From: ISO Standards Discussion
Date: Mon, 20 Mar 2000 07:23:18 -0600
Subject: Re: Structure ISO 9001/2000 /../Whitcomb/Barnes/Whitcomb

Don, and other list members

Don you asked: "Do you have any info on the changes that have to be made to the Quality Manual"? I appreciate your help! - Don

Basically the answer to your question is found in ISO 9000-2000 paragraph 5 Management Responsibility, 5.5.5: " A quality manual shall be established and maintained that includes..blah...blah" I suppose this would be the time to start a fire by saying the new standard does not say DOCUMENTED, therefore I suppose the QM could be in electronic form. 5.5.5 also says the quality manual shall be controlled. An interesting point in 5.5.5 says the quality manual can include "documented procedures or reference to them" (ISO 9000-2000 DIS 5.5.5 (b))

There is a difference in the "fine print" wording in that 9K-2K states: "The quality manual may be part of the overall documentation of the organization" (ISO 9001-2000 DIS) which could be interpreted as not having to have a separate quality manual. It does seem to me the writers have allowed that a procedure manual can double as a quality manual as long as there are additional pieces of information included in the PM that might have been in a QM like the quality policy, org chart, etc.

Don't know if this answers your question. Hopes it helps.

Gary

I must admit that in my ignorance i had never really differentiated between a Electronic or Hardcopy Manual.

I have always actively encouraged customers to bang every thing onto a server. However i have always insisted that one 'Master Copy exists that contains the original signed procedures. Or is there a way around this also?

Regards

Andy

When I see a physically signed procedure I immediately think "...these folks are living in the past...." Electronic approvals are easy. There is absolutely not requirement for a 'signed original'.

Marc,

I agree with you. In this day & age, everything should be electronic. But alas, I came across an Auditor from a world repute certification body here in UAE, who told me he "always expects to see a hard copy signed by the top executive".

Life is tough!!!

Kannan

Originally posted by Kannan:

...an Auditor from a world repute certification body here in UAE, who told me he "always expects to see a hard copy signed by the top executive".

Life is tough!!!Yes, it is. Problem is, the auditor is 'expecting' something which is NOT a requirement. Many times it is simpler to give them 'what they want'. But -- when does it stop?

Opinion only- and I could be as off base here as anyone (grin)

"I think" they are attempting to "clarify" in the sense that some systems (ours included) contain
1 Q policy written into a Quality Policy manual (the path & policies we agree to follow in a real general sense)
2 Procedure set (Who does what when)
3 Work instructions (how its done)
4 Records (how we prove it)

What they intend is that the system structure Need Not contain our current full blown Level 1 quality policy manual (generally a rewrite of the standards anyway ) - as long as the SCOPE of the system is defined along with a quality policy. They are allowing what we currently define here as Level 2 procedures to be viewed as the "Level 1 document set" it's been my experience that when our auditors ask for "the Quality Manual" they are basically talking our collection of procedures anyway.

[This message has been edited by Jim Biz (edited 21 April 2000).]

Originally posted by isodog:
HOLD ON!
The ISO 9000:2000 does NOT require a "Quality manual covering the requirements of this Standard". It only requires a scopy, procedures or reference thereto, and a description of the sequence and interaction of the processes (a flow chart?).

If I interpret this correctly, and there is every opportunity I haven't, the Quality manual is one page and a flow chart.

Opinions???
DaveYou are correct.

HOLD ON!
The ISO 9000:2000 does NOT require a "Quality manual covering the requirements of this Standard". It only requires a scope, procedures or reference thereto, and a description of the sequence and interaction of the processes (a flow chart?).

If I interpret this correctly, and there is every opportunity I haven't, the Quality manual is one page and a flow chart.

Opinions???
Dave

I am a new member on the forum. I find many interesting topics here but in many cases the discussions have stopped and no views are being posted for quite some time. UNder this thread no message has been posted after April 2000.

Allow me to revive the discussion on this important topic.

Quality manual is a mandatory document under ISO 9001: 2000 compliant QMS (clause 4.2.2). Under this requirement, the organization shall establish and maintain a quality manual. What all is to be essentially included in this document is also specified in this clause. Anything else can be included by the organization. As such, the quality manual can be a very bulky document or only a one page document. During my six years of consultancy, I have prepared quality manuals having one page to more than 50 pages depending on the organization, its employees and its customers.

