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 ISO 9001/4:2000
 ISO9001:2000 Required Procedures
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| Author | Topic: ISO9001:2000 Required Procedures |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 09 December 1999 05:17 AM
   
Subject: Re: Procedures mandatory for ISO 9001:2000 /Oliveira Date: Tue, 7 Dec 1999 16:25:42 -0600 From: ISO Standards Discussion From: Marcos Oliveira I would like to confirm the list of procedures ( second level documentation ) required for ISO 9000:2000. I made the following list and I would like to receive comments. The text is according to ISO CD2 9001:2000. I have not received a copy of the DIS. 5.3 The organization shall establish and maintain a PROCEDURE to identify and have access... 5.6.4 The organization shall establish and maintain procedures for internal communication.... 5.6.6 The organization shall establish quality management system level procedure 5.6.7 The organization shall establish and maintain quality management system level procedure for the identification, storage, retrieval, protection, retention time and disposition of quality records. 5.7 The organization shall establish a quality management system level procedure... 6.2.2 The organization shall establish and maintain system level procedures to: a) determine competency and training needs... 6.3 System level procedures for managing information shall ensure access to and protections of information 8.2.1.2 The system level procedure for internal audit shall cover the audit scope... 8.3.1 Arrangements for ensuring that nonconforming product and/or service is controlled shall be defined in a system level procedure. 8.5.2 The system level procedure for the corrective action process shall define the requirements... 8.5.3 The system level procedure for the preventive action process shall address..... Thank you for your comments IP: Logged |
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Roger Eastin Forum Wizard Posts: 345 |
posted 09 December 1999 08:43 AM
I like this list, but when the 2000 standard has a requirement for a procedure, it does not mean that the procedure has to be documented. This is like ISO14001 where the requirement must specifically state "documented procedure". Now I agree that it may be an advantage to have a documented procedure even though the standard does not require one. However, it is not necessary where there is no reference to a procedure needing to be documented. IP: Logged |
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Jase Eyre Forum Contributor Posts: 13 |
posted 09 December 1999 08:27 PM
G'day The AS/NZS ISO 9001(Int):2000 (The Antipodean version of the DIS)specifies only six requirements for documented procedures. And yes, these are only the MINIMUM requirements. They are: Jase ------------------ IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 09 December 1999 08:45 PM
Thanks for the clarification, Jase! I have to get the latest and greatest, myself. I haven't even started a cross reference matrix yet. Yeah, Roger, just like in the 'old' ISO, I recognize the 'procedure' is not the same as 'documented procedure'. This time next year..... [This message has been edited by Marc Smith (edited 09 December 1999).] IP: Logged |
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barb butrym Forum Contributor Posts: 637 |
posted 10 December 1999 09:05 AM
Ya thats all that requires documented procedures, but the meat in each of those elements 5.5.6: Control of documents is quite enhanced and must cover more than the simply stated ISO of old ... elements...which ties you to the meat of the "missing' element requirements.......IMHO. Still not too much new stuff, just well placed emphasis and details added. [This message has been edited by barb butrym (edited 10 December 1999).] IP: Logged |
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David Mullins Forum Contributor Posts: 248 |
posted 12 December 1999 09:08 PM
The DIS is very light on for stating "documented procedure", however we're not updating our QMS just to comply with the standard, right? I believe the interpretation is that you should have documented procedures for all areas of the new standard that apply to your business. The standard is supposed to be less presriptive, but at the end of the day (given the theory of "say what you do, do what you say, and prove it") you must be able to demonstrate what it is that you intend to do = documented procedure. ------------------ IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 16 December 1999 12:11 AM
From: ISO Standards Discussion Date: Thu, 9 Dec 1999 15:03:09 -0600 Subject: How Many Procedures Required in ISO DIS? /Russo From: "C.W. Russ Russo" There was a question on the discussion list the other day concerning what procedures are required in the new DIS version of the standard. Unhappily, the new DIS does not distinguish between records and documents and in several places says "shall be documented" which clearly should be "shall be recorded." Also, there are several requirements where "processes shall be defined" or "shall be determined" which do not specifically call for a procedure. I have carefully reviewed this DIS (checked it twice, just like my Christmas wish list) and here is what I see: 4.2 "documents required by the organization to ensure the effective operation and control of its processes." 5.5.5 "A quality manual shall be established....." 5.5.6 "A documented procedure shall be established...." to control documents 5.5.7 "A documented procedure" to control records. 8.2.2 "A documented procedure shall include...." for internal audits. 8.3 "These activities shall be defined in a documented procedure." refers to control of nonconformity. 8.5.3 "A documented procedure for corrective action shall define requirements...." 8.5.3 "A documented procedure for preventive action" So it looks like in addition to documents required by the organization along with a quality manual, there is a specific requirement for a procedure to: control documents, control records, internal audits, control nonconformity, corrective action, and preventive action Standby for further developments!!!! The FDIS (final draft international standard) will be issued third quarter 2000. C.W. Russ Russo IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 16 December 1999 05:51 PM
Here's another take on the situation: -------------snippo----------- From: ISO Standards Discussion From: Marcos Oliveira Russ Russo, Thanks for your information. I made a detailed analysis in required documentation and divided it in several classes. As a consultant I need to be prepared to give orientation to my clients. I would like to receive comments of other consultants. If you prefer, send them direct to me [email protected] DOCUMENTATION EXPLICITLY REQUIRED 2) GENERAL INSTRUCTIONS 3) DOCUMENTS TO BE CONTROLLED 4) ACTIONS TO BE DOCUMENTED ( How? Third level documentation? ) 5) QUALITY MANUAL 6) RECORDS TO BE KEPT 7) DOCUMENTATION AMMENDMENT 8) NEED FOR WORKING INSTRUCTIONS IP: Logged |
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