Familiarization Programme: Faculty

ISO 9001:2000
Familiarization Programme
Faculty :
Mr. K. Venkatasubramanian
October 2, 1
2019
Introduction ISO 9000:2000
The ISO 9000 Family (series) of standards are a set of

International quality management standards and
guidelines since their initial publication in 1987, they
have earned a global reputation as the basis for
establishing a QUALITY MANAGEMENT SYSTEM
(QMS) in an organization.. This has resulted in the
certification of nearly 40,00,000 organizations world
wide with many more in the process of setting up and
implementing QMS.
October 2, 2
2019
ISO 9001:2000
Quality Management System
From Conformance to Performance
Presentation by:
Mr. K. Venkatasubramanian
October 2, 3
2019
In keeping with ISO protocols of reviewing all standards
atleast every five years, the 1994 version of ISO 9000
family have been revised by ISO’s Technical Committee
TC 176 for publication in December 2000.
Extensive survey have been carried out on a world wide basis

inorder to understand better the needs of all user groups of
the ISO 9000 standards. The new revisions will take into
account previous experience with Quality Management
Systems and emerging insights into generic management
systems. This will result in closer alignment of the Quality
Management System with the needs of the day to day
running of the organization.
October 2, 4
2019
It has long been recognized that investment in Quality
Management System, in addition to responding to
customer expectations, has resulted in benefits to the
efficiency of the organization, its operations and economic
performance as well as to the quality of its products &
services.
Specifically, the revised ISO 9000:2000 standards will be of
great help for organizations wishing to go beyond simple
compliance with QMS requirements for certification
purposes. These can be readily applied to tiny, small,
medium and large organization in public, private and joint
sectors and are equally applicable to users in all areas
including industrial, software, service etc.
October 2, 5
2019
The revision of the standards as gone through the following stages before
issue as an international standard by ISO.
1997 Working Draft 1 (WD 1)

1998 Committee Draft 1 (CD 1)
1999 Committee Draft 2 (CD 2)
1997 Draft International Standard (DIS)
1998 Final Draft International Standard (FDIS)
2001 International Standard Organization (ISO 9000-2000)
October 2, 6
2019
Standards - A history of
development
• NATO Standards AQAP’s 21, 24, 29
• BS 5179:1974
• BS 5750:1979
• ISO 9000:1987
• ISO 9001:1994
• ISO 9001:2000 (Dec 2000)

October 2, 7
2019
The new family of standards
• ISO 9000 Fundamentals
• ISO 9001 The requirements
• ISO 9004 Guidance
• ISO 19011 Auditing Quality & Environmental

systems
October 2, 8
2019
ISO 9000:2000 family of standards
Reasons for Revision
• ISO Protocols require review of Standards every
five years to either
– Confirm or
– Revise or
– Withdraw
• Changed Customer / User needs based on
experiences of 1994 version and global survey
conducted in 1997.
October 2, 9
2019
ISO 9000:2000 family of standards
Reasons for Revision
• Need to improve performance continuously by
focussing on major processes in the organisation.
• Need to monitor Customer Satisfaction.
• Promoting use of Quality Management Principles
• Need for consistency between QMS requirement
and guidelines
• Need to restructure the Standards.
October 2, 10
2019
Major Changes in ISO 9001:2000
• Quality Management instead of Quality Assurance
• ISO 9001, 9002 & 9003 combined into one Standard
• New Process oriented structure
• Increased emphasis on the role of Top Management
• Significant reduction in mandatory documentation
• Terminology Changed and Improved to make it user
friendly
• Increased compatibility with ISO 14000 family of
Standards
October 2, 11
2019
• Establishment of Measurable Objectives at Relevant
Levels and Functions
• Input to Output from Management Review Meetings
has been defined
• Additional role of Management Representative (MR)
to promote awareness of Customer Requirements
throughout the Organisation.
• Increased attention to Resource Management and its
availability
• Restructuring of ISO 9000 family Standards.
October 2, 12
2019
32 Clauses of ISO 9001 : 2000 are divided into
five main clauses as given below:
• Clause 4 -
Quality Management System
• Clause 5 -
Management Responsibility
• Clause 6 -
Resource Management
• Clause 7 -
Product Realisation
• Clause 8 -
Measurement, Analysis and
Improvement
• ISO 9001 & ISO 9004 now a consistent pair of
Standards
October 2, 13
2019
New Requirements in
ISO 9001 : 2000
• Focus on Customer Satisfaction
• Stress on Continual Improvement
• Concept of Permissible Exclusions
• Consideration of Regulatory Requirement
(Legal and Statutory)
• Specific reference to Quality Management
Principles
October 2, 14
2019
New Requirements in
ISO 9001 : 2000
• Internal Communication
• Customer Communication
• Measurement and Monitoring extended to
Process
• Analysis of Data
October 2, 15
2019
Management Principles
ISO 9001:2000
• Customer focus
• Leadership
• Involvement of people
• Continual Improvements
• Factual approach to decision making
• Mutually beneficial supplier relationships
• Process approach
• System approach to management
October 2, 16
2019
Customer focus
• You DEPEND ON the customer

