ISO 9000:2000 OUTLINE

Quality Management System

2002 Systex Services

Background
US Military & NATO Standards
MIL Std AQAP

International Standards Organisation (ISO) Committee

CANADA FRANCE GERMANY SPAIN JAPAN USA UK + others ISO 9000: 2000 ISO 9000: 1994 ISO 9000: 1987

BS 5750

National Standards

International Standard

2002 Systex Services

What is ISO 9000? [1]

ISO 9000 is an internationally recognised quality management system developed by ISO (International Organisation for Standardisation)

UNIVERSALLY RECOGNISED - SOUND QUALITY SYSTEM

2002 Systex Services 3

 ISO 9000 Series

What Is ISO 9000? [2]

ISO 9000 : 2000 QUALITY MANAGEMENT SYSTEMS - Fundamentals and vocabulary - supersedes ISO 8402 and ISO 9000-1:1994 ISO 9001: 2000 QUALITY MANAGEMENT SYSTEMS - Requirements - supersedes ISO 9001/2/3:1994 ISO 9004 : 2000 QUALITY MANAGEMENT SYSTEMS - Guidelines for improvement - supersedes ISO 9004-1 ISO 19011: 2002 Guidelines on auditing quality and environmental management systems - supersedes ISO 19011:1994

2002 Systex Services

What Is ISO 9000? [3]

Standard based on 8 quality management principles
customer focus leadership involvement of people process approach system approach to management continual improvement factual approach to decision making mutually beneficial supplier relationships
2002 Systex Services 5

Process approach model

CONTINUAL IMPROVEMENT OF QUALITY MANAGEMENT SYSTEM Managemen t responsibilit y Measureme Resource nt managemen analysis t improvemen t
Input

Customer

Satisfaction
Produc t

Requirements

Product realisation

Output

2002 Systex Services

Customer
6

ISO 9001 Requirements

4. Quality management system 5. Management responsibility 6. Resource management 7. Product realisation 8. Measurement, analysis and improvement
2002 Systex Services 7

4. Quality management system

General requirements
identify QMS processes sequence & interaction of processes criteria & measures for effective operation information to support processes measure, monitor, analyse, action & improvement

General documentation requirements

procedures other documents
2002 Systex Services 8

5. Management responsibility
Management commitment Customer focus Quality policy Planning
quality objectives quality planning permissible exclusions resources continual improvement

Administration
responsibility & authority management representative internal communication quality manual control of documents control of quality records

Management review
inputs (results) outputs (actions / resources)

2002 Systex Services

6. Resource management
Provision of resources Facilities
relating to QMS customer satisfaction workspace & facilities equipment, h/ware, s/ware

Human resources

competency human & physical training factors effectiveness of training contribution to quality objectives staff records 2002 Systex Services

Work environment

10

7. Product realisation
Planning of realisation processes Customer related processes Design & development
planning inputs outputs review verification validation changes

Purchasing
control information verification

Production & service operations

control identification & traceability customer property preservation measuring & monitoring
11

2002 Systex Services

8. Measurement, analysis & improvement

Planning Measurement & monitoring
customer satisfaction internal audit processes product control of noncomformity analysis of data Continued --->
2002 Systex Services 12

8. Measurement, analysis & improvement (continued)

Improvement
planning for continual improvement corrective action
identifying nonconform. causes solutions action results review

preventive action
potential nonconformance preventive actions results of actions review

2002 Systex Services

13

1. Brief management team

Certification Milestones

2. Prepare quality manual, policy, processes, planning 3. Prepare procedures, work instructions & records
Quality Quality Policy Policy Quality Quality Manual Manual
Processes Processes

4. Implement procedures 5. Train internal auditors

Proced Proced -ures -ures Work Work Instructs Instructs Quality Quality Records Records

QMS QMS

6. Conduct internal audits 7. Conduct management review 8. Preliminary assessment

ISO 9000 ISO 9000 Certificate Certificate

Quality Quality Plan Plan

9. External assessment 10. Certification

2002 Systex Services

14

Who requires ISO 9000?

Credible suppliers Major customers Government agencies Retailers

NO LONGER A FEATURE - INCREASINGLY AN EXPECTATION

2002 Systex Services

15

What Are The Benefits?

Sound quality system ADDED VALUE, MARKET ACCESS & PRIDE Single systems audit Eligibility for tenders Evidence of compliance Recognition of standard achieved Opportunity to improve existing processes A process for continual improvement
2002 Systex Services 16

How long will it take?

It has been done in less than 6 months It has taken longer than 18 months It can normally be done COMFORTABLY within 12 months
Actions Prepare & approve quality manual Prepare & approve procedures Prepare documentation Implement procedures Conduct internal audit training Conduct internal audits Conduct management review Apply for certification Conduct staff awareness training Receive external assessment Receive certification Months 1 2 3 4 5 6 7 8 9 10 11 12

SET YOUR OWN SCHEDULE - AND HOLD IT!

2002 Systex Services 17

Management representative - for overall project & process control Prime & support - to develop & implement each ISO 9000 section
# 4 4.1 4.2 5 5.1 5.2 5.3 5.4 5.5 5.6 6 6.1 6.2 6.3 7 7.1 7.2 7.3 7.4 7.5 7.6 8 8.1 8.2 8.3 8.4 8.5 Section Quality management system General requirements General documentation requirements Management responsibility Management commitment Customer focus Quality policy Planning Administration Management review Resource management Provision of resources Human resources Work environment Product realisation Planning realisation process Customer related processes Design and or development Purchasing Production and service operations Control of measuring & monitoring devices Measurement, analysis & improvement Planning Measurement & monitoring Control of nonconformity Analysis of data Improvement Prime Support

Responsibilities

2002 Systex Services

18

0830

DAY 1

Schedule - short term

DAY 2 DAY 3
7.1 REALISATION PROCESS 7.4 PURCHASING 7.2 CUSTOMER RELATED PROCESSES 7.5 PRODUCTION & SERVICE OPERATIONS

DAY 4
0830

PLANT TOUR 1000 1100

PRESENTATIONS, QUESTIONS & ASSIGNMENTS

8.3 CONTROL OF NONCONFORMITY 0930 8.4 ANALYSIS OF DATA 1130 8.5 IMPROVEMENT 1230

4. QUALITY MANAGEMENT SYSTEMS 1230 LUNCH 1330

LUNCH

LUNCH 7.6 CONTROL OF MEASURING & MONITORING DEVICES 8.2 MEASURING & MONITORING

LUNCH 1330 DOCUMENT PREPARATION 1500 REVIEW & ACTION PLANNING CONSULTING 1700 1600

1430 1530

5. MANAGEMENT RESPONSIBILITY

7.3 DESIGN AND OR DEVELOPMENT

1700
TOUR TEAM

2002 Systex Services

GROUP

SOLO

19

ISO 9001 Outline Questions

Prepared for Electranet Partners by:

Ray Spencer - Systex Services

Tel: +1279 321 352 Fax: +1279 310 749 E-mail: ray.spencer@ntlworld.com

2002 Systex Services

20