Fitness for use

 Conformance to requirements
 Accuracy
 Perfection
 Zero Defect
 Adequacy
 Cost Effectiveness

“ DEGREE TO WHICH INHERENT CHARACTERISTICS FULFILLS REQUIRMENTS “

“ THE TOTALITY OF FEATURES AND CHARACTERISTICS OF A PRODUCT OR SERVICE THAT BEAR UPON

ITS ABILITY TO SATISFY STATED OR IMPLIED NEEDS “

2
Quality does not occur by accident
 Identify, understand and agree
customer requirements

 Plan to achieve them

 Measure, monitor & control
processes/activities

 REQUIRES A SYSTEM
Understanding the customer requirements

“Look lady...you’re the one who asked for a famous film star with
dark hair, strong nose and deep set eyes...”
Quality does not occur by accident

 Identify, understand and agree

customer requirements
 Plan to achieve them
 Measure, monitor & control
processes/activities

 REQUIRES A SYSTEM
Quality does not occur by accident

 Identify, understand and agree

customer requirements
 Plan to achieve them
 Measure, monitor & control
processes/activities

 REQUIRES A SYSTEM
 A group of interacting, interrelated, or
interdependent elements forming a
complex whole
 Set of detailed methods ,procedures and
routines established or formulated to
carry out a specific activity , perform a
duty , or solve a problem
Quality Management System
A System of coordinated activities which is meant to “direct”
and “control” an organization with regard to quality .
 Objectives of the process? Measurement and steering?
1 4
?

Which contributes to the goals

Results of the process?
of the organization?

Process set-up? Resources and

conditions?

Risks?

2 3
International Organization for Standardization
I SO1 4
Founded in 1946 in Geneva , Switzerland 001

ISO 9000
ISO is a non-governmental organization that forms a bridge between the public
SA80
and private sectors. 00

World's largest developer and publisher of International Standards.

OHSAS1
8001
Approximately There are 170 members one from each country of the world
0
 "ISO", derived from the Greek. ISO, meaning "equal". Whatever the country, QS9

whatever the language, the short form of the organization's name is always ISO.

 "ISO", is a system audit not for product audit

 1. Simple to use. 2. Clear in language.

3. Focus on customer satisfaction. 4. Process management model.

5. Greater orientation towards continual improvement.

 SOME OF THE OTHER STANDARDS :
1. ISO- 9000:2000 rev. 9000:2005 QMS - Quality Fundamentals Vocabulary.
2. ISO- 9001:2008 QMS - Quality Management Requirements.
3. ISO- 9004:2000 QMS - Guidelines for performance improvements.
4. ISO- 14001:1996 Revision ISO 14001:2003 EMS –Environmental Mgmt.
System.
5. ISO- 19011 Part 1/2/3 –1990/1991 Guidelines for Auditing Quality System.
6. HACCP (Hazard Analysis & Critical Control Points) Revision ISO22000:2005.
(For FOOD SAFETY )
7. BS 18001(OHASH) – Occupational Health & Safety Mgmt. System.
8. QS – 9000/ TS – 16949 – Quality Std. for Automobiles Industries.
9. ISO- 13485 – Quality Std. For Medical Devices.
10. CE Marking – Conformity of European Standards. ( FOR PRODUCT )
a. Relationship between ISO and BIS
Being a National Standard Institute BIS (Bureau of Indian Standard) is a
member body of ISO (International Organization for Standardization )
representing India.

b. Difference between ISO & ISI

ISO - International Organization for standardization ISO – is for the

organization certification ( Certificates are issued by external certification
body).

ISI – Indian Standard Institute - ISI is for product certification . ( Certificates are

issued by BIS (Bureau of Indian Standard).