• Need to understand current & future needs
• Meet customer requirements
• Strive to exceed customer expectations
October 2, 17
2019
Leadership
• Leaders establish the vision and direction

• Create the environment for people to
become fully involved in achieving goals &
objectives
October 2, 18
2019
Involvement of people
• People at ALL levels are the company
• Their involvement will enable their skills &
abilities to be used for company’s maximise
benefits
the
TEAM
October 2, 19
2019
TEAM WORK
A TEACHER TALKED TO SOME CHILDREN ABOUT MAKING AND FLYING KITES AND
QUOTED THE FOLLOWING LINES :
Who flies the kite?
“I” said the boy, “It is my Joy!
I fly the kite”
Who flies the kite?

“I” said the wind, “It is my whim!
I fly the Kite!”
Who flies the kite?

“I” said the string, “I am the thing,
That flies the kite”
Who flies the kite?

“I” said the tail, “I make it sail!
I fly the kite”
Who flies the kite?

All are wrong.
October 2, All are right. 20
2019 All fly the kite!!!
TEAM WORK
Finally to remember
If you think it doesn’t pay to stick together,

consider the banana. As soon as it leaves
the bunch it gets skinned.
October 2, 21
2019
Continual Improvements
(DEMING WHEEL)
• A permanent objective to continually improve
Do
• PDCA - Plan - Do - Check - Action
Plan Check
Can we do it better ??
Action
October 2, 22
2019
Factual approach to decision
making
• Effective decisions are based on the logical or
intuitive analysis of data & information
Collect data Pareto 80/20 rule

(Brain Storming) (Vital Few & Trivial Many)
October 2, 23
2019
Process Approach
• Results are achieved more efficiently when
resources & activities are managed as a
process
October 2, 24
2019
A Process
INPUTS The Process diagram OUTPUTS
People MONITOR
Product
Equipment
Service
Material PROCESS
Information
Methods
Records
Environment
Managing the inputs - Prevention Checking - Detection
October 2, 25
2019
Process Control System
• Detection v Prevention
– Detection (Fire Fighting)

• after the event - tolerates waste
– Prevention (Vaccination)
• before the event - avoids waste
October 2, 26
2019
Prevention
• Are we capable of doing the job correctly

– We need to know and understand the Process
October 2, 27
2019
System approach to management
• Identifying, understanding & managing

a system of interrelated processes for a
given objective contributes to the
effectiveness & efficiency of the
company
October 2, 28
2019
System approach to
management
October 2, 29
2019
System approach to management
The Systematic Approach
• What steps to take

