ISO 9001:2000 Required Procedures Listing

[Marc]

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.


8.4 A system level procedure for the analysis of aplicable data shall be established to determine the effectiviness....

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

[Roger Eastin]

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.

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:
5.5.6: Control of documents
5.5.7: Control of quality records
8.2.2: Internal audit
8.3: Control of nonconformity
8.5.2: Corrective action
8.5.3: Preventive action
The rest, I guess, is up to you: whatever you need to get your system pumping.

Jase

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JasE

[Marc]

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).]

[barb butrym]

Ya thats all that requires documented procedures, but the meat in each of those elements

5.5.6: Control of documents
5.5.7: Control of quality records
8.2.2: Internal audit
8.3: Control of nonconformity
8.5.2: Corrective action
8.5.3: Preventive action

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).]

[David Mullins]

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.

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[Marc]

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

[Marc]

Here's another take on the situation:

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From: ISO Standards Discussion
Date: Tue, 14 Dec 1999 11:49:19 -0600
Subject: Re: How Many Procedures Req in ISO DIS? /Russo/Oliveira

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.

DOCUMENTATION EXPLICITLY REQUIRED
1) PROCEDURES REQUIRED ( second level documentatior ) - MANDATORY
5.5.6 DOCUMENT CONTROL: A documented procedure shall be established
5.5.7 CONTROL OF RECORDS:A documented procedure shal be establlished for....
8.2.2 INTERNAL AUDITING: A documented procedure shall include
responsabilities...
8.3 CONTROL OF NONCONFORMITY: These activities shall be defined in a
documented procedure.
8.5.2 CORRECTIVE ACTION: The documented procedure for corrective action shall
define requirements...
8.5.3 PREVENTIVE ACTION: The cocumented procedure for preventive action
shall define...

2) GENERAL INSTRUCTIONS
4.1 The organization shall .... document.......a quality management system
QMS ).......
4.2 The QMS documentation shall include:
a) documented procedures required in this International Standard ( IS) -
see list above
b) documents required by the organization to ensure the effective operation
and control of its process -
So the organisation is free to propose the other required documents.

3) DOCUMENTS TO BE CONTROLLED
5.3 The qualiy policy shall be controlled ( see 5.5.6 )
5.5.5 The quality manual shall be controlled
5.5.6 Documents defined as quality records shall be controlled ( see 5.5.7 )
5.5.7 Records required for the QMS shall be controlled ( the same as above )

4) ACTIONS TO BE DOCUMENTED ( How? Third level documentation? )
5.4.2 The output of the planning shall be documented.
7.1 Planning of the realization processes..........and shall be documented
in a form suitable for the organization's method of operation.
7.3.2 Inputs relating to product requirements shall be defined and documented.
7.3.3 The outputs.....shall be documented.
7.3.4 The results of reviews...shall be recorded.
7.3.5 The results of the verification.......shall be recorded.
7.3.6 The results of the validation.....shall be recorded.
7.3.7 Design and development changes shall be.... documented.
The results of the review changes...shall be documented.
7.4.1 The results of evaluations...shall be recorded.
8.2.4 Evidence of conformity with the acceptance criteria shall be
documented.

5) QUALITY MANUAL
5.5.5 A quality manual shall be established and maintained.....

6) RECORDS TO BE KEPT
6.2.2.e) Maintain appropriate records of education.....
7.2.2 The results of the review....shall be recorded.

7) DOCUMENTATION AMMENDMENT
7.2.2 Where the product requirements..........that relevant documentation is amended.

8) NEED FOR WORKING INSTRUCTIONS
7.5.1 b) where necessary, the availability of work instructions.