ISO 9000-3 Digest Wednesday, 2 April 1997 Volume 01 : Number 044 In this issue: U.S. 9000-3 Listing BOUNCE iso9000-3@quality.org: Non-member submission from [Erich] (fwd) A serial mini-Survey (No.11) A serial mini-survey (No.12) European MDD Classification A serial mini-survey (No.14) ---------------------------------------------------------------------- From: Erich Date: Mon, 24 Mar 1997 14:06:25 -0500 Subject: U.S. 9000-3 Listing I am interested to review a listing of U.S. companies who have achieved 9000-3 registration or, are in the process of achieving 9000-3 status. Thanks. ------------------------------ From: "Bill Casti, CQA (Moderator)" Date: Tue, 25 Mar 1997 12:46:27 -0500 (GMT-0500) Subject: BOUNCE iso9000-3@quality.org: Non-member submission from [Erich ] (fwd) NOTE: Quality Digest has a FREE, searchable online database of ISO/QS9000-registered North American companies at: http://www.qualitydigest.com/html/iso9000.html - ---------- Forwarded message ---------- Date: Mon, 24 Mar 1997 16:13:36 -0500 From: Erich To: iso9000-3@quality.org Subject: U.S. 9000-3 Listing I am interested to review a listing of U.S. companies who have achieved 9000-3 registration or, are in the process of achieving 9000-3 status. Thanks. ------------------------------ From: Yingxu Wang Date: Wed, 26 Mar 1997 10:47:10 -0800 Subject: A serial mini-Survey (No.11) Dear colleagues, - - A Survey of Base Process Activities Towards Software Process Excellency Thank you very much for your response! Attached please find the mini-survey No.11. Best regards, Yingxu Wang - --------------------------------------------------------------------------- Research Centre for Systems Engineering | Email:wang_s@solent.ac.uk or Southampton Institute | yingxu.wang@comlab.ox.ac.uk Southampton SO14 0YN, UK | Tel: +44 1703 319773 In collaboration with IVF, IBM, and ESI | Fax: +44 1703 334441 - --------------------------------------------------------------------------- *********************************************************************** Questionnaire 3: Base process activities on management processes (1/12) *********************************************************************** 3. Management processes 3.1 Software quality assurance (SQA) 3.1.1 SQA procedure definition 197. (3.1.1.1) Define SQA procedure Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 198. (3.1.1.2) Define project software engineering standards Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 199. (3.1.1.3) Document SQA system Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 200. (3.1.1.4) Issue quality manual Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 201. (3.1.1.5) Distribute quality policy Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 202. (3.1.1.6) Report SQA results Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 203. (3.1.1.7) Assess process quality Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 204. (3.1.1.8) Take correct actions Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 205. (3.1.1.9) Assign independent reviewers Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 206. (3.1.1.10) Define extent of inspection Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 207. (3.1.1.11) Conduct SQA for each process Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 208. (3.1.1.12) Assign qualified person(s) to special process Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 209. (3.1.1.13) Document quality records Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 210. (3.1.1.14) Review SQA system suitability Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 211. (3.1.1.15) Decisional role of SQA in processes Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 212. (3.1.1.16) Decisional role of SQA in final products Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 213. (3.1.1.17) Adopt SQA tools Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. ------------------------------ From: Yingxu Wang Date: Thu, 27 Mar 1997 09:50:49 -0800 Subject: A serial mini-survey (No.12) Dear colleagues, - - A Survey of Base Process Activities Towards Software Process Excellency Thank you very much for your response! Attached please find the mini-survey No.12. Best regards, Yingxu Wang - --------------------------------------------------------------------------- Research Centre for Systems Engineering | Email:wang_s@solent.ac.uk or Southampton Institute | yingxu.wang@comlab.ox.ac.uk Southampton SO14 0YN, UK | Tel: +44 1703 319773 In collaboration with IVF, IBM, and ESI | Fax: +44 1703 334441 - --------------------------------------------------------------------------- *********************************************************************** Questionnaire 3: Base process activities on management processes (2/12) *********************************************************************** 3.1.2 Requirements review 214. (3.1.2.1) Specification verification Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 215. (3.1.2.2) Formal review requirements Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 216. (3.1.2.3) Review statutory requirements Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 217. (3.1.2.4) Customer accepts specifications Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 218. (3.1.2.5) Adopt specification verification tools Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 3.1.3 Design review 219. (3.1.3.1) Define design review procedure Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 220. (3.1.3.2) Document design review Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 221. (3.1.3.3) verify prototypes Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 