• Measure what we do (Quality)
• So that we can Manage more effectively
(Quality)
• What system can we use?
October 2, 30
2019
Terms and Definitions
• Quality (Customer Delight)
Degree to which set of inherent
Characteristics fulfills requirements
• Quality Management System
Management(Coordinated Activities)
system(Set of interacting elements) to direct
and control an Organization with regard to
Quality
October 2, 31
2019
• Quality Control
Part of Quality Management focussed on
fulfilling Quality requirements
• Quality Assurance
Part of Quality Management focussed on
providing confidence that Quality
requirements will be fulfilled.
October 2, 32
2019
• Effectiveness
Extent to which Planned activities are
Realized and Planned results achieved
• Efficiency
Relationship between the result Achieved
and the Resources used.
October 2, 33
2019
• Process
Set of interrelated or Interacting activities
which transforms input into output
• Product
Result of a Process
• Procedure
Specified way to carryout an activity or a
process
October 2, 34
2019
• Document
Information and its Supporting Medium
• Record
Documents stating result achieved or
providing evidence of activity performed
October 2, 35
2019
Quality Management Systems
ISO 9001:2000
Quality Management System Standard
October 2, 36
2019
1.1 Scope
To demonstrate the ability to provide consistent
products & meet regulatory requirements
To address Customer satisfaction by effective

application of the system
Process for continual Improvement
Prevention of nonconformities
October 2, 37
2019
1.2 Permissible exclusions NEW
• Limited to clause 7 Product Realisation

Inputs The Process Activities Outputs
• Exclusions cannot affect the ability to

produce acceptable product that meets:
Customer requirements
Applicable regulatory requirements
October 2, 38
2019
Continuous Improvement
4. Quality Management System
5. Management Responsibilities
6 Resource management 8. Measurement, analysis

& improvements
INPUTS
OUTPUTS
7 Product realisation
October 2, 39
2019
4 Quality management system
October 2, 40
2019
4.1 General requirements
• The organisation shall

– establish,
– document,
– implement,
– maintain and
– continually improve in accordance with the
International Standard.
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2019
• To implement the organisation shall:
 identify the processes needed for QMS and

their application throughout the organisation
 determine the sequence and interaction of these
processes
 determine criteria and methods required to
ensure that both the operation and control of
these processes are effective
October 2, 42
2019
 availability of resources & information
necessary to support the operation and
monitoring of these processes
 measure, monitor and analyse these
processes, and
 implement action necessary to achieve
planned results and continual improvement.
The organisation shall manage these processes
in accordance with the requirements of this
October 2, International Standard. 43
2019
Where an organisation chooses to outsource any
processes that affects the product conformity with
requirements, the organisation shall ensure control
over such processes. Control of such outsourced
processes shall be identified within the QMS.
NOTE Processes needed for QMS referred to above should

include processes for management activities, provision of
resources, product realisation and measurement.
October 2, 44
2019
4.2 Documentation
4.2.1 General requirements
• The quality management system

documentation shall include:
 documented statements of a Quality Policy &
Objectives
 Quality manual
 procedures required by this International
Standard.
October 2, 45
2019
4.2 Documentation
4.2.1 General requirements
• documents required by the organisation to

ensure the effective planning, operation and
control of its processes, and
 records required by this International
Standard.
NOTE 1 Where the term “documented
procedure” appears within this International
Standard, means procedure has to be
October 2, established, implemented and maintained. 46
2019
4.2 Documentation requirements
NOTE 2 The extent of the quality management
system documentation can differ from one
organisation to another due to
 size of the organisation and type of activities,

 complexity and interaction of the processes;
 competence of personnel.
NOTE 3 The documentation can be in any form

or type of medium
October 2, 47
2019
4.2.2 Quality Manual
• A quality manual shall be established and maintained

that includes the following:
• the scope of the quality management system,
including details of, and justification for, any
exclusions (see 1.2);
• documented procedures or reference to them;
• a description of the interaction between the
processes of QMS.
October 2, 48
2019
4.2.3 Control of documents
• Documents required for the quality management system
shall be controlled. Records are a special type of document
and shall be controlled according to the requirements given
in 4.2.4.
• A documented procedure shall be established:
 to approve documents for adequacy prior to issue;
 to review, update as necessary and re-approve
documents;
 to ensure that changes and current revision status of
documents are identified;
 to ensure that relevant versions of applicable documents
are available at points of use;
October 2, 49
2019
4.2.3 Control of documents
 to ensure that documents remain legible, readily

identifiable and retrievable;
 to ensure that documents of external origin are
identified and their distribution controlled;
 to prevent the unintended use of obsolete documents,
and to apply suitable identification to them if they are
retained for any purpose.
October 2, 50
2019
4.2.4 Control of records
• Records shall be established and maintained to provide

