Internal Audit

ISO 9001:2000
QUALITY MANAGEMENT SYSTEM
INTERNAL AUDIT
1
What is Quality ??
 Fitness for use
 Conformance to requirements
 Accuracy
 Perfection
 Zero Defect
 Adequacy
 Cost Effectiveness
“ THE TOTALITY OF FEATURES AND CHARACTERISTICS OF A PRODUCT OR
SERVICE THAT BEAR UPON ITS ABILITY TO SATISFY STATED OR IMPLIED
NEEDS “
2
Quality
Customers’ expectations of quality are not the same for
different classes of products or services.
Best-in-Class Quality
Best-in-class quality means being the best product or
service in a particular class of products or services.
World-Class Company
Being a world-class company means that each of its products and
services are considered best-in-class by its customers.
3
ISO International Organization for Standardization
Founded in 1946 in Geneva , Switzerland
ISO is a non-governmental organization that forms a bridge between
the public and private sectors.

World's largest developer and publisher of International Standards.
ISO is composed of more than 90 members countries
"ISO", derived from the Greek. ISO, meaning "equal". Whatever the
country, whatever the language, the short form of the organization's
name is always ISO.

"ISO", is a system audit not for product audit
ISO 9001:2000
ISO - International Organization for Standardization
9001 - Number assigned by ISO

4
? 5
OBJECTIVES OF ISO 9000:2000 requirements
EXPECTED PLANNED
QUALITY QUALITY
by the Customer by the Company
Measurement of the Measurement of the

Customer’s satisfaction Performance of the Company
PERCEIVED PRODUCED
QUALITY QUALITY
by the Customer by the Company
6
The 8 principles of QMS …
• Customer focus
• Leadership
• Involvement of people
• Process approach
• System approach to management
• Continual improvement
• Decisions based on facts
• Relationship with suppliers mutually beneficiary
7
Customer Focus
Organizations Determine customer needs

& expectations
Depends on
Customers .
Requirements
Customer satisfaction
Principle 1
8
Applying the principle of Customer Focus typically leads to

 Researching and understanding customer needs and
expectations
 Ensuring that the objectives of the organization are
linked to customer needs and expectations
 Communicating customer needs and expectations
throughout the organization
 Measuring customer satisfaction and acting on the
results.
 Systematically managing customer relationships.
 Ensuring a balanced approach between satisfying
customers and other interested parties (such as
owners, employees, suppliers, financiers, local
communities and society as a whole).
9
Leadership
Leaders must set the direction of the

organization
Leaders must create and maintain internal

environment that encourages people to
achieve the organization’s objectives
Principle 2
10
Applying the principle of Leadership typically leads to
 Establishing a clear vision of the organization's

future
 Establishing trust and eliminating fear.
 Setting challenging goals and targets.
 Providing people with the required resources,
training and freedom to act with responsibility and
accountability
 Inspiring, encouraging and recognizing people's
contributions.
11
Involvement of people
Must encourage the involvement of people at
all level
Must help people to develop and use their

abilities
Principle 3
12
Applying the principle of Involvement of people

typically leads to
 People understanding the importance of their

contribution and role in the organization.
 People accepting ownership of problems and their
responsibility for solving them.
 People freely sharing knowledge and experience.
 People openly discussing problems and issues.
 People identifying constraints to their performance.
13
Process Approach
Control
Input Activities Output

+
Resources
A desired result is more efficiently achieved when

resources and activities are managed as a process
Principle 4
14
Processes – understand interaction
Process A Process C
Process B Process D
Input
Output
Control
15
Applying the principle of Process approach

typically leads to
 Identifying the interfaces of key activities within

and between the functions of the organization.
 Focusing on the factors such as resources,
methods, and materials that will improve key
activities of the organization.
 Systematically defining the activities necessary to
obtain a desired result.
 Establishing clear responsibility and accountability
for managing key activities.
16
System Approach to Management
Identifying, understanding and managing

interrelated processes as a system contributes
to the organization's effectiveness and
efficiency in achieving its objectives.
Principle 5
17
Applying the principle of System approach to

management typically leads to
 Structuring a system to achieve the organization's
objectives in the most effective and efficient way.
 Providing a better understanding of the roles and

responsibilities necessary for achieving common
objectives and thereby reducing cross-functional
barriers
 Targeting and defining how specific activities within a

system should operate
 Continually improving the system through

measurement and evaluation
18
Continual Improvement
Customer Focus
Deming’s
wheel PLAN DO
(P.D.C.A.)
CHECK Continual
ACT Improvement
ISO
Principle 6 9000
Continual improvement of the organization's overall performance

should be a permanent objective of the organization.
19
Applying the principle of continual improvement

typically leads to
 Providing people with training in the methods and tools of

continual improvement.
 Making continual improvement of products, processes and
systems an objective for every individual in the organization
 Establishing goals to guide, and measures to track,
 Establishing goals to guide, and measures to track,
20
Decision based on facts

Effective decisions are based on the analysis of data
and information
Principle 7
21
Applying the principle of Decision based on the facts

typically leads to
 Ensuring that data and information are sufficiently accurate

and reliable.
 Making data accessible to those who need it.
 Analyzing data and information using valid methods.
 Making decisions and taking action based on factual
analysis, balanced with experience and intuition.
22
Mutually beneficial supplier relationships
An organization and its suppliers are interdependent and a

mutually beneficial relationship enhances the ability of
both to create value
Principle 8
23
Applying the principle of mutually beneficial

relationships typically leads to
 Inspiring, encouraging and recognizing improvements and

achievements by suppliers.
 Clear and open communication.
 Establishing joint development and improvement activities
 Identifying and selecting key suppliers.
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ISO 9000:2000 Family
•ISO 9001:2000 – Quality Management Systems:

REQUIREMENTS (WHAT ?)
ISO 9001 oriented effectiveness and certification,
•ISO 9004:2000 - Quality Management Systems:

GUIDELINES FOR PERFORMANCE IMPROVEMENTS
(HOW ...?)
•ISO 9000:2000 – Quality Management Systems:

Fundamentals and vocabulary
•ISO 19011:200X – Guidelines for quality and/or

environmental management systems auditing.
25
ISO 9000:2000 Support Documents
TWO TECHNICAL SUPPORT DOCUMENTS :
•ISO 1000x – Technical brochure - Selection & Use
•ISO 1000y - Principles and application of quality

management
26
The ISO 9000:2000 requirements
Five Operating Elements
4- QUALITY MANAGEMENT SYSTEMS
(QMS, documentation requirements)
5- MANAGEMENT RESPONSIBILITY
(Management commitment, Customer focus, Quality Policy, Planning,
Responsibility, Authority and Communication, Management Review)
6- RESOURCE MANAGEMENT
(Provision of Resources, Human Resources, Infrastructure, Work
Environment)
7- PRODUCT REALIZATION
(Planning, Customer Related Processes, Design and Development),
Purchasing, Service Provision, Control of Measuring Devices)
8- MEASUREMENT, ANALYSIS AND IMPROVEMENT
(Monitoring and Measurement, Control of Non-conforming Product,
Analysis of Data, Improvement)
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The ISO 9000:2000 requirements
Continual improvement of the
Quality Management System
Management
Responsibility
Satisfaction
CUSTOMERS
CUSTOMERS
Measurement,
Resource
Analysis and
Management
Improvement
Requirements
Product /
Input Output Product
Service
Data Data Service
Realization
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4 Quality management system

4.1 General requirements
Establish , document , implement and maintain a

QMS and continually improve its effectiveness in
accordance with the standard
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4.1 General Requirements

• Identify the processes necessary for QMS
• Determine the sequence and interaction of processes
• Determine criteria & methods to ensure effective
operation & control of the processes
• Ensure availability of resources and information needed
to support the operation & monitoring of the processes
• Measure , monitor and analyze processes
• Implement action necessary to achieve planned results
& continual improvement
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4.1 General Requirements

• Manage the processes in accordance with standard
• Ensure control of outsourced processes affecting product
conformity
• Identify control of outsourced processes within the QMS
Note: Processes needed for QMS include processes for

management activity , provision of resources ,
product realization and measurement
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4.2 Documentation requirements

4.2.1 General
QMS documentation must include

• Quality Policy
• Quality objectives
• Documented procedure required by standard
• Documents required by organization to ensure effective
planning , operation & control processes
• Quality records required by the standard
32
4.2.1 General
Basis of Auditing ( Auditor may look for )
Availability of
• Statements of Quality Policy and Objectives

• Quality Manual
• Availability of Documented Procedure
4.2.3 Control of Documents
4.2.4 Control of records
8.2.2 Internal Audit
8.3 Control of Nonconforming products
8.5.2 Corrective Action
8.5.3 Preventive Action 33

4.2.2 Quality manual

The Organization shall establish and maintain a quality
manual that include as minimum :
• The scope of QMS including details of , and justification

for , and exclusions
• Documented procedures or reference
• Description of the interaction between the processes of
the QMS
34

Documents required by the quality management system
Shall be controlled
Documented procedures to:
• Approve documents prior to issue
• Review , update as necessary and re-approve
documents
• To identify the changes and the current revision status
of documents
• To ensure documents remain legible , readily identifiable
• Ensure relevant versions of applicable documents are
available at points of use
• Ensure that the documents of external origin are
identified and distribution controlled
• Obsolete documents are prevented from unintended use
and identified if kept for any reason
35

Basis of Auditing (Auditor may look for )
• Procedures for document approval , document review ,re approval , distribution
and control mechanism
• Availability of relevant version of documents at all points of use
• Mechanism for preservation of obsolete copies usage
• Systems for control of use external origin documents
36
4.2.4 Control of Records

• Records must be established and maintained
• Records must be legible , readily identifiable and
retrievable
• Documented procedure for control of identification ,
storage , retrieval ,retention time and disposition of
quality records
• Procedure for record control
• Details of retention period
37
MANAGEMENT RESPONSIBILITY
5 . Management Responsibility
5.1 Management 5.5 Responsibility , authority
commitment and communication
5.5.1 Responsibility , authority
5.2 Customer focus
5.5.2 Management
representative
5.3 Quality policy 5.5.3 Internal communication
5.4 Planning
5.6 Management review
5.4.1 Quality objectives
5.6.1General
5.4.2 QMS planning
5.6.2 Review input
5.6.3 Review output
38
5.1 Management Commitment

Top Management shall provide evidence of commitment
to the development implementation and improvement
of QMS by:
• Communicating the importance of meeting customer
and statutory and regulatory requirements
• Establishing quality policy & objectives
• Conducting Management review
• Ensuring the availability of resources
39
5.2 Customer Focus

Top Management shall ensure that customer
requirements are determined and are met with the aim
of enhancing customer satisfaction
• Evaluation of customers survey

• Market analysis
• Complaint documentation / analyses
• Customer satisfaction analyses
40
5.3 Quality policy

Top management shall ensure that the quality
policy
a) is appropriate to the purpose of the organization
b) commitment to comply with requirements &
continually improve the effectiveness of the QMS
c) framework for establishing and understood within the
organization
d) is reviewed for continuing suitability
• Documentation of quality policy
• Able to give frame-work to establish objectives
• Mechanism for communication of the quality policy to the employees
– Training schedule and evidence 41

5.4.1 Quality Objectives

• Establish quality objectives at relevant functions and
level
• Objectives must be measurable & consistent with the
quality policy
• Include those needed to meet requirements for product
{ see 7.1 (a)}
• Documented {see 4.2.1 (a)}
• Availability of quality objectives at relevant levels of the organization
• Mechanism for the communication to employees
• Are there SMART objectives ?
• Improvement objective related to the product

