Well that should grab some attention.

Just wondering where the old 4.9.c clause of the 1994 standard has its equivalent in the 2000 standard.

This is the clause that those of you who only audited for compliance to procedures were actually auditing, but it doesnt appear to be in the 2000 version.

Therefore is it no longer a requirement to comply with your own procedures ?

Let the fun begin.........

Martin,

Great topic….this should be fun!!!!!
Couple of quickies I pulled out.

"5.4.1 Top management shall ensure that quality objectives, including those needed to meet requirements for product….."

This paragraph states that the requirements for product need to be defined and measured, but nothing about compliance to the requirements.

"7.1.c requried verification…….and the criteria for product acceptance"

You could say this may cover it, because your process should include how to handle parts that are non-compliant.

Just a couple of penny's tossed in!

Regards,
CarolX

The one clause that immediately came to my mind is 7.2.1d - any additional requirements determined by the organization.

In our case this is where we plug in the procedures that apply - including job-specific procedures. So from our perspective, in order to carry out our work, we must follow these procedures. They are required by our org to effectively plan, carry out, and measure performance.

If we fail to follow these procedures, we are failing to meet 7.2.1d.

Lucinda

The clause you quote is related to determining product requirements - I cant see how this fits with my question ??

Then look past your paradigm Martin!:)

7.2.1 refers to the determination of ALL requirements that are related to the product - not just direct product requirements such as specifications.

7.2.1d says "any additional requirements determined by the organization"

These requirements are those that the org imposes on itself to produce the product. These org requirements are communicated as "procedures".

OK Lucinda, its a tenuous link though isnt it. I mean the 1994 clause 4.9.c was clear and unambiguous - is there such a clause in the 2000 standard ?

M,

When I read your post I couldn't determine if you were being facetious or serious. It seemed a strange question. I'm not a 9001-2000 expert (not even close!) but I figured, maybe you're serious. It also kinda intrigued me -- all those experts with all those man-days working on a "new and improved" standard couldn't miss that, could they? So I took a quick look. Nothing real obvious. How about 4.2.1 Note 1? Waddaya think?

Mike S.

Yes Martin, that did grab my attention :vfunny:

How about 4.1? Annexe B in the std doesn't make the connection, but...:

4.1 states:

"The organisation shall establish, document, implement and maintain a quality management system..."

...and...

"These processes shall be managed by the organisation in accordance with the requirements of this international standard."

Comments?

/Claes

I wouldn't call it a tenuous link Martin. Particularly when strengthened by Internal Audit 8.2.2a "....and to the quality management system requirements (italics my own) established by the organization"

Not following these requirements results in a nonconformance and those must be addressed per the last paragraph of 8.2.2.

Sorry to douse your debate so quickly Martin. :truce: You are quite right that the corresponding clause is missing, but I submit that it is adequately covered by these that I've cited.

It was a cute thought though!:smokin: :bigwave:

Thanks Mike and Claes

Yes that looks like it could be it !!

Great I know which clause to pin my NC's on now.

Happy to oblige Martin,

Well, you got your attention... Look at the time span for this thread: You started it at 03:50 PM and all those replies already.

That was a good one..

/Claes

7.5.1 specifically states: "The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable:
b) the availability of work instructions, as necessary.

To me...this includes all written procedural information (direct or indirect) necessary to effectively produce the product/service for sale.

Elieen (I hope I have the name right), your post brings up another interesting point. I have seen places that have procedures that are in reality work instructions (esp in aerospace). I've also seen places that have 'work instructions' that are really procedures. :confused:

The standard does not, unless I'm mistaken, call out the differences between the two.

Now to the matter of the topic at hand. Where is the shall that requires an organization to comply with their own procedures. I think Lucinda hit it correctly with the pairing of 4.2.1 d) and 8.2.2 a). :agree:

db said:
The standard does not, unless I'm mistaken, call out the differences between the two.
db,

I tend to use those terms ("work instructions" and "procedures") synonymously, but I'm not sure this is technically correct.

ISO9000-2000 2.7.2 e under "types of documents" says "documents that provide information about how to perform activities and processes consistently; such documents can include documented procedures, work instructions, and drawings".

I can't tell you I know the technical difference between WI's and procedures. Is there a difference? What are the definitions/differences?

Mike S.

db said:

I think Lucinda hit it correctly with the pairing of 4.2.1 d) and 8.2.2 a). :agree:

http://Elsmar.com/Forums/showthread.php?s=&threadid=4064&highlight=Stupid+requirement :biglaugh:
here we go again!
:ko: :smokin:

There are many compaines that do not comply with their own SPs and WIs. Most are registered, I have even heard of one that is not going to register to the 00 because they have to do what they say!!!!! Makes you wonder.

we are doing process audits now.......right? aren't our process' our procedures?...LOL

WI vs P........NOT AGAIN????????????????

A level 2 tells you what is to be done, A WI tells you how.....So why not combine the 2??????????? Unless it makes the document (notice I was generic? :bigwave: ) too long...and to me more than 1 page is long

any one else?

Never responsible for grammatical errors of any type.
Greetings BB and all: Last time I read ISO/TR 10013- Guidelines for QMS Documentation, I found dozens of should’s. Hence, here’s what I have done with Procedures vs. Work Instructions. First, I combine both of them and dub them a Process Instruction (call ‘em doilies, if you want, who cares)- a quality document that both shows you what objective is to be done and how it is achieved. Secondly, they are never more than one page. Granted, a couple of them are on an 11” x 17” layout, but still only one page. No flipping back and forth like we still do with time honored multi-level bullet and verbiage-laden procedures that impress 3rd party folks. Thirdly, they’re bright and colorful and electronic and flow charty and hyperlinked to all other reference documents. Here’s the moral of the story: construct your documents, however you feel they appear effective and have a couple people, with limited knowledge of that process, go through a dry run to see if they are useful. If so, you’re done. Miller Time. If not, make the appropriate changes until they are effective.

Should we follow them? Is it easier to a) circumvent a system or b) comply? If you choose a), you may want to ask yourself why.

This format works well for our manufacturing and distribution business. It may not be possible in all businesses to simplify them as much as we do here. But, I was pleased and surprised when I began trying it because it forced me to keep it simple and short; then voila, it worked! Common sense is a terrible thing to waste. Put the documents in the places need in the appropriate format and make them work, period. Am I missing something? A great day to all. May your Cpk always be a positive integer.

:eek: :D