evidence of conformity;
• Records shall remain legible, readily identifiable and
retrievable;
• A documented procedure shall be established for
controls needed for identification, storage, retrieval,
protection, retention time and disposition of quality
records.
October 2, 51
2019
5 Management responsibility
October 2, 52
2019
5.1 Management commitment
• Top management shall provide evidence of its commitment
to the development and implementation of QMS and
continually improving its effectiveness by:
 communicating to the organisation the importance of
meeting customer as well as regulatory and legal
requirements;
 establishing the quality policy and quality objectives;
 conducting management reviews;
 ensuring the availability of necessary resources.
October 2, 53
2019
5.2 Customer focus
• Top management shall ensure that customer

requirements are determined, converted into
requirements and fulfilled with the aim of achieving
customer satisfaction (see 7.2.1 and 8.2.1).
October 2, 54
2019
5.3 Quality policy
• Top management shall ensure that the quality policy:

 is appropriate to the purpose of the organisation;
 includes a commitment to meeting requirements and
to continual improvement;
 provides a framework for establishing and
reviewing quality objectives;
 is communicated and understood at appropriate
levels in the organisation;
 is reviewed for continuing suitability.
October 2, 55
2019
5.4 Planning
October 2, 56
2019
5.4.1 Quality objectives
• Quality objectives shall include those needed
to meet requirements for product (see 7. 1a),
are established at relevant functions and levels
within the organisation.
• The quality objectives shall be
– measurable,
– consistent with the quality policy including
– commitment to continual improvement.
October 2, 57
2019
5.4.2 Quality Management
System Planning
• Quality planning shall ensure that:
 the planning of the policy management system is
carried out to meet the requirements given in clause
4.1, as well as quality objectives, and
– the integrity of the quality management system is
maintained when changes to the quality
management system are planned and implemented.
October 2, 58
2019
5.5 Responsibility, authority,
and communication
October 2, 59
2019
5.5.1 Responsibility and
Authority
• Top management shall ensure that

responsibilities and authorities are
defined and communicated within the
organisation.
October 2, 60
2019
5.5.2 Management representative
• Top management shall appoint a member of the
management team who, irrespective of other
responsibilities, shall have responsibility and authority that
includes:
 ensuring that processes needed for the quality
management system are established and maintained;
 reporting to top management on the performance of the
quality management system, and any need for
improvement;
 ensuring the promotion of awareness of customer
requirements
NOTE The responsibility includes liaison with external
parties on matters relating to the QMS
October 2, 61
2019
5.5.3 Internal communication
• The organisation shall ensure that
appropriate communication processes are
established within the organisation and
that communication takes place regarding
the effectiveness of the quality
management system.
Department A Department B
October 2, 62
2019
5.6 Management review
5.6.1 General
• Top management shall review the quality management
system, at planned intervals, to ensure its continuing
suitability, adequacy and effectiveness.
• The review shall evaluate the need for changes to the
organisation's quality management system, including
quality policy and quality objectives.
• Records from review shall be maintained
October 2, 63
2019
5.6.2 Review input
• Inputs to management review shall include information on:
 results of audits;
 customer feedback;
 process performance and product conformance;
 status of preventive and corrective actions;
 follow-up actions from earlier management reviews;
 changes that could affect the quality management
system.
 Recommendations for improvement
October 2, 64
2019
5.6.3 Review output
• The output from the management review shall include

decisions and actions related to:
 improvement of the effectiveness management
system and its processes;
 improvement of product related to customer
requirements;
 resource needs.
October 2, 65
2019
6 Resource management
October 2, 66
2019
6.1 Provision of resources
• The organisation shall determine and

