N 705

Document: ISO/TC 176/SC 2/N
705
Our ref
Secretariat of ISO/TC 176/SC 2 To the Members of ISO/TC 176/SC 2 Quality Management and Quality Assurance/ Quality Systems
Date:
15 February 2005
Final Report to ISO/TC 176/SC2 on the findings of the survey of users of ISO 9001:2000 and ISO 9004:2000
Please find attached a copy of the above final survey report. This is being given due consideration by ISO/TC 176/SC 2/WG18 during the development of the "Design Specifications" for the amendment of ISO 9001 and for the revision of ISO 9004. On behalf of SC2, we would like to take this opportunity to thank the members of ISO/TC 176/SC 2/WG18/TG 1.11 for their excellent work. Yours sincerely
Charles Corrie For BSI Secretariat ISO/TC 176/SC 2
BSI Standards, 389 Chiswick High Road, London W4 4AL Telephone: + +44 208 996 9000 Fax: + +44 208 996 7400
Page 1 of 45
Final Report to ISO/TC 176/SC2 on the findings of the survey of users of ISO 9001:2000 and ISO 9004:2000 Prepared by Task Group 1.11
INTRODUCTION At the request of ISO/TC 176/SC2/WG18, TG1.11 established an Internet-based survey of users of the ISO 9000:2000 series of standards in order to collect data to determine the degree of acceptance of the standards in the market-place. The survey was launched on January 5th 2004, and has been open for direct input by any and all users of the standards world-wide. This report summarizes the responses received up to 08 November 2004. EXECUTIVE SUMMARY A wide variety of sectors and countries were represented in the survey. Responses were received from users in 63 countries. The four ISO 9001:2000 product categories (Hardware, Software, Processed Materials and Services) were well represented. The number of respondents who participated in the survey by 08 November 2004 was 941 (this was an increase of 59 over the previous, interim report of 31 July 2004), and they provided over 1477 individual comments (an increase of 143 ) in respect of specific clauses of ISO9001:2000. Approximately 80% of the respondents declared themselves satisfied with the ISO9001:2000 standard. Approximately 50% of the respondents declared themselves satisfied with the ISO9004:2000 standard. The 1477 comments received in respect of ISO9001:2000 clauses were analyzed to give a general impression of the nature of the experience of the users. The following seven clauses of the standard received the most comments: 4.1 Quality management systems - General requirements 4.2 Quality management systems documentation 6.2 Human resources 7.3 Design and development 7.5 Production and Service Provision 8.2 Monitoring and Measurement 8.5 Improvement
08 November 2004 Page 2 of 45 ISO/TC 176/SC 2/N705
The 112 comments received in respect of ISO9004:2000 clauses were analyzed to give a general impression of the nature of the experience of the users. The general impression given was that there were no major areas of concern with regard to this standard. The few comments received for ISO9004:2000 were widely scattered against a range of clauses. The highest number of comments received against any one clause was five (for the very general clause 4.1). There were several comments about the lack of alignment between ISO 9001:2000 and ISO 9004:2000. As planned in designing the survey, no detailed information was requested in respect of ISO 9000:2000.
Significant points noted overall 1. The responses received represented users over wide geographical regions, business sectors and organization size. Conclusions drawn can, therefore, be considered to be as valid as could have been expected from such an open survey. The other national surveys support the results of this survey with no significant differences. The level of user satisfaction with ISO 9001:2000 was approximately 80% and with ISO 9004:2000 was approximately 50%. A large number of individual comments were made against specific clauses of ISO 9001:2000. The majority of these relate to seven clauses. The nature of the comments indicates a significant level of confusion in relation to these particular clauses. The responses to ISO 9004:2000 indicated a much lower level of awareness or interest in this standard.
2. 3. 4. 5.
Notes: In a few questions there are a large number of Blank and No Comment responses (e.g. 2.2.2.8). Care should be taken when interpreting the results of these questions. To avoid possible misinterpretation, the pictorial data are reflected in numbers, not in percentages.
08 November 2004
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ISO/TC 176/SC 2/N705
Survey Findings
1. User Profile (Demographics)
1.1.3 Country of respondent

20 25 28 32
229 337
UNITED STATES CHINA GERMANY UNITED KINGDOM MEXICO JAPAN CANADA COLOMBIA
Observations Highest response from USA. Good response from nonEnglish speaking countries
39 45 58 58
70
AUSTRALIA ITALY Other
14 126
149
Executive
1.2 Position of respondent

