Hello all......

Just wondering if anyone has written a Quality Manual for ISO 2K for a very small company....The one I am writing it for has a total of three employees and only does consulting in the food industry....

Primarily the owner wants the badge...he is not concerned with the system....About the only things I have figured out that they do is control documents, records, training, contract review in the form of a phone log, they do however sometimes give a customer a guide of "suggestions" that would help them pass their certification (HAACP, AIB..etc..) but nothing is concrete...

I'm having a hard time writing/completing the manual and corresponding OPs since their isn't a whole lot of meat......

I figure I can put all the OPs into one flowchart/OP and get the QM down to a few pages......

I appreciate any comments/suggestions....maybe I'm missing something but it is damn hard when their whole company consists essentially of a administration office!!! LOL..

Thanks for any help
C.S. :bonk:

I would suggest that the first thing you need is a good clear understanding of just what your client's "product" is. In other words, what is he providing to the customer. Could be just a service. But once you establish that, it is less difficult to deal with the rest of the challenge. You obviously have to go through the entire Standard, but the questions will include:
1. How does he establish customer requirements?
2. What does he do to meet them?
3. How does he monitor his work/output?
4. How does he do all the monitoring and measurement things required by the Standard?
5. What are his processes? And how do they interact?Conceivably, one operation could constitute one process, if simple and discrete enough.
This goes on and on, but until you have a clear understanding of what he's providing to the customer, it will be a murky mess.
Good luck!

I think one of my favorite saying fit here: "Management consultants (and systems) must follow the rule doctors do: above everything else DO NO HARM!"
The QMS documentation SIZE must be proportional to the SIZE of the company, if you want your QMS to work and help not to bother and annoy emplayees!
So if you have a company with 3 emplayees, i would suggest you to write them 3 or 4 procedures and thats it.
Standard requires 6 of its element to be supported by procedures BUT NOT IN 6 SEPARATE PROCEDURES! So you can easily e. g. merge corrective and preventive actions in one procedure and so on.
MAKE IT SIMPLE THIS TIME, THEY WILL THANK YOU TRUST ME! :smokin:

You've struck a familiar quandary. What about the little guy. I, of course, agree with all replys to your dillema thus far but must add some things.

First of all many may think so but the standard does not require just the six procedures so commonly referred to. The very first requirement in the manual is;

"The organization shall establish, DOCUMENT, implement and maintain a Quality Management System..."

So the first thing you must do is to define the Quality Management System. ISO 9000:2000 - Fundamentals and Vocabulary does this for us. Take a look. Then you can figure out what to document.

Secondly, it may just be the registrars I work with but so far each and every one of them will take the Quality Manual and review it page by page, paragraph by paragraph and sentence by sentence. If they see where something in the standards has not been addressed they write it up. This has happened over 30 times with me and the clients I work with.

In other words, the registrar has expectations beyond popular belief - they expect the Quality Manual (QM) to address every requirement in the standard.

Third, small companys do the same thing big companys do only in a smaller context. Therefore they must have the same quality system - only smaller. If you produce one product, using one raw material coming in from one supplier you must still establish the "Criteria for selection, evaluation and re-evaluation..." Incidentally, this is one of those areas thought not to require documentation because it doesn't read "...documented procedure..." but how will you justify that you have 'established' anything if I can't touch it?

In other words, it will be much simpler for the small company but you must still address each and every requirement of the standards. Small does not equate to diminish. Your only allowable exclusion are in clause 7 and only then if the exclusions "...do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements."