provide the resources needed:
 to improve and maintain the quality
management system and continually improve
its effectiveness, and
 to enhance customer satisfaction by meeting
customer requirements.
October 2, 67
2019
6.2 Human resources
• 6.2.1 General
• Personnel performing work affecting
product quality shall be competent on the
basis of applicable education, training, skills
and experience.
October 2, 68
2019
6.2.2 Competency, awareness
and training
• The organisation shall:
 determine competency needs for personnel performing
work affecting product quality;
 provide training, or other actions, to satisfy these needs;
 evaluate the effectiveness of the actions taken;
 ensure that its employees are aware of the relevance
and important of their activities and how they
contribute to the achievement of the quality objectives;
and
 maintain appropriate records of education, training,
skills and experience (see 4.2.4).
October 2, 69
2019
6.3 Infrastructure
The organisation shall identify, provide, and

maintain the infrastructure needed to achieve
conformity to product requirements.
Infrastructure includes as applicable:
 buildings, workspace and associated
utilities;
 process equipment (hardware and software);
 supporting services (transport,
communication, etc).
October 2, 70
2019
6.4 Work environment
• The organisation shall determine and

manage the work environment needed to
achieve conformity to product requirements.
October 2, 71
2019
7 Product realization
October 2, 72
2019
7.1 Planning of Product
realization
• The organisation shall plan and develop needed for product
realisation and it shall be consistent with the requirements of other
processes of QMS.
• The organisation shall determine the following as appropriate:
– quality objectives and requirements for the product
– need to establish processes, documents, and provide resources
specific to the product
– required verification, validation, monitoring, inspection and test
activities specific to the product and the acceptance criteria
– records to provide evidence that the realisation processes and
the resulting product meet requirements
October 2, 73
2019
7.1 Planning of Product
realization
• The organisation shall plan and develop needed for product
realisation and it shall be consistent with the requirements of other
processes of QMS.
• The organisation shall determine the following as appropriate:
– quality objectives and requirements for the product
– need to establish processes, documents, and provide resources
specific to the product
– required verification, validation, monitoring, inspection and test
activities specific to the product and the acceptance criteria
– records to provide evidence that the realisation processes and
the resulting product meet requirements
The Planning output shall be in a form suitable for the methods of
operation of the organisation
October 2, 74
2019
7.2 Customer - related
processes
October 2, 75
2019
7.2.1 Determination of
customer requirements
• The organisation shall determine:
– customer specified requirements including requirements for
delivery and post-delivery activities
– requirements not specified by the customer but necessary for
intended or specified use
– Statutory and regulatory and requirements related to the product
– any additional requirements determined by the organisation
October 2, 76
2019
7.2.2 Review of requirements
related to the Product
• The organisation shall review the requirements related to
the product
• The review shall be conducted prior to the commitment to
supply a product to the customer (e.g. submission of a
tender, acceptance of a contract or order) to ensure that:
– product requirements are defined
– contract or order differences are resolved
– the organisation has the ability to met the defined requirements
• Records of the review shall be maintained
Where the customer provides no documented statement of
requirements, the same shall be confirmed by the
organisation before acceptance.
October 2, 77
2019
7.2.2 Review of requirements
related to the Product
The organisation shall ensure that:
– where requirements are changed, relevant
documentation is amended.
– relevant personnel are made aware of the changed
requirements.
October 2, 78
2019
7.2.3 Customer
communication
• The organisation shall identify and implement
arrangements for communication with
customers relating to:
 product information;
 enquiries, contracts or order handling, including
amendments;
 customer feedback, including customer complaints.
October 2, 79
2019
7.3 Design and development
October 2, 80
2019
7.3.1 Design and development
planning
• The Organisation Shall plan and control design and

development of the product. Design and development
planning shall determine:
 the design and development stages
 review, verification and validation activities
appropriate to each design and development stage
October 2, 81
2019
planning
 responsibilities and authorities for design and

