Quality Manual and Procedure

[Heathklo222]

Good morning everyone,
I am trying to find out if the Quality Manual needs to have a procedure? The company I am working for has one and I have looked up everywhere and have not found one or an example of one. I just want to verify and make sure I do not need one and am not missing it anywhere in the ISO9001:2015 standards.

 

[Bev D]

If you mean a procedure on how to create the Quality Manual: NO.

 

[qusys]

Good morning everyone,
I am trying to find out if the Quality Manual needs to have a procedure? The company I am working for has one and I have looked up everywhere and have not found one or an example of one. I just want to verify and make sure I do not need one and am not missing it anywhere in the ISO9001:2015 standards.

Probably I did not understand the question.
ISO 9001 does not require to have a quality manual, it is up to the organization.
However, ISO 9001 does not have any requirement of how to do a Quality manual if you are searching for this.
Vice versa IATF 16949 has a requirement for this, and it also explains the minimum requirements for that.
Could you better explain you request?

 

[Heathklo222]

Probably I did not understand the question.
ISO 9001 does not require to have a quality manual, it is up to the organization.
However, ISO 9001 does not have any requirement of how to do a Quality manual if you are searching for this.
Vice versa IATF 16949 has a requirement for this, and it also explains the minimum requirements for that.
Could you better explain you request?

My company has a procedure for Quality Manual Maintenance which I didn't think we needed one and that wasn't required. I just wanted to verify that we didn't. Thank you everyone for your responses, apologies for not explaining it better.

 

[qusys]

My company has a procedure for Quality Manual Maintenance which I didn't think we needed one and that wasn't required. I just wanted to verify that we didn't. Thank you everyone for your responses, apologies for not explaining it better.

Ok, understoord.
Probably you are referring to a general procedure for the control of documented information , that could also embrace Quality Manual.
It is a document that should be reviewed, approved , maintained up to date etc etc following the clause of ISO 9001 documented information ( 7.5.1., 7.5.2 7.5.3). Clearly if the organization has additional requirement and have them established , they are required to be followed.
However ISO 9001 does not have any requirements fro QualityMaintenance Procedure.
Hope this helps.

 

[Heathklo222]

Ok, understoord.
Probably you are referring to a general procedure for the control of documented information , that could also embrace Quality Manual.
It is a document that should be reviewed, approved , maintained up to date etc etc following the clause of ISO 9001 documented information ( 7.5.1., 7.5.2 7.5.3). Clearly if the organization has additional requirement and have them established , they are required to be followed.
However ISO 9001 does not have any requirements fro QualityMaintenance Procedure.
Hope this helps.

Thank you so much it does help.

 

[Randy]

People have short memories.

As stated, there is no requirement for a manual, but there is a reference you can use and it comes from the out of date ISO 9001:2008

4.2.2 Quality manual The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system

What can it look like? Whatever way you choose. My suggestion (and what I see all the time) is in "c" reference, don't include, just reference your higher level procedures, SOP, instruction, or whatever you call stuff, like doc control, records management, internal audit, management review, all of those must have's in the manual.

How complicated does it need to be? Up to you, but this attachment was an actual quality manual used by a place for certification under the old ISO 9001:2008 (it's been sanitized and made generic) and it could be edited, brought up to the 2015 revision to meet its requirements which are at this time NONE.

 

[Big Jim]

Keep in mind that the word procedure is not in ISO 9001:2015. You don't need any written procedures unless you have determined you need them.