iso 9000 : 2000 outline
TRANSCRIPT
© 2002 Systex Services 1
ISO 9000:2000 OUTLINE
Quality Management System
© 2002 Systex Services 2
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
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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
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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
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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
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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
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ISO 9001 Requirements
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realisation
8. Measurement, analysis and improvement
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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
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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)
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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
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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
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8. Measurement, analysis & improvement
• Planning• Measurement & monitoring
– customer satisfaction
– internal audit
– processes
– product
– control of noncomformity
– analysis of dataContinued --->
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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
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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
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Who requires ISO 9000?
• Credible suppliers
• Major customers
• Government agencies
• Retailers
NO LONGER A FEATURE - INCREASINGLY AN EXPECTATION
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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
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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!
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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
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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
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ISO 9001 Outline Questions
Prepared for Electranet Partners by: Ray Spencer - Systex Services
Tel: +1279 321 352Fax: +1279 310 749
E-mail: [email protected]