Procedures Required by ISO 9001:2008

Randy

Super Moderator
Re: ISO 9001:2008 Required Procedures

I had a procedure back in 1997 when I had 3 hernia's repaired.

Does that count?
 
J

JaneB

Re: ISO 9001:2008 Required Procedures

Well, since you insist. :notme:
 

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Chris_Anderson

Re: ISO 9001:2008 Required Procedures

While six procedures are required of the 2000/2008, this does not mean that six separate documents are required. "Documented procedures" means that it is documented in QMS procedures somewhere.

In 1994, many thought that 20 procedures were required of the standard. This was not true, in fact it illustrates an element-by-element approach--which is a bad idea from the perspective of quality assurance.

Now that the 2000/2008 standard explicitly requires six procedures, many think that six is the clever/magic number of procedures. Same mistake.

The number of procedures depends upon how many processes are in operation that impact quality. Don't confuse activities with processes here, and you'll be okay. (Focus on major processes--processes at their highest level, maybe.)

A procedure simply describes how a process is carried out. If you have a process, you have a procedure. The standard does not, and never has, identified companies' "quality system processes" (with the exception of the required support processes). So the number of procedures (beyond the required six) depends on the organization--not upon the standard.

Don't write procedures to address the requirements you sited, write procedures to describe the processes. Then review them to make sure that conformity to the sited requirements is clear, as applicable.

:)
The standard requires that (4.1a) processes are determined, (4.1b) sequence and interaction of these processes are determined, (4.1c) criteria and methods are effective, (4.1d) resources and information are available, (4.1e) monitor, measure, and analyze these processes, and (4.1f) improvement actions happen. Nowhere does it say this has to be documented. Determined--yes.

I can conform to all of these requirements without a documented procedure using a lean system. Work cells aligned in balanced flow order, just in time signals, visual indicators, andon lights, takt times, 5S, error proofing, etc. And there would be no doubt to anyone what the the process is, its sequence, interaction, criteria, methods, measurements, and improvement are occurring. Would you insist that I must document this in a procedure? For whom? Everyone already knows what to do and they can show that they are doing it.
 

Randy

Super Moderator
Re: ISO 9001:2008 Required Procedures

The standard requires that (4.1a) processes are determined, (4.1b) sequence and interaction of these processes are determined, (4.1c) criteria and methods are effective, (4.1d) resources and information are available, (4.1e) monitor, measure, and analyze these processes, and (4.1f) improvement actions happen. Nowhere does it say this has to be documented. Determined--yes.

I can conform to all of these requirements without a documented procedure using a lean system. Work cells aligned in balanced flow order, just in time signals, visual indicators, andon lights, takt times, 5S, error proofing, etc. And there would be no doubt to anyone what the the process is, its sequence, interaction, criteria, methods, measurements, and improvement are occurring. Would you insist that I must document this in a procedure? For whom? Everyone already knows what to do and they can show that they are doing it.

The answer is in 4.2.1d. If ya hafta...Yes If ya don't hafta....No
 
A

aboziad55

Hi All

I'm new member in the cove

Could you tell me if I can merge all 6 mandatory procedure in one procedure and write each one in the separate section

Could you attach blank or example of 6 mandatory procedures
 
B

Bonhomme

Re: ISO 9001:2008 Required Procedures

Well, since you insist. :notme:

Very useful, thank you :eek:

Even if I wonder why the dog is part of the "call for help" team but not the "give a hug once safe" one :bonk:

edit : to be somehow useful, Aboziad55, you can indeed merge part or all 6 of the mandatory procedures into a single document if it better suits your company needs. 9001 doesn't require a specific template/format

As for examples, you could try searching the Post Attachment List : https://elsmar.com/elsmarqualityfor...&sortby=filename&pageamt=1&criteria=procedure
 
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