ISO 9000:2000 OUTLINE Quality Management System

Background MIL Std US Military & NATO Standards AQAP National Standards BS 5750 CANADA FRANCE GERMANY SPAIN JAPAN USA UK + others International Standards Organisation (ISO) Committee ISO 9000: 1987 International Standard ISO 9000: 1994 ISO 9000: 2000

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

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

What Is ISO 9000? [2] ISO 9000 Series 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 19011: 2002 Guidelines on auditing quality and environmental management systems - supersedes ISO 19011:1994 ISO 9004 : 2000 QUALITY MANAGEMENT SYSTEMS - Guidelines for improvement - supersedes ISO 9004-1

ISO 9000 Series

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

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

Process approach model CONTINUAL IMPROVEMENT OF QUALITY MANAGEMENT SYSTEM Customer Customer Requirements Satisfaction Resource management Product realisation Input Product Output Measurement analysis improvement Management responsibility

ISO 9001 Requirements 4. Quality management system 5. Management responsibility 6. Resource management 7. Product realisation 8. Measurement, analysis and improvement

4. Quality management system

5. Management responsibility

6. Resource management

7. Product realisation

8. Measurement, analysis and improvement

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

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

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)

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)

6. Resource management Provision of resources relating to QMS customer satisfaction Human resources competency training effectiveness of training contribution to quality objectives staff records Facilities workspace & facilities equipment, h/ware, s/ware Work environment human & physical factors

Provision of resources

relating to QMS

customer satisfaction

Human resources

competency

training

effectiveness of training

contribution to quality objectives

staff records

Facilities

workspace & facilities

equipment, h/ware, s/ware

Work environment

human & physical factors

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

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

8. Measurement, analysis & improvement Planning Measurement & monitoring customer satisfaction internal audit processes product control of noncomformity analysis of data Continued --->

Planning

Measurement & monitoring

customer satisfaction

internal audit

processes

product

control of noncomformity

analysis of data

8. Measurement, analysis & improvement (continued) Improvement planning for continual improvement corrective action identifying non-conform. causes solutions action results review preventive action potential non-conformance preventive actions results of actions review

Improvement

planning for continual improvement

corrective action

identifying non-conform.

causes

solutions

action

results

review

preventive action

potential non-conformance

preventive actions

results of actions

review

Certification Milestones 2. Prepare quality manual, policy, processes, planning 3. Prepare procedures, work instructions & records 10. Certification 9. External assessment ISO 9000 Certificate Proced -ures Work Instructs Quality Records 1. Brief management team 4. Implement procedures 5. Train internal auditors 6. Conduct internal audits 7. Conduct management review 8. Preliminary assessment Quality Policy Quality Manual QMS Processes Quality Plan

Who requires ISO 9000? Credible suppliers Major customers Government agencies Retailers NO LONGER A FEATURE - INCREASINGLY AN EXPECTATION

Credible suppliers

Major customers

Government agencies

Retailers

What Are The Benefits? Sound quality system Single systems audit Eligibility for tenders Evidence of compliance Recognition of standard achieved Opportunity to improve existing processes A process for continual improvement ADDED VALUE, MARKET ACCESS & PRIDE

Sound quality system

Single systems audit

Eligibility for tenders

Evidence of compliance

Recognition of standard achieved

Opportunity to improve existing processes

A process for continual improvement

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 SET YOUR OWN SCHEDULE - AND HOLD IT!

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

Responsibilities Management representative - for overall project & process control Prime & support - to develop & implement each ISO 9000 section

Management representative - for overall project & process control

Prime & support - to develop & implement each ISO 9000 section

Schedule - short term LUNCH DOCUMENT PREPARATION REVIEW & ACTION PLANNING LUNCH LUNCH LUNCH PRESENTATIONS, QUESTIONS & ASSIGNMENTS PLANT TOUR CONSULTING DAY 1 DAY 2 DAY 3 DAY 4 TOUR TEAM SOLO GROUP 0830 1000 1100 1230 1330 1430 1530 1700 0830 0930 1130 1230 1330 1500 1600 1700 4. QUALITY MANAGEMENT SYSTEMS 5. MANAGEMENT RESPONSIBILITY 7.1 REALISATION PROCESS 7.2 CUSTOMER RELATED PROCESSES 7.3 DESIGN AND OR DEVELOPMENT 7.4 PURCHASING 7.5 PRODUCTION & SERVICE OPERATIONS 7.6 CONTROL OF MEASURING & MONITORING DEVICES 8.2 MEASURING & MONITORING 8.3 CONTROL OF NONCONFORMITY 8.4 ANALYSIS OF DATA 8.5 IMPROVEMENT

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