Concessions - ISO 13485:2016 requires concession approval from customers

R

Rockdog

#1
Under ISO 13485:2016 it requires concession approval from customers for product dispositioned as "use as is". We supply product that could end up in countless Doctors offices or hospitals. The disposition generally is for some kind of minor cosmetic defect or internal marking deviation.

The issue is that we could send a permission form to all of these customers and never receive a response back because 9 out of 10 do not care or understand what we are requesting. Is their a way to circumvent doing this since we hold design control and the nature of the nonconformity does not effect safety of efficacy of the product?
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Is their a way to circumvent doing this since we hold design control and the nature of the nonconformity does not effect safety of efficacy of the product?
Yes, there is.

Since you have design responsibility and can specify the criteria for cosmetic imperfections and internal markings, make the criteria broader so, these "minor" imperfections are not "rejectable offenses". By doing so, you are not required to "reject and disposition" the product.

Just make sure you are not bypassing any regulatory review.
 

Mark Meer

Trusted Information Resource
#3
...Since you have design responsibility and can specify the criteria for cosmetic imperfections and internal markings, make the criteria broader so, these "minor" imperfections are not "rejectable offenses". By doing so, you are not required to "reject and disposition" the product.
This is a good idea. However, you might want to be careful that such devices, when released, are still somehow identified (in internal records) as having the aesthetic blemishes.
This way, if you start to get complaints in the field that a device is blemished you can sort out whether it happened prior to delivery or not.
 
Thread starter Similar threads Forum Replies Date
B AS NZS 5131 - Procedure on Concessions with focus on Steel Fabrication Document Control Systems, Procedures, Forms and Templates 1
M DHR (Design History Record) Requirements - Concessions Quality Manager and Management Related Issues 12
L The Perfect Engineering Change and Concessions Management System Document Control Systems, Procedures, Forms and Templates 8
J Do auditors make concessions for smaller companies - AS9100 Small Company Questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
J Concessions - Raising a concession untill the BOM (Bill of Materials) is updated Quality Tools, Improvement and Analysis 1
S FDA expectation of Concessions - Changes to a DMR ISO 13485:2016 - Medical Device Quality Management Systems 10
R Ink and Label Shelf Life and Internal Concessions for Expired Stock ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
C Concessions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 3
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
B ISO 17025:2017 risk management Risk Management Principles and Generic Guidelines 0
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet ISO 26262 ISO 26262 - Road vehicles – Functional safety 3
Marc ISO 26262- Road vehicles – Functional safety ISO 26262 - Road vehicles – Functional safety 0
John C. Abnet ISO 26262 IATF 16949 - Automotive Quality Systems Standard 0
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
K PDCA cycle and ISO processes alternative model Quality Management System (QMS) Manuals 14
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
D Which ISO Standard to purchase? ISO 13485:2016 - Medical Device Quality Management Systems 7
V ISO 10360-5: 2020 Gap analysis and Action plan Excel .xls Spreadsheet Templates and Tools 1
Q ISO 9001 - Reseller Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Inventory Listing and ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 3
C ISO 45001 6.1.2.1 Hazard Identification Occupational Health & Safety Management Standards 1
T The difference between ISO 14644-3:2005 and ISO 14644:2019 Other Medical Device Related Standards 2
S Any ISO standards around Artificial Intelligence and Machine Learning? Medical Information Technology, Medical Software and Health Informatics 4
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M ISO 13485:2016 Certification Scope ISO 13485:2016 - Medical Device Quality Management Systems 2
N ISO 9001 - Training business with fewer than 5 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
J Opportunity in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
P ISO 8 classified medical manufacturing room Qualification and Validation (including 21 CFR Part 11) 1
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3

Similar threads

Top Bottom