Business Excellence Through QMS
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  • 1. Business Excellence Through QMS Conformance to Performance By Arefin Khan Director, QUICK ISO.com (B.Sc. IT, MBA Marketing, Lead Auditor ISO 9001 series, ISO 14001, ISO 18001, ISO 27001,HACCP) E-mail: [email_address] , Web: www.quickiso.com Contact : +91 9768374277
  • 2. WHAT IS THE ‘IOS’
    • ( 1) International organisation for standardisation:
    • Formed in Geneva Switzerland
    • 300(+) countries are members
    • 800(+) new and revised standards issued annually
    • (2) Technical committee 176 – responsible for Quality standard creation – members:
    • ANSI - American national Standards Institute
    • SCC –standards Council of Canada
    • BSI – British Standards Institute
  • 3. FOUNDATION DOCUMENTS
    • MIL 9850
    • BSI 5750
    • CAN Z299
    • EN 29000
    • Universal ISO 9000 adopted (1987)
    • Revised: 1994 & 2000
  • 4. Other Standards
    • New QMS- ISO 9001:2008
    • EMS- ISO 14001:2004
    • OHSAS- ISO 18001
    • FSMS-ISO 22000 : 2005
    • INFO SEC-ISO 27000
    • Social A/C- SA 8000
  • 5. Evolution of Quality System
    • Inspection
    • Quality control
    • Quality Assurance
    • Quality Management system
  • 6.
    • ISO Family of Standards :
    • ISO 9000 :- FUNDAMENTALS AND VOCABULARY
    • * ISO 9001 :- REQUIREMENTS
    • * ISO 9004 :- GUIDELINES FOR PERFORMANCE
    • IIMPROVEMENT
    • * Consistent Pair
    QUALITY SYSTEMS
  • 7. What is Quality ?
    • Meeting specification?
    • Fitness for use?
    • Good – satisfactory?
    • Great – excellence?
    • Bad – liability?
    • Customer satisfaction?
    • Repeat business?
    • I know when I see it?
    • It is a state of mind, not an activity
    • It must be defined for each organization
  • 8. Scope of ISO 9001 : 2008 (Requirements for a QMS)
    • To demonstrate its ability to provide consistently product that meets customer and applicable regulatory requirements
    • To address customers satisfaction through the effective application of the system, including processes for continual improvements and the prevention of non conformity
  • 9. P- D- C- A CYCLE ACT CHECK PLAN DO TAKE APPROPRIATE ACTION Check effects Determine goal Determine Method of Reaching goal Education & training Implementation
  • 10. Principles of Quality Management
    • Customer focused organization
    • Leadership
    • Involvement of people
    • Process approach
    • System approach to management
    • Continual improvements
    • Factual approach to decision making
    • Mutually beneficial supplier relationships
  • 11. Process Definition Process Outputs Input A system of activities which uses resources to transform inputs into outputs. Effectiveness of process:Ability to achieve desired result Efficiency of process: Results achieved Vs resources used Includes resources Product- result of process
  • 12. Training and competence
    • ‘ Competence focused approaches can provide the much needed ”glue” to assure that the frame work for quality is structurally sound’
    • A system that provides clearly understandable and measurable standards for all personnel
    • A gap in standards ( a deficit in knowledge, attitude, skills or habits) can indicate a training need
    • When training has been provided, how do we know that it has done us any good?
    • A system that provides clearly understandable and measurable standards for all personnel
    • A gap in standards ( a deficit in knowledge, attitude, skills or habits) can indicate a training need
    • When training has been provided, how do we know that it has done us any good?
  • 13. Benefit of the standard
    • Availability of competent and skilled employees
    • More time for top management to think about organizational growth and development
    • Brings order and discipline into the organization
    • Working system is more effective and efficient.
    • Easy for top management to know performance of organization any time.
    • Employees feel more comforts and ease in performing task.
    • Satisfied internal and external customers.
    • Problems are prevented to occur. Customers are happy with excellent product and services
    • Easy to face competition and challenge
    • More business oriented, less procedure oriented
    • Company wide involvements
    • Customer focus than product focus
    • Less emphasis on documentation
  • 14. 4.1 General Requirements
    • Identify the Processes
    • Determine sequence and interaction
    • Determine criteria and methods for effective control
    • Ensure availability of resources and information
    • Monitor, measure and analyze processes
    • Implement actions for continual improvement.
  • 15. 4.2 Documentation Requirement
    • The QMS Documentation shall include :
    • Documented statements of Quality Policy and Quality Objectives
    • A Quality Manual
    • Documented Procedures
    • Documents to ensure effective planning, Operation and control.
    • Records.
  • 16. ISO 9001 - Requirements
    • 5. Management Responsibility
    • 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
  • 17. ISO 9001 - Requirement
    • 6. Resource Management
    • 6.1 Provision of Resources
    • 6.2 Human Resources
    • 6.3 Infrastructure
    • 6.4 Work Environment
  • 18. Exclusions
    • Limited to clause 7 requirement only
    • Such exclusions do not effect the organizations’ ability or responsibility to provide a service that fulfils members’ and applicable regulatory requirements.