42
5.4.2 Quality planning

Top management shall ensure that
• Planning of the QMS is carried out in order to meet
requirements given in 4.1 , as well as the quality
objectives
• the integrity of the QMS integrity must be maintained
when changes are planned and implemented
43
5.5 Responsibility ,authority and communication
5.5.1 Responsibility and authority

Top management shall ensure that the responsibilities
and authorities are defined and and communicated
within the organization
• Role , function and responsibility matrices
• Organizational chart
• Authorities shall be clearly known to employees along with responsibilities
44
5.5.2 Management Representative

Top management shall appoint a member of the management who , irrespective of
other responsibility , shall have responsibility and authority that includes
 Ensuring that processes needed for the QMS are established , implemented and
maintained
 Reporting on performance of QMS including needs for improvement
 Ensuring the promotion of awareness of customer needs & requirements
Note : Responsibility may include liaison with external parties in relation to QMS
45
5.5.3 Internal communication

Top management shall ensure that appropriate communication processes are established
within the organization , and that communication takes place regarding the
effectiveness of the QMS
 Minutes and reports of meeting

 Notice boards , internal magazines and circular letter
 Audio-visual and electronic media
 Employee suggestion system
46
5.6 Management Review

5.6.1 General
Review of the QMS by top management at planned
intervals to:
 Ensure QMS suitability , adequacy &

effectiveness
 Assess opportunities for improvement
 Evaluate the need for changes to QMS including
policy & objectives
47

5.6.2 Review input
Review performance and improvement opportunities
related to :
 Audit results
 Customer feedback
 Process performance & product conformity
 Status of preventive and corrective actions
 Follow up actions from earlier reviews
 Changes that could affect the QMS
 Recommendation for improvement
48

5.6.3 Review output
Output to include actions related to :
 Improvement of the effectiveness of the QMS and

its processes
 Improvement of product related to customer
requirements
 resource needs
Result of management review must be recorded
49

Availability of
 Management review meeting reports

 Customer complaints
 Process data analysis
 Product data analysis
 Evidence of corrective and preventive action
 Resource requirements and application planning
 Objectives and targets achievements
 Business plan
 Investment plan
 HR Planning 50
RESOURCE MANAGEMENT
6. RESOURCE MANAGEMENT
6.1 Provision of resource
6.2 Human resource
6.2.1 General
6.2.2 Competence , awareness and training
6.3 Infrastructure
6.4 Work environment
51
RESOURCE MANAGEMENT
6.1 Provision of Resources

The organization shall determine and provide the
resources needed to :
 Implement , maintain the QMS and continually
improve its effectiveness
 Enhance customer satisfaction by meeting
customer requirements
 Investment planning related to human resource

 Staffing schedules
 Other target budgets / Equipment enhancement program
52
RESOURCE MANAGEMENT
6.2 Human Resources

6.2.1 General
Personnel performing work affecting product quality
must be competent on the basis of appropriate
education , training , skills and experience
 Job / function profiles – competency requirements at various levels

 Competency mapping – minimum requirements v/s actual available
53
RESOURCE MANAGEMENT
6.2 Human Resources

The organization shall
Determine the necessary competence for
personnel performing work affecting product
quality
Provide training or take other actions to satisfy
these needs
Evaluate the effectiveness of the actions taken
Ensure that its personnel are aware of the
relevance and importance of their activities and
how contribute to the quality objectives
Maintain appropriate records of education ,
training , skills and experience
54
RESOURCE MANAGEMENT
6.2 Human Resources

 Competence needed
 Skill gap analysis
 Identification of training needs
 Provision of training
 Evaluation of training effectiveness
 Job descriptions
 Related records
 Employee’s awareness about relevance and importance of their work
 Analyses of labor turnover or staff absenteeism
55
RESOURCE MANAGEMENT
6.3 Infrastructure
The organization shall Identify ,provide & maintain the
infrastructure needed to achieve product conformity .
Infrastructure includes as applicable
 Building ,workspace & associated utilities
 Process equipments (hardware & software )
 Supporting services ( Transport , communication )
 Plants and production facilities

 Corrective and Preventive maintenance
 Trends of maintenance
 Equipment Performance 56
RESOURCE MANAGEMENT
6.4 Work Environment

The organization shall determine and manage the work
environment needed to achieve conformity to product
requirements
Physical factors
• Heat • Noise • Vibration • Cleanliness
•Light • Pollution • Air flow •Hygiene
 Evidence of instruction in occupational safety

 Evidence of the satisfaction of statutory and regulatory requirements or
conditions
 Work place investigations 57

PRODUCT REALIZATION
7 Product Realization
7.1 Planning of product realization

7.2 Customer related processes
7.3 Design & development
7.4 Purchasing
7.5 Production & service operation
7.6 Control of measuring & monitoring devices
58
PRODUCT REALIZATION
7.1 Planning of product realization

The organization shall plan and develop the processes needed
for product realization .
Planning must determine as appropriate :

 Quality objectives and requirements for the product
 the need for processes , documentation , resources specific to
the product
 verification and validation activities & acceptance criteria for
product acceptance
 Records
The output of this planning shall be in a form suitable for the
organization’s methods of operations.
Examples
Production Control plan
Project Plan
59
PRODUCT REALIZATION
7.2 Customer related process

7.2.1 Determination of requirements related to the products
The organization shall determine
 Requirements specified by the customer , including the
requirements for delivery and post delivery activities
 Requirements not stated by the customers but
necessary for specified or intended use
 Statutory and regulatory requirements related to the
products
 Any additional requirements determined by the
organization
 Customer inquiries
 Orders
60
 Records on discussion with customers
PRODUCT REALIZATION