development activities.
 interfaces between different groups involved in
design and development shall be managed to
ensure effective communication and clarity of
responsibilities.
• Planning output shall be updated, as appropriate, as
the design and development progresses.
October 2, 82
2019
inputs
• Inputs requirements shall be determined and recorded.
These inputs shall include:
 functional and performance requirements;
 applicable statutory and regulatory requirements;
 applicable information derived from previous similar
designs, and
 other requirements essential for design and
development.
• Inputs shall be reviewed for adequacy. Incomplete,
ambiguous or conflicting requirements shall be resolved
October 2, 83
2019
outputs
• The outputs shall be provided in a manner that enables
verification against the design and development inputs.
• Output shall:
 meet the input requirements
 provide appropriate information for purchasing,
production, and service operations
 contain or reference product acceptance criteria
 specify the characteristics that are essential for safe and
proper use.
Output documents shall be approved prior to release.
October 2, 84
2019
review
• At suitable stages, systematic reviews shall be conducted
to:
 evaluate the ability of the results of the design
process to meet requirements;
 identify problems and propose necessary actions.
• Participants shall include representatives of functions
concerned with the design stage(s) being reviewed.
• Results of the reviews and any necessary actions shall be
recorded
October 2, 85
2019
verification
• Verification shall be performed to ensure
that the design outputs meets the input
requirements.
• The results of the verification and any
necessary actions shall be recorded.
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2019
validation
• Validation shall be performed to confirm that resulting
product is capable of meeting the requirements for the
intended use.
• Wherever applicable, validation shall be completed prior to
the delivery or implementation of the product.
• Validation records shall be maintained.
October 2, 87
2019
7.3.7 Control of design and
development changes
Design and Development changes shall be identified and
records maintained.
• Changes shall be verified and validated, and approved
before implementation.
• Control includes evaluation of the effect of the changes
on constituent parts and products already delivered.
• The results of the review of changes and any necessary
actions shall be maintained.
October 2, 88
2019
7.4 Purchasing
October 2, 89
2019
7.4.1 Purchasing process
• Shall control purchasing processes to ensure purchases
product conforms to requirements.
• The type and extent of control shall be dependent upon the
effect on subsequent realisation processes and to the final
product.
• The organisation shall evaluate and select suppliers, in
accordance with specified criteria, based on their ability to
supply in accordance with the requirements.
• Records of evaluation and necessary action shall be
maintained
October 2, 90
2019
7.4.1 Purchasing control
• Criteria for supplier selection and periodic

evaluation shall be defined.
• The results of evaluations and any
necessary actions arising shall be recorded.
October 2, 91
2019
7.4.2 Purchasing information
• Purchasing documents shall contain information describing
the product to be purchased, including where appropriate:
 requirements for product, procedures, processes
and equipment,
 Requirement for qualification of personnel, and
 quality management system requirements.
• Shall ensure the adequacy of specified requirements
contained in the purchasing documents prior to their
communication to the supplier.
October 2, 92
2019
7.4.3 Verification of purchased
products
• Shall identify and implement the activities necessary for
verification.
• Where the organisation or its customer proposes to
perform verification activities at the supplier's premises,
the organisation shall specify the intended verification
arrangements and method of product release in the
purchasing information.
October 2, 93
2019
7.5 Production and service
provision
October 2, 94
2019
7.5.1 Control of Production and
Service Provision
• The organisation shall control operations through:
 the availability of information that specifies the
characteristics of the product;
 where necessary, the availability of work instructions;
 the use of suitable equipment
 the availability and use of measuring and monitoring
devices.,
 the implementation of monitoring activities;
 the implementation of release, delivery and post-
delivery activities.
October 2, 95
2019
7.5.2 Validation of processes for
Production and Service
Provision
• Shall validate any processes for production and service
processes where the resulting output cannot be verified
by subsequent measurement or monitoring.
• This includes any processes where deficiencies may
become apparent only after the product is in use or the
service has been delivered.
October 2, 96
2019
7.5.2 Validation of processes
for Production and Service
Provision
• Validation shall demonstrate the ability of the processes to
achieve planned results by the following, as applicable:
 Defined criteria for review and approval of the
processes;
 Approval of equipment and qualification of personnel;
 use of defined methodologies and procedures;
 requirements for records;
 re-validation
October 2, 97
2019
7.5.3 Identification and
Traceability
• Shall identify, where appropriate, the product by suitable
means throughout product realisation.
• Shall identify the status of the product with respect to
measurement and monitoring requirements.
• Shall control and record the unique identification of the
product, where Traceability is a requirement.
October 2, 98
2019
7.5.4 Customer property
• Shall exercise care with customer property, while it

