Revised documents

Elsmar Forum Sponsor

geoffairey

Involved In Discussions
#2
ISO 9001 doesn’t detail how long records need to be retained, you need to determine that as relates to applicable Laws, Regulations, Contracts, and then risks.

but I would want a lot more context on the specifics before providing any further guidance.

When You say revised, what do you mean? A new version of the “form”? A new check which replaces last year’s check? An updated calibration record?
 

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
#5
Hello, can anyone tell me, by 9001 standards, if one has to keep a record after it has been revised, i.e., if updated from B to C, do you have to retain A and B?

Thanks.
In addition to the wise council you received from @geoffairey , remember to be selfish. In other words, what does your ORGANIZATION need ? For example, is there a risk of having future problem raised as result of products in the field ? If so, what length of time would your organization wish they had record of exactly what the "old" /previous process was/may have been when that product was produced? That is one type of example only, ...regardless of the context of your organization, determine what your organization needs and then selfishly make that determination your practice (of course, ensuring it is at least as long as any customer or industry standards may mandate).

Hope this helps.
Be well.
 
Thread starter Similar threads Forum Replies Date
bio_subbu NBOG Publishes revised best practice guidance documents (Nov 2014) EU Medical Device Regulations 1
bio_subbu EU publishes several new & Revised MEDDEV guidance documents (FEB 2012) EU Medical Device Regulations 0
J Managing New and Revised Electronic Documents (Procedures) - Share Point Document Control Systems, Procedures, Forms and Templates 8
E New and revised documents - Acknowledgement of distribution required? Document Control Systems, Procedures, Forms and Templates 3
M Should DoC be updated every time Technical Documentation is revised? EU Medical Device Regulations 2
William55401 21 CFR 11 Password Aging - What does "periodically" revised mean in your org? Qualification and Validation (including 21 CFR Part 11) 3
M 6.1.2.3 Contingency plans SI 3 revised and reissued July 2021 IATF 16949 - Automotive Quality Systems Standard 7
Ed Panek External Standards List - Should this document include previously revised standards? ISO 13485:2016 - Medical Device Quality Management Systems 4
B Updated IATF 16949 - Will IATF 16949 get revised when ISO 9001:202X is released? IATF 16949 - Automotive Quality Systems Standard 7
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
G New CAPA Work Flow with Revised 8D Approach Process Maps, Process Mapping and Turtle Diagrams 35
M Informational EU – EMA revised guidance – Questions & Answers on Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 201 Medical Device and FDA Regulations and Standards News 2
M Informational Several revised or updates USFDA guidance - 9/9/2019 Medical Device and FDA Regulations and Standards News 12
J Revised MDSAP Audit Model - Health Canada - October 30, 2017 ISO 13485:2016 - Medical Device Quality Management Systems 7
Sidney Vianna SCMH Awareness Webinar Focused on the revised Advanced Product Quality Planning APQP AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
Marc Release of New or Revised Procedures Document Control Systems, Procedures, Forms and Templates 5
V Revised ISO std vs ISO13485:2003 - Help Please!!! ISO 13485:2016 - Medical Device Quality Management Systems 4
Q Evalaution of the On Market Device to a Revised Standard Other ISO and International Standards and European Regulations 4
R Re-validating revised Medical Device and Aerospace Product COTS software ISO 13485:2016 - Medical Device Quality Management Systems 2
V Is MHLW Std No.169 - 2004 being Revised in Nov 2014? Other ISO and International Standards and European Regulations 5
J What are the changes in CMDR that was revised in Dec 2013? Canada Medical Device Regulations 2
T CFDA seeks for public comments on newly revised medical device classification rules China Medical Device Regulations 1
M Any new or revised EU or FDA regulatory requirements for IVD diagnostics in 2013? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Singapore - Revised Adverse Event reporting and FSCA Reporting Guidance Other Medical Device Regulations World-Wide 0
M Inventory Parts Have Been Revised Quality Manager and Management Related Issues 7
Ajit Basrur New & Revised Draft Guidances CDER is planning to publish in 2013 US Food and Drug Administration (FDA) 1
L Keeping current on new/revised MEDDEVs EU Medical Device Regulations 8
S Revised MEDDEV 2.12-1 rev 8 Vigilance System - Released EU Medical Device Regulations 3
E Will EN ISO 13485:2012 be revised when ISO 13485 is reviewed?? ISO 13485:2016 - Medical Device Quality Management Systems 3
S Previewing changes to revised Standards US Food and Drug Administration (FDA) 2
P Revised Fiat CSR (Customer Specific Requirements) Customer and Company Specific Requirements 1
S Numbering of Pages in a Revised Procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
bio_subbu GHTF issues revised document "Definitions of ?Medical Device? and ?IVD? Other Medical Device Regulations World-Wide 1
bio_subbu EU publishes revised guidance on Medical Devices Vigilance system MEDDEV 2.12-1 Rev7 EU Medical Device Regulations 8
M ISO 13485 and FDA QSR Employee Training Requirements when Procedures are Revised Manufacturing and Related Processes 5
J Standards Management - How do we know if a new standard is issued or revised? CE Marking (Conformité Européene) / CB Scheme 9
J What to be reported on "New or Revised Regulatory Requirement" at Management Review? Management Review Meetings and related Processes 8
bio_subbu Hong Kong MDCO issues revised guidelines on listing system for the Medical Devices Other Medical Device and Orthopedic Related Topics 1
J Revised Honda Supplier Quality Manual dated 5/1/2011 Available Customer and Company Specific Requirements 0
S Rolling out a Revised Quality Manual to all the Employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
xcanals_tecno-med.es Revised List of Harmonized Standards for Medical Device Directives (MDD) in the EU EU Medical Device Regulations 48
C Keeping Employees Updated on Newly Revised Procedures Document Control Systems, Procedures, Forms and Templates 15
xcanals_tecno-med.es Revised list of harmonized standards for medical device directives in the EU (7/7/10) EU Medical Device Regulations 0
S FDA revised Guidance on Clinical Investigator Disqualification Process-reg.. US Food and Drug Administration (FDA) 0
bio_subbu Eucomed published revised guideline on Good Distribution Practice ISO 13485:2016 - Medical Device Quality Management Systems 3
bio_subbu COCIR Recommendation on DoC under revised 93/42/EEC EU Medical Device Regulations 0
Stijloor Toyota Supplier Quality Assurance Manual (SQAM) is revised - April 2010 Customer and Company Specific Requirements 4
L Update CE Declaration when standards are revised? EU Medical Device Regulations 4
M Revised list of harmonized standards for medical device directives in the EU EU Medical Device Regulations 1
L Changes in Revised Document are not Highlighted and Communicated ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8

Similar threads

Top Bottom