Professional Documents
Culture Documents
Familiarization Programme
Faculty :
Mr. K. Venkatasubramanian
October 2, 1
2019
Introduction ISO 9000:2000
October 2, 2
2019
ISO 9001:2000
Quality Management System
From Conformance to Performance
Presentation by:
Mr. K. Venkatasubramanian
October 2, 3
2019
Introduction ISO 9000:2000
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.
October 2, 5
2019
Introduction ISO 9000:2000
The revision of the standards as gone through the following stages before
issue as an international standard by ISO.
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
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
Major Changes in ISO 9001:2000
• 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
Major Changes in ISO 9001:2000
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
October 2, 17
2019
Leadership
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”
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
October 2, 24
2019
A Process
INPUTS The Process diagram OUTPUTS
People MONITOR
Product
Equipment
Service
Material PROCESS
Information
Methods
Records
Environment
October 2, 25
2019
Process Control System
• Detection v Prevention
– Prevention (Vaccination)
• before the event - avoids waste
October 2, 26
2019
Prevention
October 2, 27
2019
System approach to management
October 2, 28
2019
System approach to
management
October 2, 29
2019
System approach to management
The Systematic Approach
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
Terms and Definitions
• 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.
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2019
Terms and Definitions
• Effectiveness
Extent to which Planned activities are
Realized and Planned results achieved
• Efficiency
Relationship between the result Achieved
and the Resources used.
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2019
Terms and Definitions
• 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
Terms and Definitions
• 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
Prevention of nonconformities
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2019
1.2 Permissible exclusions NEW
October 2, 38
2019
Continuous Improvement
4. Quality Management System
5. Management Responsibilities
October 2, 39
2019
4 Quality management system
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2019
4.1 General requirements
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2019
4.2 Documentation
4.2.1 General requirements
October 2, 45
2019
4.2 Documentation
4.2.1 General requirements
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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;
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2019
4.2.3 Control of documents
October 2, 50
2019
4.2.4 Control of 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.
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2019
5.2 Customer focus
October 2, 54
2019
5.3 Quality policy
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.
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2019
5.5 Responsibility, authority,
and communication
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2019
5.5.1 Responsibility and
Authority
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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
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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
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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
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2019
5.6.3 Review output
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2019
6 Resource management
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2019
6.1 Provision of resources
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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.
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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).
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2019
6.3 Infrastructure
October 2, 71
2019
7 Product realization
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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
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2019
7.2 Customer - related
processes
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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
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2019
7.3.1 Design and development
planning
October 2, 81
2019
7.3.1 Design and development
planning
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2019
7.3.2 Design and development
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
7.3.3 Design and development
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
7.3.4 Design and development
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
7.3.5 Design and development
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.
October 2, 86
2019
7.3.6 Design and development
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.
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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
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
October 2, 100
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
7.6 Control of monitoring and
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
7.6 Control of monitoring and
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
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2019
8.1 General
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2019
8.2 Monitoring and
Measurement
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2019
8.2.1 Customer satisfaction
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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.
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2019
8.2.2 Internal audit
• 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
8.2.2 Internal audit
• 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.
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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.
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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.
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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.
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2019
8.3 Control of Non-conformances
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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.
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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.
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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
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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
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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.
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2019
8.5 Improvement
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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.
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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.
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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.
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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
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Thank You
for
being with us
October 2, 125
2019