I have always believed that quality manual is a very useful document and should be used to serve as a statement of intent of the management for both inside and outside users. My quality manual is an introduction to the organization and its QMS.

We do not sign any procedures, forms etc showing that they have been approved. The approval process is done thru a separate 'change' system. If you want to change or issue a document you make a suggestion for the change. It must be signed off by the relevant manager and this then becomes the approval. It does not require the original to be signed off as it is 'electronic'. We will, hopefully, soon have a system where our 'Change' system is electronic and then there will be NO signatures and NO paper.

We do not sign any procedures, forms etc showing that they have been approved. The approval process is done thru a separate 'change' system. If you want to change or issue a document you make a suggestion for the change. It must be signed off by the relevant manager and this then becomes the approval. It does not require the original to be signed off as it is 'electronic'. We will, hopefully, soon have a system where our 'Change' system is electronic and then there will be NO signatures and NO paper.

As per clause 4.2.3 of ISO 9001: 2000, all documents required by the QMS are controlled documents. The organization has to define the control mechanism to ensure compliance to control-requirements as specified in a) to g) of the clause. Requirement a) requires that documents should be approved for adequacy before issue. Now, who will do it, how it will be done, whether it will be a hard copy or a soft copy, whether it will be signed off by the relevant manager or not, is to be decided by the organization.

I have always believed that quality manual is a very useful document and should be used to serve as a statement of intent of the management for both inside and outside users. My quality manual is an introduction to the organization and its QMS.

The issue, betterlife, comes from the fact that many organizations believe the quality manual is merely a document to help out auditors and, to some degree, the Customers, but in no way helps the organization itself.

Even I will admit that our current quality manual is pretty much a mirror-image of the standard with a few little company-related things thrown in, and the links to the relevent information.

When I do training, I describe the quality manual as a "library" or "index". It will not tell me how to do internal audits, for example, but it will tell me where I find more information on them.

I have until September (current deadline) to integrate our quality, environment and safety programs into one manual. The intent is to develop a useful, meaninful document that will, in essence, describe who we are, what we do, why we do what we do and how we do it. If successful, this will be the first document read by new employees so that they understand our philosophies, mehtodologies, values and beliefs. Hopefully, a document will be born that meets the needs of all Stakeholders!

My question to those successful with their transition, how did you structure your policy manual? I have found information suggesting several methods;

1) re-write the standard while inserting co. specifics where needed - the advantage appears to be the security of having a fully written manual, and follows the traditional approach of level 1 to 4 documentation.

- OR -
2) Indicate the scope of the quality system, and provide a process map with all processes listed and their interractions defined as a 1 page (legal size I assume) manual. The rest of the system is documented, I presume, through flowcharts, instructions, forms, etc. the advantage to this approach appears to be lean, and KISS. the disadvantage seems to be that it may be easy to miss something, or to over generalize.

- OR -
3) Some short verbiage adressing each item of the standard, a statement of how each aspect is handled with references to the specific procedures.

What has been your experience with these formats, and which do you recommend for someone starting out? We are at the beginning of the transition from QS9000:TE to ISO. Certification to ISO is April of 06, so I do have a bit of time. We have a fully functioning system, but I want to pare the documentation to the bone.

I certainly appreciate the help
thanks,
Barbt :thanx:

Dear Barbt,
All three formats suggested by you are OK. The only difference is the state of understanding amongst the employees about ISO 9001. If employees are not aware then 1) will be needed. For employees fully aware 2) will be the best choice. For employees falling in the middle 3) will be OK.

Hello All,

I recently re-wrote our quality manual, removing all replication of the standard. It is now a 2-page document with scope, control, policy, objectives and 2 process maps showing the integration of our processes (documented and undocumented - undocumented processes are identified by colour-coding).

We had no problems during the audit, the BSI Auditor was impresssed with the manual.

I have attached a copy of the manual in case anyone is interested.

I suppose you have separate Procedures and Work Instructions which are equally graphic. If so, I applaud the minimalist attitude you bring to the task of Quality Management System documentation.

If you do use graphic Work Instructions, I'd be appreciative if you could post a sample of one of those as well.

Phil P

All I can say is WOW! :applause: Your example is what I was striving for! thank you for sharing. I will not copy it, but if you don't mind, I will use it as a guide for simplicity. :thanx:

Barb T.