  • 19. ISO 9001 – Requirements
    • 7 Product Realization ( Permissible Exclusions)
    • 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
  • 20. ISO 9001 – Requirement
    • 8. Measurement, Analysis and Improvement
    • 8.1 General
    • 8.2 Monitoring and measurement
    • 8.3 Control of non conforming product
    • 8.4 Analysis of data
    • 8.5 Improvement
  • 21. Quality policy & Quality Objectives
    • Policy to include a commitment to meeting ISO 9001:2000 requirements
    • Quality objective shall be measurable and consistent with quality policy
    • Communicated and understood at appropriate levels in the organization
  • 22. Quality Objectives
    • Establish to provide focus to direct the organization
    • Objective determine the the intended result and lead the organization to utilize resources to realize the results
    • Objectives need to be measurable and achievable
    • Achievements:positive impact on product quality, System effectiveness, financial performance, satisfaction / confidence of stake holders
  • 23. Quality Management System
    • “ All activities of overall management function that determines the quality policy, quality objectives and responsibilities and implement them by means of such as quality planning, quality assurance and quality improvements within the quality system” or in short “ this is a management system to direct and control an organization with regard to quality”
    • The quality management system defines the quality environments within a business. Every business is different and so each QMS will be unique and different.
  • 24. System Monitoring
    • Correction, corrective & preventive action
    • Internal Audit
    • Management Review
    • Improvement
  • 25. Corrective action
    • Process Approach
    • Identify root cause
    • Establish action necessary to eliminate root cause
    • Establish risk / implications of no action
    • Implement action
    • Monitor success
  • 26. Preventive action
    • Taking steps to prevent the occurrence of problems
    • What could go wrong?
    • Priorities action on the basis of risk
    • ( both to the organization and members)
    • Ensuring that the management system is suitable to fulfill the the current and future needs and expectation of the customer
  • 27. Internal Audit
    • Systematic examination to determine compliance and effectiveness
    • Compliance with ISO 9001: 2000
    • Planning to consider status and importance
    • Suitably chosen and trained auditors are a crucial resource within the management system
  • 28. Management Review
    • A top management activity undertaken to ensure suitability adequacy, effectiveness and efficiency of the system to achieve established objective
  • 29. Management Review Input
    • Meeting or circulated report subscribed to / commented up on by top management Review to encompass:
    • Policy and objective review
    • Results of audits
    • Customer feed back
    • Resource needs
    • Improvement activities – system – product / service
    • Process performance
    • Changing circumstances
    • System changes
    • Action from previous reviews
  • 30. Improvements
    • Improvements required where requirements (customer, legal, policy, and objectives) are not being met
    • Improvement should be integral to and achieved through the quality system
  • 31. List of Mandatory Records Required Design & Development - review 7.3.4 6 Design & Development - input 7.3.2 5 Customer Related Processes 7.2.2 4 Service Realization 7.1 3 Human Resources 6.2.2 2 Management Review 5.6.1 1 Type of Record Clause No. Sl.No.
  • 32. Continued......... Customer Property 7.5.4 7.5.4 14 Validation of Processes for Production and Service Provision 7.5.2 7.5.3 13 Process Validation 7.5.2 12 Planning 7.5.1 11 Purchasing/Supplier Evaluation 7.4.1 10 Design & Development –review of changes 7.3.7 9 Design & Development - validation 7.3.6 8 Design & Development - verification 7.3.5 7
  • 33. Continued......... Preventive Action 8.5.3 20 Corrective Action 8.5.2 19 Control of Nonconforming Services 8.3 18 Monitoring & Measurement of Services 8.2.4 17 Internal Audit 8.2.2 16 Control of Monitoring & Measuring Devices 7.6 15
  • 34. Essential documents for ISO 9001:2008
    • Quality Policy
    • Quality Objectives
    • Apex Quality Manual
    • Mandatory Procedures
    • Control of documents
    • Control of records
    • Internal Audit
    • Control of Non conformity
    • Corrective Action
    • Preventive Action
  • 35. Continued ......
    • Functional Procedures as required by the Organization such as---
    • Policy, Audit Review & evaluation, Failure/
    • Deviation Analysis,Approvals, Manpower Planning & Training , Support & Coordination, PQM, Correlation Programmes, Information Sharing,Lab facilities,Budget, MIS etc.
  • 36. About Certification
    • New ISO 9001:2008 Certification valid for 3 years , Surveillance Audit will be held after 1 year,9 months or 6 months of certification Audit to ensure continued implementation & Continual improvements in the Organization.
    • Surveillance Audit Schedule
    • Frequency No. of Audit
    • 1 Year 2
    • 9 Months 3
    • 6 Months 5
  • 37.
    • Thank For Your Patience!
    • For more details please logon to our site www.quickiso.com
    • And write a comment in our blog www.blog.quickiso.com
    .