BIS (Bureau of Indian Standard) is the member of Technical Committee TC /

176 At Geneva.
 It helps the unit in putting its house in order, in terms of clarity of all
operation.
 It help that customers to feel confident about their internal quality
assurance system.
 It brings a positive change in work culture.
 It is proved that only one quality management system can satisfy the
requirement of various customers.
 quality cost reduces and hence increases profit.
 It ensure quality and production can be increased.
 Being globally accepted third-party certification scheme, it eliminates
frequent second party assessments, required earlier by the customers.
 Increase bottom line result and profitability with optimum use of resources.
 Enhance customers, stake holder and interested parties satisfaction.
A. FOR THE COMPANY :-
1. Consistent Quality Products and Internal Recognition.
2. Cost savings – Improvement in production efficiency and reduction in rejection.
3. Raw materials components quality can improve – adequate control over suppliers.
4. Exporters place a premium – preferential treatment from potential customers.
5. New business can be increased – company is recognized in a better way.
6. Company will get greater customer reliability –customer requirements / needs are
satisfied.
7. Company can use ISO – for publicity , marketing , advertising to win more sales.
B. FOR THE CUSTOMER :-
1. Customer will receive product or services of best quality – as QMS is followed.
2. Customer will have more confidence in the company’s products – as QMS is followed.
3. Customer can save frequent visits at suppliers premises because of efficient QMS.
C. FOR THE EMPLOYEES :-
1. Better understanding in their role and objectives.
2. Reduces stress levels, because of efficient Management Systems.
3. Their morale and sense of pride will rise when they achieve ISO and customers
satisfaction.
4. New staff will be trained and learn the job immediately because every thing is in system.
5. More profits more benefits to the employees.
 Quality System &
Standard Development
• Quality means expense
• Quality Systems are expensive nice to have
• Good Quality is high specification
• Quality Control about testing and checking
• Quality is the responsibility of the Quality
Department
• Quality comes from Inspection
• Inspection was once considered the normal means of
attaining quality
• Inspection has been proved to be expensive as it is
always performed after the problem has occurred
• Inspection does not always find all the faults and
there is a risk that faulty items can be received by
the customer
• As there is always a delay between the problem
happening and the inspection it means that many
more faulty items can be produced at cost
• Quality planning is carried out to plan exactly how
consistent quality can be achieved
• Quality planning is less expensive as it involves a
few peoples’ time and does not tie up the
production line equipment and staff or waste
materials
• Controlling suppliers and getting them to ensure
the quality of the supplies is cheaper and more
reliable than inspection
• Training of staff in understanding the processes
they operate and control is more efficient than
employing inspectors
We control processes by controlling the inputs
into the processes rather than inspecting the
outputs
• People – By training or qualification
• Materials – Control of suppliers and specification
• Methods – By procedures & standards
• Machines – By maintenance systems
• Environment – By organisation and care
• Process – Set of interrelated or interacting
activities which transforms inputs to outputs
• Product ( Service ) – Result of a process
• Outputs of one process may be inputs into
another process
• Control the inputs to ensure outputs meet
requirements
• Analyse and review for continual Improvement
There are Eight Quality Management
Principle have been taken into
consideration during development of
ISO 9001:2008
 Customer p
focus Leadershi

Mutual
beneficial nt
supplier Involveme
ip d o n eight of people
relationsh Ba se
quality
ent
managem
Factual principles
to
approach
decision Process
making approach

System
Continual approach
to
ent nt
improvem Manageme
Principle 1
 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
People at all levels are the essence of an organisation and
their full involvement enables their abilities to be used for
the organisation's benefit

Must help people to develop and use their abilities

Must encourage the involvement of people at all level

Principle 3
 Control

Input Activities Output

+
Resources

A desired result is more efficiently achieved when

resources and activities are managed as a process

Principle 4
 Processes – understand interaction

Process A Process C

Process B Process D

Input
Output
Control
 Process

Any activity that takes “inputs” and

converts them to “outputs”

