ISO 9001:2008 training

ISO 9001:2008 Quality Management
System - Requirements
Quality Management Series
y g

© 2010 www.TechnoSysCon.com. All rights reserved.

Overview

Evolution of Quality Systems

Brief about ISO

History of ISO 9000 Series of Standards,

Aims, Approach and Principles

Key benefits to the Organizations
y g

Clauses of ISO 9001:2008

Key Requirements of ISO 9001:2008

Certification Process

Discussions

TechnoSysCon Slide 2 . . . .preferred partner for sustainable systems .

Contributing factors
Globalization & increased competition
Changer over of Market to Buyers Market

Customer - Quality Conscious

Need
Changed perception of Quality - PRICE, DELIVERY, PERFORMANCE,

Result - Development of common Quality System Guidelines by ISO, which are
Globally recognized.


Quality Systems – Approach recognizes continuous Improvement in Quality can
be best achieved through planning and preventing problems form arising at
source with the introduction of Quality Control Tools and Techniques. This
y q
helped to move emphasis from detection to prevention.
Quality Assurance – Approach recognizes the inherent inefficiency of
waiting for the mistakes to happen. Analysis of Nonconformance and
happen
Cause in a systematic manner. Design Quality into the process and
practices so that things cant go wrong
Quality Control – Approach recognizes that Quality Should be
Designed into a detailed specification and that Quality Checks should
be made throughout the Production or Service Delivery. This will not
g y
improve the product or Service Quality, it will only high light when it
will not present.
Quality Inspection – Simple Approach that relies on identifying
defects in the Product or service before they reach the customer
by introducing “Inspection Stage or stages. Against the
specification
ifi i


International Organisation for Standardization
• ISO is a network of the national standards institutes of 156 countries, on the
basis of one member per country, with a Central Secretariat in Geneva,
Switzerland, that coordinates the system.
• "International Organization for Standardization" would have different
abbreviations in different languages ("IOS" in English, "OIN" in French for
g g ( g ,
(Organisation internationale de normalisation). - a word derived from the
Greek isos, meaning "equal".
• International Electro technical Commission (IEC) was established in 1906.
• National Standardizing Associations (ISA), which was set up in 1926.
• ISO, officially began operations on 23 February 1947.
• ISO standards are developed by TECHNICAL COMMITTEES comprising experts
from the industrial, technical and business sectors which have asked for the
standards, and usage.


History of ISO 9000 Series
In the year 1985 the Quality Management systems Concept came into the
Existence by ISO
In the year 1987 First Guidelines as requirements of Q
y q Quality Management
y g
Systems has been published for the Purpose of Certification.
In the year 1994 First revision took place to make it more practical for the
Implementation and Simple to understand. Four Standards published ISO 9001,
ISO 9002, ISO 9003, ISO 9004.
In th
I the year 2000 Second revision t k place t make it generic f th
S d i i took l to k i for the
application in any type of Industry and simplified form the Audit Point of View.
15th November 2008 Third revision published to give more clarity for
implementation and use. Clauses and structure is same as earlier.

Process of Drafting and Publication of Standards by ISO –
ISO Draft Standard (DIS) , ISO / PAS , ISO / TS , ISO


About ISO 9000 Series

• Developed by TC 176.
• Applicable to all types of Industries.
• This means what the organization does to enhance customer satisfaction by
meeting customer and applicable statutory & regulatory requirements related
to product and continually to improve its performance.
• More focus on awareness and implementation rather than documentation,
Efforts towards Continual Improvement in Performance, Focus on identifying
Customer requirements, customer Satisfaction and customer communication.
• I is a model f Q li M
It i d l for Quality Management S
System.
• An Organisation is assessed by the third party (Certification Body) and
certificate of ISO 9001 2008 i i
tifi t f 9001:2008 is issued.
d


ISO 9001:2008 - Quality Management System

The Global Management System for all types of Industries
AIM OF QMS
Q
iDefect prevention rather than Detection
iData analysis based Planning
iReduction in wastage’s
iCustomer satisfaction
iContinual Improvement


Approach of ISO 9001:2008 ( QMS )

• Structured on PDCA Cycle Management Principle Plan
Act
in every activity. What to do?
How to improve
How to d it?
H t do
next time?
• Process Approach. When ?