is under the organisations control.
• Shall identify, verify, protect and safeguard
customer property provided for use or
incorporation into the product.
• If customer property is lost, damaged or otherwise
found to be unsuitable for use shall be recorded and
reported to the customer.
NOTE Customer property may include intellectual
property (e.g. information provided in
confidence).
October 2, 99
2019
7.5.4 Preservation of product
• Shall preserve conformity of product with customer
requirements during internal processing and final delivery
to the intended destination.
• Include identification, handling, packaging, storage and
protection. Shall also apply to the constituent parts of a
product.
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2019
7.6 Control of monitoring and
measuring devices
• Shall identify the measurements to be made and the
monitoring and measuring devices required to assure
conformity of product to specified requirements.
• Processes shall be established to ensure that monitoring
and measurement are carried out in a manner that is
consistent with the monitoring and measurement
requirements.
October 2, 101
2019
measuring devices
• Where applicable, monitoring and measuring devices shall:
 be calibrated and adjusted periodically or prior to use,
against measurement standards traceable to
international or national measurement standards; where
no such standards exist, the basis used for calibration
shall be recorded;
 Be adjusted or re-adjusted as necessary;
 be identified to enable the calibration status to be
determined
October 2, 102
2019
measuring devices
 be safeguarded from adjustments that would invalidate
the calibration
 be protected from damage and deterioration during
handling, maintenance and storage;
 have the results of their calibration recorded;
 have the validity of previous results re-assessed if they
are subsequently found to be out of calibration, and
corrective action taken.
Software used for measuring and monitoring of specified
requirements shall be validated prior to use.
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2019
8 Measurement, analysis and
improvement
October 2, 104
2019
8.1 General
• Shall define, plan and implement the monitoring,

measurement, analysis and improvement processes:
– needed to ensure conformity of the product
– needed to ensure conformity of the quality management
system
– needed to continually improve the effectiveness of the quality
management system
• Shall include the determination of applicable methods,
including statistical techniques, and the extent of their
use.
October 2, 105
2019
8.2 Monitoring and
Measurement
October 2, 106
2019
8.2.1 Customer satisfaction
• Shall monitor information on customer satisfaction and/or

