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
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
ISO is composed of more than 90 members countries
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

 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 organization’s
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 Output

+
Resources

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 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.
 Example - Purchasing Process

Purchasing
Purchasing Outputs
Outputs
Inputs
Inputs Procedure
Procedure •• Receipt
Receiptof
ofMaterial
Material
•• Demand
Demandforfor on
material onright
rightcondition
condition
material •• Right
•• Item RightQuality
Quality
Itemspecs
specsand
and Right
RightQuantity
Quantity
Date
Date
Interactions •• Right
RightTime
•• Supplier
Suppliersource
source Interactionstoto Time
••Storage
Storage
•• Suppliers
Suppliers ••Inspection
Inspectionand
andTesting
Testing
capability
capabilityto
tomeet
meet ••Manufacturing
our Manufacturing
ourrequirements
requirements ••Finance
Finance

Performance
PerformanceMeasurements
Measurements
••Delivery
Deliverystatus
status––On-time,
On-time,On
Onspec,
spec,etc
etc
••Supplier
Supplierevaluation
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
Deming’s
wheel
wheel
(P.D.C.A.)
(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
 Continual improvement of the
Quality Management System

Management
Responsibility

Satisfaction
CUSTOMERS

CUSTOMERS
Measurement,
Resource
Analysis and
Management
Improvement
Requirements

Product /
Input Output Product
Service
Data Data Service
Realization
 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
 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
• Note3 (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 Focus – 5.5.1 Responsibility &
authority
– 5.5.2 Management
• 5.3 Quality policy
representative
– 5.5.3 Internal
• 5.4 Planning communication
– 5.4.1Quality • 5.6 Management Review
objectives
– 5.6.1 General
– 5.4.2 Quality
– 5.6.2 Review input
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:
• 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 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

• 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 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 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 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 product
Measurement • 8.4 Analysis of data
– 8.2.1 Customer • 8.5 Improvement
satisfaction – 8.5.1 Continual
– 8.2.2 Internal audit improvement
– 8.2.3 Monitoring and – 8.5.2 Corrective action
measurement of – 8.5.3 Preventive action
processes
– 8.2.4 Monitoring and
measurement of
product
 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 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

• 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 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
 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 !