Good luck

Gary MacLean

First of all many may think so but the standard does not require just the six procedures so commonly referred to. The very first requirement in the manual is; "The organization shall establish, DOCUMENT, implement and maintain a Quality Management System..." So the first thing you must do is to define the Quality Management System. ISO 9000:2000 - Fundamentals and Vocabulary does this for us. Take a look. Then you can figure out what to document.
Documenting your system does not mean you need a procedure for everything or that your manual must address every shall. A nice process interaction diagram will usually do along with procedures or process maps to describe complex processes.
Secondly, it may just be the registrars I work with but so far each and every one of them will take the Quality Manual and review it page by page, paragraph by paragraph and sentence by sentence. If they see where something in the standards has not been addressed they write it up. This has happened over 30 times with me and the clients I work with.
I suspect it is the industry you work in. ISO9001:2000 does not encourage this.
In other words, the registrar has expectations beyond popular belief - they expect the Quality Manual (QM) to address every requirement in the standard.
Mine does not. I recently sent my manual along with some requests for quote to quite a few registrars. Not one had issue with it not regurgitating the standard.

Agree with Cari again.

The 1994 version of ISO9001 used to say that the quality manual had to show how the company addressed the requirements of the standard (or words to that effect), which resulted in everyone re-spewing the text of ISO9001:1994 into their quality manual.

Thankfully this requirement was removed from the 2000 version of ISO9001.

If auditors are still insisting on this then I am afraid they are incompetent, and I would suggest you look elsewhere for your auditors.

Years ago I was an observer for an ISO 9001-1994 registrar surveillance audit of a small company that had between 30 and 40 employees, including 2 shifts. For most elements there was a single flowchart for each procedure with both English and Vietnamese, since most of the workers spoke only Vietnamese, with supervisors and team leaders speaking both languages. It was a "thing of beauty" in its simplicity.

You've struck a familiar quandary. What about the little guy. I, of course, agree with all replys to your dillema thus far but must add some things.

First of all many may think so but the standard does not require just the six procedures so commonly referred to. The very first requirement in the manual is;

"The organization shall establish, DOCUMENT, implement and maintain a Quality Management System..."

So the first thing you must do is to define the Quality Management System. ISO 9000:2000 - Fundamentals and Vocabulary does this for us. Take a look. Then you can figure out what to document.

Secondly, it may just be the registrars I work with but so far each and every one of them will take the Quality Manual and review it page by page, paragraph by paragraph and sentence by sentence. If they see where something in the standards has not been addressed they write it up. This has happened over 30 times with me and the clients I work with.

In other words, the registrar has expectations beyond popular belief - they expect the Quality Manual (QM) to address every requirement in the standard.

Third, small companys do the same thing big companys do only in a smaller context. Therefore they must have the same quality system - only smaller. If you produce one product, using one raw material coming in from one supplier you must still establish the "Criteria for selection, evaluation and re-evaluation..." Incidentally, this is one of those areas thought not to require documentation because it doesn't read "...documented procedure..." but how will you justify that you have 'established' anything if I can't touch it?

In other words, it will be much simpler for the small company but you must still address each and every requirement of the standards. Small does not equate to diminish. Your only allowable exclusion are in clause 7 and only then if the exclusions "...do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements."

Good luck

Gary MacLean
Very Good....Jennifer Acosta/Louisiana

You've struck a familiar quandary. What about the little guy. I, of course, agree with all replys to your dillema thus far but must add some things.

First of all many may think so but the standard does not require just the six procedures so commonly referred to. The very first requirement in the manual is;

"The organization shall establish, DOCUMENT, implement and maintain a Quality Management System..."

So the first thing you must do is to define the Quality Management System. ISO 9000:2000 - Fundamentals and Vocabulary does this for us. Take a look. Then you can figure out what to document.

Secondly, it may just be the registrars I work with but so far each and every one of them will take the Quality Manual and review it page by page, paragraph by paragraph and sentence by sentence. If they see where something in the standards has not been addressed they write it up. This has happened over 30 times with me and the clients I work with.

In other words, the registrar has expectations beyond popular belief - they expect the Quality Manual (QM) to address every requirement in the standard.

Third, small companys do the same thing big companys do only in a smaller context. Therefore they must have the same quality system - only smaller. If you produce one product, using one raw material coming in from one supplier you must still establish the "Criteria for selection, evaluation and re-evaluation..." Incidentally, this is one of those areas thought not to require documentation because it doesn't read "...documented procedure..." but how will you justify that you have 'established' anything if I can't touch it?