108 72
Operational Quality Auditor Other Blank
Observation See table for breakdown of satisfaction level related to respondents position (page 19)
472
08 November 2004
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3 290 271 small medium large Blank
1.3 Size of organization Observation Good spread of responses.
377
41 17 9
Standardization body Accreditation body Certification body Sector Blank
1.4 Respondents user category
131
743
1.4 Sector break-down
Manufacturing - durable/non-durable Engineering services / consulting Business services / consulting Telecommunications Automotive Education (elementary, secondary and higher) Finance / banking Healthcare Hospitality Insurance Transportation Utilities Wholesale / Retailing Other Blank
391 105 72 34 38 9 7 0 2 2 13 6 16 106 102
08 November 2004
Page 6 of 45
500 450 400 350 300 250 200 150 100 50 0
449
1.5 Respondents generic product category

Note: Some organizations operate under more than one category heading.
335 266
101
Services
Software
Hardware
Processed materials
08 November 2004
Page 7 of 45
2. Experience of using the ISO 9000 series of standards

450 400 350
2.1.1 How long (in years) have you been using/implementing ISO 9001/2/3? Observation Most had experience of previous editions.
424
300 250 200 150 100 50 0
250
264
3 0-3 4-10 10+ Blank
08 November 2004
Page 8 of 45
2.2.1 ISO 9000:2000 Quality Management System - Fundamentals and Vocabulary
112
13
2.2.1.1 Do you have experience with ISO 9000:2000?
Yes No Blank
816
2.2.1.2 If Yes, how well does the standard, overall, meet your needs?
150
100 15
88
Excellent Good No comment (or NOT APPLICABLE) Needs to be improved
41
Not adequate
547
Blank
08 November 2004
Page 9 of 45
Blank, 35
2.2.1.3 Do you have experience with ISO 9000 series Supporting materials? Observation A significant majority uses these materials.
No, 237 Yes No Blank Yes, 669
60
Excellent Good No comment (or NOT APPLICABLE) Needs to be improved
2.2.1.4 If Yes, in general how well does the documentation meet your needs?
15
218
416 155 77
Not adequate Blank
08 November 2004
Page 10 of 45
2.2.2 ISO 9001:2000 Quality Management System - Requirements

