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This thread is carried over and continued in the Current Elsmar Cove Forums |
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 The Old Elsmar Cove Forums
 General ISO Topics
 Structure in ISO-documentation
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| Author | Topic: Structure in ISO-documentation |
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gilsg Lurker (<10 Posts) Posts: 1 |
posted 05 October 2000 06:04 AM
   
Hai, I am just starting to get acquainted to documentation for ISO (and FDA). I have 2 questions regarding the structure of required ISO-documentation: 1: I see level2, level3 or level4 in ISO-documentation. Can anyone tell me (or give me references) what those levels mean? 2: When you want to set up a new documentation system, is a certain structure recommended (required)? Do you have any references? IP: Logged |
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Jim Evans Forum Contributor Posts: 45 |
posted 05 October 2000 09:09 AM
Basically, Level 1 is your quality manual which defines your approach and responsibility. Level 2 is your Procedures which defines Who will do What and When. Level 3 are your job instructions which answers How you will do your procedures. Level 4 are your prompts for recording information such as forms, labels, test reports etc. Once completed they become quality records. The format for documentation is entirely at your discretion. Find a way that works for your organaization. I used an element approach exactly laid out in the ISO/QS manual. If you use this approach (and are going for ISO only) you may want to wait until the new version of ISO comes out. A question from me: Does anyone know if the ISO 9001/2000 is still on schedule for release next month? Best Regards, Jim IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 05 October 2000 11:36 AM
See http://Elsmar.com/doc-hier.html for 'standard' documentation structure. > A question from me: Does anyone know if the ISO 9001/2000 is still on I haven't heard. IP: Logged |
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Jim Biz Forum Wizard Posts: 275 |
posted 05 October 2000 02:27 PM
Did find out yesterday at a Quality 9000:2000 conference from a knowledgeable committee member that the FDIS standard as currently worded (with the exception of a possible comma or period here & there) - is on schedule and expected to be voted IE official by mid-November - But ASQ "probably" would not have time to get official published print copies made up & available for purchase until mid to late December. Regards [This message has been edited by Jim Biz (edited 05 October 2000).] IP: Logged |
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Jim Triller Forum Contributor Posts: 26 |
posted 09 October 2000 12:28 PM
An auditor (with LRQA) I spoke with last week is (realistically) expecting it to be released January-February, 2001. He also said that currently registered organizations would have three years to transition to the new standard. IP: Logged |
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David Mullins Forum Contributor Posts: 248 |
posted 09 October 2000 08:50 PM
Order now - and you will get it before the month is out. LRQA - there is a name to remember and avoid! ------------------ IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 10 October 2000 09:01 AM
quote:You had a bad experience with LRQA??? IP: Logged |
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rrramirez Forum Contributor Posts: 23 |
posted 14 October 2000 08:44 AM
LRQA registered a venezuelan bank where the previous knowledge in quality management was "0" and where most people don«t know anything about ISO 9000. This register was made with an implementation process of 3 month in one branch of 100. Reinaldo Ram’rez IP: Logged |
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