7.2.2 Review of requirements related to the products
The organization shall review the requirements related to the
product.
This review shall be conducted prior to the organization’s
commitment to supply a product to the customer and shall
ensure that
 Product requirements are defined
 Contract or order requirements differing from those
previously expressed are resolved
 The organization has the ability to meet the defined
requirements
 Evidence of contract review

 Documentation of amendments
61
 Order conformation records
PRODUCT REALIZATION

7.2.3 Customer Communication
The organization shall determine and implement effective
arrangements for communication with customers in relation to
 Product information
 Enquiries , contracts or order handling , including
amendments
 Customer feedback , including customer complaints
 Customer’s product specification

 Contracts
 Acknowledgement of order
 Customer requests for changes 62
PRODUCT REALIZATION
7.3 Design and Development

7.3.1 Design & development planning
7.3.2 Design & development input
7.3.3 Design & development output
7.3.4 Design & development review
7.3.5 Design & development verification

7.3.6 Design & development validation
7.3.7 Control of design & development changes
63
PRODUCT REALIZATION

7.3.1 Design & development planning
The organization shall plan and control the design and
development of product
During the planning to include :
* D&D stages
* required review , verification and validation activities
* responsibilities & authorities for D&D
 Interfaces between groups must be managed
 Planning output shall be updated as the D&D progresses
64
PRODUCT REALIZATION

7.3.2 Design & development input
 Determine & record product requirements including
* functional & performance requirements
* applicable statutory and regulatory requirements
* information from previous similar designs
* any other essential requirements
 Review input for adequacy
65
PRODUCT REALIZATION

7.3.3 Design & development outputs
 D&D output must
* meet the input requirements
* provide information for purchasing ,production or
service provision
* contain or reference acceptance criteria
* define characteristics essential for proper & safe
use
 Approve output prior to release
66
PRODUCT REALIZATION

7.3.4 Design & development review
 At suitable stages systematic reviews of D&D to
* evaluate the ability to fulfill requirements
* identify problems and propose follow up
 Involve all functions concerned
 Record the results and any necessary actions
67
PRODUCT REALIZATION

7.3.5 Design & development verification
 Verify D&D to ensure that output meets the input

requirements
 Record the results of verification and necessary actions
68
PRODUCT REALIZATION

7.3.6 Design & development validation
 Perform D&D validation to confirm that product is
capable of meeting the requirements for the specified or
known intended use
 Whenever applicable to be completed prior to delivery
 Results of validation and necessary action must be
recorded
69
PRODUCT REALIZATION

7.3.7 Control of design and development changes
 Design and development changes must be identified and
records maintained
 Changes must be reviewed , verified and validated as
appropriate and approved before implementation
 Record results of review of changes and any necessary
actions
70
PRODUCT REALIZATION

 Design and Development plan
 Milestones and schedule in plan
 Approval provisions in D&D plan
 Drawing
 Quality Plans
 Design input records
 D&D review records
 D&D verification records
 Test records
 D&D validation records
 Validation approval
71
PRODUCT REALIZATION
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of Purchased product
72
PRODUCT REALIZATION
7.4 Purchasing
7.4.1 Purchasing process
 Ensure that purchased product meets requirements
 Evaluate and selects suppliers based on their ability to
supply conforming product
 Establish criteria for selection , evaluation and re-
evaluation of suppliers
 Results of evaluation and any necessary actions must be
recorded
73
PRODUCT REALIZATION
7.4 Purchasing
7.4.2 Purchasing information
Purchasing information must describe the product to be
purchased including where appropriate :
* requirements for approval of product , procedures
processes and equipment
* requirements for qualification of personnel
* quality management system requirements
Ensure adequacy of specified purchase requirements

prior to their communication to supplier
74
PRODUCT REALIZATION
7.4 Purchasing
 Purchase specification
 Evidence of supplier evaluation
 List of approved suppliers
 Evaluation Criteria
 Purchase order – clarity in terms of commercial and technical
 Quality assurance agreements
 Order approval documents
75
PRODUCT REALIZATION
7.4 Purchasing
7.4.3 Verification of Purchased product
Establish & implement inspection or other activities
needed to ensure purchased product conformity
Where organization or its customer propose verification

at supplier’s premises , organization must specify in
purchasing information :
* verification arrangements
* method of product release
 Verification plan
 Acceptance criteria
 Test records of suppliers
76
PRODUCT REALIZATION
7.5 Product and service provision
7.5.1 Control of production and service provision

7.5.2 Validation of processes for production and service
provision
7.5.3 Identification & traceability
7.5.4 Customer property
7.5.5 Preservation of products
77
PRODUCT REALIZATION

7.5.1 Control of production and service provision
The organization shall plan and carry out production &

service provision under controlled conditions . Controlled
conditions include as applicable:
 availability of information describing product
characteristics
 availability of work instruction
 the use of suitable equipment
 availability & use of measuring & monitoring devices
 implementation of monitoring and measurement
 the implementation of release , delivery and post
delivery activities
78
PRODUCT REALIZATION

7.5.2 Validation of processes
Processes where outcome is not verified and / or
where deficiencies may become apparent after delivery
must be validated to demonstrate ability to achieve
planned results
Arrangements must be established for these
processes including , as applicable :
 criteria for review and approval of the process
 approval of equipment
 qualification of personnel
 use of defined methods & procedures
 requirements for records
 re-validation
79
PRODUCT REALIZATION

 Maintenance schedule
 Service Contracts
 Spare parts management
 Identification of Special process
 Availability of validation specification
80
PRODUCT REALIZATION

7.5.3 identification & traceability
 Where appropriate identify product by suitable means
throughout realization
 Identify status with respect to measurement &
monitoring requirements
 Where traceability is required control & record unique
identification of product
 Product identification
 Routing tag
 segregation slips
81
PRODUCT REALIZATION

