Structure in ISO 9001 documentation - Level 1, Level 2, Level 3, Level4, etc.



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?

Jim Evans

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 Biz

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.


[This message has been edited by Jim Biz (edited 05 October 2000).]

David Mullins

Order now - and you will get it before the month is out.

LRQA - there is a name to remember and avoid!


Jim Triller

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.


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 Ramírez
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