Re: Review my ISO 9001:2000 Quality Manual - Radio Broadcaster (Latvia)

J

Juris

#1
Hello everyone there,
First of all, I have to apologize for my english, thats my third language as you can see :)
I`m a new one in this forum, and I have found this forum very valuable.
Could somebody review my QM, please.
In attachment you will find QM and some kind of "procedures" in ppt.

After pre-audit (ISAS BC 9001) we have to "make the necessary changes within the Management Manual (exclusions, scope of certification, definitions, process diagrams, etc.) and follow the architecture of ISAS BC 9001 standard" which is the same ISO 9001 but plus special req. for broadcasters.

I need some help, I`m stressed since I dont understand what I have to do. I can follow the architecture of ISAS BC 9001, But what does it mean " make the necessary changes in process diagrams" .
I`m also have some misunderstanding regarding our company`s internal regulations (unit by-lows describing units objectives and functions, roles for work organization and so on) - is this unit by-lows has to be linked to policies, process or procedures documentary level ? :(

Thank in advance.
Juris
 

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Ted Schmitt

Quite Involved in Discussions
#3
Hello everyone there,
First of all, I have to apologize for my english, thats my third language as you can see :)
I`m a new one in this forum, and I have found this forum very valuable.
Could somebody review my QM, please.
In attachment you will find QM and some kind of "procedures" in ppt.

After pre-audit (ISAS BC 9001) we have to "make the necessary changes within the Management Manual (exclusions, scope of certification, definitions, process diagrams, etc.) and follow the architecture of ISAS BC 9001 standard" which is the same ISO 9001 but plus special req. for broadcasters.

I need some help, I`m stressed since I dont understand what I have to do. I can follow the architecture of ISAS BC 9001, But what does it mean " make the necessary changes in process diagrams" .
I`m also have some misunderstanding regarding our company`s internal regulations (unit by-lows describing units objectives and functions, roles for work organization and so on) - is this unit by-lows has to be linked to policies, process or procedures documentary level ? :(

Thank in advance.
Juris
Juris,

Welcome to the Cove !!

In regards to your quality manual :

Exclusions : They are on page 7, not sure what the auditor wants, since they are there... you exclude 7.3 and 7.5.2

Scope of Certification : I also could not find it.... you need to define this as this is what is going to be printed on your certificate and it´s the product/service that your quality manual system applies to.

Quality policy : Could not find a reference to continual improvement. Also not sure how your Policy will provide a framwork for establishing and reviewing quality objectives.

Following "the architecture of the ISO standard" is not mandatory... it does make it easier to follow... for the auditor and for the user of the manual.

Definitions : They are not required to be in the QM, but since you put them there, they should be clear to the reader what they mean... Remember that not everyone knows all the particular terms of your organization or product/service : radio broadcasting.

Procedures : In general, I (personally) found your procedures very simplified... lacking detail as to how the process really works...

I´ll sign off here, I´m sure the experts from the site who have more experience in reviewing QM and procedures will give their valuable opinions...
 
J

Juris

#4
Juris,

Welcome to the Cove !!

In regards to your quality manual :

Exclusions : They are on page 7, not sure what the auditor wants, since they are there... you exclude 7.3 and 7.5.2

Scope of Certification : I also could not find it.... you need to define this as this is what is going to be printed on your certificate and it´s the product/service that your quality manual system applies to.

Quality policy : Could not find a reference to continual improvement. Also not sure how your Policy will provide a framwork for establishing and reviewing quality objectives.

Following "the architecture of the ISO standard" is not mandatory... it does make it easier to follow... for the auditor and for the user of the manual.

Definitions : They are not required to be in the QM, but since you put them there, they should be clear to the reader what they mean... Remember that not everyone knows all the particular terms of your organization or product/service : radio broadcasting.

Procedures : In general, I (personally) found your procedures very simplified... lacking detail as to how the process really works...

I´ll sign off here, I´m sure the experts from the site who have more experience in reviewing QM and procedures will give their valuable opinions...
Thanks for you answer!
Regarding Exclusions - we have to apply 7.3. since our company produce and test new programs. Our company is certified since 2005 and 7.3. was excluded.

Quality policy - thanks, I agree, there is no clarity enough concerning improvement. Auditors remark according quality policy "The Quality policy should appear in the form of a stand alone formalized document, widely communicated inside and outside the radio, that should clearly show Mission (for what purpose do we exist) and Vision (what we want to be tomorrow)"

Procedures - yes, these procedures are very simple, actually auditors have mentioned (n.c.) "the hierarchy of the management documents is not clearly established; processes and procedures (in the sense of ISO 9001 standard) are mixed together and the distinction between both concepts is some way confuse"
According documentary system - I have some misunderstanding. Auditors have mentioned "Link each and every document to 4 layers documentary pyramid (operational documents, procedures, processes, manuals & codes). I can understand what is policy level (manuals, codes etc.), procedure level (procedures, etc), operational level (instructions, forms, even records), but I can`t understand which documents make "process" level:(
 

Ted Schmitt

Quite Involved in Discussions
#5
Thanks for you answer!
Regarding Exclusions - we have to apply 7.3. since our company produce and test new programs. Our company is certified since 2005 and 7.3. was excluded.
OK, then you have to remove it from your QM as an exclusion...

