Fitness for use

Conformance to requirements
Accuracy
Perfection
Zero Defect
Adequacy
Cost Effectiveness

THE TOTALITY OF FEATURES AND CHARACTERISTICS OF A PRODUCT OR

SERVICE THAT BEAR UPON ITS ABILITY TO SATISFY STATED OR IMPLIED
NEEDS
2

 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.

International Organization for Standardization

Founded in 1946 in Geneva , Switzerland
ISO is a non-governmental organization that forms a bridge
between the public and private sectors.
World's largest developer and publisher of International Standards.
ISO is composed of more than 90 members countries

"ISO", derived from the Greek. ISO, meaning "equal".

Whatever the country, whatever the language, the short form of
the organization's name is always ISO.
"ISO", is a system audit not for product audit

I S O1 4

001

ISO
SA80

9000

00

OHSAS1
8001

0
Q S9

r
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Principle 1

 Leaders must set the direction of the organization

Leaders must create and maintain internal environment
that encourages people to achieve the organizations
objectives

Principle 2

 Must help people to develop and use their abilities

Must encourage the involvement of people at all level

Principle 3

Control

Input

Activities
+
Resources

Output

AA desired
desired result
result is
is more
more efficiently
efficiently achieved
achieved when
when
resources
resources and
and activities
activities are
are managed
managed as
as aa process
process

Principle 4

Processes understand interaction

Process C

Process A

Process B
Input
Output
Control

Process D

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.

Example - Purchasing Process

Inputs
Inputs

Demand
Demandfor
for
material
material
Item
Itemspecs
specs
and
andDate
Date
Supplier
Supplier
source
source
Suppliers
Suppliers
capability
capabilityto
to
meet
meetour
our
requirements
requirements

Purchasing
Purchasing
Procedure
Procedure

Interactions
Interactionsto
to

Storage
Storage
Inspection
Inspectionand
and
Testing
Testing
Manufacturing
Manufacturing
Finance
Finance

Performance
PerformanceMeasurements
Measurements

Delivery
Deliverystatus
statusOn-time,
On-time,On
On
spec,
spec,etc
etc
Supplier
Supplierevaluation
evaluation

Outputs
Outputs
Receipt
Receiptof
of
Material
Materialon
on
right
rightcondition
condition
Right
RightQuality
Quality
Right
RightQuantity
Quantity
Right
RightTime
Time

Identifying , understanding
and managing a system of
interrelated process for a
given objective improves the
organization
effectiveness
and efficiency

Principle 5

Customer Focus

Demings
Demings
wheel
wheel
(P.D.C.A.)
(P.D.C.A.)

Principle 6

ISO
9000

PLAN

DO

ACT

CHECK

Continual
Improvement

Continual improvement of the organization's overall performance

should be a permanent objective of the organization.

The Plan-Do-Check-Act Cycle

(Demings 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

Continual improvement of the

Quality Management System

Input
Data

Product /
Service
Realization

Output
Data

Product
Service

CUSTOMERS

Requirements

CUSTOMERS

Measurement,
Analysis and
Improvement

Resource
Management

Satisfaction

Management
Responsibility

The
Structure
Introduction

0
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
Management
System

General
requirements (4.1)
Documentation
Requirements(4.2)

5 Management
Responsibility

Management
Commitment(5.1)

Customer focus
(5.2)

6 Resource
Management

Provision of
resources(6.1)

8 Measurement
Analysis &
improvement

Planning(7.1)

General (8.1)
Customer

Human
resources(6.2)

Quality policy(5.3)

Planning(5.4)

7 Product
Realization

Infrastructures(6.3
)

related

processes(7.2)

Monitoring &
measurement(8.2)

Design &
development(7.3)

Control of NCP(8.3)
Purchasing(7.4)

Responsibility,
authority &
communication(5.
5)
Management
Reviews (5.6)

Work
environment(6.4)

Analysis of data(8.4)
Production &
service
provision(7.5)
Control of monitoring &
measuring devices(7.6)

Improvements(8.5)

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

4.2 Documentation Requirements

General

Extent
Size and type of
organization
Complexity and
interaction of processes
Competence of personnel
Note3 (Documentation
may be in any type of
media)

To Include
Documented procedures
required by standard
Documents required by
organization to ensure
effective operation and
control process
Note 1 (Where the term
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
Commitment

5.2 Customer Focus

5.3 Quality policy

5.4 Planning
5.4.1Quality
objectives
5.4.2 Quality
Planning

5.5 Responsibility,
authority and
communication
5.5.1 Responsibility &
authority
5.5.2 Management
representative
5.5.3 Internal
communication
5.6 Management Review
5.6.1 General
5.6.2 Review input
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:
Set
Measurable
Achievable
Realistic
Timed

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
determine 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
7.2
7.3
7.4
7.5
7.6

Planning of product realization

Customer related processes
Design & development
Purchasing
Production & service operation
Control of measuring & monitoring devices

7.1

Planning of Product Realization

Sequence of process to achieve product

Consistent with QMS and documented to suit
method of operations
Quality objectives and requirements for the
product
The need for processes, documentation, resources
and facilities specific to the product
Verification and validation activities and
acceptance criteria
Records

7.2
7.2.1
7.2.2
7.2.3

Customer Related Processes

Determination of requirements related to the
product
Review of product requirements
Customer communication

7.2.1 Determination of requirements related

to the product

Product requirements specified by the customer

including requirements for delivery and postdelivery 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 identified requirements and ensure before

commitment to supply product that;
Product requirements are defined
For verbal orders requirements are confirmed
Difference between tender and contract are
resolved
Organization has ability to meet the
requirements
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, including where
appropriate:
Requirements for approval of
product,procedures, processes and
equipment.
Requirements for qualification of
personnel.
Quality management system
requirements.

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

Validation arrangements must be defined
and must include as applicable
qualification of the process
qualification of equipment and
personnel
use of defined methodologies &
procedure
requirements for record
re-valuation

7.5.3

Identification &
Traceability

Where appropriate identify product

through all stages of operations
Identify status with respect to
measurement & monitoring requirements
Where traceability is required control &
record unique identification of product
I can not
remember

7.5.4 Customer Property

Care for customers property being under
organizations 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

Measurement, Analysis
and Improvement

8.1 General
8.2 Monitoring &
Measurement
8.2.1 Customer
satisfaction
8.2.2 Internal audit
8.2.3 Monitoring and
measurement of
processes
8.2.4 Monitoring and
measurement of
product

8.3 Control of nonconforming product

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

8.1 General

Define, plan & implement measurement

and monitoring activities needed to
assure conformance and achieve
improvement
This include determination of the need
and use of applicable methodologies and
statistical techniques

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 customers
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
D
E
IFI
R
VE

01
/
5
9/

PA
SS
ED

D
HOL

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

Collect & analyze data, determine
suitability and effectiveness of QMS and to
identify improvements that can be made
Data from measurement & monitoring &
other related sources
Analyze data provide info on:
Customer satisfaction and/or
dissatisfaction
Conformance to customer requirement
Process, product characteristics and their
trends
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 nonconformances 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

EXPECTED BENEFITS
Transparency in working at all level
Data availability : Hidden Factors are open
Creates Accountability
Planning & scheduling improved
Rework & Rejection are known and being
controlled
Customer feedback through regular surveys
Employees Participation enhanced
Continuos Improvements Program launched
Market Reputation

Thank You !