1000 900 800 700 600 500 400 300 200 100 0 898
27 Yes No
16 Blank
16 42 167
2.2.2.2 If Yes, in general how well does the standard meet your needs?
137
Excellent Good No comment (or NOT APPLICABLE) Needs to be improved Not adequate Blank
14
565
08 November 2004
Page 11 of 45
2.2.2.3 What were the most important benefits of applying ISO 9001:2000 to your organization? Observation Users identified a wide variety of benefits.
216 158 150
481
352 446
434
Note: More than one choice allowed.
509
Improved customer satisfaction Improved customer communication Increased management commitment More effective management review s Effective use of data as business management tool Increased supplier performance Improved supplier communication Other
2.2.2.4 Were you able to integrate ISO 9001:2000 with other management systems? Observation Over half of users have attempted to integrate their management systems. The other category contained approximately 20 different standards and schemes.
190
256
ISO 14001 (environmental management s ys tems ) OHSAS 18001 (occupational health and safety management s ys tems ) Not attempted
114
Other
504
08 November 2004
Page 12 of 45
700 600 590
2.2.2.5 Does ISO 9001:2000 have a major impact in preventing nonconformity?
500 400 300 200 100 0 Yes No Blank 19 332
22
2.2.2.6 Is the new structure of the standard (based on the process approach) appropriate for your organization?
70
Yes No Blank
849
08 November 2004
Page 13 of 45
2.2.2.7 Does your organization use ISO 9001:2000 as one of the selection criteria for your own suppliers?
24 352 565
Yes No Blank
2.2.2.8 If Yes, are you generally satisfied with the performance of those suppliers that are certified (or who have demonstrated conformity in some other way) to ISO 9001:2000? Observation 146 responders were dissatisfied with the performance received.
307
Yes No Blank
488
146
08 November 2004
Page 14 of 45
2.2.2.9 If you converted from an earlier version of ISO 9001 what was the effect on your quality system documentation in terms of volume? Observation 345 respondents noted a decrease in documentation, while 162 noted an increase.
300 250 200 150 100 50 0 131 214
267 167 131 31
D ec re as ed D a ec lo re t as ed a lit A tle bo ut th e sa In m cr e ea se d a lit tle In cr ea se d a lo t
62
2.2.2.10 Is there anything in ISO 9001:2000 that is not beneficial? Observation Compare the 272 Yes responses with chart 2.2.3.9 for ISO9004:2000 (84 Yes)
272
Yes No Blank
607
08 November 2004
B la nk
Page 15 of 45
2.2.3 ISO 9004:2000 Quality Management Systems Guidelines for Performance Improvements
36
2.2.3.1 Do you have experience with ISO 9004:2000? Observation 357 had no experience with ISO 9004:2000.
357 548
Yes No Blank
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08 November 2004
No
co
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No
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2.2.3.2 If Yes, in general how well does the standard meet your needs?
400 350 300 250 200 150 100 50 0
319
361
80
74
87 20
Page 16 of 45
123
2.2.3.3 Have you used the ISO 9001:2000 and ISO 9004:2000 standards as a consistent pair?
448
Yes No Blank
370
Increased performance
155
2.2.3.4 What were the most important benefits of using ISO 9004:2000? Observation Users identified a wide variety of benefits.
Note: More than one choice allowed.
230
67 70 183 228 130 205 210
Improved customer satisfaction Improved customer communication Increased management commitment More effective management review s Effective use of data as business management tool Increased supplier performance Improved supplier communication Other
08 November 2004
Page 17 of 45
87 266
2.2.3.5 Is your organization interested in achieving European Quality MB, Deming Prize etc.?
Yes No Blank
588
600 500 400
556
2.2.3.6 If Yes, will ISO 9004:2000 assist in achieving this?
300 200 100 0
218 167
Yes
No
Blank
08 November 2004
Page 18 of 45
264
299
Yes No Blank
378
208
2.2.3.8 Do you find the quality management principles helpful?
Yes No
96 637
Blank
08 November 2004
Page 19 of 45
84
2.2.3.9 Is there anything in ISO 9004:2000 which is not beneficial? Observation Compare the 84 Yes responses with chart 2.2.2.10 for ISO9001:2000 (272 Yes)
322
Yes No Blank
534
08 November 2004
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User satisfaction with the standards related to the users product category
The two tables below summarize the respondents overall satisfaction with the two standards. ISO 9001:2000 How well the standard meets user needs Users Product category Excellent (number) Software (101) Hardware (266) Services (449) Processed Material (335) 19 (19%) 32 (12%) 73 (16%) 50 (15%) Good 54 (54%) 170 (64%) 253 (56%) 204 (61%) No comment 3 (3%) 14 (5%) 31 (7%) 13 (4%) Needs improvement 23 (22%) 42 (16%) 85 (19%) 62 (18%) Not adequate 2 (2%) 8 (3%) 7 (2%) 6 (2%) % 100 100 100 100
ISO 9004:2000 How well the standard meets user needs Users Product category Excellent number) Software (101) Hardware (266) Services (449) Processed Material (335)
08 November 2004
Good 27 (27%) 80 (30%)
No comment 49 (49%) 133 (50%)
Needs improvement 16 (16%) 25 (9%) 46 (10%) 32 (10%)
Not adequate 4 (4%) 10 (4%) 11 (2%) 4 (1%)
% 100 100 100 100

