Retention of records - Original Order Form vs. Computer Entry record - ISO 13485

R

r.daling

#1
Hi,
Here's an interesting question:

My company is changing over to a new computer system and we are trying to eliminate as much paper use and storage as possible. We have customers fill out an order form and mail it to us which defines the customer requirements for the product. My question is; if we enter all of the information from the order form into the computer system, do we still need to keep the original order form (definition of customer requirements) for the lifetime of the medical device?

I have taken the stance that we do need to retain the original order form. The plan now is to scan each order form and store it electronically to save storage space. The scanners required to do this are quite expensive. Before we go out and spend a lot of money on a fancy scanner, I was wondering if anyone can confirm that we have the correct understanding of the requirements of ISO 13485:2003.

Any help would be much appreciated! :agree1:
 
Elsmar Forum Sponsor

Al Rosen

Staff member
Super Moderator
#2
r.daling said:
Hi,
Here's an interesting question:

My company is changing over to a new computer system and we are trying to eliminate as much paper use and storage as possible. We have customers fill out an order form and mail it to us which defines the customer requirements for the product. My question is; if we enter all of the information from the order form into the computer system, do we still need to keep the original order form (definition of customer requirements) for the lifetime of the medical device?

I have taken the stance that we do need to retain the original order form. The plan now is to scan each order form and store it electronically to save storage space. The scanners required to do this are quite expensive. Before we go out and spend a lot of money on a fancy scanner, I was wondering if anyone can confirm that we have the correct understanding of the requirements of ISO 13485:2003.

Any help would be much appreciated! :agree1:
IMO, I don't think you have to retain the original form. Hypothetically, if the customer called in the order while the order clerk entered the information on a computer screen, the computer data would be the record.
 

Scott Catron

True Artisan
Super Moderator
#3
shouldn't be too expensive

r.daling said:
The plan now is to scan each order form and store it electronically to save storage space. The scanners required to do this are quite expensive. Before we go out and spend a lot of money on a fancy scanner
Our copier machine doubles as a scanner. It works at the same speed as when it maked copies, only it emails a pdf document to a pre-selected address. It wasn't that expensive an add on. If you're due for a new copier, ask about scanning capabilities or see if you can get it added to your current machine.
 

Wes Bucey

Quite Involved in Discussions
#4
How many original incoming documents or pages do you deal with per day?

A simple scanner (less than $100) can save the document in a number of formats. Hard copy can be kept until order is fulfilled, then destroyed, keeping the image as long as necessary as an archive - no different than microfilming was 20 years ago. As far as a computer is concerned, a file is a file, regardless of format.

If you are a large multinational, dealing with thousands of pages of documents, then there are organizations which can supply cost-effective solutions, even though the base cost is high.
 

Caster

An Early Cover
Trusted Information Resource
#5
Yes, and registrar tested

r.daling said:
r.daling said:
I have taken the stance that we do need to retain the original order form. The plan now is to scan each order form and store it electronically to save storage space. The scanners required to do this are quite expensive. Before we go out and spend a lot of money on a fancy scanner, I was wondering if anyone can confirm that we have the correct understanding of the requirements of ISO 13485:2003.

Any help would be much appreciated! :agree1:


At least for ISO 9001 and TS16949 you are right on.

In fact our registrars (BSI, AQSR) actually told us to destroy the paper copies after they were entered into the database. If you only have one record, it defines reality.

A diligent, trained and competent person enters the data. It is their job. And they do it well. Why keep the original?

Now if you start to gets lots of customer complaints from incorrect data entry, you may want to re think this. Even then, I'd be more inclined to poka yoke the data entry system rather than keep the original around.

OK, I just looked up 13485 - medical devices - ick, I know nothing about it, perhaps you need the original paper work, notarized, copied, filed, stapled, mutilated....

Over to a 13485 expert...
 
R

r.daling

#6
Thank you

Thanks for the replies.

The type of scanner we are looking at will scan a barcode we place on the order form and automatically associate the file with the relevenat work order. Nice function, but not cheap!

So, ISO is not concerned about the inevitable mistakes that the data entry operater will make on a Friday afternoon? The analogy with taking an order over the phone makes sense, but I can't help but feel a little nervous about not having the original record to look back on... :confused:
 
Q

qualeety

#7
is it ISO 9001 requirement?

Interesting discussion happend with my colleague.

According to him, there is no ISO requirement for keeping hard copies per ISO9001 Section 4.2.4. His company keeps every records in the computer database and destroys all hard records.

The problem i see in his company is that....

they manually re-enter records in to the computer database and there is no way of "proving" the connection between "actual" vs "computer database".

It seems the registar did not think it was a big deal and his company got a big seal of approval.........which makes me shake my head :frust:

I guess as long as the company can function as is, who am i to argue..... :truce:

any comments?
 

Al Rosen

Staff member
Super Moderator
#8
I think there is a distinction between what the standard requires and what works or makes sense for your organization. If you have a chimpanzee entering the orders it would be prudent to keep the hard copy.
 

Wes Bucey

Quite Involved in Discussions
#9
Al's comment is pretty close to mine -
"It all depends on the procedures and failsafes in transcribing data from a hard copy to a computer. Transcribing errors (typos) could occur anywhere along the line when a document is prepared."

I wouldn't do it the way described except if the number of documents were less than two per week (giving time to proofread before destroying the original document.) Any more than that and I would be looking for some serious methods of mistake proofing the process.
 

Al Rosen

Staff member
Super Moderator
#10
r.daling said:
Thanks for the replies.

