1 quality management standards. 2 the iso 9000 family iso 9000: 2005 identifies the fundamentals and...
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Quality Management Standards
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THE ISO 9000 FAMILY
ISO 9000: 2005• Identifies the fundamentals and vocabulary for Quality Management
Systems (QMS)
ISO 9001:2008• Specifies requirements for a QMS where capability to provide product
that meets customer and regulatory requirements needs to be demonstrated
ISO 9004:2009• Provides guidance on QMS that contributes to the satisfaction of
customers and other interested parties
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ISO 9000 : 2008
Eight quality management principles1. Customer focus2. Leadership3. Involvement of people4. Process approach5. System approach to management6. Continual improvement7. Factual approach to decision making8. Mutually beneficial supplier relationships
ISO 9001:2008CONTINUAL IMPROVEMENT OF THE QUALITY
MANAGEMENT SYSTEM
CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM
Measurement, analysis and improvement
Measurement, analysis and improvement
ProductProductInput Output
Management responsibility
Resource management
Resource management
Clause 5
Clause 6 Clause 8
Clause 7
Requirements
Product
realization
Satisfaction
Value adding activitiesInformation flow
Customers
Customers
5
Inputs
With What?(Materials / Equipment)
How Many?(Measurement /
Controls)
How?(Methods/
Procedures)
WHO?Special Skills? / Competence?
Outputs
Process Linkages
Objectives
and Targets
Business Process
Source: AIAG ISO/TS 16949:2002 Implementation Guide
PROCESS REQUIREMENTS
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SCOPE OF STANDARD
1. Scope General
Application
2. Normative reference
3. Terms and definitione.g., Supplier Organization Customer
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QUALITY MANAGEMENT SYSTEM REQUIREMENTS
4.1 General requirements Document, implement, maintain and continually improve Identify and determine sequence and interaction of processes Determine criteria and methods needed Ensure availability of resources Monitor, measure and analyze processes Implement actions to achieve planned results
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QUALITY MANAGEMENT SYSTEM REQUIREMENTS
4.2 Documentation requirements Management system documentation Quality Manual Control of documents Control of records
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MANAGEMENT RESPONSIBILITY
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
Must be documented Must be used for setting objectives
5.4 Planning
Document objectives- Must be Measurable
Quality management system planning
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MANAGEMENT RESPONSIBILITY
5.5 Responsibility, authority and communication Responsibility and authority Management representative Internal communication
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MANAGEMENT RESPONSIBILITY
5.6 Management Review General Review input Review output
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RESOURCE MANAGEMENT
6.1 Provision of resources
6.2 Human resources General Competence, awareness and training
6.3 Infrastructure
6.4 Work environment
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PRODUCT REALIZATION
7.1 Planning of product realization
7.2 Customer-related processes Determination of requirements related to
the product
Review of requirements related to the product
Customer communication
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PRODUCT REALIZATION
7.3 Design and development Planning, inputs, outputs, systematic
reviews, verification and validation, control of changes
7.4 Purchasing Supplier evaluation and selection Relevant purchasing information Verification of purchased product
- receiving, source
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PRODUCT REALIZATION
7.5 Production and service provision Controlled conditions including product
characteristics, work instructions (as necessary), suitable equipment, monitoring and measuring devices, monitoring and measurement, and release, delivery and post- delivery activities
Validation of processes when no other method Identification and traceability of product and
it’s status Care of customer property Preservation of product
Includes constituent parts
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PRODUCT REALIZATION
7.6 Control of monitoring and measuring devices Calibrated or verified where necessary Adjusted and re-adjusted as necessary Identified to enable calibration status Safeguarded from invalid adjustment Protected from damage and deterioration
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MEASUREMENT, ANALYSIS, AND IMPROVEMENT
8.1 General8.2 Monitoring and measurement
Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of product
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MEASUREMENT, ANALYSIS, AND IMPROVEMENT
8.3 Control of nonconforming product8.4 Analysis of data8.5 Improvement
Continual improvement Corrective action Preventive action
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ISO 9001:2008
A Structured
Approach to Quality Manageme
nt
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Documented Systems
Diaco Inc. [email protected] 505 780-3185 21
QUALITY SYSTEMDOCUMENTATION STRUCTURE
1st LevelQuality Manual2nd Level
Procedures
3rd LevelWork Instructions
Machine instructions Computer inputs Detailed work
instructions4th Level
Technical Data International standards Computer operating
manuals Detailed product
specifications
Policy and ObjectivesWhat the company wishes to achieve
How the company implements its policy Structured to reflect process flow of events
Detailed instructions How to completea job or task
TQM
• TOTAL QUALITY MANAGEMENT
Total quality management is a systemic approach to productivity improvement using qualitative and quantitative methods and involving all stakeholders to continuously improve the quality of all products and services.
TQM
TQM
• IS THE SET OF MANAGEMENT PROCESSES AND SYSTEMS THAT CREATE DELIGHTED CUSTOMERS THROUGH EMPOWERED EMPLOYEES, LEADING TO HIGHER REVENUES & LOWER COST
THE JURAN INSTITUTE, Inc.
TQM
• It is the process of individual & organizational development the purpose of which is to increase the level of satisfaction of all the stakeholders
PIKE, R J BARNES
WHY TQM?
B/C IT IS FOR BENEFIT OF ALL STAKEHOLDERS
• INTERNAL SATKEHOLDER
• EXTERNAL STAKEHOLDER
COMPONENTS OF TQM
1. PRICE REDUCTION
2. CUSTOMER SATISFACTION
3. INVOLVEMENT OF EVERYONE
4. CONTINUOUS QUALITY IMPROVEMENT
5. LEADERSHIP
PRICE REDUCTION
• COST AN ESSENTIAL ELEMENT OF TQM
• CROSBY PHILOSPHY QUALITY IS FREE QLTY IS THE RIGHT OF CUSTOMER
Who determines quality?
THE CUSTOMER
If the customer does not perceive you as offering quality service you are not.
INVOLVEMENT OF EVERYONE
CONTINUOUS IMPROVEMENT
• Improve each and everyday - Do not focus on problems, focus on improvements.
• IF YOU’RE NOT PART OF THE SOLUTION, YOU’RE PART OF THE PROBLEM.
CONTINUOUS IMPROVEMENT
• Customers are not interested in excuses, they’re interested in results.
• Be proactive - because if you don’t someone else will.
• Ishikawa Says The organization which does not make a change in the 06 months is a dead organizations
LEADERSHIP
• NO EFFORT FOR QUALITY IMPROVEMENT CAN SUCCEED WITHOUT COMMITMENT OF TOP MANAGEMENT
LEADERSHIP
A NATION WITHOUT LEADERSHIP IS THE HERD OF SWINE
EINSTEIN