• Efforts towards Continual Improvement in Check Do
Performance. Did things happen Do what was
according to plan? planned

• More focus on awareness and implementation rather than documentation.
• Focus on identifying Customer requirements, customer Satisfaction and
customer communication
•C
Compatible with ISO 14001:2004 E i
tibl ith 14001 2004 Environmental M
t l Management system.
t t


Schematic Representation of Process

EFFECTIVENESS
EFFECTIVENESS
PROCEDURE* OF PROCESS ==
OF PROCESS
Ability to achieve
y
( Specified
(“Specified way to carry out an activity or a Ability to achieve
desired results
desired results
process” - may be documented or not) (Focus of ISO
(Focus of ISO
9001:2000)
9001:2000)

Input PROCESS Output
PRODUCT
(
(Includes
(“Set of interrelated
Resources) or i t
interacting activities”)
ti ti iti ”) ( Result
(“Result of a
process”)

EFFICIENCY OF
EFFICIENCY OF
MONITORING AND PROCESS ==
PROCESS
MEASUREMENT OPPORTUNITIES Results achieved
Results achieved
vs resources used
vs resources used
(Before, during and after the process) (Focus of ISO
(Focus of ISO
9004:2000)
9004:2000)

* Note – This is the definition of “procedure” given in ISO 9000:2000.
This does not necessarily mean one of the 6
“documented procedures” required by ISO 9001:2008


Process Approach based QMS
Continual Improvement
of QMS

Management
Responsibility
espo s b l ty
nts

isfaction
n
uiremen
Custome Requ

Custom Sati
Resource Measurement,
Management analysis &

mer
improvement
p ove e t
C er

Product
Input Realization Product


Process Approach Turtle Diagram

Enter the details of machine, Enter resource requirements, pay
materials, test equipments, particular attention to required
Software systems, computers Knowledge, skills and competence
criteria, safety equipments etc.

Enter the details of Enter the details of
actual Inputs this required output this
may be Information, Process may be product,
Documents,
Documents Input Cop
C or Support
S t Output document, record,
document record
Materials, Tooling, process name and should be actual
Schedule measure of
effectiveness

Methods / procedures - Enter the Measurement of Effectiveness -
details of actual Inputs this may Enter the details of process
be Information, Documents, measurement parameters, KPI,
Materials, Tooling, Schedule
, g, PMI etc
etc.


Principles of Management Systems

Customer focus

Leadership

Involvement of people

Process approach

System approach to management

Continual improvement

Factual approach to decision making

Mutually beneficial supplier relationships


Key Benefits to the Organisations
• Increased revenue and market share obtained through flexible and fast
responses to market opportunities.
• Increased effectiveness in the use of the organization's resources to enhance
organization s
customer satisfaction.
• Improved customer loyalty leading to repeat business.
• People will understand and be motivated towards the organization's goals and
objectives.
• Activities are evaluated, aligned and implemented in a unified way.
• Miscommunication between levels of an organization will be minimized.
• Lower costs and shorter cycle times through effective use of resources.
d h l h h ff f
• Improved, consistent and predictable results. Ability to focus effort on the key
processes.
• Focused and prioritized improvement opportunities.
• Integration and alignment of the processes that will best achieve the desired
g g p
results.


Key Benefits to the Organisations
• Providing confidence to interested parties as to the consistency, effectiveness
and efficiency of the organization.
• P f
Performance advantage th
d t through i
h improved organizational capabilities.
d i ti l biliti
• Alignment of improvement activities at all levels to an organization's strategic
intent.
intent
• Flexibility to react quickly to opportunities. Increased ability to create value
for both parties.
p
• Flexibility and speed of joint responses to changing market or customer needs
and expectations.
• Optimization of costs and resources.
• An increased ability to demonstrate the effectiveness of past decisions through
reference to factual records.
• Increased ability to review, challenge and change opinions and decisions.


