A document is controlled when.........

K

kgott

#1
I'm fairly new at quality management in terms of experience.

I thought I was pretty good with the knowledge side of things but this morning I got struck by a bag of sand when I was asked by a manager how do we know whether a document is controlled or not without a "controlled document" stamp? (re ISO 9001)

I said; errrrrrrrrrrrrrrrrrr when ..................:

· it’s been approved by the approver (who is normally the person accountable for the work the document relates to.)
· there is a revision status on the document
· its legible and identifiable
· its location is known

Anything else I should have said?
 
Elsmar Forum Sponsor

Colin

Quite Involved in Discussions
#2
Not sure where the requirement for a 'controlled stamp' is in ISO 9001, it is one way of doing it but certainly not a requirement.

Perhaps the question to ask is "why do we need to control documents?"

Well, they need reviewing and approving before issue so that people know it is a legitimate document.
They need to be reviewed periodically and updated when required and we should know what has changed.
They need some method of ensuring that people are working to the correct version - typically an issue No or Rev No. which can be verified against a 'master'
Obsolete documents need removing or marking to stop them being used accidentally.
And its not just our own documents, control must be applied to external documents such as customer drawings and standards, etc.

Back to your question - if it is a document, it must satisfy the above points - or could it be a record? which requires a different set of controls to be applied.
 

somashekar

Staff member
Super Moderator
#3
I'm fairly new at quality management in terms of experience.

I thought I was pretty good with the knowledge side of things but this morning I got struck by a bag of sand when I was asked by a manager how do we know whether a document is controlled or not without a "controlled document" stamp? (re ISO 9001)

I said; errrrrrrrrrrrrrrrrrr when ..................:

· it’s been approved by the approver (who is normally the person accountable for the work the document relates to.)
· there is a revision status on the document
· its legible and identifiable
· its location is known

Anything else I should have said?
A document is controlled when .....
it has been reviewed and approved prior to use, and is current.
How is the review and approve process done depends upon the organization.
Who reviews and approves depends upon the background information and knowledge / competency upon which the decision to approve is made.
It is just this much.
 

qusys

Trusted Information Resource
#4
A document is controlled when .....
it has been reviewed and approved prior to use, and is current.
How is the review and approve process done depends upon the organization.
Who reviews and approves depends upon the background information and knowledge / competency upon which the decision to approve is made.
It is just this much.
I would also kindly suggest that it is also distributed to the affected people after the related approval.:bigwave:
 

Ajit Basrur

Staff member
Admin
#5
I'm fairly new at quality management in terms of experience.

I thought I was pretty good with the knowledge side of things but this morning I got struck by a bag of sand when I was asked by a manager how do we know whether a document is controlled or not without a "controlled document" stamp? (re ISO 9001)

I said; errrrrrrrrrrrrrrrrrr when ..................:

· it’s been approved by the approver (who is normally the person accountable for the work the document relates to.)
· there is a revision status on the document
· its legible and identifiable
· its location is known

Anything else I should have said?
Refer to an existing thread on same topic - Controlled Document Definition - What constitutes a controlled document?
 

somashekar

Staff member
Super Moderator
#6
I would also kindly suggest that it is also distributed to the affected people after the related approval.:bigwave:
To the OP and his situational question, it is not relevant what else is done to ensure how a document (controlled document) has to be managed. While the 4.2.3 of the ISO9001 defines the controls needed, pretty much is about how to ensure controlled document's are managed and unintended use prevented.
My views .....
 
G

Geoff Withnell

#7
I'm fairly new at quality management in terms of experience.

I thought I was pretty good with the knowledge side of things but this morning I got struck by a bag of sand when I was asked by a manager how do we know whether a document is controlled or not without a "controlled document" stamp? (re ISO 9001)

I said; errrrrrrrrrrrrrrrrrr when ..................:

· it’s been approved by the approver (who is normally the person accountable for the work the document relates to.)
· there is a revision status on the document
· its legible and identifiable
· its location is known

Anything else I should have said?
If you are talking about a specific copy of a document, I would add that it is in fact the correct "latest and greatest revison. If you are talking about the document in general, and not this specific copy:

  • It's been approved per your doc. control process
  • It's revison status and history are recorded
  • The copies in use are current, usable and able to be updated when the document is updated.


Hope this helps.


Geoff Withnell
 
K

kgott

#8
Wonderful; thanks for that people. Much appreciated. At least it seems I did OK when I had the sword pointed at me.