Page 21 of 45 ISO/TC 176/SC 2/N705
5 (5%) 18 (7%) 47 (11%) 28 (8%)
161 (36%) 184 (41%) 113 (34%) 158 (47%)
User satisfaction with the standards related to number of years experience with the standards
ISO 9001:2000 How well the standard meets user needs Years experience 0-3 (250) 4-9 (424) 10 up (264) Excellent 36 (14%) 56 (13%) 45 (17%) Good 137 (55%) 276 (65%) 152 (58%) No comment 26 (10%) 15 (4%) 12 (5%) Needs improvement 46 (18%) 69 (16%) 52 (20%) Not adequate 5 (2%) 8 (2%) 3 (1%) % 100 100 100
ISO 9004:2000 How well the standard meets user needs Years experience 0-3 (250) 4-9 (424) 10 up (264) Excellent 14 (6%) 41 (10%) 25 (10%) Good 58 (22%) 140 (33%) 121 (46%) No comment 151 (60%) 204 (48%) 77 (30%) Needs improvement 20 (9%) 30 (7%) 37 (14%) Not adequate 7 (3%) 9 (2%) 4 (2%) % 100 100 100
08 November 2004
Page 22 of 45
User satisfaction with the standards related to the size of the users organization
ISO 9001:2000 How well the standard meets user needs Excellent Size Small (271) Medium (353) Large (274) 53 (19%) 46 (13%) 34 (12%) 139 (51%) 227 (64%) 174 (64%) 18 (7%) 21 (6%) 11 (4%) Good No comment Needs improvement 54 (20%) 56 (16%) 49 (18%) Not adequate 7 (3%) 3 (1%) 6 (2%) % 100 100 100
ISO 9004:2000 How well the standard meets user needs Excellent Size Small (271) Medium (353) Large (274) 27 (10%) 31 (9%) 18 (7%) 85 (31%) 114 (32%) 101 (37%) 130 (48%) 170 (48%) 117 (43%) Good No comment Needs improvement 19 (7%) 35 (10%) 31 (11%) Not adequate 10 (4%) 3 (1%) 7 (2%) % 100 100 100
08 November 2004
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User satisfaction with the standards related to the position of the respondent
Executive Excellent Good No comment (or NOT APPLICABLE) Needs to be improved Not adequate Blank Total 35 78 3 20 5 8 149 23.5% 52.3% 2.0% 13.4% 3.4% 5.4% 100.0% Satisfied 113 75.8%
Dissatisfied Neither
25 11
16.8% 7.4% 100.0%
Operational
Excellent Good No comment (or NOT APPLICABLE) Needs to be improved Not adequate Blank Total Excellent Good No comment (or NOT APPLICABLE) Needs to be improved Not adequate Blank Total Excellent Good No comment (or NOT APPLICABLE) Needs to be improved Not adequate Blank Total
11 34 1 16 4 6 72 58 309 8 84 4 9 472 12 70 0 20 1 5 108
15.3% 47.2% 1.4% 22.2% 5.6% 8.3% 100.0% 12.3% 65.5% 1.7% 17.8% 0.8% 1.9% 100.0% 11.1% 64.8% 0.0% 18.5% 0.9% 4.6% 100.0%
Satisfied
45
62.5%
20 7
27.8% 9.7% 100.0% 77.8%
Quality
Satisfied
367
88 17
18.6% 3.6% 100.0% 75.9%
Auditor
Satisfied
82
21 5
19.4% 4.6% 100.0%
08 November 2004
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Other
Excellent Good No comment (or NOT APPLICABLE) Needs to be improved Not adequate Blank Total Excellent Good No comment (or NOT APPLICABLE) Needs to be improved Not adequate Blank Total
20 68 2 26 2 8 126 1 6 0 1 0 6 14
15.9% 54.0% 1.6% 20.6% 1.6% 6.3% 100.0% 7.1% 42.9% 0.0% 7.1% 0.0% 42.9% 100.0%
Satisfied
88
69.8%
28 10
22.2% 7.9% 100.0% 50.0%
No stated
Satisfied
1 6
7.1% 42.9% 100.0%
08 November 2004
Page 25 of 45
Analysis of Comments received against ISO9001:2000 and ISO 9004:2000

