Preface |
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xv | |
Introduction |
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xvii | |
How to read this book |
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xvii | |
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The Most Important Changes in the Structure and Coherence of the ISO 9000 Series |
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1 | (8) |
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What will be the structure of the new ISO 9000 series and what is its relationship to the other standards and guidelines in the ISO 9000 family? |
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1 | (2) |
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Why was the ISO 9000 series revised? |
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3 | (1) |
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Was there something wrong with the 1994 version of the ISO 9000 series? |
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4 | (1) |
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What happened to ISO 9002 and 9003? |
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5 | (1) |
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What requirements of ISO 9000:2000 can I exclude? |
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5 | (1) |
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When was the new ISO 9000 series published? |
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6 | (1) |
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Why are translations of the ISO 9000 series released later than the internationally published series? |
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6 | (1) |
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Why do ISO standards have different designations in different countries? |
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7 | (1) |
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Why has the ISO 9000 series also become an American National Standard? |
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7 | (2) |
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Major Changes to the Content of the ISO 9000 Series |
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9 | (12) |
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How does the basis of the 1994 ISO 9000 series differ in content from that of 2000? |
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9 | (1) |
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How does ISO 9001:2000 differ from ISO 9001:1994? |
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10 | (1) |
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How does ISO 9004:2000 differ from ISO 9004:2000? |
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10 | (2) |
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What is the relationship between ISO 9001:2000 and ISO 9004:2000? |
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12 | (2) |
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How is the process approach integrated into ISO 9001:2000 and ISO 9004:2000? |
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14 | (1) |
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What does the model for a process-based quality management system look like? |
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15 | (1) |
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Why has the title of ISO 9001:2000 been revised? |
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16 | (1) |
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What is the meaning of the term quality in ISO 9000:2000? |
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17 | (1) |
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How does the term supplier change? |
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18 | (1) |
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What does the term product mean in ISO 9000:2000? |
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19 | (1) |
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What are the quality management system principles on which the new ISO 9000 series is based? |
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19 | (2) |
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Quality Management Principles |
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21 | (12) |
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What is a quality management principle? |
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21 | (1) |
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Why have the quality management principles been established? |
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21 | (1) |
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What does principle 1, customer focused organization, mean? |
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22 | (1) |
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What does principle 2, leadership, mean? |
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23 | (1) |
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Is there a particular management theory for principle 2 on leadership? |
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24 | (1) |
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What does principle 3, involvement of people, mean? |
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25 | (1) |
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What does principle 4, process approach, mean'? |
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26 | (1) |
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What does principle 5, system approach to management, mean? |
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27 | (1) |
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What does principle 6, continual improvement, mean? |
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28 | (1) |
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What does principle 7, factual approach to decision making, mean? |
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29 | (1) |
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What does principle 8, mutually beneficial supplier relationships, mean? |
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29 | (2) |
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What is the relationship between the quality management principles and ISO 9001:2000? |
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31 | (1) |
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Can I comply with ISO 9001:2000 without adhering to quality management principles? |
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31 | (2) |
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Quality Management System |
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33 | (10) |
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Should I base my quality management system on the model of a process-based system? |
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33 | (1) |
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Is outsourcing of quality-related processes allowed? |
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34 | (1) |
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Is anything changing in the quality manual, procedures, instructions, or other documentation? |
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34 | (1) |
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Can I operate using fewer procedures? |
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35 | (2) |
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What documented procedures and documents are mandatory? |
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37 | (1) |
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How can I convert a function-based quality management system into a process-based quality management system? |
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38 | (2) |
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Which records does ISO 9001:2000 require? |
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40 | (3) |
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Management Responsibility |
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43 | (10) |
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Has top management's responsibility toward the customer changed? |
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43 | (1) |
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What is the role of top management in achieving customer-focus? |
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44 | (1) |
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How do I determine customer requirements? |
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44 | (1) |
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Our organization rarely or never receives complaints or suggestions from our customers. Can we assume that they are satisfied? |
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45 | (1) |
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If customer focus is a prime concern, then what is the position of other interested parties, such as employees? Are they not important? |
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45 | (1) |
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What is the position of regulatory requirements in ISO 9001:2000? |
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46 | (1) |
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What else is changing for top management? |
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47 | (1) |
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Are there additional requirements for quality policy? |
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47 | (1) |
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Which additional requirements apply to quality management system planning? |
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48 | (1) |
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We have a large company with various divisions. It would be useful to appoint more than one management representative. Is this possible? |
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49 | (1) |
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What does the new requirement on internal communication mean? |
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50 | (1) |
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Does management review change? |
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51 | (2) |
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53 | (6) |
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What does resource management mean? |
