iso 9000 2000 outline2850

© 2002 Systex Services 1

ISO 9000:2000 OUTLINE

Quality Management System


MIL Std

US Military & NATO Standards

AQAP

National Standards

BS 5750

Background

CANADAFRANCEGERMANYSPAINJAPANUSAUK+ 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 SYSTEMUNIVERSALLY RECOGNISED - SOUND QUALITY SYSTEM


What Is ISO 9000? [2]• ISO 9000 Series

ISO 9000 : 2000QUALITY MANAGEMENT SYSTEMS - Fundamentals and vocabulary

- supersedes ISO 8402 and ISO 9000-1:1994

ISO 9000 : 2000QUALITY MANAGEMENT SYSTEMS - Fundamentals and vocabulary

- supersedes ISO 8402 and ISO 9000-1:1994

ISO 9001: 2000QUALITY MANAGEMENT SYSTEMS - Requirements

- supersedes ISO 9001/2/3:1994

ISO 9001: 2000QUALITY MANAGEMENT SYSTEMS - Requirements

- supersedes ISO 9001/2/3:1994

ISO 19011: 2002Guidelines on auditing quality and environmental management

systems- supersedes ISO 19011:1994

ISO 19011: 2002Guidelines on auditing quality and environmental management

systems- supersedes ISO 19011:1994

ISO 9004 : 2000QUALITY MANAGEMENT SYSTEMS - Guidelines for improvement

- supersedes ISO 9004-1

ISO 9004 : 2000QUALITY MANAGEMENT SYSTEMS - Guidelines for improvement

- supersedes ISO 9004-1


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


Process approach modelCONTINUAL IMPROVEMENT OF

QUALITY MANAGEMENT SYSTEMCONTINUAL IMPROVEMENT OF

QUALITY MANAGEMENT SYSTEM

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ProductrealisationProductrealisation

InputProductProduct

Output

Measurementanalysis

improvement

Measurementanalysis

improvement

ResourcemanagementResource

management

ManagementresponsibilityManagementresponsibility


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

• 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)


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


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


8. Measurement, analysis & improvement

• Planning• Measurement & monitoring

– customer satisfaction

– internal audit

– processes

– product

– control of noncomformity

– analysis of dataContinued --->


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


Certification Milestones2. Prepare quality manual, policy, processes, planning

3. Prepare procedures, work instructions & records

10. Certification

9. External assessmentISO 9000Certificate

ISO 9000Certificate

Proced-uresProced-ures

WorkInstructs

WorkInstructs

QualityRecords

QualityRecords

1. Brief management team

4. Implement procedures

5. Train internal auditors

6. Conduct internal audits

7. Conduct management review

8. Preliminary assessment

QualityPolicyQualityPolicy

QualityManual

QualityManual

QMS Processes

QMS Processes

QualityPlanQuality

Plan


Who requires ISO 9000?

• Credible suppliers

• Major customers

• Government agencies

• Retailers

NO LONGER A FEATURE - INCREASINGLY AN EXPECTATION


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


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 monthsMonths

Actions 1 2 3 4 5 6 7 8 9 10 11 12Prepare & approve quality manualPrepare & approve proceduresPrepare documentationImplement proceduresConduct internal audit training Conduct internal auditsConduct management reviewApply for certificationConduct staff awareness trainingReceive external assessmentReceive certification

SET YOUR OWN SCHEDULE - AND HOLD IT!


Responsibilities• Management representative - for overall project & process control

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

# Section Prime Support4 Quality management system4.1 General requirements4.2 General documentation requirements5 Management responsibility5.1 Management commitment5.2 Customer focus5.3 Quality policy5.4 Planning5.5 Administration5.6 Management review6 Resource management6.1 Provision of resources6.2 Human resources6.3 Work environment7 Product realisation7.1 Planning realisation process7.2 Customer related processes7.3 Design and or development7.4 Purchasing7.5 Production and service operations7.6 Control of measuring & monitoring devices8 Measurement, analysis & improvement8.1 Planning8.2 Measurement & monitoring8.3 Control of nonconformity8.4 Analysis of data8.5 Improvement


Schedule - short term

LUNCH

DOCUMENT PREPARATION

REVIEW & ACTIONPLANNING

LUNCHLUNCH LUNCH

PRESENTATIONS, QUESTIONS & ASSIGNMENTS

PLANT TOUR

CONSULTING

DAY 1 DAY 2 DAY 3 DAY 4

TOUR TEAM SOLOGROUP

0830

1000

1100

1230

1330

1430

1530

1700

0830

0930

1130

1230

1330

1500

1600

1700

4. QUALITYMANAGEMENT

SYSTEMS

5. MANAGEMENTRESPONSIBILITY

7.1 REALISATIONPROCESS

7.2 CUSTOMERRELATED

PROCESSES

7.3 DESIGNAND OR

DEVELOPMENT

7.4 PURCHASING

7.5 PRODUCTION & SERVICE

OPERATIONS

7.6 CONTROL OFMEASURING &MONITORING

DEVICES

8.2 MEASURING& MONITORING

8.3 CONTROL OFNONCONFORMITY

8.4 ANALYSISOF DATA

8.5 IMPROVEMENT


ISO 9001 Outline Questions

Prepared for Electranet Partners by: Ray Spencer - Systex Services

Tel: +1279 321 352Fax: +1279 310 749

E-mail: [email protected]

iso 9000 2000 outline2850

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