005)
¾ CORRECTION
ACTION TO ELIMINATE A DETECTED NON-CONFORMITY
¾ CORRECTIVE ACTION
ACTION TO ELIMINATE THE CAUSE OF A DETECTED
NON-CONFORMITY OR OTHER UNDESIRABLE SITUATION
¾ PREVENTIVE ACTION
ACTION TO ELIMINATE THE CAUSE OF A POTENTIAL
NON-CONFORMITY OR OTHER UNDESIRABLE POTENTIAL
SITUATION
Apr 2010 251
STEPS TAKEN BY AN AUDITEE TO CARRYOUT OUT CORRECTIVE ACTIONS
EXTERNAL AUDIT (2ND / 3RD PARTY)

RESPONSIBILITY
NCR IDENTIFIED AUDITOR
OBSERVATION WITNESSED GUIDE / AUDITEE
NCR FORMAT FILLED AUDITOR
NCR CATEGORISED AUDITOR / LEAD AUDITOR
NCR PRESENTED IN CLOSING AUDITOR / LEAD AUDITOR

MEETING
TARGET DATE COMMITTED AUDITEE
CAUSE IDENTIFICATION AND AUDITEE

DETAILED PLAN OF ACTION
IMPLEMENT ACTION AUDITEE
INFORM COMPLETION OF
CORRECTIVE ACTION TO M.R. AUDITEE
INTERNAL QUALITY AUDIT M.R. / INTERNAL AUDITORS
NO
IS STATUS OK ? M.R. / INTERNAL AUDITORS
YES
INFORM EXTERNAL BODY ON

COMPLETION OF ACTION M.R
Apr 2010 252
126
EXERCISE E:08
Learning Objective : Understanding effectiveness of
Corrective action proposal
Method : Read two scenarios and evaluate the
effectiveness of the corrective action proposal
Time : Discuss in pairs. Arrive at consensus. Record
findings on Flip Charts
15 minutes for discussion
15 minutes for presentations
Apr 2010 253
VERIFICATION OF CORRECTIVE ACTION

) FIRST PARTY
REGULAR SCHEDULED AUDIT
SPECIAL FOLLOW–UP AUDITS / FOLLOW-UP
ACTIVITIES
) SECOND PARTY
AS PER CONTRACTUAL REQUIREMENT OR AS
DECIDED IN THE CLOSING MEETING
) THIRD PARTY
WRITING TO CERTIFICATION BODY AND/OR
SUBMISSION OF DOCUMENTARY EVIDENCE
SPECIFIC FOLLOW – UP AUDIT
DURING REGULAR SURVEILLANCE
Apr 2010 254
127
NCR / CORRECTIVE ACTION STATUS LOG
N CR D ate I nitiator Subject D ate of Approval V erified by Closed

N O. I ssued of Response of (N ame) (D ate)
N CR Response (D ate)
Apr 2010 O 255
EVALUATION OF CORRECTIVE &

PREVENTIVE ACTION
¾ WHETHER THE ACTION HAS BEEN COMPLETED WITHIN
THE TARGETED TIME.
¾ THE METHODOLOGY OF INTERNAL REVIEW FOR
EFFECTIVENESS
¾ DOES THE REVIEW FOR EFFECTIVENESS COVER THE
FOLLOWING AS APPLICABLE
NEED FOR CHANGE IN QMS PROCEDURES
NEED FOR ADDITIONAL TRAINING
NEED FOR APPLICATION OF MISTAKE PROOFING
TOOLS.
NOTE : IF ANY OF THE THREE ACTIVITIES DETAILED ABOVE HAS NOT
BEEN CONSIDERED, THERE ARE CHANCES OF PROBLEM
RECURRENCE
Apr 2010 256
128
SURVEILLANCE AUDIT
• PERIODIC AUDITS ON A CERTIFIED
ORGANISATION FOR DETERMINING THE
CONTINUING AND EFFECTIVE
IMPLEMENTATION OF THE QUALITY
MANAGEMENT SYSTEM
Apr 2010 257
SURVEILLANCE AUDIT
¾ANNOUNCED
− GENERAL PRACTICE
− ENSURES AVAILABILITY OF KEY
PERSONNEL
− UNLIKELY TO BE ABORTED
Apr 2010 258
129
SURVEILLANCE AUDIT ACTIVITIES
AUDIT OF LIMITED SECTION / AREA
HOWEVER THE FOLLOWING MUST BE AUDITED

