Record Retention - How long must a company keep the following records?

S. Moore

Quality Assurance
#1
Hello friends,

How long must you keep the following records and is there a list out there showing the type of record with the retention time? ISO 2001:2015, IATF 16949:2016 and ISO 14001:2015

Employee Training Records
Obsolete Job Instructions
Obsolete Job Procedures
CAPA forms
Non-conformities reports
Costumer complaints
Internal audit records
3rd party audit records
Management reviews
Risk assessments
RGA's
 
Last edited:
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
For what standard (or other requirement such as local, state, national and/or international regulations)?
 

normzone

Trusted Information Resource
#5
We have one customer that in their terms and conditions includes the following:

... records will be retained " forever " ...

Yes - quotation marks and all. We envision this as us maintaining a working Windows 95 platform to view them on long after the sun has burned out, since the customer relationship goes back that far.
 

Illek

Involved In Discussions
#6
Our record retention is based on our strictist requirement witch turns out to be customer based. We have hardcopy requirements and electronic file requirements listed with their own retention periods. We try to keep the amount of paper we need to keep to a minimum but it adds up quickly.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#7
We have one customer that in their terms and conditions includes the following:

... records will be retained " forever " ...

Yes - quotation marks and all. We envision this as us maintaining a working Windows 95 platform to view them on long after the sun has burned out, since the customer relationship goes back that far.
I've run into that. I've always answered "as part of our record disposition process, we would be happy to send you any records specific to your custom products after our internal record retention time period expires."
 

smohanarangan

Starting to get Involved
#8
Hello friends,

How long must you keep the following records and is there a list out there showing the type of record with the retention time? ISO 2001:2015, IATF 16949:2016 and ISO 14001:2015

Employee Training Records
Obsolete Job Instructions
Obsolete Job Procedures
CAPA forms
Non-conformities reports
Costumer complaints
Internal audit records
3rd party audit records
Management reviews
Risk assessments
RGA's
Retention period can be set internally based on the necessity. I have set for 3 years for important documents / records and 1 year for not important records.

If there is statutory requirement on retention period from Government bodies for certain records that need to be adhered.
 

smohanarangan

Starting to get Involved
#9
We have one customer that in their terms and conditions includes the following:

... records will be retained " forever " ...

Yes - quotation marks and all. We envision this as us maintaining a working Windows 95 platform to view them on long after the sun has burned out, since the customer relationship goes back that far.
We mandated our vendors to destroy "our data" with agreed timeline and not agreed to their terms of retention period.
 

Crusader

Trusted Information Resource
#10
I am fed up with saving records for 3 years. No one refers back to them. I am changing record retention to 1 year minimum.
 
Thread starter Similar threads Forum Replies Date
Raffy Defining Record Retention Times - Is 5 years long enough? Records and Data - Quality, Legal and Other Evidence 41
D IATF16949 7.5.3.2.1 Record Retention - Our Product or Customer Product? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
M Defining and Documenting Record Retention CE Marking (Conformité Européene) / CB Scheme 5
N ISO 13485 Quality Record Retention Period ISO 13485:2016 - Medical Device Quality Management Systems 4
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
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
T Record Retention Requirements - IATF 16949 Clause 7.5.3.2.1 Records and Data - Quality, Legal and Other Evidence 15
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
D Production Record Retention Requirements Records and Data - Quality, Legal and Other Evidence 9
S Are there any new FDA requirements on Record Retention ? US Food and Drug Administration (FDA) 4
S Aerospace Record Retention Requirements Records and Data - Quality, Legal and Other Evidence 5
D Question... Record retention Prior to FDA NDA application and approval Records and Data - Quality, Legal and Other Evidence 3
C Record retention/retrieval for 30+ years? (The lifespan of the medical device) ISO 13485:2016 - Medical Device Quality Management Systems 5
N Notification Sample Regarding Record Retention ISO 13485:2016 - Medical Device Quality Management Systems 5
M Record Retention requirements for Safety Items Document Control Systems, Procedures, Forms and Templates 7
S Electronic Record Retention per FDA Requirements - Electronic Data Capture (EDC) Records and Data - Quality, Legal and Other Evidence 4
K 820.180(b) Record Retention - Does it apply here? We act as the initial Importer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B 21 CFR 820.180 Quality Record Retention Requirements Document Control Systems, Procedures, Forms and Templates 1
W Calibration Record Retention Requirements Document Control Systems, Procedures, Forms and Templates 18
T Control of Records - API Q1 8th Edition Record Retention Requirements Oil and Gas Industry Standards and Regulations 7
A Canada Importer Record Retention Requirements - Disagreement with NB auditor Canada Medical Device Regulations 5
R Record Retention Requirements per FDA 820 Regulations Records and Data - Quality, Legal and Other Evidence 10
D MDD (Medical Device Directive) 6.1 Record Retention Requirements question Records and Data - Quality, Legal and Other Evidence 2
Q US Distributor Record Retention Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P Record Retention requirements of Calibration and Verification Service Providers ISO 13485:2016 - Medical Device Quality Management Systems 11
E Approval Signature Record Retention Document Control Systems, Procedures, Forms and Templates 2
C Record Retention Time for Sterile Products 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q Customer Purchase Order: TS 16949 Record Retention Requirements Records and Data - Quality, Legal and Other Evidence 4
S Minimum Record Retention Period for ISO 14001 Records and Data - Quality, Legal and Other Evidence 2
S Record Retention Log - What Records are required in a Record Retention Log Records and Data - Quality, Legal and Other Evidence 7
C What is the Minimum Regulatory Requirement for Record Retention of DHR by Suppliers Records and Data - Quality, Legal and Other Evidence 9
B Training Record Retention Training - Internal, External, Online and Distance Learning 6
D Record Retention Requirements - TS 16949 Records and Data - Quality, Legal and Other Evidence 4
M Information Technology Record Retention time best practices Quality Management System (QMS) Manuals 2
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
T 21 CFR Part 11, "enforcement discretion" - Validation, Audit Trail, Record Retention Qualification and Validation (including 21 CFR Part 11) 4
Y Record Retention by R&D Shop After Handover ISO 13485:2016 - Medical Device Quality Management Systems 5
P ANSI NCSL Z540.1 Calibration Record Retention Period General Measurement Device and Calibration Topics 3
M Medical and Administration department Document and Record Retention policy Document Control Systems, Procedures, Forms and Templates 8
H Record Retention Time of Part Life + 1 Year Records and Data - Quality, Legal and Other Evidence 7
CarolX Record retention ideas for a sheet metal job shop supplying to a medical device mfg. ISO 13485:2016 - Medical Device Quality Management Systems 11
B Minimum retention or the date of destruction of a record - ISO 9001-2000 Para. 4.2.4 Records and Data - Quality, Legal and Other Evidence 13
J Record Control - Who are the Record Custodian and Retention Times - ISO9001 - 7.5.3 Records and Data - Quality, Legal and Other Evidence 9
M Record Retention - Obsolete revisions shall be maintained until the next revision Records and Data - Quality, Legal and Other Evidence 24
R Retention of records - Original Order Form vs. Computer Entry record - ISO 13485 Records and Data - Quality, Legal and Other Evidence 12
E Document and record retention periods for the different OEM's Customer and Company Specific Requirements 2
G Bombardier Aerospace Imposes Infinite Record Retention Period Records and Data - Quality, Legal and Other Evidence 2

Similar threads

Top Bottom