7.5.4 Customer Property
 Care for customer’s property while it is under
organization’s control or being used by organization
 Identification , verification , protection & safeguarding
customer property provided for use or incorporation
 Any customer property that is lost , damaged or found
unsuitable must recorded & reported to customer
Note: Customer property includes intellectual property
82
PRODUCT REALIZATION

7.5.5 Preservation of product
 Preserve conformity of product during internal
processing and final delivery to intended destination
 Include identification , handling , packaging , storage
and protection
 This applies to constituent parts of a product
 Inventory list
 Dispatch methods
 regulation on packing , storage , preservation and delivery
83
PRODUCT REALIZATION

 Determine monitoring and measurement to be made &
measurement & monitoring devices needed to provide
evidence of conformity of product
 Ensure measuring and monitoring is carried out
consistently with monitoring and measurement
requirements
 Suitability of measuring / monitoring software must be
confirmed prior to use
 Identification of Equipments
 Calibration standards and Records
 Acceptance Criteria
84
 Calibration instruction
PRODUCT REALIZATION

 Calibrate or verify measuring and monitoring devices
(MMD)at specified intervals
 Adjust or re-adjust as necessary
 Identify to enable the determination of calibration status
 Safeguard MMD from adjustments invalidating calibration
 Protect MMD from damage or deterioration during handling
, maintenance & storage
 Record results of calibration
 Identification of Equipments
 Calibration standards and Records
 Acceptance Criteria
 Calibration instruction 85
MEASUREMENT , ANALYSIS AND IMPROVEMENT
8 Measurement , analysis and improvement

8.1 General
8.2 Monitoring / measurement
8.2.1 Customer satisfaction
8.2.3 Monitoring & measurement of processes
8.2.4 Monitoring & measurement of product
8.3 Control of nonconforming product

8.4 Analysis of data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective action
8.5.3 Preventive action
86

8.1 General
Plan & implement measurement , monitoring analysis
and improvement processes needed to :
> demonstrate conformity of the product
> ensure conformity of QMS
> continually improve the effectiveness of the QMS
This includes determination of applicable methods

including statistical techniques and extend of their
use
87

8.2.1 Customer satisfaction
 Organization shall monitor information related to

customer perception as to whether the organization
has fulfilled customer requirements
 The methods for obtaining and using this information
must be determined
 Availability of effective system of customer satisfaction measurements

 Customer satisfaction analysis
88

Conduct internal audits as planned intervals to determine if
 QMS conform to the planned arrangements,
requirements of the standard and organization’s
requirements
 QMS is effectively implemented & maintained
Plan the audit programme considering :

 Status and importance of the processes and the areas
 Results of previous audits
Define audit criteria ,scope ,frequency & methodologies
Auditor must not audit own work
89

 Internal auditing procedure
 Audit plans and schedules
 Audit reports
 Audit notes / proof of verified objective evidence
 Nonconformity report
 Discussion of audit results in MRM
 Auditor qualification certificates
 Corrective actions 90

8.2.3 Monitoring and measurement of processes
Apply suitable methods for monitoring and , where
applicable , measurement of QMS processes
 These methods shall demonstrate the ability of the
processes to achieve planned results
 Where planned results are not achieved corrections
and corrective actions must be taken to ensure
conformity of the product
 Process parameters
 Statistical Techniques
 KPI / Performance indicators
 Are the KPI in line with functional objectives 91

8.2.4 Monitoring and measurement of product
 The organization shall monitor & measure characteristics of
the product requirements have been met.This shall be
carried out at appropriate stages of realization processes in
accordance with planned arrangements
 Evidence of conformity with the acceptance criteria must be
maintained . Records must indicate the person(s)
authorizing release of the product
 Product release or delivery must not processed until all the
planned arrangements have been satisfactorily completed ,
unless otherwise approved by a relevant authority , and
where applicable by the customer
92

8.2.4 Monitoring and measurement of product
 Procedure for inspection . Quality plan and test plan
 Person approving the check and release of the product shall be
identified
 Inspection reports
 Deviation accepted by customer or approved by designated
authorities
93

 Nonconforming product must be identified and controlled to
prevent unintended use or delivery
 Documented procedure to define controls , responsibility
and authority
 When nonconformance detected after delivery take
appropriate action
 Organization must deal with nonconforming product by one
or more of the following ways
>action to eliminate detected nonconformity
> concession
 When the nonconforming product is corrected it must be re-

verified to demonstrate conformity
 Records of the nature of nonconformity and any subsequent
action including concessions must be maintained
94

What options an organization has selected when a non conforming
product is detected
- Reworking the product to make it confirm to specification
- Negotiating with the customers to accept the product as it or after
repair
- Scrapping the product
95

 Determine ,collect & analyze appropriate data to
demonstrate the suitability and effectiveness of QMS
and to evaluate where continual improvement of the
QMS can be made
 Data from measurement & monitoring & other relevant
sources
 Analyze data to provide info on:
 Customer satisfaction
 Conformance to product requirements
 Process , product characteristics and their trends
including opportunities for preventive action
 Suppliers
96

Analysis that provide information on
- Customer satisfaction
- Conformity to product requirements
- Characteristics and trend of processes and product
- Suppliers
97

8.5 Improvement
8.5.1 Continual improvement
Organization shall continually improve the
effectiveness of the QMS through use of :
 Quality policy
 Quality objectives
 Audit results
 Analysis of data
 Corrective action
 Preventive action
 Management review
98
8 Measurement , Analysis and Improvement

SPC
Benchmarking
Quality Circles
Risk Assessment
Teamwork for Quali
Quality Function Deployme
99

Problem Solving Techniques

 Cause & effect diagram
 Pareto analysis
 Flowcharting
 Brain storming
100

8.5.2 Corrective action
Organization shall take action to eliminate the

causes of nonconformities to prevent recurrence .
Corrective actions appropriate to the impact of the
problem
Documented procedure shall define requirements
for :
 Reviewing nonconformities (including customer
complaints)
 Evaluating the causes of nonconformities
 Determining & implementing action needed
 Recording results of action taken
 Reviewing corrective action taken
101

