1. ISO 9000 Implementation
Imran Hussain

2. ISO 9000: 1994 Clauses Management Responsibility Quality System
Contract Review
Design Control
Document Control
Purchasing
Purchaser Supplied Product
Product Identification and Traceability
Process Control
Inspection and Testing

3. ISO 9000: 1994 Clauses Inspection Measuring and Test Equipment
Inspection and Test Status
Control of Non-Conforming Product
Corrective Action
Handling, Storage, Packaging and Delivery
Quality Records
Internal Quality Audits
Training
Servicing
Statistical Techniques

4. ISO 9000:2000 Clauses Quality Management System Resource Management
Product or Service Realization
Management Responsibility
Measurement, Analysis and Improvement

5. ISO 9000: 2000 Quality Management System

6. Quality Management System Documentation
Standard
ISO 9000
Quality Manual
Policy Statement, Commitment, Organisation, Responsibilities
LEVEL 1
Quality System Procedures
Company Practices, Interfaces
LEVEL 2
Work Instructions
Written Instructions to Control Tasks
LEVEL 3
Forms
Quality Records
LEVEL 4
Sales
Design
Purchasing
Manufacturing
Accounts
Personnel
After Sales

7. Why have a Quality Policy?

8. Need for Quality Policy
All organizations have in mind some principles, beliefs which are their broad guides to managerial conduct
These guides rest on a philosophical and ethical base
They concern important issues and are intended to have a long life, i.e. to act as a stabilizer
Such principles and beliefs are referred to as a Quality Policy

9. Need for Quality Policy
When organizations grow, there are different managers working under which various employees are working
Things need to be defined at that stage as things start becoming ambiguous
As the unwelcome incidents accumulate, there arises a growing urge to think through, write out, and publish quality policies to serve as guides to managerial action

10. Advantages of Policies
It provides insiders and outsiders with a new, superior form of predictability, i.e. a written guide to managerial action
It forces the organization to think about quality problems to a depth never before achieved. “before you write it down, you must think it out”
It establishes legitimacy and can be communicated in an authoritative, uniform manner
It permits practices to be audited against that policy

11. Disadvantages of Policies
Major disadvantage is work involved
Some managers think that written policies tend to restrict innovation and to narrow the range of action available to adapt to changing conditions

12. Corporate Quality Policies
As a company grows, it becomes evident that no one set of quality policies can fit all company activities
This problem is solved by creating several levels of quality policy out of which one is corporate policy which usually consists of
The purpose of writing and publishing quality policies
A brief statement of corporate intent
The minimal actions to be taken by the company divisions with respect to quality
Interdivisional relationships concerning quality
Relationship of quality policies to other company policies

13. Corporate Quality Policies
A delegation of authority to subordinate company organization units to establish subsidiary quality policies appropriate to their needs
Summary statement
It is the policy of the company to provide products and services of a quality that meet the initial and continuing needs and expectations of customers in relation to the price paid and to the nature of competitive offerings, and in doing so, to be the leader in product quality reputation

14. Corporate Quality Policies
Importance of quality
Leadership in quality has top priority
Quality shall be given equal priority to costs and delivery
Quality competitiveness
Equal or exceed competitive quality
Be of the highest quality
Customer relations
Provide customer satisfaction
Meet customer perception of good quality

15. Corporate Quality Policies
Internal Customers
We regard the receivers of our work results as “customers” whose needs are important to understand and satisfy
Work Force Involvement
Our policy is to foster a spirit of pride among employees regarding the company’s quality performance
Quality improvement
Resources will be allocated primarily to the prevention of defects and corrective action will be focused on rot-cause identification and elimination

16. Divisional Quality Policies
The same design shall be used in all factories making a specific product.
Quality of design shall be used in all factories making a specific product

17. Quality Policies for Functional Areas
Many of the policies are prepared to provide guidance to managers in specific functional departments such as product development, manufacturing and marketing
New product introduction
Design reviews shall be conducted with customer, market and regulatory bodies in order to ensure the compliance of the design for quality
Suppliers
We seek to establish long-term, open relations with our suppliers

18. Quality Policies for Functional Areas
Manufacturing
Manufacturing process capability must be verified during the product development cycle
Production
Involvement and a spirit of pride will be fostered among employees by encouraging ideas and resolutions regarding the company’s quality performance
Customer service
Service operations shall be conducted so as to minimize customers’ shutdowns

19. Quality Objectives
An objective is an aimed-at-target– an achievement toward which effort is extended.
Quality objective is an aimed-at-quality target
Quality objectives should be quantifiable in nature (measurable) - SMART

20. Objectives vs. Policies

21. Objectives vs. Standards

22. Implementing ISO 9000:2000 Awareness Training Establish a Team
Establish ISO 9000 Status
Prepare Action Plan
Track Action Plan
Present Status of Action Plan
ISO 9000 Readiness Assessment
Contact Registrar (Certification Body)
Official ISO 9000 Audit
Continuous Improvement
Celebrate!

23. ISO 9000:2000 Clauses Quality Management System Resource Management
Product or Service Realization
Management Responsibility
Measurement, Analysis and Improvement

24. Quality Management System (QMS)
Concerned with the documentation and management of the QMS
Sub-clauses:
Quality Manual
Control of documents
Control of records

25. Management Responsibility
Concerned with the responsibility of management in the implementation of the quality system
Sub-clauses:
Management commitment
Customer focus
Quality policy
Planning
Responsibility, authority, and communication
Management review

26. Resource Management
Concerned with the provision of resources needed to implement the QMS
Sub-clauses:
Provision of resources
Human resources
Infrastructure
Work environment

27. Product or Service Realization
Concerned with the provision of processes to implement the product or service
Sub-clauses:
Planning of product realization
Customer related processes
Customer requirements
Customer communication
Design and development
Control of changes
Purchasing process
Production and service provision
Validation of processes
Identification and traceability
Customer property
Preservation of product
Control of measuring and monitoring devices

28. Measurement, Analysis and Improvement
Concerned with the establishment of a measurement program to measure QMS performance and to identify problems
Sub-clauses:
Measurement of customer satisfaction
Internal audits
Measurement and monitoring of processes
Measurement and monitoring of product
Control of nonconformity
Analysis of data
Continual improvement
Corrective action
Preventive action

29. References
Software Quality Management and ISO 9001, by Michael Jenner, Ch. 1, 2
A Practical Approach to Software Quality, by Gerard O’Regan, Ch. 3