Do You Need A Quality Manual? Is a Quality Manual Required?

[Marc]

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

[Andy Bassett]

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

[Marc]

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'.

[eskay]

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

[Marc]

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?

[Jim Biz]

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).]

[Marc]

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???
Dave

You 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