8.5.3 Preventive action
Organization shall take action to eliminate the
causes of potential nonconformities to prevent
recurrence .
Actions appropriate to the impact of the potential
problem
Documented procedure shall define requirements
for :
 Determining potential nonconformance &their
causes
 Evaluating the need for preventive action
 Determining & implementing action needed
 Recording results of action taken
 Reviewing corrective action taken
102

8.5.2 ,8.5.3 – Corrective action , Preventive action
 Non conformity records
 Instructions related to corrective action
 Complaints analysis
 System approach to identify root cause
 Avoiding nonconformities due to same cause
 Use of data analysis to identify potential causes
 Review of trends to identify potential non compliance an necessary

preventive action
103
QMS DOCUMENTATION
Quality System Documentation

QMS Documentation shall include :
 Documentation statement of Quality Policy and
Objectives
 A Quality Manual
 Documented Procedures required by Standard
 Documentation needed by the organization to
ensure effective planning , operation and control
of its processes
 Records required by the standard
 Records required by the organization
104
QMS DOCUMENTATION
Quality Manual
Quality Manual: Document specifying the QMS of an
organization
Documented Procedure
Documented Procedure : Specified way to carry out an activity
or process
Record
Record : Document stating result achieved or providing
evidence of activities performance
105
QMS DOCUMENTATION
Document
Document : Information and its supporting medium
Documentation can be in any format or medium
Document provides guidelines
Information Medium
- Procedure Paper
- Specification Electronic
- Drawing Photographic
- Standard Magnetic
Document may be established in any form or type of medium

- Flow chart
- Text
- Drawing Sketches
- Audio or video tapes
106
QMS DOCUMENTATION
Difference between documents & records

Document Record
 It provides guidelines  It provides evidence of
 Documents are work done
dynamic and can be  Records cannot be
revised changed
Examples Examples
- Procedure for production - Production Report
planning - Inspection Results
- Drawing
- Part Quality Standard
- Work Instruction for
Printing
107
QMS DOCUMENTATION
WHY
Define WHAT will be
Stated Once done
Policy ,
Manual
WHO
WHEN
Procedures
WHERE
HOW Work Instructions
Or
Practices
Evidence
Records
Or
Proof
Documentation Pyramid
108
INTERNAL AUDIT
INTERNAL AUDIT
109
INTERNAL AUDIT
INTERNAL AUDIT
• Audit Definition and criteria

• Audit objectives
• Types and stages of Auditing
• Auditing Process
• Audit and Assessment
110
INTERNAL AUDIT
What is Audit
AUDIT is a Fault Finding Exercise

AUDIT is a Fact Finding Exercise
111
INTERNAL AUDIT
Audit Definition
Audit :
Systematic , documented verification process
of objectively obtaining and evaluating
evidence to determine whether specified
activities , events , conditions , management
systems or information about these matters
conform with audit criteria , and
communicating these results of this process
to the client
Audit Evidence :
A statement of facts or other information relevant
to audit criteria
- based on actual observation
- uninfluenced by emotion
- stated or documented
- verifiable 112
INTERNAL AUDIT
Definitions
Auditee :
Organization to be audited
Auditor :
A person qualified to perform audits
Lead Auditor :
A person qualified to manage and perform audits
Audit Scope :
Audit scope provides the extend and boundaries of
the audit
113
INTERNAL AUDIT
Audit criteria
Audit Criteria :
Policies , practices , procedures or requirements
against which the auditor compares the collected
evidence about the subject matter
Requirements may include but are not limited to

- Customer requirements
- ISO 9001:2000 system requirements
- Organization QMS requirements
- Statutory and regulatory requirements
114
INTERNAL AUDIT
Audit Objectives
Objectives of the audit are
- Conformity wrt Requirements

- Effectiveness wrt Objectives
- Opportunity wrt Improvements
- Compliance wrt regulatory requirements
115
INTERNAL AUDIT
Type and stages of audit

Types of Audit
- First party audit
Self Audit , by an organization on itself for
their own purposes – Internal audit
- Second party audit

By an interested organization in another
organization
- Third party audit

By an independent organization
- Certification audit
116
INTERNAL AUDIT

Type of Audit - System wise:
a) Quality System Audit
Done to verify whether the quality systems are meeting
the standard's requirements and whether they are being
followed or not.
b) Process Quality Audit
Done to verify whether a particular production procedure
is followed or now to meet the product specification.
c) Inspection Audit
Done on the product itself to verify whether it meet the
specifications or not. It is simply an inspection activity to
identify whether the product is conforming or non-
conforming.
d) Service Quality Audit
Done to verify whether the services rendered meet the
procedure laid down in the quality manual. (Service to
customer satisfaction must be the motto to be established
by audit). 117
INTERNAL AUDIT

Stages of audit
- Adequacy audit / Document review audit
An exercise to determine the extend to
which the documented quality system
represented by the quality manual and the
associated procedures.
- Compliance audit
An audit to establish the extent to which the
documented system is implemented
118
INTERNAL AUDIT
Audit Process
Audits are expensive
Audits must be well managed
Audits must not be carried out by surprise
Always agree mutually convenient dates well in
advance
119
INTERNAL AUDIT
Audit Process
Audit Plan Preparation
Audit Schedule Preparation
Audit schedule Communication
Conduct Audit
Briefing the findings to auditee
Report preparation
Hand over Report to MR
120
INTERNAL AUDIT
Audit Checklist
 Audit checklists are used during the audit to collect the
information / evidence / notes
Benefits
 To assist memory
 Maintains continuity during the audit
 To ensure depth & continuity of the audit
 Help in time management
 Part of audit report
121
INTERNAL AUDIT
Auditing skills and approach

