Level 1, Level 2 Very Confused

[KRAPO]

I HAVE RECENTLY TAKEN OVER AS QUALITY DIRECTOR. I HIRED A CONSULTANT TO REWRITE OUR QUALITY MANUAL, WHICH HE DID, BUT LEFT OUR LEVEL 2 ALONE, I.E. WITH 20 ELEMENTS. I HAVE BEEN TRYING TO REWRITE THE LEVEL 2 BUT I'M NOT SURE WHAT I NEED TO DO FOR THIS DOCUMENT. CAN ANYONE SHED SOME LIGHT ON WHAT I SHOULD BE DOING WITH LEVEL 2. ARE THERE TEMPLATES TO HELP?

 

[Aaron Lupo]

Can't you use your current tier/level 2 documents as a template?

 

[KRAPO]

MAYBE THAT IS THE QUESTION I SHOULD BE ASKING. DO I TAKE THE LEVEL 2, 20 ELEMENTS AND REDO THEM TO CONFORM INTO THE 5 CLAUSES PER 9001:2000?

 

[db]

Do you need to change them? The standard does not require your procedures to align numerically with the standard. I've worked with several companies that decided to keep their existing procedures and use them as is (only updating them where they absolutely need to).

Another option would be to just re-number them to match the new standard. Also, look very closely to determine if you really need them. If not, now is your opportunity to dump them. BTW, you might find you need additional procedures. It is your program and it is mostly up to you.

 

[Randy]

You hired someone to write your (actually his by the way) quality manual? Why didn't you just send me 50% of what your paying that person so I could send you one of the ones that have been posted here in Word format and I could do the cut & paste. Apparently this indivual took the money and ran if your still operating under the infamous "20 elements".

As for your Tier 2's (I hate that classification along with other tripe and trivia....buzzword bingo anyone?) .....just take account of what you do or need to do, and put it in writing...Who, what, where, when, how, why. Implement it. Then see if it works. If it doesn't...fix it. If it does...move on to more important stuff. There is a ton of stuff here in the Forums that can give you the help you need. Seek and ye shall find!!

 

[KRAPO]

UNFORTUNATELY I JUST FOUND THIS GREAT SITE OR I WOULD HAVE SENT YOU THE $$$. THANX FOR THE INPUT.

NOT SO CONFUSED NOW,

KRAPO

 

[apestate]

hahahaha.

Come on. If you wanted to do everything yourself, you wouldn't have to pay anyone.

em, Krapo, what you have now is what lots of registrars are suggesting. Basically, the 20 element quality system is revamped and updated to include the new requirements of ISO 9001:2000. To do this, a new Level 1 quality manual is written, and it references the old QOP procedures since they really cover most of the requirements of ISO 9001:2000. I think I've seen this called a "bridge manual."

This is what has been suggested by the registrar that will audit our company. As you can see, there is much debate over the spirit of the standard among the quality professionals here on this website. I don't know if anyone here would accept a bridge manual as a serious attempt at the new standard. However, the registrar is who suggested such a thing to me in the first place.

As you can see, you must consider what the registrar wants and what you want. If you have the time and interest, I suggest you work with your procedures. You can really make those documents worth having.

As far as templates and help in that task, I suggest premium files access on this website. The cost is minimal for the amount of information you get.

However, a real set of templates for ISO 9001:2000 procedures may not exist. Not in any reasonable quality, anyway. If you look through the standard, I could name you seventeen, twenty, or twenty-five possible procedures. Six are required, you know, and four of those six can be combined into two. So a complete fill in the blanks set of procedures is not really natural. So much must be original and unique, or at least suited to your business.

I've been new to quality management for a while, and this website has been my greatest aid. When I first came into this, I purchased a complete documentation package for almost a thousand dollars. I have completely abandoned its documentation, at this point, preferring my documents be created from scratch. The internet site I bought it from referred me here for some of my questions, however, so I guess I owe them that.

 

[apestate]

re-read db's reply, KRAPO.

If you choose to go with what you have, you're still going to need to review the updates to the standard. You may want to add to your existing procedures, in some cases, and you may want to create new ones to address some new requirements.

Some procedures may no longer have a place in documentation.

You're going to have to do some work to the system, just to be reasonably assured registration.

 

[KRAPO]

THE FOG IS STARTING TO CLEAR, THANX

KRAPO

 

[Randy]

Whatever you do, don't be afraid to ask for advice here. What you get may not be perfect, but it will definitely start the old thought juices flowing. Some pretty good folks have supplied many fine examples of material that you or anyone else can use for their system development.

Good luck