Transcript iso 9000 requirements interpretation

STANDARDIZATION & QUALITY ASSURANCE
Quality
Control
Circle
Policy
Management
Standardization
Suggestio
n
System
&
Quality Assurance
CrossFunctional
Management
Daily
Management
5
S
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STANDARD
Definition
Is the
• best way
• easiest way
• safest way
in particular time
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STANDARDIZATION
OBJECTIVE(1)
• Gather and “preserve “ know-how
• As standard to measure
performance
• Prevent the occurrence of the same
mistake
• As a basis for improvement
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STANDARDIZATION
OBJECTIVES (2)
• Assure stability
• As basis for Training
• Ease the job delegation and its
monitoring
• As basis for audit
• Increase efficiency
• Lower cost
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STANDARD TYPES
• Company (In-House)
Standard
• Association Standard
• National Standard
• International Standard
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TYPES OF WRITTEN STANDARDS
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Regulations
Norms
Specifications
Engineering / Technical Standards
Work/ Process Standards
Manuals
Circular Notices
Memos
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QUALITY ASSURANCE
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•
•
Provide product/service the customer
want at the time required and at
reasonable price
Formal quality system
Prevention not Detection
– getting it right at the first time,
every time
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FORMAL QUALITY SYSTEM
Method defined to manage whole
necessities that affect quality
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WHAT IS ISO 9000 ?
 ISO, is a non-government organisation
 ISO means “same” used as name for
standards made by International
Organization for Standardization
 International Organization for
Standardization based in Geneva, Swiss
 ISO 9000 is Quality system standard not
product standard
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THE HISTORY OF ISO 9000 SERI
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EXPERIENCE FROM WORLD WAR II
Europe : NATO - AQAP (1945)
UK: MINDEF, DEF STANS 05-21 SERIES (1960)
UK: BS 4891, A GUIDE TO QUALITY
ASSURANCE (1972)
UK: BS 5179, PART 1,2 AND 3 (1975)
UK: BS 5750, PART 1,2 AND 3 (1979)
INTERNATIONAL: ISO 9000 SERIES
EUROPE: EN 29000 SERIES
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ISO 9000
QUALITY STANDARD SYSTEM
Structure of ISO 9000 Seri
ISO 9000
Selection of Model
Non Contractual
ISO 9004
Reference
Contractual
ISO 9001
ISO 9002
ISO 9003
Model
Quality system
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ISO 9000
QUALITY SYSTEM STANDARD
• ISO 9000
– Quality Management and Quality Assurance Standard Guidelines for Selection and Use
• ISO 9001
– Quality Systems- Model for Quality Assurance in
Design/Development, Production, Installation, and Servicing
• ISO 9002
– Quality Systems- Model for Quality Assurance in Production and
Installation
• ISO 9003
– Quality systems- Model for Quality Assurance
• ISO 9004
– Quality Management and Quality System Element- Guidellines
• ISO 8402
– Quality - Vocabulary
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CROSS REFERENCE OF
QUALITY SYSTEM ELEMENT
Clausul
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
4.11
4.12
4.13
4.14
4.15
4.16
4.17
4.18
4.19
4.20
Element
Management responsibility
Quality system
Contract review
Design control
Document and data control
Purchasing
Control of supplied good owned by purchaser
Identification and traceability of product
Process control
Inspection and Measurement
Control of inspection, measurement and test equipment
Inspection and measurement status
Control of non-conformance product
Corrective action and prevention
Handling, Storage, and maintenance of delivery
Quality record
Internal quality audit
Training
Service
Statistic technique
ISO 9001
ISO 9002
ISO 9003
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N/A
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N/A
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N/A
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N/A
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N/A
V
N/A = Not Applicable
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EVOLUTION OF QUALITY SYSTEM
ELEMENTS
improvement
TOTAL QUALITY
MANAGEMENT
Design
QUALITY ASSURANCE
INSPECTION
ISO 9003
Sorting
ISO 9002
QUALITY CONTROL
ISO 9001
Processing
20 clauses
external contractual
19 clauses
external contractual
16 clauses
external contractual
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ISO 9001
