Transcript Document

WHAT IS ISO 9000
1
WHAT IS ISO 9000
•
ISO is a ‘nickname’ to “International
Organization for Standardization”.
•
An international standard more than 100
countries
•
ISO is a non-governmental organization
established in 1947 by International Standard
Agency headquartered in Geneva.
•
Principles are applicable to all organizations
2
WHAT IS ISO 9000
ISO 9000 is a written set of standard which
describe and define the basic
elements/clauses of the quality system
needed to ensure that an organization’s
products/or services meet or exceed
customer needs and expectations
3
Principles of ISO 9000
-
ISO 9000 is a standard for a quality system, not product.
-
ISO 9000 is based on documentation and is premised on the
following:- Document what you do;
- Do what your document;
- Prove it and improve it
-
ISO 9000 emphasizes prevention.
-
ISO 9000 is a universal standard; the focus is on what
needs to be done and not on how it is to be carried out
4
WHY QUALITY SYSTEM - ISO 9000
•
to satisfy customers through a quality
product
•
to gain self confidence – we get what
we planned
•
to achieve competitiveness in both the
local and overseas markets.
•
as a blueprint for efforts to improve
the quality system of the organization.
5
QUALITY SYSTEM
=
VEHICLE
QUALITY MANAGEMENT =
DRIVER
QUALITY POLICY
ROAD MAP
=
6
ADVANTAGES OF ISO 9000
IMPLEMENTATION
7
WHAT IS IT INTENDED FOR?
This International Standard specifies quality
system requirements for use where
organization’s capability to design and supply
conforming product needs to be
demonstrated.
The requirements specified are aimed
primarily at achieving customer satisfaction
by preventing nonconformity at all stages
from design through to servicing
8
BENEFITS OF ISO 9000 IMPLEMENTATION
For the company:-
- Well defined organization and
responsibilities,
i.e., minimize grey areas and possible
resources wastage.
- Standardize practice and establishment
of proper communication channel, i.e.
maximize productivity and
communication efficiency.
9
BENEFITS OF ISO 9000 IMPLEMENTATION
For the company:- A greater degree of internal control.
- Ultimately, increase profitability and
market share, improve competitive position.
For the customer:-
- Increase satisfaction and growth in
confidence.
10
QUALITY MANAGEMENT
SYSTEM – ISO 9001:2000
Set of comprehensive and fundamentals rules or beliefs for
leading and operating an organization. The aim is to improve
performance continually , by focusing on customers while
addressing the needs of all stakeholders.
11
ISO 9000-2000
QMSProvides fundamentals of
|Fundamentals and QMS and specifies QM
vocabulary
terms and definitions
ISO 9001-2000
QMSRequirements
Specifies requirements for a
QMS where an
organization needs to
demonstrate its capability to
meet customer requirement
for product/service and its
assessment
ISO 9004-2000
QMS- Guidance
for performance
improvements
Provides guidance on QMS
as a mean of continual
improvement of processes
that contribute to the
satisfaction of customers
12
Eight Quality Management Principles
which can facilitate any organization in
creating quality work culture
•
Customer - focused organization
• Leadership
• Involvement of people
• Process approach
• System approach to management
• Continual improvement
• Factual approach to decision making
• Mutually beneficial supplier
relationship
13
Customer focused organization
•
•
•
•
•
•
Identify customer needs
Design a product that respond to customer needs
Produce and deliver the product as per the design
Enhance after sales service
Measure customer satisfaction
Improve quality to delight the customer
14
Leadership
• Senior leaders set directions and create customer
orientation.
• Values, directions and expectations must address all
stakeholders.
• Leaders needs to ensure the creation of strategies,
systems and methods for achieving excellence.
• Should encourage participation, learning innovation
and creativity.
• Serve as role models who reinforce values and
expectations.
15
Involvement of people
• Involvement of all people is one way of improving
quality and productivity.
• Involvement of people at all levels by providing a
good corporate culture
• providing an interesting environment, and building
the capability to perform tasks in the organization
16
Process Approach
• A desired result is achieved more efficiently when
related resources and activities are managed as a
process.
17
System approach to Management
• Identifying, understanding and managing a system of
interrelated processes for a given objective
contributes to the effectiveness and efficiency of the
organization
18
Continuous Improvement
• Continually improve the performance by addressing
the needs of all the interested parties is the
permanent objective of the organization
19
Factual approach to Decision-making
• Effective decisions are based on the logical or
intuitive analysis of data and information
20
Mutually Beneficial Supplier Relationship
• To create value mutual beneficial relationship
between the organization and supplier in necessary
21
Structure of the ISO 9001:2000 standard
• 20 elements of ISO 9001:1994 still there but in
the context of a model based on organizational
processes
Core organizational processes covered under:
Clause 4.
QUALITY MANAGEMENT SYSTEM
Clause 5.
MANAGEMENT RESPONSIBILITY
Clause 6.
RESOURCE MANAGEMENT
Clause 7.
PRODUCT REALISATION
Clause 8.
