Quality Record Retention (Internal Audits, CA's)

Gman2

Involved - Posts
#1
Is there any requirement for retention time on quality records like Internal Audits, CA's, Management Reviews for ISO 9001:2015?

We do not have any customer specific requirements for any of our records really, can I put it all at 1 year and be done with it? ISO have a problem with that? Auditors?
 
Elsmar Forum Sponsor

Ninja

Looking for Reality
Trusted Information Resource
#2
No requirement that I am aware of...though I, personally, would not be comfortable with 1yr.
I would set it at 5yr as a default...but then again I would hold them electronically...so storage space would not be an issue...

HTH
 

Ninja

Looking for Reality
Trusted Information Resource
#5
Just out of my own curiosity...what is the drive to discard? Space? Liability?

Culling out files costs money...most places I've worked hold records "at least X years"...which in fact ends up being 20+ yrs. Why spend the time sorting and throwing? (thus my reference to electronic...a 2TB drive costs less than the meeting to set retention time...
 

JoshuaFroud

Involved In Discussions
#6
For 9001:2015 the above posters are correct there is nothing in the standard requiring a specific holding time, however, things can be learned from old records. I would be hesitant to remove anything under 3-5 years old. I still find myself referring back to internal audits, non-conformance or production records from that time or even further ago. It is sometimes very illuminating to look back at the last time a problem was "fixed".
 

Gman2

Involved - Posts
#7
Just space in my cabinet really. I will keep the e-stuff indefinitely I guess. There is just some paper checklists and stuff that I could toss to make room.
 
Y

Yukon

#8
Put them in database folders and keep them for 10 years. Use the records for adjusting the frequency in whiich processes are audited. If you start out doing each process once per year and after three cycles you notice Process A never has problems nor does Process B but Process C is getting worse each year. You have historical data with which to decrease the frequency of A and B to say once every 2 years and you can increase C to once every 18 months.

As a CB auditor I want any reduction to be justified with historical data and you will have it.
 
Y

Yukon

#9
I like to see a retention period of current year plus 3. That way you always have a full three-year registration cycle available. RR, S1, S2
 

Eredhel

Quality Manager
#10
I've always tried to do one thing across the board (when it is logical to do so), rather than a lot of "if this then that". So I tend to do record retention based on customer requests. Typically I see 3, 5, or 7 year requirements, I've rarely seen 10 years. We keep everything at 7, but not because of a standard requirement.
 
Thread starter Similar threads Forum Replies Date
N ISO 13485 Quality Record Retention Period ISO 13485:2016 - Medical Device Quality Management Systems 4
B 21 CFR 820.180 Quality Record Retention Requirements Document Control Systems, Procedures, Forms and Templates 1
M Quality Record Retention Time - ISO 9001 vs. CFR 820.180(b) Records and Data - Quality, Legal and Other Evidence 25
M Loss of a Quality Record - FDA Inspection Records and Data - Quality, Legal and Other Evidence 4
B Quality Records - Should any record be signed? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Is there any difference between QUALITY SYSTEM RECORD & QUALITY MANUAL 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
leftoverture Must the Signature on a Quality Record be Legible? Records and Data - Quality, Legal and Other Evidence 33
A Are all In-Process Quality Records required in final QA Batch Record Review. 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
M Quality Procedures - General Detail Level and Record Keeping Requirements Document Control Systems, Procedures, Forms and Templates 6
A Performer, Verifier, Reviewer & Approver Signatures on a Quality Record US Food and Drug Administration (FDA) 3
H What defines a Quality Record ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
T Life Time Quality Record (evidence book) and Quality Plan Document Control Systems, Procedures, Forms and Templates 2
D Difference between Record and Quality Record ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
W Quality System Record as required by CFR 21 Part 820.186. ISO 13485:2016 - Medical Device Quality Management Systems 13
M Is a Quality Plan a document or record? Document Control Systems, Procedures, Forms and Templates 7
A AS9100 Quality Record - 4.2.4 simply states Records, not Quality Records Records and Data - Quality, Legal and Other Evidence 3
F ISO 9001:2000 Clause 4.2.4 - Control of Quality Records - What constitutes a record? Records and Data - Quality, Legal and Other Evidence 42
L Quality Records - What is classified as a Quality Record? Records and Data - Quality, Legal and Other Evidence 1
M Quality Manual Change History - Can I eliminate the revision record from the manual? Quality Management System (QMS) Manuals 33
J Quality Engineering Long Term Career Advice Career and Occupation Discussions 3
M Quality Management-ISO 9001:2015 General Auditing Discussions 1
M UDI barcode quality EU Medical Device Regulations 3
H Quality planning sign-off in AIAG APQP Manual IATF 16949 - Automotive Quality Systems Standard 0
S Creating a Quality culture! AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Root cause for lack of quality objectives for HSE Dept. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
V Quality Manager Reporting US Food and Drug Administration (FDA) 0
Q BMW Supplied Parts Quality Management -> Is there any new supplier quality manual? Customer and Company Specific Requirements 0
J COST OF POOR QUALITY IATF 16949 - Automotive Quality Systems Standard 5
Beth Savage Quality Solutions Sales Representative--Dayton, OH Job Openings, Consulting and Employment Opportunities 0
ernieto Outsourced Processes Quality Agreements ISO 13485:2016 - Medical Device Quality Management Systems 4
J ISO 17020 Quality Manual Other ISO and International Standards and European Regulations 1
M Resume Review Request - Quality Assurance Career and Occupation Discussions 11
E History of quality Book, Video, Blog and Web Site Reviews and Recommendations 7
Q How to classify several systems for Quality Reliability Analysis - Predictions, Testing and Standards 10
PQ Systems Preparing for Your Quality Meeting Using SQCpack Software 0
PQ Systems Defining Quality with Specifications Using SQCpack Software 0
PQ Systems Data Security in the Quality Industry Using GAGEpack Software 0
M Who should quality representative report to? ISO 13485:2016 - Medical Device Quality Management Systems 5
Tagin Using a meme generator to poke fun at quality Funny Stuff - Jokes and Humour 2
N Quality Inspection Quality Tools, Improvement and Analysis 10
O Quality Management System Implementation framework and Gap analysis checklist Manufacturing and Related Processes 7
R Statistical Methods for comparing test and reference product equivalence for quality attributes US Food and Drug Administration (FDA) 3
T Quality Management System Q1 and Q2 Interpretations Misc. Quality Assurance and Business Systems Related Topics 0
Sidney Vianna Informational ISO/CD 7101 Health Care Quality Management System Standard Hospitals, Clinics & other Health Care Providers 0
K MHLW MO169 2021 Japan Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics Japan Medical Device Regulations 2
Nihls Quality Control (stability) Chart for CMM's - How the control limits are to be calculated Capability, Accuracy and Stability - Processes, Machines, etc. 2
M How to manage Sop's & other quality documents after business transfer Document Control Systems, Procedures, Forms and Templates 3
F So my quality management position is being marginalized by my job. Quality Manager and Management Related Issues 10
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
R Quality adjusting inventory in ERP system AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14

Similar threads

Top Bottom