Process Approach

The systematic identification and management of these

activities and the interaction between activities.
 9001:2008

9001:2008
9001:2008

9001:2008
 Example - Purchasing Process

Purchasing Outputs
Inputs
Procedure • Receipt of Material
• Demand for on right condition
material
• Right Quality
• Item specs and Right Quantity
Date
Interactions to • Right Time
• Supplier source
•Storage
• Suppliers •Inspection and Testing
capability to meet •Manufacturing
our requirements •Finance

Performance Measurements
•Delivery status – On-time, On spec, etc
•Supplier evaluation
Identifying , understanding
and managing a system of
interrelated process for a
given objective improves the
organization effectiveness
and efficiency

Principle 5
 Customer Focus

PLAN DO
Deming’s
wheel
(P.D.C.A.) ACT CHECK Continual
Improvement
ISO
Principle 6 9000

Continual improvement of the organization's overall performance

should be a permanent objective of the organization.
The “Plan-Do-Check-Act” Cycle
(Deming’s Cycle)
Effective decisions are based on the analysis
of data and information

Principle 7
An organization and its suppliers are interdependent,
and a mutually beneficial relationship enhances the
ability of both to create value

Principle 8
 The Structure
0 Introduction
1 Scope
2 Normative reference
3 Terms and definitions
4 Quality management system
requirements
5 Management responsibility
6 Resource management
7 Product realization
8 Measurement, analysis and improvement
 System Requirements / Structure of the Standard

4 Quality 5 Management 6 Resource 7 Product 8 Measurement

Management Responsibility Management Realization Analysis &
System improvement

Management
General Planning(7.1)
Commitment(5.1) Provision of
requirements (4.1) General (8.1)
resources(6.1)
Customer
Documentation Customer focus related
Requirements(4.2) (5.2) Human processes(7.2) Monitoring &
resources(6.2) measurement(8.2)
Quality policy(5.3)
Design &
development(7.3)
Infrastructures(6.3 Control of NCP(8.3)
)
Planning(5.4)
Purchasing(7.4)
Work
Analysis of data(8.4)
environment(6.4)
Responsibility,
authority & Production &
communication(5. service
5) provision(7.5) Improvements(8.5)

Management Control of monitoring &

measuring devices(7.6)
Reviews (5.6)
 4.1 General requirements

Establish , document , implement and maintain a

QMS and continually improve its effectiveness in
accordance with the standard
4.1 General Requirements
 Determine 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
 Control over outsourced processes
 4.2 Documentation Requirements
General
• Extent • To Include
• Size and type of • Documented procedures
organization required by standard
• Complexity and • Documents required by
interaction of processes organization to ensure
• Competence of personnel effective operation and
control process
• Note2 (Documentation
may be in any type of • Note 1 (Where the term
media) “documented procedure”
appears)
 4.2 Documentation Requirements
• 4.2.2 Quality Manual
– The organization shall establish a Quality Manual that
include:
• Scope of QMS
• Documented procedures or reference to them
• Description of interaction between the process of QMS
 4.2 Documentation Requirements
4.2.3 Control of Documents
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
 4.2 Documentation Requirements

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
• 5.1 Management • 5.5 Responsibility,
Commitment authority and
communication
• 5.2 Customer – 5.5.1 Responsibility &
Focus authority
– 5.5.2 Management
• 5.3 Quality policy representative
– 5.5.3 Internal
communication
• 5.4 Planning
• 5.6 Management Review
– 5.4.1Quality
– 5.6.1 General
objectives
– 5.6.2 Review input
– 5.4.2 Quality
Planning – 5.6.3 Review output
 5.1 Management Commitment
• Provide evidence of commitment to the
development and improvement of QMS by:

– Communicating the importance of meeting

customer and legal/regulatory requirements.
– Establishing quality policy and objectives.
– Management Reviews
– Provision of resources.
 5.2 Customer Focus
• Top Management shall ensure that
customer needs & expectations are
determined, converted into
requirements & fulfilled with the aim of
achieving customer satisfaction
 5.3 Quality Policy
• Appropriate to the purpose of
organization.
• Commitment to meeting
requirements and continual
improvements
• Frame work for establishing and
reviewing quality objectives
• Communicated and understood at
appropriate levels
• Is reviewed for continuing suitability
 5.4 Planning
5.4.1 Quality Objectives (Cont)
• Establish quality objectives at relevant
functions and levels
• Objectives must be measurable and consistent
with the quality policy including the
commitment to continual improvement
• Include those needed to meet requirements
for product
 5.4 Planning
5.4.1 Quality Objectives (Cont)
Quality Objectives should be:
• Specific
• Measurable
• Achievable
• Realistic
• Time bound
5.4.2 Quality Management System Planning
• Identify and plan
processes needed to
achieve quality
objectives
• Plan the development of QMS
• Plan the implementation of
QMS
• Plan the improvement of QMS
5.5 Responsibility, Authority and
Communication

5.5.1 Responsibility and authority

Functions and their interaction,

responsibilities and authorities
shall be defined and
communicated to facilitate
effective quality management
5.5.2 Management Representative
• Member of the management who has responsibility
and authority for
– ensuring that processes of the QMS are established
and maintained
– Reporting on performance of QMS including needs for
improvement
– Promoting awareness of customer needs and
requirements
• Note: Responsibilities may include liaison with
external parties in relation to QMS
5.5.3 Internal Communication

• Ensure communication between various

levels and functions regarding the
processes of the QMS and their
effectiveness
 5.6 Management Review
5.6.1 General

• Review of QMS by top

management at planned
interval to;
– ensure QMS suitability,
adequacy and effectiveness
– Evaluate the need for
changes to QMS including
policy and objectives
Records from Management
Reviews shall be maintained
(see 4.2.4).
 5.6.2 Review Input
• Review performance and improvement
opportunities related to:
– Audit results
– Customer feedback
– Process performance and product conformance
– Status of preventive and corrective actions
– Follow up actions from earlier reviews
– Change that could affect the QMS
– Recommendations for improvement
 5.6.3 Review Output
• Output to include actions related to
– improvement of the effectiveness QMS and its
processes
– improvement of product related to customer
requirements
– resource needs
• 6.1 Provision of resources
• 6.2 Human resources
– 6.2.1 General
– 6.2.2 Competence, awareness and training
• 6.3 Infrastructure
• 6.4 Work environment
 6.1 Provision of Resources

• The organization shall determine and provide

the resources needed for :
– implement and maintain the QMS and
continually improve its effectiveness.
– Enhance customer satisfaction by meeting
customer requirements.
 6.2 Human Resources
6.2.1 General
• Those who have responsibilities defined in the
QMS must be competent on the basis of
appropriate education, training, skills and
experience
 6.2.2 Competency, Awareness and Training

• Identify competency needs

• Provide required training
• Evaluate the effectiveness of
training provided
• Ensure staff is aware of
relevance and importance of
their activities and contribution
to achieving quality objectives
• Maintain appropriate records of
education, training, qualification
and experience
 6.3 Infrastructure

• Identify, provide and maintain the infrastructure

needed to achieve product conformity
• This shall include :
– Workspace & associated utilities
– Equipment, hardware and software
– Supporting services (transport or
communication)
 6.4 Work Environment

• The organization shall determine and manage the

work environment needed to achieve conformity
to product requirements.
 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
 7.1 Planning of Product Realization

Plan and develop processes & determine –

• Quality objectives & requirements for product
• Need for processes, documents, and provide resources
• Verification, validation, monitoring and test activities, and
criteria for acceptance
• Records to provide evidence of conformity
• Outputs shall be in a suitable form
 7.2 Customer Related Processes

7.2.1 Determination of requirements related to the

product
7.2.2 Review of product requirements
7.2.3 Customer communication
7.2.1 Determination of requirements related
to the product