QUALITY SYSTEM CONTROL
THE OPERATING PROCESS
SUPPORT ACTIVITIES
SALES & MARKETING
4.3. Contract Review
4.6. Purchasing
4.11. Inspection, Measuring &
Test Equipment
4.18. Training
DESIGN
4.1. Management Responsibility
4.4. Design Control
4.2. Quality System
4.5. Document Control
4.14. Corrective Action
4.17. Internal Quality Audits
QUALITY RESOURCES
SHOPFLOOR
4.9. Process Control
4.10. Inspection & Testing
4.7. Purchaser Supplied Product
4.12. Inspection & Test Status
4.13. Control of Non-Conforming Products
QUALITY DATA
4.8. Product Identification &
Traceability
4.16. Quality Records
4.20. Statistical Techniques
DISTRIBUTION
4.15. Handling, Storage, Packaging & Delivery
AFTER SALES
4.19. Servicing
Source: BS 5750-THE STANDARD FOR QUALITY SYSTEM
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STRUCTURE OF QUALITY SYSTEM
DOCUMENTATION
What
How, what,
who, where
when, why
How,
what with
QUALITY MANUAL
QUALITY SYSTEM PROCEDURE
WORK INSTRUCTION
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QUALITY MANUAL
 Company
profile (brief history, scope of
business, domicile, quality system had and
currently applied)
 Quality policy
 Quality objectives
 Management representative
 Company organization description
 Job description
 Job qualification
 Outline of quality system currently applied
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QUALITY SYSTEM
PROCEDURE
 Procedure objective
 Scope of procedure
 Term of definition
 Cross reference with other relevant document
 Procedure description
 Form attachment, checklist, or label used
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QUALITY PLAN
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Process of production affecting quality
Handling tools
Machine / production tool
Number and Qualification of employee
needed
Inspection and Test point for each job
Inspection and test method
Acceptance criteria at each inspection and
test point
Measuring tool, inspection and test used
production, inspection and test record
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WORK INSTRUCTION

Can be in form of simple flowchart diagram
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Step by step guidelines for conducting job
 Filling forms
 Production process
 Operating machine/ tool
 Conducting inspection and test
 Handling / storage of product
 Calibration tools
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Work Instruction consist :
 Tools/ Material/Operator qualification
 Work step (includes description of acceptance criteria
“workmanship” or with product sample/ prototype/ mockup/ show unit.)
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IMPLEMENTATION PROCESS
 SURVEY AND SYSTEM EVALUATION
 DEVELOPING IMPLEMENTATION
ORGANIZATION
 PROJECT PLANNING
 BRIEFING FOR TOP MANAGEMENT
 COACHING DOCUMENTATION TECHNIQUE
 DESIGN, REVIEW, IMPLEMENTATION,
DOKUMENTATION AND SYSTEM
IMPROVEMENT
 AWARENESS TRAINING
 INTERNAL QUALITY AUDIT
 CERTIFICATION
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CERTIFICATION PROCESS
 APPLICATION
 QUESTIONER
 QUESTIONER EVALUATION + QUALITY
MANUAL
 AUDIT AT PLACE
 IMPROVEMENT STEPS (If any)
 RECOMMENDATION FOR CERTIFICATION
 CERTIFICATION
 SURVEILLANCE AUDIT
 CERTIFICATION RENEWAL (Every three year)
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WHY ISO 9000 IS ESSENTIAL ?
Company benefit(1)
 Assure quality consistence of the product/service
 minimize rework - and save cost
 build good foundation to enable fast evolvement ( to
facilitate training and Human resources development)
 Customize company to act based on data
 Equip management with tool to make a tight observation
of quality achievement possible
 Increase the clarity of responsibility and authority in
every function
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WHY ISO 9000 IS ESSENTIAL?
Company Benefit (2)
 Standardize and distribute good practices
 Eliminate quality dependency on one / few personnel
 A program where commitment and employee motivation
are realized (example: targeted time for certification
drives every action to achieve same goal)
 Quality system documented will improve communication
inter department
 Quality system documented will contribute the training
 Quality system documented will become a ground for
continuous improvement
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MENGAPA ISO 9000 PENTING ?
Marketing benefit
 Improve company “Quality Image”
 Open up the access to large market requiring
ISO 9000 certificate
 Increase Customer confidence of company
quality
 A prerequisite for applying other certificate,
such as CE mark
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