SBS - The Best Value in QMS software

Record Retention requirements of Calibration and Verification Service Providers

P

pangchiaboon

#1
Hi all,
Base on ISO13485 "the organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than 2 years from the date of the product release by the organization or as specified by relevant regulatory requirements".

We have defined the retention period for product related records to be retained for at least 55 years, including records of outsourced process for traceability in the future.

How about records generated by external monitoring and measuring equipment calibration / verification service provider? Normally calibration / verification service provide will issue us calibration / verification cert.

1. Is it the only record that we need to retain?
2. Do we need to request calibration / verification supplier to keep their other internal records for 55 years? I think ISO 17025 does not required calibration/verification service provider to keep the records for so long.
3. What is our industrial practice?

Please advise. Thank you.
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Hi all,
Base on ISO13485 "the organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than 2 years from the date of the product release by the organization or as specified by relevant regulatory requirements".

We have defined the retention period for product related records to be retained for at least 55 years, including records of outsourced process for traceability in the future.

How about records generated by external monitoring and measuring equipment calibration / verification service provider? Normally calibration / verification service provide will issue us calibration / verification cert.

1. Is it the only record that we need to retain?
2. Do we need to request calibration / verification supplier to keep their other internal records for 55 years? I think ISO 17025 does not required calibration/verification service provider to keep the records for so long.
3. What is our industrial practice?

Please advise. Thank you.
Can someone with this expertise help?

Thank you!!

Stijloor.
 
G

George Weiss

#3
From FDA 21CFR820:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1
Reviewing Sec. 820.72 lists Calibration records, Sec. 820.180 General requirements, the answer is clear:
All records required by this part shall be maintained for past life of device, or 2 years at least! Exceptions in red
Sec. 820.72 Inspection, measuring, and test equipment.
(a)Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented.
(b)Calibration. Calibration procedures shall include specific directions and limits for accuracy and precision. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device's quality. These activities shall be documented.
(1)Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.
(2)Calibration records. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.
Sec. 820.180 General requirements.
All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections.Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up.
(a)Confidentiality. Records deemed confidential by the manufacturer may be marked to aid FDA in determining whether information may be disclosed under the public information regulation in part 20 of this chapter.
(b)Record retention period. All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.
(c)Exceptions. This section does not apply to the reports required by 820.20(c) Management review, 820.22 Quality audits, and supplier audit reports used to meet the requirements of 820.50(a) Evaluation of suppliers, contractors, and consultants, but does apply to procedures established under these provisions. Upon request of a designated employee of FDA, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required under this part, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken.
This is my prudent observation.
 
Last edited by a moderator:
A

arios

#6
Check the guidance on ISO/TR 14969 :read:

There you will find an explanation regarding retention of records related to the product and the QMS
 
G

George Weiss

#7
Only the black was to be read. I was a bit silly last night. I was also assuming the 2 years + life cycle time, and not just 2 years. I amaze my self when re-reading what I wrote. I must be the same when I speak.
All help is apreciated!
 
G

George Weiss

#8
FDA Laboratory stores the QA Calibration Records for 3 years. Refer the Attachment A in the ORA Laboratory procedure.
.
I wonder if this policy would apply to a medical device, as the 21CFR820 was refering to? I also did see exemption(s) in the 21CFR820 similar to much of the QMS documents in the ORA list. I is additional documentation to go with! The best answer will appear I hope.
This article adds to the FDA pile of statements about medical device, and maintenance records retention @
http://medicaldeviceschool.com/A00008.html
 
Last edited by a moderator:
G

George Weiss

#9
Check the guidance on ISO/TR 14969 :read:

There you will find an explanation regarding retention of records related to the product and the QMS
I didn't see anything about the time of retention in ISO 14969? There was some descriptions. I realy like this read the book smiley face!

I reviewed another ISO 13485 QM and did see the life of the product, or 2 years minimum stated there also. I like this as the way to go!
I am sure asking a calibration provider to hold documents for 55 years is a stretch, but if this is the requirement, then everyone should be doing it.
 

Ajit Basrur

Staff member
Admin
#10
I wonder if this policy would apply to a medical device, as the 21CFR820 was refering to? I also did see exemption(s) in the 21CFR820 similar to much of the QMS documents in the ORA list. I is additional documentation to go with! The best answer will appear I hope.
Remember, the retention period that is being discussed is for Calibration Records and not for the medical device itself. If its a medical device, your answer is most appropriate.
 
Thread starter Similar threads Forum Replies Date
T Record Retention Requirements - IATF 16949 Clause 7.5.3.2.1 Records and Data - Quality, Legal and Other Evidence 15
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
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
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
Q Customer Purchase Order: TS 16949 Record Retention Requirements Records and Data - Quality, Legal and Other Evidence 4
D Record Retention Requirements - TS 16949 Records and Data - Quality, Legal and Other Evidence 4
A Deviation Record Retention Requirements Records and Data - Quality, Legal and Other Evidence 2
M Record Retention Verbiage Needed for "Lifetime" Retention EU Medical Device Regulations 5
E Record Retention - Raw Material (Steel Certs) Records and Data - Quality, Legal and Other Evidence 3
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
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
Pmarszal FDA Global UDI Database: Record Submission Retention Other US Medical Device Regulations 1
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
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
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
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
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

Similar threads

Top Bottom