ISO 9001: 2008

QUALITY MANAGEMENT
SYSTEM
Presentation
by
Virendra Sahdev
 ABOUT ISO 9001
Its a Quality Management System Standard

Initially published in 1987

First revision in 1994, Second revision in 2000

ISO 9001:2008 is the latest version released in 14

Nov 2008

Strong emphasis on Customer Satisfaction and

Continual Improvement
 INTRODUCTION
Quality
Fitness for purpose
Excellence
Meeting Customer Expectations not just needs

Management
Planning, Organizing, Directing, Controlling, Structuring
System
Work culture
Framework
Policies & procedures
 GENERIC STANDARD
ISO 9001 :2008 is a generic standard.

Generic means that the same standards

can be applied:

to any organization, large or small, whatever

its product or service,
in any sector of activity, and
whether it is a business enterprise, a public
administration, or a government department
 PROCESS APPROACH
PLAN

ACT DO

CHECK

Understanding and meeting requirements

The need to consider processes in terms of added value
Obtaining results of process performance and
effectiveness
Continual improvement of processes based on objective
measurement
 WHAT IS A PROCESS
Sequence of interdependent and
linkedPROCEDURES which, at everySTAGE,
consume one or moreRESOURCES
(employees, time,energy,machines,money)
toCONVERT inputs
(data, material, parts, etc.)
intoOUTPUTS.
These outputs then serve as inputs for the next
stage until a knownGOALor END RESULT is
reached.
 PROCESS APPROACH
MODEL
CONTINUAL
CONTINUAL IMPROVEMENT
IMPROVEMENT OF
OF
QUALITY
QUALITY MANAGEMENT
MANAGEMENT SYSTEM
SYSTEM

Management
Management

Satisfaction
Satisfaction
responsibility
responsibility
Customer

Customer
Requirements
Customer

Customer
Measurement
Measurement
Resource
Resource analysis
analysis
management
management improvement
improvement

Input Product
Product Output
realisation
realisation Product
Product

2002 Systex Services 7

Continuous v/s Continual Improvement

Point of Failure Point of Failure

Last Improved Level

Improvement
Phase
Consolidation Phase

Initial Level of Performance Initial Level of Performance

Continuous Improvement Continual Improvement

A comparision
 ISO 9001:2008 MAIN
CLAUSES

4. Quality Management System

5. Management Responsibility
6. Resources Management
7. Product Realization
8. Measurement, Analysis and
Improvement

4 QUALITY
MANAGEMENT SYSTEM
4.1 General Requirements

4.2 Documentation requirements

4.2.1 General Requirements
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Records

vs
5 MANAGEMENT
RESPONSIBILITY

5.1 Management Commitment

Establishpolicy and objectives (SMART)
Communicate importance of meeting customer and regulatory
Requirements
Conducting Management Reviews
Ensuring availability of resources

5.2 Customer Focus

5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
5.4.2 QMS Planning
5.5 Responsibility, authority &
communication
5.5.1 Responsibility & authority
5.5.2 Management Representative Contd

5.5.3 Internal Communication

5 MANAGEMENT
RESPONSIBILITY

5.6 Management Review

5.6.1 General
5.6.2 Review Input
5.6.3 Review Output

Contd..
6 RESOURCE MANAGEMENT

6.1 Provision of Resources

6.2 Human Resources
6.2.1 General
6.2.2 Competence, training & awareness
6.3 Infrastructure
6.4 Work Environment

7 PRODUCT REALIZATION

7.1 Planning of Product Realization

7.2 Customer Related processes
7.2.1 Determination of requirements related to the
product
7.2.2 Review of requirements related to the product
7.2.3 Customer Communication

Contd
7 PRODUCT REALIZATION
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 & development Changes
7.4 Purchasing
7.4.1 Purchasing process
Vendor Selection & evaluation
7.4.2 Purchasing Information
7.4.3 Verification of Purchased product
Contd
7 PRODUCT REALIZATION

7.5 Production & Service Provision

7.5.1 Control of Production & Service Provision
7.5.2 Validation of Production & Service Provision
7.5.3 Identification & Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
7.6 Control of Monitoring &
Measuring Equipment
Calibration

Contd
8 MEASUREMENT, ANALYSIS
& IMPROVEMENT
8.1 General
8.2 Monitoring & Measurement
8.2.1 Customer Satisfaction
8.2.2 Internal Audit
8.2.3 Monitoring & Measurement of Processes
8.2.4 Monitoring & Measurement of Product
8.3 Control of Non-conforming Product
8.4 Analysis of Data
Customer Satisfaction
Conformity to product requirements

8.5 Improvement
8.5.1Continual Improvement through policy, objectives,
audit results, analysis
8.5.2 Corrective Action
8.5.3 Preventive Action

BENEFITS OF ISO 9001:2008
Clarity in definition of authorities and responsibilities
Enhanced corporate image and market positioning

Better records and documentation in case of litigation

Use of recognized mark (of certifying agency) on

stationary and advertisement

Reduction in the need for multiple second party

assessments
Better traceability to root causes of quality problems

Rectification of errors at the earliest stage

No repetition of errors

THANK YOU