dissatisfaction as one of the measurements of performance
of the quality management system.
• The methodologies for obtaining and using this
information shall be determined.
October 2, 107
2019
8.2.2 Internal audit
• Conduct internal audits at planned intervals to determine
whether the quality management system.
• Conforms to the Planned arrangements to the requirements
of this International standard and to the QMS requirements
established.
• Is effectively implemented and maintained.
October 2, 108
2019
• Audit Programme shall be planned, taking into
consideration the status and importance of the process and
areas to be audited, as well as results of previous audits.
• The audit scope, frequency and methodologies shall be
defined
• Shall be conducted by personnel other than those who
performed the activity being audited.
• Documented procedure shall include the responsibilities
and requirements for conducting audits, ensuring their
independence, recording results and reporting to
management.
October 2, 109
2019
• Management shall take timely corrective action on
deficiencies found during the audit.
• Follow-up actions shall include the verification of the
implementation of corrective action, and the reporting of
verification results.
October 2, 110
2019
8.2.3 Monitoring and
measurement of processes
• Shall apply suitable methods for measurement and
monitoring of the management system processes necessary
to meet customer requirements.
• When results are not achieved, corrective actions shall be
implemented.
October 2, 111
2019
8.2.4 Monitoring and
measurement of product
• Measure and monitor the characteristics of the product to
verify that requirements are met.
• Carried out at appropriate stages of the process.
• Evidence of conformity with the acceptance criteria shall
be documented.
October 2, 112
2019
8.2.4 Measurement and
monitoring
• Records shall indicate the authority responsible for release
of product
• Product release and service delivery shall not proceed until
all the specified activities have been completed, unless
otherwise approved by the customer.
October 2, 113
2019
8.3 Control of Non-conformances
October 2, 114
2019
8.3 Control of nonconforming
product
• Product which does not conform is identified and
controlled to prevent unintended use or delivery.
• Defined in a documented procedure.
• Nonconforming product shall be corrected and subject to
re-verification after correction to demonstrate conformity.
October 2, 115
2019
8.3 Control of nonconformity
• When nonconforming product is detected after delivery or
use has started, appropriate action shall be taken regarding
the consequences of the nonconformity.
• The proposed rectification of non-conforming product be
reported for concession to the customer, the end user,
regulatory body or other body.
October 2, 116
2019
8.3 Control of nonconformity
• Non-conforming product shall be :
– reworked to met the original requirements
– re-graded or re-categorised
– the subject of a concession
October 2, 117
2019
8.4 Analysis of data
• Collect and analyse appropriate data to determine
the suitability and effectiveness of the
management system and to identify where
continual improvements may be made.
• Data generated by measuring and monitoring
activities and other relevant sources
October 2, 118
2019
8.4 Analysis of data
• Shall analyse this data to provide information on:
 customer satisfaction and/or dissatisfaction;
 conformance to customer requirements;
 characteristics of processes, products and
opportunities for preventive action
 suppliers.
October 2, 119
2019
8.5 Improvement
October 2, 120
2019
8.5.1 Continual improvement
The organisation shall continually improve the
effectiveness of the management system through the
use of:
– the quality policy
– quality objectives
– audit results
– analysis of data
– corrective and preventive actions
– management review.
October 2, 121
2019
8.5.2 Corrective action
• The organisation shall take action to eliminate the
cause of nonconformities in order to prevent
recurrence.
• Corrective action shall be appropriate to the effect
of the non-conformities encountered.
October 2, 122
2019
8.5.2 Corrective action
• A documented procedure shall be established to define
requirements for:
 reviewing non-conformities (including customer
complaints),
 determining the causes of nonconformity;
 evaluating the need for actions to ensure that
nonconformities do not recur,
 determining and implementing the corrective action
needed;
 recording results of action taken;
 reviewing of corrective action taken.
October 2, 123
2019
8.5.3 Preventive action
• Preventive action to eliminate the causes of potential
nonconformities to prevent occurrence and be appropriate
to the effects of the potential problems.
• A documented procedure shall define
 identifying potential nonconformities and their causes
 evaluating the need for action to prevent occurrence of
non-conformities
 determining and implementing the actions needed
 recording results of action taken
 reviewing preventive action taken
October 2, 124
2019
Thank You
for
being with us
October 2, 125
2019

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ISO 9001:2000

The ISO 9000 Family (series) of standards are a set of

Extensive survey have been carried out on a world wide basis

1997 Working Draft 1 (WD 1)

• ISO 9001:2000 (Dec 2000)

• ISO 9001 The requirements

• ISO 9004 Guidance

• ISO 19011 Auditing Quality & Environmental

• You DEPEND ON the customer

• Leaders establish the vision and direction

Who flies the kite?

Who flies the kite?

Who flies the kite?

Who flies the kite?

If you think it doesn’t pay to stick together,

Collect data Pareto 80/20 rule

Managing the inputs - Prevention Checking - Detection

– Detection (Fire Fighting)

• Are we capable of doing the job correctly

• Identifying, understanding & managing

• What steps to take

To address Customer satisfaction by effective

Process for continual Improvement

• Limited to clause 7 Product Realisation

• Exclusions cannot affect the ability to

6 Resource management 8. Measurement, analysis

• The organisation shall

 identify the processes needed for QMS and

NOTE Processes needed for QMS referred to above should

• The quality management system

• documents required by the organisation to

 size of the organisation and type of activities,

NOTE 3 The documentation can be in any form

• A quality manual shall be established and maintained

 to ensure that documents remain legible, readily

• Records shall be established and maintained to provide

• Top management shall ensure that customer

• Top management shall ensure that the quality policy:

• Top management shall ensure that

• The output from the management review shall include

• The organisation shall determine and

The organisation shall identify, provide, and

• The organisation shall determine and

• The Organisation Shall plan and control design and

 responsibilities and authorities for design and

• Criteria for supplier selection and periodic

• Shall exercise care with customer property, while it

• Shall define, plan and implement the monitoring,

• Shall monitor information on customer satisfaction and/or

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