Retention Sample Requirements ISO 13485 and 21 CFR Part 820

Elsmar Forum Sponsor

chris1price

Trusted Information Resource
#2
As far as I am aware, there is no specific requirment for retention samples in ISO13485 or 21CFR820, or in any of the FDA guidance documents. There's lots of practical reasons for keeping them, but no regulatory reason.
 
D

Dublin 4

#3
Hi Chris,
I agree, I can't find anything. However, could one interpret records as referring to both written and physical? I am of the opinion that the product sample is a better record that the product meets the set specifications than the writter process and testing records.
Thanks for you input
Dublin 4
 

chris1price

Trusted Information Resource
#4
I agree, the actual product is often a better record than the paper files and reflects what was actually made compared to what the specifications said you were making. However, the sample may not tell you exactly how it was made or how it was tested. There's no substitute for a good Device Master Record.
 
D

Dublin 4

#5
Hi Chris 1,
I agree fully but both would be better. the reason I am asking this question is because one of our sites has somehow lost most of their retention sample and I wished to know if we are in non comppliance with the MDD 93/42/EEC, FDA part 820 or ISO 13485.
Regards
Dublin 4
 

Al Rosen

Staff member
Super Moderator
#6
Hi Chris 1,
I agree fully but both would be better. the reason I am asking this question is because one of our sites has somehow lost most of their retention sample and I wished to know if we are in non comppliance with the MDD 93/42/EEC, FDA part 820 or ISO 13485.
Regards
Dublin 4
If that is in their procedures, they are non compliant. You could issue a CA to prevent a more serious issue from developing.
 
S

SilverHawk

#7
Check into your own procedures related to inspection and testinmg whether the retention of samples have been described by your own organization initiates to retent them...cos' perhaps there is a non-conformity against your own requirements.
 

Ajit Basrur

Staff member
Admin
#8
Hi Chris 1,
I agree fully but both would be better. the reason I am asking this question is because one of our sites has somehow lost most of their retention sample and I wished to know if we are in non comppliance with the MDD 93/42/EEC, FDA part 820 or ISO 13485.
Regards
Dublin 4
Hi Dublin4,

Do you market your device or manufacture the device for some customer ?

If you are placing the device in the market, the losing of retention samples is a major non compliance. You will have to come up with a strong Corrective and Preventive Action against this non compliance.

If you are making the device for some customer, discuss this issue with your customer.
 
Thread starter Similar threads Forum Replies Date
M Pharmaceutical Product Sample Retention Requirements Manufacturing and Related Processes 1
W Keepsakes...Sample retention requirements? Other Medical Device and Orthopedic Related Topics 2
T Sample Retention Requirements - Quality Records procedure - ISO13485 ISO 13485:2016 - Medical Device Quality Management Systems 8
R Sample Retention - Subcontracted Plating Service - PPAP Requirements Service Industry Specific Topics 11
N Notification Sample Regarding Record Retention ISO 13485:2016 - Medical Device Quality Management Systems 5
I Is Sample Retention for Batch Production a TS 16949 Requirement Records and Data - Quality, Legal and Other Evidence 4
G Bulk Material Sample Standard Retention APQP and PPAP 2
Ajit Basrur Sample Retention - Quantity, Retention Period, Storage ISO 13485:2016 - Medical Device Quality Management Systems 15
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
J Requirement for Retention of Records of Withdrawn Documents of External Origin Document Control Systems, Procedures, Forms and Templates 3
P PPAP samples retention time IATF 16949 - Automotive Quality Systems Standard 5
M Retention period of documents and records ISO 13485:2016 - Medical Device Quality Management Systems 1
B Retention Samples when Customer Leaves Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
D IATF16949 7.5.3.2.1 Record Retention - Our Product or Customer Product? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
R Document Retention - Discard hard-copies after scanning? ISO 13485:2016 - Medical Device Quality Management Systems 2
M Defining and Documenting Record Retention CE Marking (Conformité Européene) / CB Scheme 5
Q AS9120B flow down to external providers: Records Retention AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
WEAVER Retention of golden samples for GR&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 0
N ISO 13485 Quality Record Retention Period ISO 13485:2016 - Medical Device Quality Management Systems 4
L VDA 1 Documented Information and Retention (new revision 4, August 2018) VDA Standards - Germany's Automotive Standards 0
Gman2 Quality Record Retention (Internal Audits, CA's) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Mobile app data privacy - Length of record retention in a software app Medical Information Technology, Medical Software and Health Informatics 1
L Pest Control Log Retention Time Frame ISO 13485:2016 - Medical Device Quality Management Systems 5
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
K Our local sterilizer is closing - Record Retention Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Record retention for defunct customers? ISO 13485:2016 - Medical Device Quality Management Systems 11
A Determining Retention Period for Medical Device QMS documents Document Control Systems, Procedures, Forms and Templates 5
D Document Retention Policy IATF 16949 - Automotive Quality Systems Standard 5
B Interpretation of Customer Specific Requirements of Continental - Records Retention Customer and Company Specific Requirements 6
T Record Retention Requirements - IATF 16949 Clause 7.5.3.2.1 Records and Data - Quality, Legal and Other Evidence 15
D PMA A&P Document (i.e. Promotional Brochures, Flyers) Retention Requirements Other US Medical Device Regulations 10
J Retention Requirements of Complaint Medical Devices Customer Complaints 2
Pmarszal FDA Global UDI Database: Record Submission Retention Other US Medical Device Regulations 1
WCHorn Flowdown of Aerospace record retention requirements (AS9100) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
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
V Tie-wrap pull test to verify contact retention Manufacturing and Related Processes 6
P Records Retention and Disposition - ISO 9001:2008 Requirements Records and Data - Quality, Legal and Other Evidence 5
D Production Record Retention Requirements Records and Data - Quality, Legal and Other Evidence 9
V Inactive Gauge Retention Time - PPAP Section 6 Requirements APQP and PPAP 1
D Contact Retention Tools Question General Measurement Device and Calibration Topics 3
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
S Are there any new FDA requirements on Record Retention ? US Food and Drug Administration (FDA) 4
J Should Documents and Records Retention pertaining to Implants retained for 15 years? Document Control Systems, Procedures, Forms and Templates 7
C Retention of Clinical Trial Data after a Clinical Trial has ended Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 5
H Layered Process Audit Hard Copy Records Retention Records and Data - Quality, Legal and Other Evidence 6

Similar threads

Top Bottom