• Product requirements specified by the customer

including requirements for delivery and post-
delivery activities
• Requirements not specified but necessary for
intended or specified use
• Obligations related to product, including
regulatory and legal requirements
• any additional requirements determined by the
organization
7.2.2 Review of requirements related to the product

Review the identified needs before commitment to

supply – ensure that
• Product requirements are defined
• Requirements differing from those previously expressed
are resolved
• Requirements can be met
• Records of reviews and actions kept
• If requirements change, documents change & personnel
shall be made aware of changes

– Records of the results arising from the review

shall be recorded.
 7.2.3 Customer Communication

• Identify and implement arrangements for

communication with customers relating to:
– product information
– inquiry, contract or order handling, including
amendments
– Customer feedback including complaints
 7.3 Design & Development

• 7.3.1 Design & development planning

• 7.3.2 Design & development inputs
• 7.3.3 Design & development outputs
• 7.3.4 Design & development review
• 7.3.5 Design & development verification
• 7.3.6 Design & development validation
• 7.3.7 Control of design and development
changes
 7.4 Purchasing

• 7.4.1 Purchasing process

• 7.4.2 Purchasing information

• 7.4.3 Verification of purchased product

 7.4.1 Purchasing Process

• Purchased product meets requirements

• Type & extend of control depends on effect
purchased product may have on realization
processes and their output
• Selects suppliers based on their ability to supply
conforming product
• Define criteria for selection and periodic
evaluation and re-evaluation of suppliers
• Results of evaluation and follow up actions must
be recorded
 7.4.2 Purchasing
Information
Purchasing information shall describe the product to
be purchased
May include –
• Requirements for approval of product, procedures,
processes, and equipment
• Requirements for qualification of personnel
• Any system requirements
Shall ensure adequacy prior to release
–
 7.4.3 Verification of
Purchased Product
• Identify and implement activities needed to
verify purchased product
• Where organization or its customer purpose
verification at supplier premises, organization
must specify in purchasing information:
– verification arrangements
– method of product release.
 7.5 Production & 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 and traceability
• 7.5.4 Customer Property
• 7.5.5 Preservation of Product
 7.5.1 Control of production and
service provision
Control production & services operations
through:
• Availability of information specifying product
characteristics
• Work instructions available where necessary
• Use and maintenance of suitable equipment
• Availability & use measuring and monitoring devices
• Implementation of monitoring activities
• Implementation of defined processes for release,
delivery and post delivery activities
 7.5.2 Validation of Processes

Shall validate processes where output not verified by

monitoring and measurement. Includes faults appearing
after delivery
Validation shall be planned and include –
• Defined criteria for review and approval of processes
• Approval of equipment & personnel
• Use of specific methods and procedures
• Requirements for records & re – validation
 7.5.3 Identification &
Traceability

Where appropriate –
• Identify status of product with respect to monitoring and
measurement requirements
• Where tractability is required shall control and record
the unique identification of the product

I can not
remember
 7.5.4 Customer Property

• Care for customer’s property being under

organization’s control or being used by
organization
• Identification, verification, protection &
maintenance of customer property provided for use
or incorporation
• Any customer property that is lost, damaged or
found un- suitable must be recorded & reported to
customer
• Customer Property -
tangible / intangible
 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 product
 7.6 Control of monitoring &
measuring devices
• Calibrate & adjust measuring and monitoring
devices at specified intervals as prior to use
• Traceability to international or national standards.
Where no such standard exist record the basis
• Safeguard MMD from adjustments invalidating
calibration
• Protect MMD from damage or deterioration during
handling, maintenance or storage
• Record results of calibration
• Assess validity of previous results when devices
found to be out of calibration
 8 Measurement, Analysis and
Improvement
• 8.1 General • 8.3 Control of non-
• 8.2 Monitoring & conforming
Measurement product
– 8.2.1 Customer • 8.4 Analysis of data
satisfaction • 8.5 Improvement
– 8.2.2 Internal audit – 8.5.1 Continual
– 8.2.3 Monitoring and
measurement improvement
of processes – 8.5.2 Corrective action
– 8.2.4 Monitoring and – 8.5.3 Preventive action
measurement
of product
 8.1 General