MEASUREMENT, ANALYSIS AND
IMPROVEMENT
22
Structure of the new ISO 9001:2000
standard
-
Process-oriented structure and a more logical
sequence of contents
-
Allows for more flexibility on amount of
documentation
-
Changes in terminology for easier
interpretation by all sectors.
23
QUALITY MANAGEMENT SYSTEM
Continual improvement of the
Quality management system
Management
responsibility
Customers
Resource
management
Customers
Measurement,
analysis and
improvement
Satisfaction
Requirements
Input
Information flow
Value-adding activities
Product
realization
Output
Product
24
Reference: ISO 9001:2000
The ISO 9001:2000 standard has new more
clearly defined requirements relating to :
Continual improvement;
Increased emphasis on the role of top
management;
Consideration of legal and regulatory
requirements;
Establishment of measurable objectives at
relevant functions and levels;
Monitoring of information of customer
satisfaction as a measure of system
performance;
25
The ISO 9001:2000 standard has new more
clearly defined requirements relating to :
(contd.)
Increased attention to resource
availability;
Determination of training effectiveness;
Measurements extended to systems, process and
product;
Analysis of collected data on the performance of
the QMS;
Control of outsourced processes .
26
ISO 9001: 2001
1. Scope
2. Normative reference
3. Definitions
4. Quality system requirements
4.1 General requirements
Organization shall establish document implement and maintain a QMS and
continually improve
4.2 Documentation Requirement
It includes
Quality policy
Quality objectives
Quality manual
Documented procedures
Documents to ensure effective planning
Operation and control of processes and records required by the international
standard
27
5. Management Responsibility
5.1 Management Commitment
development and implementation of QMS
Continuous Improvement in its effectiveness
5.2 Customer Focus
Constantly endeavor to enhance customer satisfaction
5.3 Quality Policy
The quality policy
is appropriate to the purpose of the organization
includes the commitment to comply with requiremtns and continually
improve QMS
framework for reviewing quality objectives
understood in the organization
reviewed for continuing stability
5.4 Planning
Quality Objectives
QMS Planning
28
5.5 Responsibility, Authority and Communication
define the responsibilities and authority of the key personnel and ensure they are
known throughout the organization.
5.6 Management Review
Review of the QMS at regular intervals
6. Resource Management
6.1 Organization shall determine and provide needed resources
6.2 Workers will be provided necessary education, training skills and experience
6.3 organization shall determine, provide and maintain the infrastructure needed to
achieve conformity to product requirement
7. Product or Service Realization
7.1 Planning of processes needed for Product/Service realization
7.2 Customer Related Processes
29
7.3 Design and development
7.3.1
7.3.2
7.3.3
7.3.4
7.3.5
7.3.6
7.3.7
Design and development planning
Design and development inputs
Design and development outputs
Design and development
Design and development verification
Design and development validation
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
7.5 Production and service provision
7.5.1
7.5.2
7.5.3
7.5.4
7.5.5
Control of production and service provision
Validation of processes for production and service provision
Identification and traceability
Customer property
Preservation of product
30
7.6 Control of monitoring and measuring devices
8. Measurement, analysis and improvement (title only)
8.1 General
8.2 Monitoring and measurement (title only)
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 (title only)
8.5.1 Continual improvement
8.5.2 Corrective action
8.5.3 Preventive action
31
DOCUMENTING THE SYSTEM
BASED ON ISO 9001:2000
STANDARD
32
Quality Management System
Documentation
The organization shall establish, document,
implement and maintain a quality management
system and continually improve its effectiveness in
accordance with the requirements of this
International Standard.
(Clause 4.1, ISO 9001:2000)
• Documentation is a set of documents, for example specifications
and records.
• Document is information (meaningful data) and its supporting
medium.
• Quality management system is a management system to direct and
control an organization with regard to quality.
• Quality manual is the document specifying the quality
management system of an organization.
33
DOCUMENTATION PYRAMID
LEVEL 1
QUALITY/ POLICY
MANUAL
OPERATION
PROCEDURES
LOW
LEVEL 2
DETAIL
WORK
INSTRUCTIONS
FORMS,
LABEL,
RECORDS,
ETC.
LEVEL 3
LEVEL 4
HIGH
A
Purchasing
Department
B
C
Production Personnel
Department Department
D
Quality
Control
E
Stores
34
LEVEL 1: QUALITY MANUAL
The quality manual as a highest level
document at the peak of a pyramid
outlining the quality system and acting as
a directory for the documents and
procedures below. It will outline the
company’s policy and commitment to
quality.
35
WHY NEED QUALITY MANUAL?
1. Communicating the organization’s quality policy,
procedures and requirements;
2. Describing and implementing an effective quality
system;
3. Providing improved control of practices and facilitating
assurance activities;
4. Providing the documented bases for auditing the
quality system;
5. Providing continuity of the quality system and its
requirements during changing circumstances;
6. Training personnel;
7. Presenting quality system for external purposes;
8. Demonstrating compliance of the quality system with
quality requirements
36
Quality Policy
Clause 5.3
The overall quality intentions and
direction of an organization related to
quality, as formally expressed by top
management
37