Quality policy - thanks, I agree, there is no clarity enough concerning improvement. Auditors remark according quality policy "The Quality policy should appear in the form of a stand alone formalized document, widely communicated inside and outside the radio, that should clearly show Mission (for what purpose do we exist) and Vision (what we want to be tomorrow)"
I´ve never seen an auditor ask that the MISSION and VISION be present in the Quality Policy.... the only things that HAVE to be in the QP is what´s stated in 5.3.

Procedures - yes, these procedures are very simple, actually auditors have mentioned (n.c.) "the hierarchy of the management documents is not clearly established; processes and procedures (in the sense of ISO 9001 standard) are mixed together and the distinction between both concepts is some way confuse"
According documentary system - I have some misunderstanding. Auditors have mentioned "Link each and every document to 4 layers documentary pyramid (operational documents, procedures, processes, manuals & codes). I can understand what is policy level (manuals, codes etc.), procedure level (procedures, etc), operational level (instructions, forms, even records), but I can`t understand which documents make "process" level:(
Who specified the names ? Policy level, procedure level? and proces level? There is no requirement in the standard that specifies that you HAVE TO HAVE anything like that....

I have my documentation system in 3 levels :

1) Quality Manual
2) Procedures
3) Work Instructions
 
J

Juris

#6
Thanks Ted,
According documentary system - auditors remark "management documents exist and are used (codex, operational instructions, description of activities, etc.), but: 1) they are not clearly referenced (numbering, indication of version number, name of the responsible person for the up dating) [we identify docs with "title", "number of pages", endorsed by board date, date of changes and I have a master list with names of responsibile parsons for up dating]
and not well communicated inside company (some people do not know of their existence or are not able to find them on the Intranet); [I think always will be some people..]
2) the hierarchy of the management documents (documentary pyramid – see opposite example scheme) is not clearly established; in fact processes and procedures (in the sense of ISO 9001 standard) are mixed together and the distinction between both concepts not well understand (as a proof there are more processes listed than procedures, when it should be the contrary – see appendix); "when it should be the contrary " -
[I`m not so sure. If we have processes like purchasing and we don`t have any (documented) procedures for that (we have National regulation and company internal regulation (some kind of unit by-laws) and records and - is it N.C.?]

3) some clarification should be done within the Management Manual to include the necessary changes resulting from the audit (including a new processes diagram); above all the structure of the Management Manual should follow the architecture of ISAS BC 9001 standard (requirement of chapter 4.2.2.);
[thats ok - I can manage it]

In attach. scheme "Doc. pyramid"
 

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J

Juris

#7
Hello again,
is anybody else here to give some advice?
What can i do with this doc pyramid levels, what is "process level" documents?

Thanks to anybody in advance!
Juris
 

Stijloor

Staff member
Super Moderator
#8
What can i do with this doc pyramid levels, what is "process level" documents?
Hello Juris,

The documentation pyramid is a graphical representation of the hierarchy of documents used in a quality management system. It is a fairly traditional representation, but works well. The top level is usually the quality manual. The second level contains the procedures (written descriptions of various main processes in your system). ISO 9001 requires six documented procedures. (See 4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2 and 8.5.3). The rest is up to you. The third level typically include the work instructions. These could be called "process-level" documents. They typically explain HOW tasks within a process are performed. In a manufacturing plant, these are the instructions an operator would use to perform a specific task. ISO 9001:2000 does not require these; only "where appropriate." It's really up to you to determine what makes most sense for the safe, effective, and efficient operation of processes. The fourth level typically includes the remaining documents such as records, forms, equipment manuals, tags, labels, etc. All documents can be available and controlled electronically. Your choice.

Hope this helps.

Stijloor.
 
J

Juris

#9
Thanks very match,
But what to do with this pyramid (see attacm. "doc pyramid.doc' above) ?
There is mentioned four documentary levels such as:
1) codes (policy)
2) processes (?) - and it comes from pre-audit final report as the recommendation ?!
3) procedures (i.e. CAPA, IA, DOC management, NC etc.)
4) Instructions (I think Forms also , etc.)
Thanks in advance!:bonk:
 

Stijloor

Staff member
Super Moderator
#10
Thanks very match,
But what to do with this pyramid (see attacm. "doc pyramid.doc' above) ?
There is mentioned four documentary levels such as:
1) codes (policy)
2) processes (?) - and it comes from pre-audit final report as the recommendation ?!
3) procedures (i.e. CAPA, IA, DOC management, NC etc.)
4) Instructions (I think Forms also , etc.)
Thanks in advance!:bonk:
Juris,

Please do not get distracted by this hierarchy (pyramid) of documents. Its only purpose is to help visualize a document structure. It is not mandatory/required by ISO 9001:2000. You must decide how you structure/organize/control your documents. Please keep in mind that other than the mandatory documents (see 4.2), you must decide what additional documents are necessary to effectively and efficiently control your processes.

Stijloor.
 
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