Hello All,

I recently re-wrote our quality manual, removing all replication of the standard. It is now a 2-page document with scope, control, policy, objectives and 2 process maps showing the integration of our processes (documented and undocumented - undocumented processes are identified by colour-coding).

We had no problems during the audit, the BSI Auditor was impresssed with the manual.

I have attached a copy of the manual in case anyone is interested.
:applause: Excellent! The only problem I see--and it's minor, pedantic perhaps--is the abrupt change to the passive voice under "Manual Control." "The Quality Manager shall control..." rather than "The Quality Manager controls..." Since the rest of the text is nicely written in the active voice, it would be good for this section to be consistent in voice.

:applause: Excellent! The only problem I see--and it's minor, pedantic perhaps--is the abrupt change to the passive voice under "Manual Control." "The Quality Manager shall control..." rather than "The Quality Manager controls..." Since the rest of the text is nicely written in the active voice, it would be good for this section to be consistent in voice.
Yes! Don't allow yourself to be spooked by the legalistic "shalls" in the Standard!

Here is a sample of one of our 'process map' type work instructions. The process has inputs on the left and outputs on the right. The little grey arrows normally have hyperlinks to the referenced document attached.

Does this seem too clunky to you? Better than text? Opinions please ;)

Silly Girl

Hi everyone,

Thanks for your comments, they are much appreciated. I have attached a copy of a typical procedure for everyone to view and I do not mind at all if anyone wishes to use either this or the manual.

Regards,

Phil.

Phil P,

I am completely taken with your concise manual, and am studying it at length to see how I can adapt something similar for our system. My goal will be to keep ours under 5 pages, so your 2 page example for me is classic!

In your Scope, you state that one of the intentions of the Quality Management System is to 'define, monitor and control any processes that may be outsourced'.

My question is how do you control a process that is outsourced? Define and Monitor I get, but not the control part. :confused:


The cove is a fountain of information - I am finding answers everywhere. thanks.

Barb T.

Hi Barb T,

The control of outsourced (sub-contracted) processes is acheived through our vendor rating system, which ensures that suppliers have sufficient control over their process. In short we ensure that they are registered to an acceptable quality standard (which ensures that regular internal and external audits are performed), or perform an audit of their facility to verify sufficient control is exercised.

Our on-going ratings ensure that we identify any problematic suppliers (we communicate our results to each supplier), are issued with performance warnings or removed from the system as approved suppliers. The scope of the vendor rating system ensures that only suppliers of materials or products which have an effect on product quality are monitored.

Hope that helps. If you have any more questions don't hesitate to ask.

Regards,

Phil.

The control of outsourced (sub-contracted) processes is acheived through our vendor rating system, which ensures that suppliers have sufficient control over their process. In short we ensure that they are registered to an acceptable quality standard (which ensures that regular internal and external audits are performed), or perform an audit of their facility to verify sufficient control is exercised.



Phil,
Ok, I'm in. that works for me.

I had originally thought that control meant having decision making power over a process. On closer examination of the paragraph, however, I came to the realization that we just have to ensure that the process itself is controlled - not necessarily control it ourselves. So much easier than I thought!

thanks, :bigwave:
Barb T.

Marc,

I agree with you. In this day & age, everything should be electronic. But alas, I came across an Auditor from a world repute certification body here in UAE, who told me he "always expects to see a hard copy signed by the top executive".

Life is tough!!!

Kannan

But I would say if there happpens any changes in the technology or any techniques of auditing etc then there has to be a forum to refreh things otherwise we would be some kind of differnce amonge one auditor or another & eventually some kind of disatisfaction on the part of the organizations or ISO clients.

But I would say if there happpens any changes in the technology or any techniques of auditing etc then there has to be a forum to refreh things otherwise we would be some kind of differnce amonge one auditor or another & eventually some kind of disatisfaction on the part of the organizations or ISO clients.

Did the auditor issue a NC as a hard copy of Quality Manual was not available? If not then why one should worry about it? Auditors make many such comments during the audit. What matters is what they give in writing.

Phil,
Ok, I'm in. that works for me.
I had originally thought that control meant having decision making power over a process. On closer examination of the paragraph, however, I came to the realization that we just have to ensure that the process itself is controlled - not necessarily control it ourselves. So much easier than I thought!
thanks, :bigwave:
Barb T.

Control on outsourced processes are same as controls on the process it was carried out in-house. Both should be effective and should produce accepable level of quality of product or service. And in both cases the company operating QMS is responsible.