The following elements were selected for the users to classify the difficulties they encountered in the use of the standards ISO 9001:2000
Meaning Unclear Not Understood Too Difficult to implement Benefit vs. cost
Contradiction
Duplication
Redundant
Ambiguity
Omission
Blank
ISO 9001:2000 Clause
1 1.1 1.2 2 3 4 4.1 4.2 5 5.1 5.2 5.3 5.4 5.5 5.6 6 6.1 6.2 6.3 6.4 6.5 7 7.1
08 November 2004
10 8 3 0 2 1 18 22 4 5 1 9 7 3 3 1 1 6 6 11 0 3 4
1 2 0 0 0 0 1 2 0 0 1 1 2 1 3 0 0 2 0 0 0 0 0
7 1 5 1 0 4 15 18 0 3 2 2 11 7 1 1 1 7 4 6 0 1 6
8 2 4 3 2 0 13 6 0 4 2 3 12 7 5 0 1 8 3 3 0 3 3
6 4 1 0 1 0 15 13 0 6 1 2 7 2 6 2 2 5 6 11 2 2 5
3 4 1 0 0 3 12 12 0 3 7 1 2 1 4 0 5 1 1 3 0 0 2
7 2 0 0 1 3 2 6 0 6 5 0 1 0 0 0 2 3 1 1 0 0 2
4 2 1 0 0 1 4 7 0 0 1 1 2 2 3 0 1 13 1 0 0 0 2
11 3 2 0 0 1 8 5 0 3 5 4 2 4 2 0 1 16 1 6 2 2 5
76 11 3 4 2 4 10 12 0 0 1 1 3 1 1 1 0 6 4 4 0 4 1
133 47 20 8 8 17 98 103 4 30 26 23 47 28 28 5 14 67 27 45 4 15 30
Total
7.2 7.3 7.4 7.5 7.6 8 8.1 8.2 8.3 8.4 8.5 Blank Total
2 11 3 15 3 0 5 11 6 1 19 4 215
1 0 1 1 2 0 0 7 1 1 3 0 32
3 13 2 14 4 1 0 14 5 2 19 1 189
7 10 2 20 2 0 0 14 2 3 20 1 181
3 5 3 8 7 0 2 13 1 4 26 0 174
6 4 2 1 1 0 3 3 0 6 14 0 106
6 4 1 5 6 1 1 6 0 4 6 1 83
1 2 2 1 1 0 1 17 1 2 10 0 85
7 15 0 9 6 2 3 23 3 11 26 0 190
7 3 3 5 0 0 2 7 2 3 9 13 222
43 67 19 79 32 4 17 114 21 37 152 20 1477
Of the 1477 comments, 813 related to the following eight clauses: 1. General (excluded from detailed analysis below due to large number of blank responses) 4.1 Quality management systems - General requirements 4.2 Quality management systems documentation 6.2 Human resources 7.3 Design and development 7.5 Production and service provision 8.2 Monitoring and measurement 8.5 Improvement Detailed Analysis The most common response given under each of these clauses is listed below. 4.1 Quality management systems - General requirements Almost every sub-clause indicated aspects of concern to users. These were mostly associated with lack of understanding of outsourcing and the process approach.
08 November 2004
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4.2 Quality management systems documentation The nature and extent of documented procedures; document control being driven by auditors; lack of understanding of the requirements by registrars; different interpretation of requirements by auditors; interaction of processes; control of documents (whether one or all of the requirements listed 4.2.3 needed to be addressed); control of documents of external origin. 6.2 Human resources Competence. How to determine it, how to measure it. 7.3 Design and development Validation and verification interpretation of what these mean. Also relates to 7.5.2. 7.5 Production and Service Provision 7.5.1 First sentence causing confusion. Service may be the problem here. The definitions of service and servicing, and the service industry. 7.5.2 The first sentence is causing confusion. How can validation be possible when the process cannot be monitored? 8.2 Monitoring and Measurement This is too difficult to do. Customer perception is difficult to define and measure. The need to audit internal audits is not understood. Measuring of processes and product is causing confusion, and whether it was necessary to do both. 8.5 Improvement There is clear indication that the difference between corrective action and preventive action is not understood. The difference between preventive action and continuous improvement is difficult to understand. To what extent is it necessary to implement risk assessment to comply with the preventive action requirement? And what is the difference? How can you prove you have taken preventive action?
08 November 2004
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ISO 9004:2000 Only 112 individual comments were made against this standard.
Meaning Unclear
Not Understood
Too Difficult to implement
Benefit vs. cost
Contradiction
Duplication
Redundant
Ambiguity
Omission
0 0.1 0.4 1 2 3 4 4.1 4.3 5 5.3 5.4.1 5.5.2 5.6.3 6 7 7.1 7.2 7.3 7.4
08 November 2004
2 1
2 1
20 1
Blank
29 1 2 2 1
1 1 2
1 1 1 1 2 1 1 1 1 1
2 1 3
1 1
1 1
3 1 1 1 1 1
1 1
10 1 2 1 4 1
Total 3 1 5 2 1 1 5 1 1
Meaning Unclear
Not Understood
Too Difficult to implement
Benefit vs. cost
Contradiction
Duplication
Redundant
Ambiguity
Omission
7.5.1 7.6 8.1 8.2 8.3 8.5 A A.2 A.3 B Blank Total 1 10 1 1 2 11 8 1 1 1 1 1 2
1 1 2 1 1 2 1 1 12 1 1 2 4 17 12 41 1
Blank
20 112
It can be seen from the table that the comments were spread over a wide range of clauses, and covered a wide range of issues. Some of the issues raised were: Clause numbering compared with ISO 9001 Use of ISO 9004 to interpret requirements in ISO 9001 The standard is not achieving its full potential The standard should contain more about good business practice. More guidance or explanation of process approach and outsourcing is required.
08 November 2004
Total 1 3 2 3 1 3 2 1 1 1
Page 30 of 45
Future action
The findings of this survey are being passed to ISO/TC 176/SC2/WG18, who will assess the findings and evaluate what appropriate action, if any, is to be recommended with regard to the two standards. The findings of this survey are to be used as inputs to the design specifications of ISO9001 and ISO9004. The lessons learned by TG 1.11 (see Appendix 3) are captured for use by future surveys.
08 November 2004
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Appendix 1
ISO 9001:2000 and ISO 9004:2000

