Technical Documents Numbering System - Manuals, Procedures and Wi's

J

JaneB

#11
Everyone - can I ask why you number documents?

It's a serious question - what is/are the benefits you/others get from numbering? And if you could give me some idea of how many documents you're dealing with/whether hardcopy or online, this would be helpful.
 
Elsmar Forum Sponsor
N

newgravy

#12
Wow, once again I'm looking for answers and the Cove supplies plenty. Using the Google approach to finding the answer to "numbering technical documents" turned up quite a few helpful suggestions. Being an Engineer I also thought that maybe ISO has a standard and that it would be easy to follow. However there are lots of arguments for and against using structured systems listed on the web. Then I came across this article (attached) This seems to follow the replies we have at the Cove. I for one will be sticking to my simple tried and trusted two/three letter starts followed by a unique number eg EF-0001 is an Engineering Form, SW-0001 is a system of work document (we use these for describing safety arrangements).

The one overiding issue that I have found to date, is ensuring that any one who is questioned during an audit must understand where the documents are!! The two/three letter start need not be understood so long as auditors can be pointed to the correct documents.

Best Regards
 
I

isotexas

#13
Im with you Andy and Jane,

We went with all titles and used the approval date as the rev, very simple and effective.

We added a layer of Folders for each department and 1 folder for "Misc" that had all the general procedures. Flew through our audit and not one person was confused as to what procedue was to be used.

Susan in Texas
 
#14
The one overiding issue that I have found to date, is ensuring that any one who is questioned during an audit must understand where the documents are!! The two/three letter start need not be understood so long as auditors can be pointed to the correct documents.
Wouldn't that tend to indicate that people using documents recognize them by the 'shape' of the document - a bit like we recognize each other by sight?? A name is useful to add, but we rarely ask each other for social security numbers.....
 
J

JaneB

#15
- a bit like we recognize each other by sight?? A name is useful to add, but we rarely ask each other for social security numbers.....
Andy, Andy, Andy. You'll horrify the engineers among the Cove with that viewpoint.
Poster Number 347654321-JB-au-1244654
 
T

Tony C

#16
Everyone - can I ask why you number documents?

It's a serious question - what is/are the benefits you/others get from numbering? And if you could give me some idea of how many documents you're dealing with/whether hardcopy or online, this would be helpful.
If you have 10 documents then little need to number but let's say in a complex operation there are 100 documents in a manual. How do you order them in order to find the document you require?
 
J

JaneB

#17
If you have 10 documents then little need to number but let's say in a complex operation there are 100 documents in a manual. How do you order them in order to find the document you require?
Still waiting for answers: why do you number them? Why does it make them 'easier to manage'?

Unfair really, you aren't answering any of my questions, but instead are asking one.

I doubt I'd number 100 either. My rough answer (without knowing any more detail, which is essential to good design of document systems) is I would group them in a way that made sense and enabled the users to find what they wanted. As Isotexas describes.

If they were all engineers and they wanted numbering and insisted on it, then I'd give it to them. But not first up.
 
T

Tony C

#19
My apologies for the delay in responding to your question. Document systems need to be user friendly. The reason for numbering documents is for the purpose of indexing so that the document is easier to find, this is however after first labelling by department and document type.

Regards,

Tony C
 
#20
My apologies for the delay in responding to your question. Document systems need to be user friendly. The reason for numbering documents is for the purpose of indexing so that the document is easier to find, this is however after first labelling by department and document type.

Regards,

Tony C
Why not do it by name? It's much easier to find an "Audit Plan' than it is QA-FM-201D...........
 
