Does a Quality Manual need to be issued a Control Number

S

samsung

#21
Re: Quality Manual and a question

It is not the fault of the standard that it is debated.
It's not the fault of the people either who fail to interpret it since the standards are written in 'foreign' language and are so much generic in nature.

Off course based on industry feedback standard gets revised. It does not in any way imply the earlier version of the standard was complex and hard to understand.
"ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000"

The above statement is an admittance to the fact that many of the requirements of the earlier version of 9001 weren't easy to interpret (atleast ISO received such feedback), else why would they have come up with 'clarifications'.
 
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Paul Simpson

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#22
Re: Quality Manual and a question

It's not the fault of the people either who fail to interpret it since the standards are written in 'foreign' language and are so much generic in nature.
But that is the role for the Cove and for Quality Professionals in general to be able to explain to people what is required to deliver quality and, as I have said more times than I care to remember, that is generally not by explaining the standard to people who don't use it but by translating the standard requirements into words they will understand. As just one example I would never use the term 'Product Realization' in any discussions because it is meaningless to most people (including most quality professionals :)). There is, however a base level of understanding that should exist for experienced quality people.

"ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000"

The above statement is an admittance to the fact that many of the requirements of the earlier version of 9001 weren't easy to interpret (atleast ISO received such feedback), else why would they have come up with 'clarifications'.
I don't agree with your explanation here. You have emphasized 'clarifications to the existing requirements' as if it is a major change for the 2008 edition when ISO was trying to emphasize that actually in the 2008 there are no major changes and they have just taken the opportunity with the review to clear up some misunderstandings that have been highlighted.

So my take on this is that there are always new people who come into the profession and find their way to the Cove to learn about quality, ISO and a million other things. Those of us who have learned at least some of this stuff over the years try to help their understanding by posting and entering into discusson and actually learn more by doing so.

But IMHO there is no benefit in making ISO out to be more complex than it is and to seek out demons where none exist.
 
S

samsung

#23
Re: Quality Manual and a question

But that is the role for the Cove and for Quality Professionals in general to be able to explain to people what is required to deliver quality and, as I have said more times than I care to remember, that is generally not by explaining the standard to people who don't use it but by translating the standard requirements into words they will understand. As just one example I would never use the term 'Product Realization' in any discussions because it is meaningless to most people (including most quality professionals :)). There is, however a base level of understanding that should exist for experienced quality people.
Agreed.

I don't agree with your explanation here. You have emphasized 'clarifications to the existing requirements' as if it is a major change for the 2008 edition
:confused::notme:It's not in my post; stated or implied.

they have just taken the opportunity with the review to clear up some misunderstandings that have been highlighted.
This is exactly what I communicated in my post. Please revisit my post.
 
X

XIO549

#24
The simplest way I seen a company comply to a particular clause was to Identify an existing record as it was already known.

It was a logging company: the operator had an old red book in the dash where he recorded the maintenance activities.

The QMS didn't have to create a high filutent name and process number, etc. it just related to the 'Log Cutters Maintenance Book', and named its location, hey presto - compliance!

I do agree that people can interpret the standard in many ways, and for a new company getting ISO certification, I feel I'm being guided to just make sure current practice complies, and if not, don't re-invent it, just tweak it to comply.
Less 'Change' in the organisation then and the transition is seamless and effortless from the staff';s point of view.

Would you agree?

Xio
 

somashekar

Staff member
Super Moderator
#25
Re: Quality Manual and a question

samsung;403654. said:
It's not the fault of the people either who fail to interpret it since the standards are written in 'foreign' language and are so much generic in nature.
Translated standard to the local language would have done no better. I am not sure if we can get the authentic translated copy. Standard will be generic, our mapping to a specific activity will make it specific to our application.

"ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000"
And the ISO 9001:2008 will continue to be debated
 
Last edited:
S

samsung

#26
Re: Quality Manual and a question

Translated standard to the local language would have done no better. I am not sure if we can get the authentic translated copy. Standard will be generic, our mapping to a specific activity will make it specific to our application.
When I said 'foreign' language, I didn't mean 'translation' (interlingual rendition) in any way. Such a rendition would have the same meaning of communication in another language as it was in the original one. 'Translated' standards are already available atleast in principle languages and they are as good (or as easy or complex) as the one published in English for the majority of users. Atleast for Indians, English is now no more a foreign language.

By 'foreign' I mean 'not-so-familiar'/'not-so-harmonious' and for that matter people do wish to have them translated in 'plain' English so that they can get themselves familiarized with the standard terminology.

I am not sure if we can get the authentic translated copy.
Why can't. BIS translates and distributes the authentic copies of ISO standards in Hindi as well and likewise other standard bodies would also be doing the same for their people.
 
2

20130523

#27
Re: Quality Manual and a question

Agreed: ISO and the FDA are open to interpretation. I will however disagree on some level. Although there is NO requirement in section 4 to actually use a document number, when you have developed a process that is vastly different than the norm, expect your auditor to dig a little deeper to get a good understanding of how it is supposed to work.

You are required to control out of date publications, and to keep users from accessing out of date documents. The simplest and easiest way to do so is through document numbering. Are you required to use numbers? No, but you do have to have a way to show control and recognition of various versions.
 
X

XIO549

#28
All documents should have a revision number, of course.

However is this question not more about giving a document a
Title Name / Title Number, making it identifiable?
as opposed to a revision number?

We use a simple version of numbering that we found a company used for years and it works very simply.
QC-R1 is a Quality Control Record No 1
QC-P1 is a Quality Control Procedure No 1 and
QC-M1 is a Quality Control Manual No 1.

I know there is no 'requirement' for a 'Number' but I find that I can index and schedule documents very easily by doing this. I See other companies using SOP1 for Standard Operating Procedure, and so on too.

:)
 
2

20130523

#29
Sounds like you have it down. As long as it works and it can be verified and controlled; You've got it. :)
 
Q

QualityDeb

#30
Re: Quality Manual and a question

Agreed: ISO and the FDA are open to interpretation. I will however disagree on some level. Although there is NO requirement in section 4 to actually use a document number, when you have developed a process that is vastly different than the norm, expect your auditor to dig a little deeper to get a good understanding of how it is supposed to work.

You are required to control out of date publications, and to keep users from accessing out of date documents. The simplest and easiest way to do so is through document numbering. Are you required to use numbers? No, but you do have to have a way to show control and recognition of various versions.
On the subject of doc numbering, do you (or anyone ) know if your method has to be defined in a procedure? I know you HAVE to have "Control of Doc" procedure but does it have to spell it out? We have a combination of old docs and new docs with different numbering systems.
 
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