Survey of user experience
Sub-committee 2 (SC 2) of ISO Technical Committee TC176 (ISO Technical Committee for Quality management and quality assurance) is currently carrying out a survey of user experience with the year 2000 editions of the ISO 9000 series of standards. The questionnaire below has been designed to ascertain the views of users of the ISO 9000:2000 series of standards in relation to the standards, their suitability and their application. The standards in question are :

ISO 9000:2000 (Quality management systems -- Fundamentals and vocabulary) ISO 9001:2000 (Quality management systems -- Requirements) ISO 9004:2000 (Quality management systems -- Guidelines for performance improvements)
Structure of the survey

The survey consists of four sections: 1. Details about the nature and size of your organization. 2. Your experience in using the ISO 9000 series, both the 2000 version and previous versions. 3. Difficulties you may have experienced with ISO 9001:2000. You have the opportunity to explain the nature of the difficulty and to suggest an alternative text that addresses your problems. You may also make a general comment about any clause without suggesting an alternative text. 4. In the same way you may suggest improvements to ISO 9004:2000.
08 November 2004
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General guidance on completing the survey

As we are interested in the experiences of different functions within organizations we would ask you to send the appropriate electronic links to persons within your organization who represent the following:

Executive level Operational level Quality Manager Auditor Quality Consultant
The survey may be completed by more than one person in an organization, provided each respondent has some experience of using either standard, for any purpose. Please note that the questionnaire must be completed on line. There is no provision for handling questionnaires returned by normal mail. We ask you to complete this questionnaire at your earliest convenience. Please note that all data submitted before 31 March 2004 will be taken forward for collation and preliminary analysis. A second collation and analysis will be made of all data submitted up to 30 June 2004, with a third collation and analysis for all data submitted up to 31 October 2004 . At the annual ISO/TC176 meeting in early December 2004 we will evaluate and determine the future plans for this user survey. Note that you are asked to comment separately on ISO 9001:2000 (Requirements) and ISO 9004:2000 (Guidelines for performance improvements).
08 November 2004
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1. User Profile (to be completed by every respondent)

1.1 Organisation identification (please fill in using capital letters)
1.1.1 Name : 1.1.2 City : 1.1.3 Country (mandatory) : 1.1.4 Contact person (mandatory): 1.1.5 E-mail (mandatory) : 1.1.6 Phone : 1.1.7 FAX :
<Please select>
1.2
Position of person completing this questionnaire
(mandatory)
Executive level Operational level Quality Manager Auditor Other, please specify:
1.3
Size of organization - in number of employees (mandatory)
Small (1-49)
Medium (50-499) Large (over 500)

1.4 User category (mandatory)
Standardization body Accreditation body Certification body Sector

<Please select>
1.5
Generic Product Category, as defined in ISO 9000:2000 paragraph 3.4.2 (mandatory)
Services Software Hardware Processed materials
2. Experience of using the ISO 9000 series of standards

2.1 Previous editions
2.1.1 How long have you been using /implementing ISO 9001/2/3 (mandatory)
0 - 3 years
4 - 10 years More than 10 years
2.2 Year 2000 editions

Please answer the remainder of the survey using the following responses where requested : 1 - Not adequate, 2 - Needs to be improved, 3 No comment (or NOT APPLICABLE), 4 Good, 5 - Excellent
2.2.1 ISO 9000:2000 Quality Management Systems - Fundamentals and vocabulary

Yes
2.2.1.2
No
If Yes, how well does the standard, overall, meet your needs?
2.2.1.3
Do you have experience with ISO 9000 series Supporting materials
Yes
2.2.1.4
No
If Yes, in general how well does the documentation meet your needs?
2.2.2 ISO 9001:2000 Quality Management Systems - Requirements

Yes
2.2.2.2
No
If Yes, in general how well does the standard meet your needs?
2.2.2.3
What were the most important benefits of applying ISO 9001:2000 to your organization? (check those that apply)
Improved customer satisfaction Improved customer communication

