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Document levels and approval requirements for lower level documents like work instructions, forms etc.

ISO_Man

Involved In Discussions
#1
I'm looking at a current document control system (manual) and the higher level documents (SOPs) all require approval, but as I go into the lower level documents like work instructions, forms etc. I see that do they don't have approvals for those individual documents. Is this normal?
 
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CCaantley

Involved In Discussions
#2
I was told by the company that helped us update to 9001:2015 that anything that gives instructions needs to be a controlled document... signature and date at least.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#3
Note that "Controlled" and "Approved" are different things.
How are you 'lower level' documents "controlled" ?

Everyone can make it however they want...isn't "controlled"... Having only one source to get it, and controlling that source (even without a singoff) may be control.

That said, the vast majority I've seen show an approval signature...
 

dubrizo

Involved In Discussions
#4
I would suggest that you do what's right with respect to the business (risk tolerance). What I mean by that is to evaluate risk/opportunity with document reviewers and signers. I.E. is the document a plan vs. a record. The plan/protocol should probably be reviewed/signed by more individuals (consider R&D, Cognizant Review, Quality, Regulatory, etc.) than the subsequent record of the protocol being run.
 

ISO_Man

Involved In Discussions
#5
Note that "Controlled" and "Approved" are different things.
How are you 'lower level' documents "controlled" ?

Everyone can make it however they want...isn't "controlled"... Having only one source to get it, and controlling that source (even without a singoff) may be control.

That said, the vast majority I've seen show an approval signature...
___
All of our documents are controlled. Still working with some former professional auditor friends to figure this one out.
 

Al Rosen

Staff member
Super Moderator
#6
I don't know what standard you are addressing, but according to ISO 9001:2015

9001:2015 said:
7.5.1 General
The organization’s quality management system shall include:
a) documented information required by this International Standard;
b) documented information determined by the organization as being necessary for the effectiveness
of the quality management system.


7.5.2 Creating and updating
When creating and updating documented information, the organization shall ensure appropriate:
a) identification and description (e.g. a title, date, author, or reference number);
b) format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
c) review and approval for suitability and adequacy
So you determined that the WIs & forms are necessary otherwise why have them? They need to be approved.
 

skb76

Involved In Discussions
#8
hi!

Just give opinion

even it is low level document/form
(for first time when the form/document been created ~ approved/sign ~ group them to Master List)
~ Until the format of the forms been 'modify/revise'

(#based on my experience, WI cant actually consider as low-level document, the Auditor will look into it (moreover with the 7.1.6clause)
 

RoxaneB

Super Moderator
Super Moderator
#10
I was just passing on what I was told. If it is wrong, I have a lot of work to do to fix everything.
No, you don't need to FIX everything. But a document with a signature and a date doesn't necessarily make it controlled. Your company probably has more to its document control process than just those two items. Before trying to fix a process, best to determine if it is indeed broken.
 
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