Skills required to conduct the effective audit :
 Time Management
 Fact Finding
 Audit Reporting
Relations between AUDITORS and AUDITEES are critical

for successful audit and the approach of the audit should
ensure that audit is conducted in a POSITIVE
ENVIRONMENT
122
INTERNAL AUDIT
Time Management
 Time is always short – avoid wasting time

 Plan well – use check list
 Do not allow your audit to get side tracked
 Remember an audit is a sampling activity
 Do not waste time on over friendly chatting
 Do not focus on trivial issues
123
INTERNAL AUDIT
Fact Finding
Collect Evidence
 Sufficient to determine conformance to the

audit criteria
 Through
- Interviews
- Examination of documents and records
- Observation of activities and conditions
124
INTERNAL AUDIT
Fact Finding
Collecting Evidence is one

important auditing skill –
Done through
- Observations
- Reading
- Communication
- Interviews
- Listening
- Use of check lists
125
INTERNAL AUDIT
Communication ( Important for Fact Finding)

 Know your auditee – could range from top
management to lowest level
 Keep the message simple – avoid complex
phrases and words
 Ensure the communication meets the objectives
 Consider the location and timing factor
 Use of most effective medium – could also be
usage of local language
126
INTERNAL AUDIT
Communication Skills
How do we communicate ?
- Verbal
- Using Body Language
- Through Facial Expressions
- Using different styles and sounds
Impact of communication is maximum

through body language
127
INTERNAL AUDIT
Factors affecting communication
 Physical Factors
 Environment Factors
 Intellectual Factors
 Emotional Factors
128
INTERNAL AUDIT
Factors affecting communication
Emotional Factors Intellectual Factors

- Ego - Concepts
- Confidence - Terminology
- Fear - Language
Physical Factors Environment Factors

- Hunger - Ventilation
- Thirst - Lighting
- Rest - Temperature
- Pain - Quality of print
129
INTERNAL AUDIT
Communication barriers
 Bad word choice

 Mumbling
 Outside distractions
 Poor listening or reading skills
 Lack of interest
130
INTERNAL AUDIT
Communication - Interviewing
 Hold interviews only during normal working
hours
 Put the auditee at ease
 Communicate the objective of the interview
 Show an interest in what THEY do
 Always start with open ended questions
 Verify the facts and records is as finding
 Avoid arguments
 Explain your observations
 Thank the auditee for participation and
opportunity for auditing
131
INTERNAL AUDIT
Communication – Interviewing Open end question
 Open end question can increase the amount of

information offered – start with them
 This shall ensure that the responder HAS to give
the information
-Can you please tell me what to do ?
-What are the aspects in your area
 Open questions are auditor friends
 Ask WHO , WHAT , WHERE , WHEN and HOW
questions
132
INTERNAL AUDIT
Communication – Interviewing Closed end question
 Avoid Closed Questions

 Closed questions yields only a simple YES / No
-Are you responsible for report preparation
-Have the objectives targets decided for the year?
 Instead of Ask
- Who is responsible for report preparation?
- What are the objectives and targets for the year ?
 Closed questing are limiting and reduce the amount
of information offered
133
INTERNAL AUDIT
Communication – Clarifying Questions
Intended to clarify , retrieve full information and

prevent misunderstanding , allowing to grasp full
picture
- can you show me another example please , I
think I am beginning to understand ?
- Sorry , I do not get you , could you please
explain that again please
Disadvantages :
If used too often may create impression that
you were not listening
Are time consuming
If you are prepared to listen in full don’t ask
them 134
INTERNAL AUDIT
Successful approach to audit
 Establish suitable climate

 Put Auditee at ease
 Use proper questioning techniques
 Use open questions and avoid closed
questions
 Be friendly and diplomatic
135
INTERNAL AUDIT
Positive Characteristics of Auditor
 Polite  Open Minded

 Friendly  Diplomatic
 Helpful  Honest
 Informative  Mature
 Judicious  Tactful
 Trained  Self disciplined
136
INTERNAL AUDIT
Negative Characteristics of Auditor
Argumentative Inflexible
Opinionated Lazy
Over conclusive Impractical
Inconsistent Know it all
Inconsiderate Indecisive
Untrained Uncommunicative
Accepts things at Unprofessional
face value
137
INTERNAL AUDIT
Auditor’s Qualities
 Auditor must be a good listener . Listen and Listen
with full attention
 Listen without your own judgment and conclusion
 Do not start teaching
 Active listening always assist auditee to give more
information
 Generate questions from what auditee says – this
possible only when auditor listens carefully
 Auditors should be situation manager
138
INTERNAL AUDIT
Sampling
No time to check everything
Select representative sample
No sampling calculation
Sample should represent all activities
Should be on random basis
Spot checking
Take permission before asking / taking samples
139
INTERNAL AUDIT
Observations
Keep observing the physical evidence
Example –Equipment in Production Area

-What is used for ?
-Need it to be calibrated ?
-Was it calibrated ?
-Is there a record ?
-What is the reading ?
-Is the reading within the acceptable range ?
-Identification ?
-Status with respect to measurement ?
-Storage location and condition
140
INTERNAL AUDIT
Reporting and audit conclusion
Definition
Requirements
- Need or expectation that is stated , generally implied
or obligatory
Conformity
- Fulfillments of a requirement
Non Conformity
- Non fulfillment of a requirement
Defect
- No fulfillment of a requirement related to intended use
Corrective Action
- Action to eliminate the cause of a detected non
conformity
141
INTERNAL AUDIT
Non conformity
Non Conformity
- Non fulfillment of a requirement
Non Conformity is established by

OBJECTIVE EVIDENCE
Intent a requirement has not been addresses
Implementation practice differs from the defined system
Effectiveness the practice is not effective
142
INTERNAL AUDIT
Categorizing Non Conformities