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53 | (1) |
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Are additional requirements for personnel included in ISO 9001:2000? |
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54 | (1) |
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What does the new requirement about training mean? |
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55 | (1) |
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Is it true that the new ISO 9000 series includes requirements for occupational health and safety? |
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56 | (1) |
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Why are requirements included for the work environment? After all, ISO 9001:2000 is not about occupational health and safety management |
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57 | (1) |
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What does ISO 9001:2000 mean by infrastructure? |
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58 | (1) |
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59 | (6) |
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What does ISO 9001:2000 mean by product realization? |
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59 | (1) |
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Does product also mean service? |
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60 | (1) |
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What new requirements apply to product realization? |
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60 | (1) |
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What does the customer communication requirement mean? |
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61 | (1) |
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Must the customer make all their requirements known? |
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62 | (1) |
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Are there new requirements for product design and development? |
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63 | (1) |
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We use software to check whether the product meets the requirements. Does ISO 9001:2000 mention anything about this? |
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63 | (2) |
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Measurement, Analysis and Improvement |
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65 | (6) |
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What does the requirement for continual improvement mean? |
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65 | (2) |
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Have the requirements for measurement, analysis and improvement changed? |
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67 | (1) |
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What are the requirements for monitoring customer satisfaction? |
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67 | (1) |
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How can I monitor customer satisfaction? |
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68 | (1) |
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Does the internal audit change? |
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68 | (1) |
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Does the external audit change? |
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69 | (2) |
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Certification and Transition Period |
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71 | (14) |
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Will there be a new standard for auditing as well? |
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71 | (2) |
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My organization is currently certified on the basis of ISO 9002:1994. Now that ISO 9002 has been withdrawn, what am I supposed to do? |
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73 | (1) |
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Our design and development activities are essential, but I still want to exclude these during certification on the basis of ISO 9001:2000. Is this possible? |
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73 | (1) |
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May I disregard other requirements of ISO 9001:2000 in addition to design and development activities? |
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74 | (1) |
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May I also add components to the quality management system that are not required in ISO 9001:2000? |
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74 | (1) |
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I only want to become ISO 9001 certified. Do I need to worry about ISO 9004:2000? |
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75 | (1) |
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When can I have my organization certified according to the requirements of ISO 9001:2000? |
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76 | (1) |
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Can my organization still receive ISO 9001:1994 certification? |
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76 | (1) |
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How long are certifications based on the ISO 9000:1994 standards valid? |
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76 | (1) |
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How can one see whether an organization is certified against the requirements of the 1994 version or the 2000 version of the ISO 9000 standards? |
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77 | (1) |
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What is recommended in the transition period: certification according to the requirements of the 1994 version or the 2000 version of ISO 9001? |
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77 | (1) |
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If I want to quickly change over to ISO 9001:2000, how can I prepare myself? |
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78 | (1) |
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Do we have to adapt our quality management system to ISO 9001:2000? |
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78 | (1) |
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How much must be changed to transition from ISO 9001:1994 to ISO 9001:2000? |
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79 | (1) |
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Will auditing be more expensive? |
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80 | (1) |
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What does the transition from ISO 9001:1994 to ISO 9001:2000 cost? |
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81 | (1) |
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Must auditors be prepared to work with ISO 9001:2000? |
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82 | (1) |
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Can I certify my organization on the basis of ISO 9004:2000, now that guidelines for self-assessment are included? |
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82 | (1) |
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I think that our organization already meets ISO 9001:2000. I want to show this to my employees and customers with a new certification, even if my current certification has not yet expired. Do I have to have everything audited again? |
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83 | (1) |
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Is an ISO 9001 certification a guarantee that the organization meets the requirements of the standard? |
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83 | (2) |
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85 | (10) |
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In the case of CE marking, European legislation refers to ISO 9001:1994, ISO 9002:1994, and ISO 9003:1994. What happens to this now that only ISO 9001:2000 remains? |
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85 | (1) |
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Our organization has just started reorganizing. Should we wait to modify our quality management system? |
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85 | (2) |
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We are a small consultancy bureau in construction services. Can the new ISO 9001 also be beneficial to us? |
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87 | (1) |
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87 | (1) |
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Are only ISO 9001 certificates that bear the logo of a national accreditation council accepted? |
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88 | (1) |
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89 | (1) |
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I want to make my certification public. Can I use the ISO logo for this, or must I do something else? |
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90 | (1) |
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Can our organization be certified by the national standardization body? |
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91 | (1) |
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What is the relationship between the national standardization body and ISO? |
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91 | (1) |
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Is ISO 9001:2000 better aligned with ISO 14001? |
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92 | (3) |
Appendix 1 Abbreviations Used |
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95 | (2) |
Appendix 2 List of Standards in the ISO 9000 Family |
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97 | (4) |
Appendix 3 Correspondence between ISO 9001:2000 and ISO 14001:1996 |
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101 | (4) |
Appendix 4 Correspondence between ISO 14001:1996 and ISO 9001:2000 |
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105 | (4) |
Appendix 5 Correspondence between ISO 9001:1994 and ISO 9001:2000 |
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109 | (4) |
Appendix 6 Correspondence between ISO 9001:2000 and ISO 9001:1994 |
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113 | (4) |
Authors |
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117 | (2) |
Index |
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119 | |