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Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
Typical Quality Management System Based On Iso 9001 2008
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Typical Quality Management System Based On Iso 9001 2008

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  • 1. Quality Management System
    Understanding our QMS for the achievement of organization and business success.
  • 2. Objectives of the Orientation
    To learn the benefits of implementing the requirements of the quality management system
    The effect of not following the requirements.
  • 3. Course Outline
    What is ISO and Quality Management System
    Clauses and Benefits of ISO 9001:2008
  • 4. ISO 9001:2008
    So what about it?
    ISO 9001 is a standard for QUALITY MANAGEMENT SYSTEM
  • 5. ISO 9001:2008
    Quality Management Systems
    - a web of interconnected processes that are used to manage a business.
  • 6. International Organization for Standardization
    ISO is not an acronym for International Organization for Standardization
    What isISO?
    The organization’s short name was taken from the Greek word “isos”, meaning “equal”.
  • 7. 1. CUSTOMER FOCUS
    2. LEADERSHIP
    ISO 9001
    3. INVOLVEMENT OF PEOPLE
    4. PROCESS APPROACH
    5. SYSTEM APPROACH
    6. CONTINUAL IMPROVEMENT
    7. FACTUAL APPROACH
    8. MUTUAL BENEFICIAL SUPPLIER RELATIONSHIPS
    8 MANAGEMENT PRINCIPLES
  • 8. THE Process Based Approach
    When ISO updated the 9000 series from 1994 to 2000 they decided to focus on a process approach to the QMS versus the old functional approach.
    All work is a process. This means that in everything we do there are inputs and outputs, suppliers and customers, and means to get the work done.
  • 9. Model of Process Based QMS
  • 10. The Customer-Supplier Chain
    Work team
    Output
    Input
    Customer
    Requirements
    Customer
    Feedback
  • 11. Elements of a Typical Quality Management System Manual
  • 12. 4
    Quality Management System
    4.1 General Requirements
    4.2 Documentation Requirements
    1
    1.1 General
    1.2 Application
    Scope
    2
    Normative Reference
    3
    Terms and Definitions
    Contents
  • 13. Contents (cont.)
    5
    5.1 Management Commitment
    5.2 Customer focus
    5.3 Quality Policy
    5.4 Planning
    5.5 Responsibility, authority and communication
    5.6 Management Review
    Management Responsibility
    6
    6.1 Provision of resources
    6.2 Human resources
    6.3 Infrastructure
    6.4 Work environment
    Resource Management
  • 14. 7
    7.1 Planning of product realization
    7.2 Customer-related processes
    7.3 Design and development
    7.4 Purchasing
    7.5 Production and service provision
    7.6 Control of monitoring and measuring devices
    Measurement, Analysis and Improvement
    Product Realization
    Contents (cont.)
    8
    8.1 General
    8.2 Monitoring and measurement
    8.3 Control of nonconforming product
    8.4 Analysis of data
    8.5 Improvement
  • 15. Quality Manual(ISO 9001:2008)
  • 16. Section 1: Scope
    Includes the design and construction of cleanroom, ventilation and air conditioning system, metal finishing system, environmental control system for automotive and other industrial or commercial applications.
    Exclusion
    • Design and development validation …
  • Section 2: Normative References
    ISO 9000:2005
    ISO 9001: 2008
    QMS ISO 9001:2000
    QMS ISO 9002:1994
  • 17. ISO 9002:1994
    4.11 Control of inspection, measuring and test equipment
    4.12 Inspection and test status
    4.13 Control of nonconforming product
    4.14 Corrective and preventive action
    4.15 Handling, storage, packaging, preservation and delivery
    4.16 Control of quality records
    4.17 Internal quality audits
    4.18 Training
    4.19 Servicing
    4.20 Statistical techniques
    1. Scope
    2. Normative Reference
    3. Definitions
    4.1 Management responsibility
    4.1.1 Quality Policy
    4.1.2 Organization
    4.1.2.1 Responsibility and authority
    4.1.2.2 Resources
    4.1.2.3 Management representative
    4.1.3 Management review
    4.2 Quality System
    4.2.1 general
    4.2.2 quality system procedures
    4.2.3 quality planning
    4.3 contract review
    4.4 design control
    4.5 document and data control
    4.6 purchasing
    4.7 control of customer-supplied product
    4.8 product identification and traceability
    4.9 process control
    4.10 inspection and testing
    Section 2: Normative References
    ISO 9001:2000 Elements
    1. Scope
    2. Normative Reference
    3. Terms and Definitions
    4. Quality Management System
    5. Management Responsibility
    6. Resource Management
    7. Product Realization
    8. Measurement, Analysis and Improvement
  • 18. Section 3: Terms and Definition
    Definitions
    Terms used by an organization:
  • 19. Section 4: General requirements
    Processes, interaction, improvement
    The focus is on looking at:
    • What we do.