Thread starter Similar threads Forum Replies Date
R Implementing Design History Documents/ Technical Documents in the QMS ISO 13485:2016 - Medical Device Quality Management Systems 3
K What technical documents need to be maintained for "manufactured for" items 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
S RAPS Article on STED (Summary Technical Documents) Other Medical Device Regulations World-Wide 1
Q How to name ISO 9001 Checklist, Documents and/or Technical Documents? Document Control Systems, Procedures, Forms and Templates 2
W Does my Technical Library belong on my Documents List? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Technical Documentation Package (TDP) - Listing of the types of documents contained Document Control Systems, Procedures, Forms and Templates 4
K Technical file for mhra CE Marking (Conformité Européene) / CB Scheme 2
H MD Technical Documentation and SALES possibility EU Medical Device Regulations 0
O Soft and technical skills for a VP of Quality Career and Occupation Discussions 1
A CE-IVD Technical File with Multiple IFUs EU Medical Device Regulations 4
A DMDIV-Variants : definition and technical documentation CE Marking (Conformité Européene) / CB Scheme 4
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
R MDR & depth of technical files review by NB's EU Medical Device Regulations 18
J Saudi Arabia Technical File Requirements Other Medical Device Regulations World-Wide 1
P MDR/IVDR Annex III - Technical documentation on PMS EU Medical Device Regulations 1
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 3
F Software as a Medical Device (SaMD) Technical File Requirements Manufacturing and Related Processes 3
S Technical File for Surgical Mask in Class 1 MDD Elsmar Cove Forum ToS and Forum Policies 1
A Technical File - Updating Applied Standards EU Medical Device Regulations 4
M What to be careful about/focus on when doing a Technical File review EU Medical Device Regulations 4
Watchcat Anyone had an MDR technical file review/audit yet? EU Medical Device Regulations 13
G Same intended use devices - Technical file EU Medical Device Regulations 5
I Maintaining Technical Documentation under MDD and MDR EU Medical Device Regulations 1
M Basic UDI and technical documentation EU Medical Device Regulations 1
B Clause 5.1.12 of Technical Standard IEC 62304/A1 IEC 62304 - Medical Device Software Life Cycle Processes 5
V Iso13485 certification vs CE technical audit ISO 13485:2016 - Medical Device Quality Management Systems 3
F Management of Software version while NB reviews Technical file CE Marking (Conformité Européene) / CB Scheme 7
D Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
F Recommended practice for furnishing Technical Procedures ISO 17025 related Discussions 1
S How to find technical specification for facilities maintainance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
L Special Processes - Technical reason concerning torque - Anaerobic compounds Manufacturing and Related Processes 10
N Technical file requirements class 1 device MDR Other Medical Device Regulations World-Wide 6
T Change in BRH (Brazilian Registration Holder) Technical Manager Other Medical Device Regulations World-Wide 2
C Maintenance of Product Technical Documentation EU Medical Device Regulations 3
O Medical Device Technical File Confidentiality - On site reviews EU Medical Device Regulations 14
N How to Write and Compile a Technical File for CE Marking CE Marking (Conformité Européene) / CB Scheme 4
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
M Informational USFDA draft guidance – Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions Medical Device and FDA Regulations and Standards News 0
M Informational USFDA draft guidance – Technical Considerations for Non- Clinical Assessment of Medical Devices containing Nitinol Medical Device and FDA Regulations and Standards News 0
C Access to Technical Documentation - MDR Chapter VI Article 61 EU Medical Device Regulations 4
M Technical File (STED) labelling - When you compile tech files do we have to include all the product labels? EU Medical Device Regulations 2
M Informational IMDRF final document – Assembly and Technical Guide for IMDRF Table of Contents Submissions Medical Device and FDA Regulations and Standards News 4
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22
M Medical Devices and ASD-STE100 (Simplified Technical English) Other Medical Device Related Standards 0
B IATF 16949:2016 – Technical Specification (eBook edition) IATF 16949 - Automotive Quality Systems Standard 1
S MDR Technical File Structure Requirements EU Medical Device Regulations 12
L 510k exemption process - Do you still need to submit technical dossier? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
D MDD to MDR - Technical File conversion EU Medical Device Regulations 4
J Connection between Technical File and Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2

Similar threads

Top Bottom