Currently available Standards of ISO 9000 series
• ISO 9000:2005 - Q lit management systems -- F d
9000 2005 Quality t t Fundamentals and
t l d
vocabulary
• ISO 9001:2008 - Quality management systems -- Requirements
• ISO 9004:2000 - Quality management systems -- Guidelines for performance
improvements
• ISO 9004:2009 - Managing for the sustained success of an organization -- A
quality management approach
• ISO 19011:2002 - Guidelines for quality and/or environmental Management
Systems Auditing
• ISO 10005:2005 - Quality management systems -- Guidelines for quality plans


Important Definition
Quality - Totality of CHARACTERISTICS and FEATURES of PRODUCT &
SERVICE that bears on it’s ability to fulfill STATED & IMPLIED needs of
EXISTING and POTENTIAL CUSTOMERS
CUSTOMERS.
Quality - Degree to which a set of Inherent Characteristics fulfills
requirements.
requirements – 2005
Inspection – conformity evaluation by observation and judgement
accompanied as appropriate by measurement testing or gauging
measurement,
Quality control – Part of Quality Management focused on fulfilling quality
Requirements.
Quality Assurance – Part of Quality Management focused on providing
confidence that quality requirements will be fulfilled.
q y q
Quality Management system – Management system to direct and control an
organisationwith regard to Quality.


ISO 9001:2008 Clauses
1.0 Scope
2.0 Normative Reference
3.0 Terms and Definitions
4.0 Quality Management System
4.1
41 General R
G l Requirements
i
4.2 Documentation Requirements
4.2.1
4 2 1 General
4.2.2 Quality Manual
4.2.3 Document Control
4.2.4 Control of Records

5.0 Management Responsibility
5.1 Management Commitment
5.2 Customer Focus


ISO 9001:2008 Clauses Continued ……
5.0 Management Responsibility Continued ……
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives.
5.4.2 Quality Management System Planning.
5.5 Responsibility , Authority and Communication
5.5.1 Responsibility and 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


6.0 Resource Management
6.1 Provision of resources
6.2
62 Human resources
H
6.2.1 General
6.2.2
622 Competence,
Competence Training and awareness
6.3 Infrastructure
6.4
64 Work Environment
7.0 Product Realization
7.1 Planning for Product Realization
g
7.2 Customer Related Processes
7.2.1 Determination of requirements related to Product
7.2.2 Review of Requirements related to Product
7.2.3 Customer Communication.


7.0 Product Realization Continued ……
7.3 Design and Development
7.3.1
731 Design d Development Pl
D i and D l Planning
i
7.3.2 Design and Development Inputs
7.3.3
733 Design and Development Output
7.3.4 Design and Development review
7.3.5
735 Design and Development verification
7.3.6 Design and Development validation
7.3.7 Control of Design and Development Changes
g p g
7.4 Purchasing
7.4.1 Purchasing Process
7.4.2 Purchasing Information
7.4.3 Verification of purchased Product


7.0 Product Realization Continued ……
7.5 Production and Service Provision
7.5.1
751 Control of P d i and S i P i i
C l f Production d Service Provision
7.5.2 Validation of processes for production and Service
Provision
7.5.3 Identification and Traceability
7.5.4 p y
Customer Property
7.5.5 Preservation of Product
7.6 Control of monitoring and measuring Equipments


8.0 Measurement Analysis and Improvement Continued ……
8.1 General
8.2
82 Monitoring d Measurement
M i i and M
8.2.1 Customer Satisfaction
8.2.2
822 Internal Audit
8.2.3 Monitoring and measurement of processes
8.2.4
824 Monitoring and measurement of product
8.3 Control of nonconforming product
8.4 Analysis of Data
y
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action


Key Requirements of ISO 9001:2008

Documentation Structure of QMS

Company profile, Organization Structure,
Quality Manual Responsibilities, Quality Policy & Objectives
and brief of QMS requirements
I

Explains What to do, whom to do it, when
Procedure to do, where to do and how it is done
II

Instructions, Guidelines, Explains how a specific Operations/
III activity has to be done
List

Formats for recording of
Forma, Formats,
Forma Formats IV Information / d t which
I f ti data hi h
Registers forms Records


Please contact us for any support……….

We believe in Sustained Relationships……….

….. and looking forward for having long term
relationship with you
l ti hi ith

+91 20 2749 0009 , Mobile : 0 9423 00 5866
- info@technosyscon.com

Visit us at ---------www.technosyscon.com
www.technosyscon.com


ISO 9001:2008 training

More Related Content

What's hot

Similar to ISO 9001:2008 training

More from TechnoSysCon

Recently uploaded

ISO 9001:2008 training