Cheers - k
 
Thread starter Similar threads Forum Replies Date
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
C Certificate of Conformance Form - COC for each customer a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Controlled Document Location Document Control Systems, Procedures, Forms and Templates 3
GreatNate Document Control info - What is required on a controlled form/document for ISO 9001: 2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Work Order Form (Controlled Document)? Document Control Systems, Procedures, Forms and Templates 5
M Training template - controlled document? Document Control Systems, Procedures, Forms and Templates 21
E Do all Controlled Document copies require a Stamp? Document Control Systems, Procedures, Forms and Templates 3
J Employer Warning Notice a Controlled Document? Document Control Systems, Procedures, Forms and Templates 7
M Definition of a controlled document --> is a form a controlled document Document Control Systems, Procedures, Forms and Templates 14
T Should a supplier self assessment form be a controlled document? Document Control Systems, Procedures, Forms and Templates 9
C Use of white-out or obliterating a portion of a controlled drawing or document Document Control Systems, Procedures, Forms and Templates 7
N Controlled Document Binders on the Production Floor Document Control Systems, Procedures, Forms and Templates 3
I Is facility floor plan a required controlled document? ISO 13485:2016 - Medical Device Quality Management Systems 8
D Are signatures required on every page of a controlled document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
B Controlled document training requirements and structure ISO 13485:2016 - Medical Device Quality Management Systems 2
G Document Control-AS9100 - Marking of Documents as Master Copy of Controlled Copy AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
S Does this document (housekeeping checklist) need to be controlled? Document Control Systems, Procedures, Forms and Templates 8
S Document Control - Different documents which must be controlled not identified Document Control Systems, Procedures, Forms and Templates 11
R Should Internal Audit criteria be a Controlled Document? Internal Auditing 5
J Controlled Document Requirements for Marketing Materials Document Control Systems, Procedures, Forms and Templates 1
N Does a Document Distribution List need to be a Controlled Document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
N Must Templates be controlled? Controlled Document Query ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Preventing Photocopies of a Controlled Document Document Control Systems, Procedures, Forms and Templates 18
D DMR (Device Master Record) Index as a Controlled Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
Chennaiite Controlled vs. Uncontrolled Document - Clarification requested IATF 16949 - Automotive Quality Systems Standard 11
T Controlled Document vs. Controlled Manual Document Control Systems, Procedures, Forms and Templates 3
H Document Control Defined? Determining what documents must be controlled ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
GStough Internal Audit Checklist as a Controlled Document - Pros and Cons Internal Auditing 19
A Document Control File - Identifying all documents which need to be controlled Document Control Systems, Procedures, Forms and Templates 11
H Distribution of Controlled Copies - Document Control Document Control Systems, Procedures, Forms and Templates 10
T Controlled Documents - Can a word document and excel spreadsheet be controlled? Document Control Systems, Procedures, Forms and Templates 5
W Design and Development Planning - Controlled Document? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
S Have you seen and What is an Unusual Controlled Document Records and Data - Quality, Legal and Other Evidence 6
A Does the PSW (Part Submission Warrant) need to be a controlled document? APQP and PPAP 7
B Stamping Documents as "Controlled Copy" - Clause 4.2.3 Document Control Stamp Document Control Systems, Procedures, Forms and Templates 17
B Document and Record Matrix - A controlled document? Document Control Systems, Procedures, Forms and Templates 10
S Interesting Discussion Controlled Copy Stamp - Document Control Document Control Systems, Procedures, Forms and Templates 70
V Should the EMS manual be a controlled document? Miscellaneous Environmental Standards and EMS Related Discussions 7
S Definition Controlled Document Definition - What constitutes a controlled document? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 9
M Examples of DCR (Document Change Record) Log and Document Controlled Log Document Control Systems, Procedures, Forms and Templates 3
F CE Mark Technical Files as controlled document in ISO9001 QMS Document Control Systems, Procedures, Forms and Templates 7
W Controlled Documents - Trying to differentiate document control levels Document Control Systems, Procedures, Forms and Templates 5
K Document Control Terms: Obsolete, Master Copy, Controlled and Uncontrolled Copy Document Control Systems, Procedures, Forms and Templates 2
J What is the difference between a controlled document and an uncontrolled document? Document Control Systems, Procedures, Forms and Templates 10
D Customer Quality Manuals - Document of external origin and must be controlled? Document Control Systems, Procedures, Forms and Templates 14
P TS16949 - Should specific process notes be considered a controlled document. IATF 16949 - Automotive Quality Systems Standard 4
W Controlled Document vs. Uncontrolled Copy - Stamp requirements Document Control Systems, Procedures, Forms and Templates 11
J How to determine which is the 'master' "controlled" version of document Document Control Systems, Procedures, Forms and Templates 9
J Document control - ISO 13485:2003 - Obsolete controlled documents shall be retained? Document Control Systems, Procedures, Forms and Templates 7
G Posted document/Visual Aid as reference - Must they be controlled? Document Control Systems, Procedures, Forms and Templates 3

Similar threads

Top Bottom