Quality Management System
ISO 9001:2008
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Quality
Fitness for use Least Variability Loss to society Conformance to specifications/requirements
Quality
Customer Satisfaction/Interested Parties Satisfaction
Degree to which inherent characteristics of a product or service meets requirements Ability to fulfill stated and implied needs Cost of poor quality
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Quality Management Principles
Customer Focus Leadership Involvement of People Quality Management Principles Continual Improvement Facts based Decisions
Mutually Beneficial Supplier Relationship
Process Approach System Approach
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Process Perspectives for QMS
Adjustments
CONTROLS
Measurements
PROCESS INPUT
set of interrelated or interacting activities which transforms inputs into outputs
OUTPUT
PRODUCT
RESOURCES
Process Approach
Process A Process B
Input Output Controls
Process C Process D
QMS Documentation
Policy
Processes
Procedures Forms/ Data/ Records/ Information
ISO 9001 QMS model
Continual Improvement of the Quality Management System
C U S T O M E R S
R e q u i r e m e n t s
Management responsibility
Resource management
Measurement, analysis, improvement
S a t i s f a c t i o n
C U S T O M E R S
Input
Product/ Service realisation
Service/ Output Product
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Improvements
Sweet Fruits
Bulk Fruits
Low Hanging Fruits
Ground Fruits
Maturity Levels of Implementation
Level 5Optimized Level 4Quantitatively Managed
Level 3Defined
Level 2Some How Managed
Level 1Chaos/ Uncertain
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4.0 Quality Management System
Technical Processes
Commercial Process Processes
Quality Systems Process
Outsourced Processes
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4.0 Quality Management System
Documents Control Record Control Auditing
Procedures
Handling Non Conforming Situations
Solving Problems Occurred to avoid re-occurrence Solving Anticipated Problems to avoid occurrence
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4.0 Quality Management System
Planning
Marketing Design Purchase Procedures, as required by industry/ customers/ Law/ Management Production Packing Finished Goods/ Other Stores Dispatch Services
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4.0 Quality Management System
Scope Exclusions Quality Management Approach Quality Manual Processes Description Quality Policy Procedures Reference Objectives Any other information, as necessary Organization Chart Strengths/ Capability Market
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4.0 Quality Management System
Departmental Activities Departmental Objectives List of Documents Departmental Manual Processes Description/ Flow Charts List of Records/ Softwares
Procedures/ SOPs/ Sample Formats
Any other information, as necessary
List of Equipments/Instruments Organization Chart/ Responsibilities List of Suppliers/ Service Providers Audit Checklist
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4.0 Quality Management System
Approval Review Update Reapprove
Changes identification
Document Control
Revision Status identification
Available at point of use Legible Documents Readily identifiable External Origin Documents identification External Origin Documents Distribution Prevention of misuse of obsolete documents
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4.0 Quality Management System
Identification Records of Conformity Records Controls Records of Effectiveness Hard Copy/ Electronic Records Legibility Storage Protection
Retrieval
Retention
Disposition
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4.0 Quality Management System
Management Reviews Competence Related Product Requirements Review Design Related Suppliers evaluation Traceability Customers Property related Communications Calibration Audits Non Conforming Products Corrective Actions Preventive Actions Quality Objectives Achievement Data Analysis Complaint Reports Process Performance Maintenance Reports Service Reports Test Reports Customer Satisfaction
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Records
Reports
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5.0 Management Responsibility
Commitment Customer Focus Quality Policy Planning for Achievement Objectives
Managing Changes
Responsibility & Authorities Internal Communication Management Review Management Representative Process Inputs
Outputs
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5.0 Management Responsibility
Development Management Commitment for QMS Implementation Continual Improvement Communication for meeting requirements Quality Policy Management Commitment by
Objectives
Management Reviews Resources
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5.0 Management Reviews
Suitability Top Management Involvement Management Reviews Planned (not equal) intervals Review of QMS Adequacy
Effectiveness Improvement Opportunity
Need for Changes
Quality Policy
Quality Objectives
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5.0 Management Reviews
Audits Customer Feedback
Process Performance
Inputs
Product Conformity Actions Status Changes Expected
Corrective Preventive Previous Actions
Management Reviews
Recommendations for Improvement Improvement in QMS Improvements in Processes
Outputs
Improvement in Product Resources Needs
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6.0 Resource Management
Allocation Human Resources
Competence Improvement
Training Awareness Machines Equipments
Plan
Do Check Effectiveness Take Actions
Resources
Infrastructure
Buildings Communication Software Hardware Work Environment Physical Factors Human Factors
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7.0 Product Realization
Process Planning Planning Process Process Development Product Requirements New/ Changed Processes Criteria of Acceptance Quality Objectives Documents Resources Planning considerations Verification Validation Monitoring Quality Plan Measurement Inspection Testing
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7.0 Product Realization
Specified Implied Product/ Service Requirements Determine Requirements Statutory Any ambiguities resolved Management Capability Assessment
Review Requirements
Agreement Verbal Requirements Confirmation Changed Requirements Management
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7.0 Product Realization
Product Information Enquiry Handling Contracts Handling Amendments Handling
Feedback Complaints
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Customer Communication
7.0 Product Realization
Planning Inputs Reviews Design and Development Verification
Validation
Outputs
Changes
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7.0 Product Realization
Purchase Requirements Purchase Considerations Control over supplier Control over purchased product Evaluation of Suppliers Selection of Suppliers
Criteria and Process for
Re-evaluation of Suppliers
Accurate Purchase Information Arrangements of Verification of Purchased Products
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7.0 Product Realization
Specifications Work Instruction Controlled Conditions
Suitable Equipments
Monitoring and Measurement
Production and Service Provision
Release/ Delivery and Post Delivery Qualifying processes to guarantee required outcome Revalidation
Validation of Processes
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7.0 Product Realization
Product Identification Production and Service Provision Product Status Identification
Traceability
Lost Customer Property Control Damaged Unsuitable Packing
Storage Preservation
Handling Delivery
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7.0 Product Realization
Measuring Instrument Selection
Calibration
Measuring Instruments/ Systems Control Validation of Software supporting monitoring activities Evaluate situation when instruments are found out of calibration
Calibration Status identification
Instruments Handling
Instruments Maintenance
Instruments Storage
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8.0 Measurement, Analysis and Improvement
Plan Measurement Statistical Techniques Direct Methods Customer Satisfaction
Indirect Methods
Plan Do Internal Audit Follow-up Process Monitoring Action Completion Product Monitoring Product Release
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8.0 Measurement, Analysis and Improvement
Identification Acceptance on Concession Non Conforming Product/ Complaints/ Returns/ Penalties
Control to avoid mixup
Rework & Reinspection
Decide for
Re-grade for different application
Scrap
What to do if already delivered
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8.0 Measurement, Analysis and Improvement
Analysis of Data Internal Audits
Management reviews
Continual Improvement using
Quality Policy
Quality Objectives
Corrective Actions (No Repetition of Problems) Preventive Actions (Right First Time)
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