Plan & implement measurement monitoring, analysis and

improvement
• To demonstrate conformity of product
• Ensure conformity of QMS
• Continually improve effectiveness of QMS
Includes determination of methods and extent of use also
Statistical Methods, Quality Tools to analyse data to
bring about improvement
 8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction

• Organization shall monitor information on

customer satisfaction and /or dis-satisfaction

• The methodologies for obtaining and utilizing

such information must be determined
 8.2.2 Internal Audit

• Conduct periodic internal audit to

determine if QMS:
– Conforms to the requirements of the
standard
– Has been effectively implemented &
maintained
• Plan the audit program considering:
– Status and importance of the activity
– results of previous audits
• Define audit scope, frequency and
methodologies performed by personnel
not performing audited work
 8.2.2 Internal Audit

• The documented procedure must cover:

– Responsibilities & authorities for
conducting audits
– Ensuring independence
– Recording results and reporting to
management
– Timely corrective actions
– Follow up to verify & report
implementation of verification
results
 8.2.3 Measurement and
Monitoring of Processes

• Apply suitable methods for measurement and

monitoring of those realization processes
necessary to meet customer’s requirements.
 8.2.3 Measurement and
Monitoring of Product
• Measure & monitor product characteristics to verify
conformance at appropriate stages of realization processes
• Evidence of conformity with the acceptance criteria must
be documented, records must indicate the authority
responsible for release of product
• Release or delivery must not proceed until all the specified
activities have been completed unless otherwise approved
by the customer

1 PA O L D
9/ 5/0 SS H
1 ED
F I ED
RI
VE
 8.3 Control of Non conforming
Product
• Documented procedures for control of
non conforming product to prevent
unintended use or delivery
• Non conforming product shall be
corrected
• Re-verify after correction
• If non-conformance detected after
delivery take appropriate action
• It is often required that the proposed
rectification be reported for concession
to the customer, the end user,
regulatory or other body
 8.4 Analysis of Data

Analyse of data for improvements –

• Suitability and effectiveness of QMS
• Process operation trends
• Customer satisfaction
• Conformity to requirements
• Characteristics of process, product and opportunities for
preventive actions
• Suppliers
 8.5 Improvement
8.5.1 Continual improvement
• Planning for Continual Improvement
• The organization must plan and manage
processes necessary for continual improvement
of the QMS
• Facilitate continual improvement using:
– quality policy
– objectives
– audit results
– analysis of data
– corrective actions
– preventive actions
• Management Review
 8.5.2 Corrective Action
• Organization must take corrective action to
eliminate the causes of non-conformance to
prevent recurrence
• Action appropriate to the impact of problem
• Documented procedures shall define
requirements for:
– identifying non conformities
– determine the causes
– evaluating the need for corrective action
– determine corrective action needed and
implemented
– Recording results of action
 8.5.3 Preventive Action
• Organization must identify preventive action to
eliminate the causes of potential non
conformances to prevent occurrences
• Actions appropriate to the impact of potential
problem
• Documented procedures must define the
requirements for
– Identification of potential non-conformances
and their causes
– Determining and ensuring implementation of
preventive action needed
– Recording results of action taken
Situation Warranting
Corrective Action
• Identification of major non-conformance.
• Large number of minor non-conformities.
• The reoccurrence of a problem with a process or
activity.
• Non-conformities observed during audits.
• Customer Complaints.
• Non-conforming deliveries from vendors.
Stages of Corrective & Preventive Action

• REPORTING
• INVESTIGATION
• ACTION
• FOLLOWUP
• CLOSING
Thank You !