Increased management commitment More effective management reviews Effective use of data as business management tool Increased supplier performance Improved supplier communication Other, please specify:
2.2.2.4 Were you able to integrate ISO 9001:2000 with other management systems (check those that apply)?
ISO 14001 (environmental management systems) OHSAS 18001 (occupational health and safety management systems) Not attempted Other, please specify:
Yes
2.2.2.6
No No No
Is the new structure of the standard (based on the process approach) appropriate for your organization?
Yes
2.2.2.7
Does your organization use ISO 9001:2000 as one of the selection criteria for your own suppliers?
Yes
2.2.2.8
If Yes, are you generally satisfied with the performance of those suppliers that are certified (or have demonstrated conformity in some other way) to ISO 9001:2000?
Yes
2.2.2.9
No
If you converted from an earlier version of ISO 9001 what was the effect on your quality system documentation in terms of volume?
Decreased a lot Decreased a little About the same Increased a little

Increased a lot
2.2.2.10 Is there anything in ISO 9001:2000 which is not beneficial?
Yes No If Yes, please explain
2.2.3 ISO 9004:2000 Quality Management Systems - Guidelines for performance improvements
Yes
2.2.3.2
No
If Yes, in general how well does the standard meet your needs?
2.2.3.3
Have you used the ISO 9001:2000 and ISO 9004:2000 standards as a consistent pair (that is, used them together to complement each other)?
Yes
2.2.3.4
No
What were the most important benefits of using ISO 9004:2000 (check those that apply)
Increased performance Improved customer satisfaction Improved customer communication Increased management commitment More effective management reviews Effective use of data as business management tool Increased supplier performance Improved supplier communication
Other, please specify:

2.2.3.5 Is your organization interested in achieving quality award standard of performance (European Quality Award, Malcolm Baldridge, Deming Prize etc.)?
Yes
2.2.3.6
No No No No
If Yes, will ISO 9004:2000 assist in achieving this?
Yes
2.2.3.7
Does ISO 9004:2000 have a major impact in preventing nonconformity?
Yes
2.2.3.8
Do you find the quality management principles helpful?
Yes
2.2.3.9
Is there anything in ISO 9004:2000 which is not beneficial?
Yes No If Yes, please explain
3 Detailed comment and suggestions on ISO 9001:2000 Quality management systems Requirements
3.1 Difficulties experienced with ISO 9001:2000
Please give details of any clauses that cause you difficulty, and indicate the reason. You may also use this section to indicate where you think the standard could be improved. To help us understand precisely the nature of your difficulty we ask you to suggest a brief alternative text. Please note that this is limited to 200 characters (approximately 25 words). By selecting a General Comment option you may immediately comment on the standard at that level, from the main sections right down to a sub-clause. By selecting a specific sub-clause you may propose alternative text that addresses your particular concerns.
Use the "Next clause" button to comment on another clause. The "Cancel" button will remove an existing comment. Clause (mandatory) Reason for difficulty
<Please select>
Ambiguity (2 or more possible meanings) Contradiction (two clauses do not agree) Requirement not understood Meaning of the words in the standard is unclear Omission (something additional is required) Redundant (not necessary) Duplication (covered twice in the standard) Benefit does not outweigh the cost Too difficult to implement
Suggest an alternative text that meets your needs Comment
Next clause
Cancel
3.2
Is your feedback based on using an English version of the standard?
(mandatory)
08 November 2004
Yes
No
4 Detailed comment and suggestions on ISO 9004:2000 Quality management systems Guidelines for performance improvements
4.1 Difficulties experienced with ISO 9004:2000
Please give details of any clauses that cause you difficulty, and indicate the reason. You may also use this section to indicate where you think the standard could be improved. To help us understand precisely the nature of your difficulty we ask you to suggest a brief alternative text. Please note that this is limited to 200 characters (approximately 25 words). By selecting a General Comment option you may immediately comment on the standard at that level, from the main sections right down to a sub-clause. By selecting a specific sub-clause you may propose alternative text that addresses your particular concerns. Use the "Next clause" button to comment on another clause. The "Cancel" button will remove an existing comment. Clause Reason for difficulty
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Ambiguity (2 or more possible meanings) Contradiction (two clauses do not agree) Requirement not understood Meaning of the words in the standard is unclear Omission (something additional is required) Redundant (not necessary) Duplication (covered twice in the standard) Benefit does not outweigh the cost Too difficult to implement
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Appendix 2
Task group membership Name Woo-ki Baek * Vctor Nava Carbellido * Steve Elvin * Rafael Gonzalez Hank Gryn * Gary Hilton * Shinichi Iguchi Alka Jarvis * Colin MacNee * Alexander Maksakov Eduardo del Rio * Matt Seaver Tetsuo Terabe * Lawrence A.Wilson * Representing Korea (Republic of) Mexico CLEPA Colombia IATF Canada Japan USA (leader) UK Russian Federation INLAC Ireland Japan USA (monitor)
Members who participated in the preparation of this final report are indicated by an asterisk (*).
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Appendix 3
LESSONS LEARNED
SURVEY Identify the goal of the survey and the data to be captured Develop questions which generate the identified data Use single answer questions Use questions suitable for computer analysis Only when appropriate, use interactive questions Design the survey to minimize the amount of text the respondent can use to answer Design the survey so no manual entry will be required to compute analysis Design the survey to ensure all individual questions receive a response (the absence of a response to individual questions skews the results) Include an option to respond generally about clauses
COMMUNICATION Use electronic survey communicated through an ISO approved website (the communication channel established by TG 1.11 is currently available for future use) Ensure the website is secured to preserve confidentiality Involve the webmaster and the software designer early Use national bodies: (a) to promote the survey (b) to translate the survey, if required (c) to remind users to meet the survey completion deadline Ensure target users are aware of the communication channel and survey
PROCESS Ensure the surveyees are identified and the survey is appropriate Pilot test the survey prior to use Provide regular progress reports to ISO authority and confirm approval Use people with appropriate knowledge and team-working experience Ensure costs are controlled Specify the duration of the survey early
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Provide users with feedback on the results of the survey Use individuals who have acquired expertise in the formation of surveys All project planning decisions must be documented
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Document: ISO/TC 176/SC 2/N