Major Non Conformity
- The absence or complete non fulfillment or
breakdown of the standard’s stated requirements
- A failure to achieve legal or statutory
requirements
Minor Non Conformity
- An isolated or sporadic lapse in the content or
implementation or procedures or records which could
reasonable lead to failure of the system , if not corrected
- isolated examples of measuring instrument

out of calibration date
143
INTERNAL AUDIT
Non Conformity Report Writing

 State the fact with the objective evidence
 Statement should be clear , unambiguous
 Refer the clause number and audit criteria against
which non conformity is established
 It should be trace up to verifiable status of facts
 Grade the non conformity as major or minor if it is
practiced in the organization
 It should be agreed , accepted and signed by the
auditee
 Other relevant details like location , auditee , date etc
should be mentioned.
144
INTERNAL AUDIT
Quality characteristics of a report

 Informative
 Factual
 Complete
 Accurate
 Precise
 Legibility
 Transparency
 Clarity
145
INTERNAL AUDIT
Timely Reporting
 Report without delay
 Don’t leave writing report till late
 Time never becomes available
 Prepare NCR’s on the spot
 Timely reporting adds value
146
INTERNAL AUDIT
Non Conformance Report

 Location / Area
 Category
 Objective Evidence
 Details of Nonconformance
 Details of corrective actions
 Details of preventive actions
 Follow up audit status
 Report Status
147
G.M.Pens International Pvt Ltd
NON - CONFORMANCE REPORT

( INTERNAL AUDIT )
Department : NCR No:

Area
Auditee : Date :
Nature of NonConformity : Adequacy Non-Conformity
Category Major
Category of Nonconrmance : Minor
Objective ISO Clause Ref : Document Ref :

Detail of Non - conformity
Nature of Non - Conformity
Evidence
Non conformance
Signature of Auditee Signature of Auditor
Agreed corrective action Responsibility
Details
Corrective action
Target Date: Signature of Auditee

details Proposed Preventive Action
Preventive action
Responsibility Target Date
Verification of Corrective Action ( Follow up Audit)
details
Verification Audit
Signature of Auditee Signature of Auditor( followup audit)
Verified Corrective Actions is Effective / Not Effective
Details
NCR Closed Yes / No
Report Status
To be discussed in management review Yes / No
148
Signature
INTERNAL AUDIT
Situation 1
The auditor enters the manufacturing area & identifies lots of filled
polythene bags kept.
Auditor : What is there inside these bags?
Auditee : These are moulded items which were
manufactured during sample production which
is done initially while developing new products.
149
INTERNAL AUDIT
Situation 2
While auditing the purchase department, auditor finds
that a P.O. for a particular raw material is given to a
new source.
Auditor: Why is this new source being identified?
Auditee: The existing source does not meet the required

specification of the materials, for which we are facing many
quality problems for the past one-month.
150
INTERNAL AUDIT
Situation 3
The Auditor while going through the Training records observed
that an employee attended an External Training Programme
conducted in May 2006. When enquired about the measurement
of effectiveness, Training manager says “ I maintain only record
of training. You have to ask the trainee for effectiveness.”
151
INTERNAL AUDIT
Situation 4
Auditor found some packed boxes laying in a corner of the
stores without having any identification.
When asked, the stores in-charge said that these are meant
for transport to godowns. Personnel doing routine truck
loading and all the stores personnel are aware of this.
152
INTERNAL AUDIT
Thank You
if any body wants more details pl mail me I will reply u
sivasankaran2001@yahoo.com
153

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ISO 9001:2000

QUALITY MANAGEMENT SYSTEM

“ THE TOTALITY OF FEATURES AND CHARACTERISTICS OF A PRODUCT OR

SERVICE THAT BEAR UPON ITS ABILITY TO SATISFY STATED OR IMPLIED

Customers’ expectations of quality are not the same for

different classes of products or services.

Best-in-class quality means being the best product or

service in a particular class of products or services.

Being a world-class company means that each of its products and

services are considered best-in-class by its customers.

Founded in 1946 in Geneva , Switzerland

ISO is a non-governmental organization that forms a bridge between

the public and private sectors.

ISO is composed of more than 90 members countries

country, whatever the language, the short form of the organization's

name is always ISO.

9001 - Number assigned by ISO

Measurement of the Measurement of the

Organizations Determine customer needs

Applying the principle of Customer Focus typically leads to

Leaders must set the direction of the

Leaders must create and maintain internal

Applying the principle of Leadership typically leads to

 Establishing a clear vision of the organization's

Must help people to develop and use their

Applying the principle of Involvement of people

 People understanding the importance of their

Input Activities Output

A desired result is more efficiently achieved when

Processes – understand interaction

Applying the principle of Process approach

 Identifying the interfaces of key activities within

System Approach to Management

Identifying, understanding and managing

Applying the principle of System approach to

 Providing a better understanding of the roles and

 Targeting and defining how specific activities within a

 Continually improving the system through

Continual improvement of the organization's overall performance

Applying the principle of continual improvement

 Providing people with training in the methods and tools of

Decision based on facts

Applying the principle of Decision based on the facts

 Ensuring that data and information are sufficiently accurate

Mutually beneficial supplier relationships

An organization and its suppliers are interdependent and a

Applying the principle of mutually beneficial

 Inspiring, encouraging and recognizing improvements and

•ISO 9001:2000 – Quality Management Systems:

•ISO 9004:2000 - Quality Management Systems:

•ISO 9000:2000 – Quality Management Systems:

•ISO 19011:200X – Guidelines for quality and/or

TWO TECHNICAL SUPPORT DOCUMENTS :

•ISO 1000x – Technical brochure - Selection & Use

•ISO 1000y - Principles and application of quality

4 Quality management system

Establish , document , implement and maintain a

4.1 General Requirements

4.1 General Requirements

Note: Processes needed for QMS include processes for

4.2 Documentation requirements

QMS documentation must include

• Statements of Quality Policy and Objectives