222. (3.1.3.4) Measure design review coverage Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 3.1.4 Code review 223. (3.1.4.1) Conduct code walk-through Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 224. (3.1.4.2) Conduct code review Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 225. (3.1.4.3) Measure code review coverage Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 3.1.5 Module and Integration testing 226. (3.1.5.1) Measure test coverage Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 227. (3.1.5.2) Estimate remaining error distribution Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 228. (3.1.5.3) Review test results Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 229. (3.1.5.4) Static/dynamic module test analysis Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 230. (3.1.5.5) Static/dynamic acceptance test analysis Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. ------------------------------ From: Thomas Miller Date: Tue, 1 Apr 1997 10:10:16 -0600 Subject: European MDD Classification I'm working through classifying our software product according to the EC Medical Device Directive, and I'd like to look up the classification of a predicate device. Does anyone have a reference for such information? Frinstance, FDA publishes US classification on medical devices. I'm hoping there is something like that available for Europe. Also, if someone knows of a better newsgroup for this question, or any other source, please pass that on. Thanks! _____________________________________________________________ Thomas R. Miller 505 N. 4th St. Director of Quality Engineering Fairfield, IA 52556 Vital Images, Inc. (515)472 7726 VOX miller@vitalimages.com (515)472 1661 FAX www.vitalimages.com ------------------------------ From: Yingxu Wang Date: Wed, 02 Apr 1997 10:42:27 -0800 Subject: A serial mini-survey (No.14) Dear colleagues, - - A Survey of Base Process Activities Towards Software Process Excellency Thank you very much for your response! Attached please find the mini-survey No.14. Best regards, Yingxu Wang - --------------------------------------------------------------------------- Research Centre for Systems Engineering | Email:wang_s@solent.ac.uk or Southampton Institute | yingxu.wang@comlab.ox.ac.uk Southampton SO14 0YN, UK | Tel: +44 1703 319773 In collaboration with IVF, IBM, and ESI | Fax: +44 1703 334441 - --------------------------------------------------------------------------- *********************************************************************** Questionnaire 3: Base process activities on management processes (4/12) *********************************************************************** 3.1.9 Peer reviews 250. (3.1.9.1) Plan peer reviews Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 251. (3.1.9.2) Select work products Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 252. (3.1.9.3) Identify review standards Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 253. (3.1.9.4) Establish completion criteria Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 254. (3.1.9.5) Establish re-review criteria Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 255. (3.1.9.6) Distribute review materials Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 256. (3.1.9.7) Conduct peer review Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 257. (3.1.9.8) Document review results Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 258. (3.1.9.9) Take actions for review results Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 259. (3.1.9.10) Track actions for review results Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 3.1.10 Defect control 260. (3.1.10.1) Plan defect prevention Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 261. (3.1.10.2) Defect reporting and record Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 262. (3.1.10.3) Defect causal analysis Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 263. (3.1.10.4) Propose process change for defect prevention Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 264. (3.1.10.5) Track problem report Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 265. (3.1.10.6) Prioritise problems Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 266. (3.1.10.7) Determine resolutions Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 267. (3.1.10.8) Correct defects Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 268. (3.1.10.9) Review defect corrections Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 269. (3.1.10.10) Distribute correction results Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 3.1.11 Subcontractor's quality control 270. (3.1.11.1) Subcontractor's quantitative quality goals Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 271. (3.1.11.2) Assess/test quality of subcontractor's product Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 272. (3.1.11.3) Acceptance test for subcontractor's software Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 273. (3.1.11.4) Safeguard customer-supplied products Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. 274. (3.1.11.5) Record customer-supplied products Importance in process: (least) [0] [1] [2] [3] [4] [5] (most) Experience: Practised [ ] Not practised [ ] Effectiveness: Yes [ ] No [ ] Comments (if any): .............................................. ------------------------------ End of ISO 9000-3 Digest V1 #44 ******************************* To remove yourself from this list, address a message to: MAJORDOMO@QUALITY.ORG with only the words "unsubscribe iso9000-3-digest" (without the quotes) in the BODY of your message.