In other words, it will be much simpler for the small company but you must still address each and every requirement of the standards. Small does not equate to diminish. Your only allowable exclusion are in clause 7 and only then if the exclusions "...do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements."

Good luck

Gary MacLean

I have to agree with Gary, I have worked for large companies that went through the certification process and now for a small company (less than 20) that is getting ready for our ISO pre-assessment audit in September 2005. The steps are the same except on a smaller scale.

Here is a simple overview of what we did:
• We first did a gap analysis of where the company was currently in regards to being ISO 9001:2000 complaint.

• We then reviewed our processes.

• We ended up establishing 20 quality procedures including the required six per ISO, we also put into place work instructions, packing instructions, receiving inspection instructions, and establishing job descriptions, training records, and a competencies matrix for the employees remember "The organization shall establish, DOCUMENT, implement and maintain a Quality Management System...".

• Training, training, and more training to get everyone on board and talking quality, in my opinion this was the hardest part since no one in the company had ever been exposed to ISO/quality systems before (Resistance to change).

Also, I have just recently received the results from our desktop audit and have found it to be as Gary stated Auditors will scan every inch of your QM and write up sections that do not address the standard. We had eight findings total and they were all based on something in the standard not being addressed.

Also, I have just recently received the results from our desktop audit and have found it to be as Gary stated Auditors will scan every inch of your QM and write up sections that do not address the standard. We had eight findings total and they were all based on something in the standard not being addressed.
Who is your registrar? I ask so I can avoid them in the future.

Also, I have just recently received the results from our desktop audit and have found it to be as Gary stated Auditors will scan every inch of your QM and write up sections that do not address the standard. We had eight findings total and they were all based on something in the standard not being addressed.I'm with Cari (as usal): You could ask the registrar what they think this is all about:The extent of the quality management system documentation can differ from one organization to another due to

a) the size of organization and type of activities,
b) the complexity of processes and their interactions, and
c) the competence of personnel.
You need to be able to show the auditor how you fulfil the requirements of the standard, but apart from the mandatory written procedures you don't necessarily have to do it in writing. She system should be adapted to your needs, not the other way around.

/Claes

I believe that the "degree of documentation varying depending on the complexity of the organization" has more to do with the types of records that might be found, or the types of safeguards such as work tickets or checklists, or the number of procedures, or the extent of review of requirements, etc. than it has to do with the documentation (read "explanation" ) of how a company addresses the elements.
A company should take the time to write down or otherwise document through flowcharts, etc., the way that they do things. Remember that done properly this is a valuable tool that is used to show how the organization's processes fit together. Just putting the pieces of the element together in one spot forces a cohesive and coherent thought process.
If it isn't documented, there is nothing that firmly establishes the policy and process. IMHO. Just because what is implemented happens to be working is not a system; it is luck without governance.
* off my soapbox and back under my rock*

A company should take the time to write down or otherwise document through flowcharts, etc., the way that they do things. Remember that done properly this is a valuable tool that is used to show how the organization's processes fit together. Oh, absolutely. I agree, but stick to my view that a system should be tailored to the companys needs. My comment should be read in the light of Allens post about auditors insisting on every clause being adressed in writing* off my soapbox and back under my rock*Whatever are you doing under that thing??? Come out from there :lol:

/Claes

I agree that the documentation should be scaled to the NEEDS of the organization. That may or may not be the same as the SIZE of the organization. But, why does everyone keep talking about the "Six" required procedures (4.2. item C) and overlook item D right below which says and other "documents needed by the organization..." There is no magic "six." It's whatever is needed by the organization. The ISO writers just pointed out wht the first six must cover. And, I agree, it doesn't matter if you write six separate procedures, or combine.

Here's an angle for a small organization with typical complexity. What if we wrote a manual that collects the six procedures and all other needed procedures into the manual. All the requirements and flowcharts that would go into a procedure could be in the manual. Call it a Handbook and SOP's (Standard Operating PROCEDURES). For a small company 20-40 pages could probably cover the whole thing and meet all the shalls to keep auditors happy. What do you think?