1. WHAT IS ISO 9000

2. 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

3. 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

4. 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

5. 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.

6. QUALITY SYSTEM = VEHICLE
QUALITY MANAGEMENT = DRIVER
QUALITY POLICY = ROAD MAP

7. ADVANTAGES OF ISO 9000 IMPLEMENTATION

8. 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

9. 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.

10. 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.

11. 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.

12. ISO
QMS- |Fundamentals and vocabulary
Provides fundamentals of QMS and specifies QM terms and definitions
ISO
QMS- Requirements
Specifies requirements for a QMS where an organization needs to demonstrate its capability to meet customer requirement for product/service and its assessment
ISO
QMS- Guidance for performance improvements
Provides guidance on QMS as a mean of continual improvement of processes that contribute to the satisfaction of customers

13. 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

14. 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

15. 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.

16. 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

17. Process Approach
A desired result is achieved more efficiently when related resources and activities are managed as a process.

18. 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

19. Continuous Improvement
Continually improve the performance by addressing the needs of all the interested parties is the permanent objective of the organization

20. Factual approach to Decision-making
Effective decisions are based on the logical or intuitive analysis of data and information

21. Mutually Beneficial Supplier Relationship
To create value mutual beneficial relationship between the organization and supplier in necessary

22. 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

23. 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.

24. QUALITY MANAGEMENT SYSTEM
Continual improvement of the
Quality management system
Management
responsibility
Customers
Customers
Measurement,
analysis and
improvement
Resource
management
Satisfaction
Requirements
The ISO 9001:2000 Requirements:
Scope
General
Application
Normative reference
Terms and definitions
Quality management system
General requirements
Documentation requirements
Quality manual
Control of documents
Control of records
Management responsibility
Management commitment
Customer focus
Quality policy
Planning
Quality objectives
Quality management system planning
Output
Input
Product
realization
Product
Information flow
Value-adding activities
Reference: ISO 9001:2000

25. 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;

26. 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 .

27. 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

28. 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

29. 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

30. 7.3 Design and development
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
Purchasing process
Purchasing information
Verification of purchased product
7.5 Production and service provision
Control of production and service provision
Validation of processes for production and service provision
Identification and traceability
Customer property
Preservation of product

31. 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)
Customer satisfaction
Internal audit
Monitoring and measurement of processes
Monitoring and measurement of product
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement (title only)
Continual improvement
Corrective action
Preventive action

32. DOCUMENTING THE SYSTEM BASED ON ISO 9001:2000 STANDARD

33. 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.

34. DOCUMENTATION PYRAMID
LOW
QUALITY/ POLICY MANUAL
LEVEL 1
LEVEL 2
LEVEL 3
LEVEL 4
OPERATION PROCEDURES
DETAIL
WORK INSTRUCTIONS
FORMS, LABEL, RECORDS, ETC.
HIGH A
Purchasing
Department B
Production
Department C
Personnel
Department D
Quality
Control E
Stores

35. 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.

36. WHY NEED QUALITY MANUAL?
Communicating the organization’s quality policy, procedures and requirements;
Describing and implementing an effective quality system;
Providing improved control of practices and facilitating assurance activities;
Providing the documented bases for auditing the quality system;
Providing continuity of the quality system and its requirements during changing circumstances;
Training personnel;
Presenting quality system for external purposes;
Demonstrating compliance of the quality system with quality requirements

37. Quality Policy
Clause 5.3
The overall quality intentions and direction of an organization related to quality, as formally expressed by top management