    • 20. Who we are doing it for.
    • 21. Improving how we provide service.
  • Section 4: General requirements
    Documentation requirements
    • Control of document
    Documents must show a control number, adoption and revision dates, in order to ensure use of the most recent information.
    • Control of records
    Each record must be controlled in order to ensure uniform quality.
  • 22. 22
    Section 4: General requirements
    LEVEL 1 - QUALITY MANUAL
    Quality Policy
    Quality Objectives
    Requirement Standard
    Other Statutory and Regulatory Requirements
  • 23. Section 4: General requirements
    Documentation requirements
    • Quality manual
    The quality manual describes our intent to establish a quality management system with an emphasis on continual improvement.
  • 24. Section 4: General requirements
    Quality Policy
    The staff and management of ___ are committed to consistent provision of quality products and services
    that will satisfy the demands and expectations of customers
    by continual improvement of the QMS and conforming to local standards and prevailing codes of practice.
  • 25. Section 4: General requirements
    Current Objectives
    Maintain good business relationship with the clients.
    Deliver quality products and services to the satisfaction of the clients
    Effect efficiency in operations by continual improvement of the Quality Management System.
    Improve employee’s competence through periodic evaluation and development of skills, knowledge and abilities by providing appropriate training.
    For revision
  • 26. LEVEL 2 - QUALITY PROCEDURES
    Control of Documents
    Control of Records
    Internal Quality Audits
    Control of Non-conforming Products
    Corrective Action
    Preventive Action
    26
    Section 4: General requirements
  • 27. 27
    Section 4: General requirements
    LEVEL 3 - QUALITY PLAN
    Incoming Inspection Plan
    In-Process Inspection Plan
    Final Test Report/ Inspection Plan
    Work Instruction
  • 28. 28
    Section 4: General requirements
    LEVEL 4 - FORMS / FORMATS/RECORDS
    Testing Report forms
    Commissioning Report Forms
    Inspection forms
    Check Sheets/Check List
    Miscellaneous Documentation Forms
  • 29. 23 MANDATORY RECORDS
    Management Review
    Competence, Training and Awareness
    Planning and Production
    Review of Requirement Related to Product
    Design and Development Input
    29
    Section 4: General requirements
  • 30. 30
    Section 4: General requirements
    23 MANDATORY RECORDS (cont’n)
    Design and Development Output
    Design and Development Review
    Design and Development Verification
    Design and Development Validation
    Control of Design and Development Changes
  • 31. 31
    Section 4: General requirements
    23 MANDATORY RECORDS (cont’n)
    Purchasing Process
    Availability of Monitoring and Measuring Equipment
    Preservation of Product
    Customer Property
    Control of Monitoring and Measuring Equipment
    Standards used for Calibrating Monitoring and Measuring Equipment
  • 32. 32
    Section 4: General requirements
    23 MANDATORY RECORDS (cont’n)
    Identify and Enable Calibration
    Result of Calibration and Verification
    Internal Audit
    Monitoring and Measurement of Product
    Control of Non-conforming Product
    Corrective Action
    Preventive Action
  • 33. Management Responsibility
    Section 5: Management Responsibility
  • 34. Summary of Section 5
    Management Responsibility
    Commitment
    Focus
    Policy
    Objectives
    Planning
    These correspond to the following principles:
    • Customer focus
    • 35. Leadership
  • Resource Management
    Section 6: Resource Management
  • 36. Summary of Section 6
    Resource Management
    Provide quality resources
    Provide quality personnel
    Provide quality infrastructure
    Provide quality environment
    This corresponds to the following principle:
    • Involvement of People
  • Section 7: Product Realization
    Product /Service Realization
  • 37. Section 7: Product Realization
    7.1 Plan and develop the processes
    • Include product objectives, relevant processes and resource, appropriate test and validation
    7.2 Customer related processes
    • Customer requirement - stated and implied
    • 38. Statutory and regulatory
    • 39. Product requirements and changes
    • 40. Organization ability
    • 41. Communication with customers
  • Section 7: 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
    • 42. Relevant purchasing information
    • 43. Verification of purchased product
  • Section 7: Product Realization
    7.5 Production and service provision