¾ internal audits and management review,
¾ a review of actions taken on nonconformities identified during
the previous audit,
¾ treatment of complaints,
¾ effectiveness of the management system with regard to
achieving the certified client's objectives,
¾ progress of planned activities aimed at continual improvement,
¾ continuing operational control,
¾ review of any changes, and
¾ use of marks and/or any other reference to certification.
Apr 2010 259
OTHER SURVEILLANCE
ACTIVITIES
Other surveillance activities may include
• enquiries from the certification body to the certified client
on aspects of certification,
• reviewing any client's statements with respect to its
operations (e.g. promotional material, website),
• requests to the client to provide documents and records
(on paper or electronic media), and
• other means of monitoring the certified client's
performance.
Apr 2010 260
130
SPECIAL AUDITS
Extensions to scope
• Can be combined with a surveillance audit
To investigate complaints, review changes or

follow up on suspensions
• additional care in selecting audit team because lack of
opportunity for client to object
Apr 2010 O 261
Apr 2010 262
131
Apr 2010 263
132

Lac Apr 2010

Caricato da

Informazioni sul documento

Descrizione originale:

Titolo originale

Copyright

Formati disponibili

Condividi questo documento

Condividi o incorpora il documento

Opzioni di condivisione

Hai trovato utile questo documento?

Questo contenuto è inappropriato?

Copyright:

Formati disponibili

Lac Apr 2010

Caricato da

Copyright:

Formati disponibili

INSTITUTE OF QUALITY

Lead Auditor / Auditor Course

¾ You are expected to find out professional information about

¾ Each participant would in turn introduce his partner to the

¾ Hand over your recorded findings to the tutors.

¾ FOR A DURATION OF FIVE DAYS

¾ COVERS THE REQUIREMENTS OF IRCA / NABET

¾ ENABLES SUCCESSFUL CANDIDATES TO REGISTER

¾ INCLUDES CLASSROOM SESSIONS, SYNDICATE

¾ EXTENSIVE EXAMPLES AND CASE STUDIES BASED ON

¾ BLEND OF LECTURES, INTERACTIVE WORKSHOPS AND

¾ ROLE PLAY ON OPENING AND CLOSING MEETINGS

¾ INCLUDES PRE-COURSE MATERIAL AND

¾ CONTINUOUS ASSESSMENT OF PARTICIPANTS

¾ TIME SCHEDULES ARE IMPORTANT

¾ BE ALERT, INTERACTIVE AND CO-OPERATIVE

¾ USE OF MOBILE PHONES PROHIBITED

¾ DELEGATES APPEAL AND COMPLAINT

EVALUATION PROCESS & CRITERIA

By the end of the session successful students will

• Explain the purpose and business benefits of a quality

Activity on understanding QMPs

¾ MANAGING AN ORGANIZATION ENCOMPASSES

¾ EIGHT QUALITY MANAGEMENT PRINCIPLES HAVE BEEN

• “INVOLVEMENT OF PEOPLE” “PROCESS APPROACH”

• PEOPLE OF ALL LEVELS ARE THE A DESIRED RESULT IS ACHIEVED MORE

• QUALITY MANAGEMENT QUALITY MANAGEMENT

• EFFECTIVE DECISIONS ARE AN ORGANISATION AND ITS

¾ CONCEPT INTRODUCED BY DR.SHEWHART IN

¾ POPULARIZED BY DR. DEMING IN THE 1950’S

¾ BECAME KNOWN AS DEMING CYCLE

¾ PDCA STANDS FOR PLAN, DO, CHECK AND ACT

¾ PDCA CYCLE CAN BE APPLIED AT ALL LEVELS WITHIN

PDCA cycle can be applied at all levels within the organization

• Apply Plan, Do, Check and Act on

• Reaching Place of work

SET OF INTERRELATED OR INTERACTING ACTIVITIES WHICH

¾ OUTPUTS FROM ONE PROCESS ARE TYPICALLY INPUTS

¾ PROCESSES MAY BE INTERRELATED OR

¾ OVERALL AIM IS TO ADD VALUE BY PLANNING AND

BASIC PROCESS MODEL

MO N ITO R ING M EASU REM EN TS

¾ THE RESULT OF A PROCESS (ISO 9000-2008)

¾ 4 GENERIC PRODUCT CATEGORIES

 HARDWARE TANGIBLE PRODUCTS

¾ MOST PRODUCTS ARE COMBINATION OF THESE

Processes are not restricted to production

EVALUATING A PROCESS WITHIN THE QMS

THROUGH THE 4 BASIC QUESTIONS

Identify the inter-linkages of a tutor given

Present on Flip Charts

• By the end of the session successful students

¾ Explain the purpose, content & inter-

Activity on identifying the Purpose of

• Read section 0.1 of ISO 9000:2005 of Pre-

• In your syndicate groups discuss and list

ISO 9000:2005 – Quality Management Systems - Fundamentals And

ISO 9001:2008 – Quality Management Systems - Requirements

ISO 9004:2009 – Managing for Sustained success of an organization – a

ISO 19011 : 2002 – Guidelines On Quality And / Or Environmental Management

ISO 9004 Perspective

Auditing Standards (Guidelines)

HARDWARE TANGIBLE PRODUCTS