Iso 9001 2008

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    Iso 9001 2008 - Presentation Transcript

    1. Euromedica Ροδος
    2. Συστάσεις
      • Βέργας Δημήτρης
      • [email_address]
    3. FRAMEWORK DIS 9001/ 2008-02-20
    4. Quality Management & ISO system
    5. Quality Definition
    6. Expectation & Perception Satisfaction
    7. ΣΥΝΕΧΗΣ ΒΕΛΤΙΩΣΗ ΤΟΥ ΣΥΣΤΗΜΑΤΟΣ ΠΟΙΟΤΗΤΑΣ ΕΥΘΥΝΗ ΤΗΣ ΔΙΟΙΚΗΣΗΣ ΔΙΑΧΕΙΡΙΣΗ ΠΟΡΩΝ ΜΕΤΡΗΣΗ ΑΝΑΛΥΣΗ, ΒΕΛΤΙΩΣΗ ΥΛΟΠΟΙΗΣΗ ΠΡΟΪΟΝΤΟΣ ΠΡΟΪΟΝ ΕΙΣΡΟΗ ΕΚΡΟΗ ISO 9000: 200 8-The structure Ι Κ Α Ν Ο Π Ο Ι Η Σ Η Π Ε Λ Α Τ Ω Ν Α Π Α Ι Τ Η Σ Ε Ι Σ Π Ε Λ Α Τ Ω Ν Π Ε Λ Α Τ Ω Ν
    8. Quality System Documentation Stracture
    9. ISO 9001 :2008
      • Changes
    10. Expected date Οκτ/ Νοε 2008 Development Of International Standards Total at 31 December 2007 17 041 International Standards
    11. Changes Types
      • Clause changes
      • Emphasis
    12. 02. Process Approach
      • More Emphasis
      • to produce the desired outcome
    13. 02. Διεργασία
    14. 02. Διαδικασία: Ορισμοί
      • Διαδικασία: ορίζονται οι ενέργειες και οι δραστηριότητες που πραγματοποιούνται για τον μετασχηματισμό των εισροών σε εκροές με ταυτόχρονη αύξηση της αξίας των εκροών
      • Βασικές (Κύριες) Διαδικασίες: οι απαραίτητες Διαδικασίες για την παραγωγή, πώληση και παροχή των προϊόντων και υπηρεσιών
      • Υποστηρικτικές (Δευτερεύουσες) Διαδικασίες: οι Διαδικασίες που είναι αναγκαίες για την υλοποίηση των Βασικών Διαδικασιών
    15. 02.Performance Levels
    16. Process Improvement Methods
      • Minimize or eliminate non value added activities
      • Apply Specifications
      • Move control points forward
      • Eliminate control points
      • Incoming & Supplier evaluation
      • Time studies
      • Move steps to other processes
      • parallel steps
    17. 02.Process Improvement
    18. 0 4 . Compatibility ISO 14001 No incorporation
    19. 1.1 Application + Intermediate products
    20. 4.1 Outsource Process
      • Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements
      • Expands controls
    21. 4.2 & 4.2.3 Documentation
      • Clarification about the required documents
      • Control of external origin doc
    22. 5.4.1 Quality Objectives
      • Objectives= CSF
    23. 5.5.2 Management Rep
      • member of the organization’s management
    24. 5.5.3 Internal Communication
      • Effectiveness
      • Communication regarding effectiveness
    25. 6.2 Human resources
      • Personnel performing work effecting directly or indirectly
      • Training: ‘where applicable’
      • Ensure that competence has been achieved VS checking the effectiveness of training
      • On the Job training: records
      • Performance review: not a requirement
    26. 6.3 Infrastructure
      • + information systems
    27. 6.4 Work Environment NOTE The term "work environment" relates to conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting, or weather).
    28. 7.2 Customer Related Processes NOTE Post delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal .
    29. 7.3 Design & Development
      • NOTE
      • Design and development review, verification and validation have distinct purposes. They may be conducted and
      • recorded separately or in any combination as suitable for the product and the organization.
      • Information for production and service provision may include details for the preservation of product.
    30. 7.5.4 Customer Property NOTE + Personal data
    31. 7.6 Control of monitoring & measuring equipment NOTE Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.
    32. 8.2.1 Customer Satisfaction NOTE Monitoring customer perception may include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, dealer reports
    33. 8.2.2 Internal Audit The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes
    34. 8.2.3 Monitoring & measurement of processes NOTE When determining suitable methods, the organization should consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system
    35. 8.2.4 Monitoring & measurement of product The release of product and delivery of service to the customer shall not proceed until ...
    36. Certification
      • No changes til the FDIS & IS
      • Transition: 12-18 months
      • Upgrade: surveillance or re-certification
      • Internal Auditor training
    37. Ευχαριστούμε Στην διαθεσή σας, αν υπάρχουν ερωτήσεις.

    + Dimitris VergasDimitris Vergas, 2 years ago

    custom

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