    • Controlled conditions including product characteristics, work instructions, suitable equipment, measuring devices, and system
    • 44. Release, delivery and post delivery activities
    • 45. Validation of processes when no other method
    • 46. Identification and traceability of product and it’s status
    • 47. Care of customer property
    • 48. Preservation of product
    • 49. Includes constituent parts
  • Section 7: Product Realization
    7.6 Control of monitoring and measuring devices
    • Calibrated where necessary
    • 50. Adjusted and readjusted
    • 51. Identifies status
    • 52. Safeguarded from invalid adjustment
    • 53. Protected from damage or deterioration
  • Summary of Section 7
    Control of the following process
    realization planning
    customer communication
    product development
    purchasing function
    operation
    monitoring
    These correspond to:
    • Get the facts before you decide
    • 54. Focus on customers
    • 55. Use a process approach
    • 56. Work with your suppliers
  • CONTINUAL IMPROVEMENT OF THE QUALITY MANGEMENT SYSTEM
    Section 8: Measurement, Analysis & Improvement
  • 57. Section 8: Measurement, Analysis & Improvement
    General
    • Measurement and monitoring processes
    • 58. To demonstrate product conformity, system conformity and continually improve the Quality Management System.
    • 59. Customer satisfaction
    • 60. Perception of fulfillment.
  • Section 8: Measurement, Analysis & Improvement
    Monitoring and Measurement
    • Internal planned audit, etc.
    • 61. Process Auditors, independent of their own work will audit department process.
    • 62. Processes
    • 63. Demonstrate achievement of planned results.
  • Section 8: Measurement, Analysis & Improvement
    Monitoring and Measurement
    • Product
    • 64. Monitor and measure characteristics.
    • 65. Conformity with acceptance criteria.
    • 66. Waivers / concessions.
    • 67. Nonconforming process/product
    • 68. Elimination or correction of nonconforming processes.
  • Section 8: Measurement, Analysis & Improvement
    Analysis of data
    • Customer satisfaction
    • 69. Product and process requirements and trends
    • 70. Suppliers
  • Section 8: Measurement, Analysis & Improvement
    Improvement
    • Continually improve effectiveness of the system
    • 71. Corrective action
    • 72. Preventive action
  • Summary of Section 8
    Measurement, Analysis and Improvement
    Perform remedial processes
    Monitor and  measure quality
    Control nonconforming products
    Analyze quality information
    Make quality improvements
    This corresponds to:
    • Get the facts before you decide
    • 73. Encourage continual improvement
  • End Of Presentation
  • 74. A SHORT QUIZ
  • 75. What do you do when accepting a task?(Answerable by Yes or No)
    Before accepting an assignment, do you make sure you understand completely what you are supposed to do?
    Are the deadlines clear?
    Is it clear how much responsibility and authority you have in the project?
    Do you know which tasks you can perform on your own. Without reporting back to your boss?
    Do you let your boss know if a new assignment makes it difficult for you to do your other jobs?
  • 76. What do you do when accepting a task (Continuation)
    Do you make suggestions to make priorities on how much time you will allow the project?
    Do you get the information and background material you need to do the job properly?
    Do you try to imagine all the problems and obstacles that could arise while you are doing the job – then plan accordingly?
    Is it clear who makes decisions when your boss is not available?
    If a problem arises that you can’t handle, do you talk to your boss about the situation?
  • 77. Are You Quality-Conscious?(Answerable by True or False)
    When it comes to quality, there’s always room for improvement.
    Nobody can be aware of quality needs all the time.
    Customers pay little attention to quality.
    A quality program must mesh with the organization’s goals and profit plans.
    Quality means conformance to standards.
  • 78. Are You Quality-Conscious?(Continuation)
    Quality should operate in all parts of a business
    Personal quality standards and business quality standards have little in common.
    Quality requires commitment.
    Quality relates to the process as much as to the goal.
    People who talk about quality are mostly idealists.
  • 79. Now . . . TELL me what’s is going on !!!
    Reflection
  • 80. Prepared by: Sid Calayag
    Presented by:
    Sid Calayag – Lead Auditor ISO 9001:2008
    Reference:
    Quality Management System
    ISO 9001:2008

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