ISO 9000 Implementation

Imran Hussain

ISO 9000: 1994 Clauses

1.

2.
3. 4. 5. 6. 7. 8.

9.
10.

Management Responsibility Quality System Contract Review Design Control Document Control Purchasing Purchaser Supplied Product Product Identification and Traceability Process Control Inspection and Testing

ISO 9000: 1994 Clauses

11.

12.
13. 14. 15. 16. 17. 18.

19.
20.

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

ISO 9000:2000 Clauses

1.

2.
3. 4. 5.

Quality Management System Resource Management Product or Service Realization Management Responsibility Measurement, Analysis and Improvement

ISO 9000: 2000 Quality Management System

Quality Management System Documentation

Standard ISO 9000
Quality Manual
LEVEL 1

Policy Statement, Commitment, Organisation, Responsibilities

Quality System Procedures

LEVEL 2

Company Practices, Interfaces

Work Instructions
LEVEL 3

Written Instructions to Control Tasks

Forms
LEVEL 4

Quality Records

Sales

Design

Purchasing

Manufacturing

Accounts

Personnel

After Sales

Why have a Quality Policy?

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

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

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

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

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

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

Corporate Quality Policies

Importance of quality

Leadership in quality has top priority Quality shall be given equal priority to costs and delivery Equal or exceed competitive quality Be of the highest quality Provide customer satisfaction Meet customer perception of good quality

Quality competitiveness

Customer relations

Corporate Quality Policies

Internal Customers

We regard the receivers of our work results as customers whose needs are important to understand and satisfy Our policy is to foster a spirit of pride among employees regarding the companys quality performance
Resources will be allocated primarily to the prevention of defects and corrective action will be focused on rot-cause identification and elimination

Work Force Involvement

Quality improvement

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

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
We seek to establish long-term, open relations with our suppliers

Suppliers

Quality Policies for Functional Areas

Manufacturing

Manufacturing process capability must be verified during the product development cycle Involvement and a spirit of pride will be fostered among employees by encouraging ideas and resolutions regarding the companys quality performance
Service operations shall be conducted so as to minimize customers shutdowns

Production

Customer service

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

Objectives vs. Policies

Objectives vs. Standards

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!

ISO 9000:2000 Clauses

1.

2.
3. 4. 5.

Quality Management System Resource Management Product or Service Realization Management Responsibility Measurement, Analysis and Improvement

Quality Management System (QMS)

Concerned with the documentation and management of the QMS Sub-clauses:

Quality Manual Control of documents Control of records

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

Resource Management

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

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

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

References

Software Quality Management and ISO 9001, by Michael Jenner, Ch. 1, 2 A Practical Approach to Software Quality, by Gerard ORegan, Ch. 3