Charles Corrie For BSI Secretariat ISO/TC 176/SC 2

ISO/TC 176/SC 2/N705

1.1.3 Country of respondent

AUSTRALIA ITALY Other

1.2 Position of respondent

Operational Quality Auditor Other Blank

ISO/TC 176/SC 2/N705

3 290 271 small medium large Blank

1.3 Size of organization Observation Good spread of responses.

1.4 Respondents user category

1.4 Sector break-down

391 105 72 34 38 9 7 0 2 2 13 6 16 106 102

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500 450 400 350 300 250 200 150 100 50 0

1.5 Respondents generic product category

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2. Experience of using the ISO 9000 series of standards

300 250 200 150 100 50 0

3 0-3 4-10 10+ Blank

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2.2.1 ISO 9000:2000 Quality Management System - Fundamentals and Vocabulary

2.2.1.1 Do you have experience with ISO 9000:2000?

Excellent Good No comment (or NOT APPLICABLE) Needs to be improved

ISO/TC 176/SC 2/N705

No, 237 Yes No Blank Yes, 669

Excellent Good No comment (or NOT APPLICABLE) Needs to be improved

ISO/TC 176/SC 2/N705

2.2.2 ISO 9001:2000 Quality Management System - Requirements

2.2.2.1 Do you have experience with ISO 9001:2000?

ISO/TC 176/SC 2/N705

216 158 150

ISO/TC 176/SC 2/N705

700 600 590

2.2.2.5 Does ISO 9001:2000 have a major impact in preventing nonconformity?

500 400 300 200 100 0 Yes No Blank 19 332

ISO/TC 176/SC 2/N705

ISO/TC 176/SC 2/N705

300 250 200 150 100 50 0 131 214

267 167 131 31

D ec re as ed D a ec lo re t as ed a lit A tle bo ut th e sa In m cr e ea se d a lit tle In cr ea se d a lo t

ISO/TC 176/SC 2/N705

400 350 300 250 200 150 100 50 0

ISO/TC 176/SC 2/N705

67 70 183 228 130 205 210

ISO/TC 176/SC 2/N705

600 500 400

2.2.3.6 If Yes, will ISO 9004:2000 assist in achieving this?

300 200 100 0

ISO/TC 176/SC 2/N705

2.2.3.7 Does ISO 9004:2000 have a major impact in preventing nonconformity?

ISO/TC 176/SC 2/N705

ISO/TC 176/SC 2/N705

Good 27 (27%) 80 (30%)

No comment 49 (49%) 133 (50%)

Needs improvement 16 (16%) 25 (9%) 46 (10%) 32 (10%)

Not adequate 4 (4%) 10 (4%) 11 (2%) 4 (1%)

% 100 100 100 100

5 (5%) 18 (7%) 47 (11%) 28 (8%)

161 (36%) 184 (41%) 113 (34%) 158 (47%)

ISO/TC 176/SC 2/N705

ISO/TC 176/SC 2/N705