QMS Training

Quality Management System
ISO 9001:2008
10/10/2011
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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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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Planning
Marketing Design Purchase Procedures, as required by industry/ customers/ Law/ Management Production Packing Finished Goods/ Other Stores Dispatch Services
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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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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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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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Identification Records of Conformity Records Controls Records of Effectiveness Hard Copy/ Electronic Records Legibility Storage Protection
Retrieval
Retention
Disposition
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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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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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Product Information Enquiry Handling Contracts Handling Amendments Handling
Feedback Complaints
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Customer Communication

Planning Inputs Reviews Design and Development Verification
Validation
Outputs
Changes
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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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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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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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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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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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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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What are the principles of quality management?

What are the principles of quality management?

What are the perspectives of a process approach to quality management?

What are the perspectives of a process approach to quality management?

Quality Management System

Customer Satisfaction/Interested Parties Satisfaction

Quality Management Principles

Mutually Beneficial Supplier Relationship

Process Perspectives for QMS

Procedures Forms/ Data/ Records/ Information

ISO 9001 QMS model

Measurement, analysis, improvement

Product/ Service realisation

Service/ Output Product

Maturity Levels of Implementation

Level 2Some How Managed

Level 1Chaos/ Uncertain

4.0 Quality Management System

Commercial Process Processes

Quality Systems Process

4.0 Quality Management System

Handling Non Conforming Situations

4.0 Quality Management System

4.0 Quality Management System

4.0 Quality Management System

Procedures/ SOPs/ Sample Formats

4.0 Quality Management System

Revision Status identification

4.0 Quality Management System

4.0 Quality Management System

5.0 Management Responsibility

5.0 Management Responsibility

5.0 Management Reviews

Effectiveness Improvement Opportunity

Need for Changes

5.0 Management Reviews

Product Conformity Actions Status Changes Expected

Corrective Preventive Previous Actions

Recommendations for Improvement Improvement in QMS Improvements in Processes

6.0 Resource Management

7.0 Product Realization

7.0 Product Realization

Agreement Verbal Requirements Confirmation Changed Requirements Management

7.0 Product Realization

7.0 Product Realization

7.0 Product Realization

Criteria and Process for

7.0 Product Realization

Monitoring and Measurement

Production and Service Provision

7.0 Product Realization

7.0 Product Realization

Calibration Status identification

8.0 Measurement, Analysis and Improvement

8.0 Measurement, Analysis and Improvement

Control to avoid mixup

Rework & Reinspection

Re-grade for different application

What to do if already delivered

8.0 Measurement, Analysis and Improvement