ISO 9001:2008 Changes

Transcript

1 ISO 9001:2008 Changes

2 Συστάσεις Βέργας ηµήτρης

3 FRAMEWORK DIS 9001/

4 Quality Management & ISO system Quality Management ISO 9001

5 Quality Definition Product T.Q Service

6 Expectation & Perception Satisfaction Expectation Perception Expectation Perception

7 ISO 9000: 2008-The structure Α Π Α Ι Τ Η Σ Ε Ι Σ Π Ε Λ Α ΠΤ ΩΕ ΝΛ Α Τ Ω Ν ΙΑΧΕΙΡΙΣΗ ΠΟΡΩΝ ΣΥΝΕΧΗΣ ΒΕΛΤΙΩΣΗ ΤΟΥ ΣΥΣΤΗΜΑΤΟΣ ΠΟΙΟΤΗΤΑΣ ΕΥΘΥΝΗ ΤΗΣ ΙΟΙΚΗΣΗΣ ΜΕΤΡΗΣΗ ΑΝΑΛΥΣΗ, ΒΕΛΤΙΩΣΗ Ι Κ Α Ν Ο Π Ο Ι Η Σ Η Π Ε Λ Α Τ Ω Ν ΕΙΣΡΟΗ ΥΛΟΠΟΙΗΣΗ ΠΡΟΪΟΝΤΟΣ ΕΚΡΟΗ ΠΡΟΪΟΝ 7

8 Quality System Documentation Structure Εγχειρίδιο Ποιότητας ιαδικασίες Πλάνα Ποιότητας (Quality Plans) ΟδηγίεςΕργασίας Instructions) (Work Αρχεία

9 Changes ISO 9001:2008

10 Expected date Οκτ/ Νοε 2008 Development Of International Standards Total at 31 December International Standards

11 Changes Types Clause changes Emphasis

12 02. Process Approach More Emphasis to produce the to produce the desired outcome

13 02. ιεργασία

14 02. ιαδικασία: Ορισµοί ιαδικασία: ορίζονται οι ενέργειες και οι δραστηριότητες που πραγµατοποιούνται για τον µετασχηµατισµό των εισροών σε εκροές µε ταυτόχρονη αύξηση της αξίας των εκροών Βασικές (Κύριες) ιαδικασίες: οι απαραίτητες ιαδικασίες για την παραγωγή, πώληση και παροχή των προϊόντων και υπηρεσιών Υποστηρικτικές ( ευτερεύουσες) ιαδικασίες: οι ιαδικασίες που είναι αναγκαίες για την υλοποίηση των Βασικών ιαδικασιών

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 04. Compatibility ISO 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 & 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: months Upgrade: surveillance or re- certification Internal Auditor training

37 Ευχαριστούµε Στηνδιαθεσήσας, ανυϖάρχουν ερωτήσεις.