The type of scanner we are looking at will scan a barcode we place on the order form and automatically associate the file with the relevenat work order. Nice function, but not cheap!

So, ISO is not concerned about the inevitable mistakes that the data entry operater will make on a Friday afternoon? The analogy with taking an order over the phone makes sense, but I can't help but feel a little nervous about not having the original record to look back on... :confused:
BTW, how do you generate the barcode?
 
Thread starter Similar threads Forum Replies Date
J Requirement for Retention of Records of Withdrawn Documents of External Origin Document Control Systems, Procedures, Forms and Templates 3
M Retention period of documents and records ISO 13485:2016 - Medical Device Quality Management Systems 1
Q AS9120B flow down to external providers: Records Retention AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
T MDR - Regarding the “Retention Period” of Documents and Records CE Marking (Conformité Européene) / CB Scheme 6
S Record Retention - How long must a company keep the following records? Records and Data - Quality, Legal and Other Evidence 17
B Interpretation of Customer Specific Requirements of Continental - Records Retention Customer and Company Specific Requirements 6
L GMW15920-2010 Records Retention for GM Customer and Company Specific Requirements 3
S Retention time requirement for various for quality records Records and Data - Quality, Legal and Other Evidence 1
x-files Control of Records - Retention Time vs. Retention Period Document Control Systems, Procedures, Forms and Templates 5
P Records Retention and Disposition - ISO 9001:2008 Requirements Records and Data - Quality, Legal and Other Evidence 5
C Financial Records Retention Requirements for a Manufacturing Company Records and Data - Quality, Legal and Other Evidence 3
S Retention of Training Records question Training - Internal, External, Online and Distance Learning 2
J Should Documents and Records Retention pertaining to Implants retained for 15 years? Document Control Systems, Procedures, Forms and Templates 7
H Layered Process Audit Hard Copy Records Retention Records and Data - Quality, Legal and Other Evidence 6
F AS9100 Records Retention Time Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
T Control of Records - API Q1 8th Edition Record Retention Requirements Oil and Gas Industry Standards and Regulations 7
Marc FDA Document and Records Retention Policy Requirements US Food and Drug Administration (FDA) 4
T Retention Period for IQA (Internal Audit) Records Internal Auditing 12
V Retention of Documents and Records Document Control Systems, Procedures, Forms and Templates 1
S Control of Records: "Retention" Records and Data - Quality, Legal and Other Evidence 18
S Record Retention Log - What Records are required in a Record Retention Log Records and Data - Quality, Legal and Other Evidence 7
S Retention Periods of Quality Records Records and Data - Quality, Legal and Other Evidence 1
B Training and Competency Records Retention - UK Health Service Records and Data - Quality, Legal and Other Evidence 5
M Turtle diagram for Records retention Process Maps, Process Mapping and Turtle Diagrams 3
A Retention and disposal of documents and records procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Retention time of quality records for parts with Critical (safety) Characteristics? Document Control Systems, Procedures, Forms and Templates 2
T Sample Retention Requirements - Quality Records procedure - ISO13485 ISO 13485:2016 - Medical Device Quality Management Systems 8
Douglas E. Purdy Control of Disposition of Records - Record Retention - TS 16949 Clause 4.2.4.1 Records and Data - Quality, Legal and Other Evidence 8
L Customer Requirements related to Retention Documents and Records period Records and Data - Quality, Legal and Other Evidence 1
P Defined Records Retention Time Of Customer/Regulatory Requirements Records and Data - Quality, Legal and Other Evidence 4
T Is there a minimum retention time for any of the Quality Records? ISO9001 Records and Data - Quality, Legal and Other Evidence 8
M Machine Build Records Retention Requirements Records and Data - Quality, Legal and Other Evidence 1
amjadrana ISO 13485 Records Retention Requirements Records and Data - Quality, Legal and Other Evidence 21
K Supporting Site Certification - Employee Training Records Retention Location IATF 16949 - Automotive Quality Systems Standard 2
D Retention periods for corrective/preventive action records Records and Data - Quality, Legal and Other Evidence 9
M Defined retention time of quality records - ISO 9001:2000 Paragraph 4.2.4 Records and Data - Quality, Legal and Other Evidence 10
T Quality Records - Retention and Required Controls Records and Data - Quality, Legal and Other Evidence 8
E Record Retention - NC for keeping records longer than our defined minimum Records and Data - Quality, Legal and Other Evidence 9
Q Records: Electronic E-mail Retention Requirements Records and Data - Quality, Legal and Other Evidence 2
I Changing Companies: Retention of Records Records and Data - Quality, Legal and Other Evidence 2
M How do I determine Records Retention Time requirements? Medical Devices Records and Data - Quality, Legal and Other Evidence 2
D Inspection and Test Records - Question on electronic retention Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
S 25 Year Retention period - Records of destroyed or discarded controlled documents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
J Retention of Quality Records - NC for "access and disposal of quality records" Records and Data - Quality, Legal and Other Evidence 3
D Retention List - Documents and Records with mandated retention periods QS-9000 - American Automotive Manufacturers Standard 9
L 4.16 Quality Records - Retention - Customer Purchase Orders (POs) Records and Data - Quality, Legal and Other Evidence 2
R Control of Quality Records - What is the required retention time? Records and Data - Quality, Legal and Other Evidence 6
E Record Retention - Raw Material (Steel Certs) Records and Data - Quality, Legal and Other Evidence 3
C Retention of QMS Plans and Reports ISO 13485:2016 - Medical Device Quality Management Systems 5
P PPAP samples retention time IATF 16949 - Automotive Quality Systems Standard 5

Similar threads

Top Bottom