Reference to an archived template in multiple SOPs

MDRepair Canada

Starting to get Involved
#1
Hi all,
I have a question.
We have decided to archive a non conformance template as we are now recording them directly in our IT system.
Problem is that this form is referenced in multiple SOP or Work instructions.
It will take some time for me to update all the documents where is it referenced.
We will be audited by an external auditor in few weeks. Will it be a non conformity if all documents are not updated that day?
There is an action planned to update those.

Thanks in advance for your help!
Regards,
MD
 
Elsmar Forum Sponsor

yodon

Leader
Super Moderator
#2
Who knows what an auditor will write you up for! :) It probably would be if there was evidence someone used the old form after the switch-over date. (So you should have a well-defined switch-over date!)

This ties directly to 13485 5.4.2(b) (maintaining the integrity of the QMS). You say you already have a plan (good!) and that's certainly helpful. Be sure to show that you're sticking to your plan.

I suggest you also establish a plan and take actions necessary to ensure that after the switch-over date, there's no possibility for using the old form. This probably involves some bit of training and communications. Again, be prepared to show what those actions were and how they are successful in ensuring no missteps.
 

MDRepair Canada

Starting to get Involved
#3
Thanks a lot @yodon for your answer. It helps a lot.
i am the only one using this template so probability that someone is using the wrong one if very low. I will show my plan et cross fingers the auditor doesn’t have anything to say about that :)
 
Thread starter Similar threads Forum Replies Date
I Hold Time studies for Primary Reference standards Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
E 510k reference devices US Food and Drug Administration (FDA) 4
G Seeking reference guides/ documentation /tips on verification best practices Other Medical Device Related Standards 6
B Qualifying a reference analyzer 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
E MSA Reference Manual 2nd Edition Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
R Statistical Methods for comparing test and reference product equivalence for quality attributes US Food and Drug Administration (FDA) 3
K COPLANARITY: Composite profile tolerance on multiple surfaces- what does" lower dimensional reference frame tolerance" control? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
C KAPPA index Reference Value for Visual inspection IATF 16949 - Automotive Quality Systems Standard 1
G GD&T applied to reference dimension. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
C IVD Metrological traceability without a reference measurement procedure General Measurement Device and Calibration Topics 11
M Reference part calibration or verification General Measurement Device and Calibration Topics 12
G Need journal and reference of abnormal bar chart SPC Statistical Analysis Tools, Techniques and SPC 4
W Do Reference materials for IATF need to be 17025? IATF 16949 - Automotive Quality Systems Standard 15
W What is okay to use as a reference material for ISO 17025? ISO 17025 related Discussions 4
M SOPs - Reference Documents Section Document Control Systems, Procedures, Forms and Templates 4
B Reference to IEC 60950-1 in Amendment 2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Question on equipment - when to use reference only or research only stickers ISO 13485:2016 - Medical Device Quality Management Systems 5
J Marking "Distributed By" to product with distributors' reference-code EU Medical Device Regulations 3
Dazza 9001, 14001 and 45001 mandatory documents and records cross reference matrix Process Maps, Process Mapping and Turtle Diagrams 2
T CSE 5.01 reference on drawing Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
N IEC 60601-1-1 - Stress test, reference voltage IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
CycleMike GD&T - Hole pattern - Print (attached) has a single Datum Reference Frame Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
J Sample size for creating a data base as a reference to a tested variable Other Medical Device and Orthopedic Related Topics 6
R ASQ reference material clarification - Spiral bound materials allowed in ASQ Exam? Professional Certifications and Degrees 1
D Good Acceptance Activity/Inspection flowchart for reference - Wanted Please Process Maps, Process Mapping and Turtle Diagrams 2
G Customer complaint over a Reference Dimension Manufacturing and Related Processes 9
G Measure 3 times, for calibration report? Customer Owned Reference Standard General Measurement Device and Calibration Topics 4
I Data Backup Plan - Document Reference ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q How to efficiently and compliantly reference external standards/regulations Other Medical Device Related Standards 2
S Lot assignment for secondary reference standard - Pharmaceuticals Manufacturing and Related Processes 0
V Inspection with 3D Scanning - Reference Data Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
E Ethylene Oxide Sterilization Validation-Reference Load Other Medical Device Related Standards 8
C Must your reference standard provider be ISO17034 certified to meet your testing lab's ISO 17025 certification requirements? Other ISO and International Standards and European Regulations 2
C Do Calibration Reference Standards require an MSA study? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
J Purpose of Reference Section in SOPs Document Control Systems, Procedures, Forms and Templates 6
M Quality Policy - Standards and reference numbers ISO 13485:2016 - Medical Device Quality Management Systems 14
M Reference to IATF 16949 clause 8.4.3 in clause 8.3.4.4, Is it right? IATF 16949 - Automotive Quality Systems Standard 1
S Reference calibration tools (traceable to NIST) that are not used in production ISO 13485:2016 - Medical Device Quality Management Systems 4
S Contract Manufacturer Question - Whether or not the reference to the ex-CMO ISO 13485:2016 - Medical Device Quality Management Systems 6
B Need to convert Reference Only M&TE to a calibration schedule General Measurement Device and Calibration Topics 3
M Looking for Cross reference of AS9100:2016 to ISO13485 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
E Print only has Reference Dimensions Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
V QMS / QSR - Reference to Framework - Templates - Procedures for Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
R How to Cross-Reference Controlled Documents Document Control Systems, Procedures, Forms and Templates 3
E IEC 60601-2-25 Reference to 60601-1 2nd Edition IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
D Visual Inspection with No Visual Reference General Measurement Device and Calibration Topics 2
M AS9100 Rev. D - Can anyone recommend a good reference book? Book, Video, Blog and Web Site Reviews and Recommendations 7
B When to use "For Reference Use Only" on documentation Document Control Systems, Procedures, Forms and Templates 4
G BCARs/EASA to ISO9001/AS9100 cross reference matrix/table wanted EASA and JAA Aviation Standards and Requirements 1
J In the ISO 9001:2008 company, can give reference to sister company also. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom