Can a single supplier fit two or more categories for risk?

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#1
Hello,

We have a supplier we classified as category I (critical) that was our electronics board manufacturer. We have specific audit requirements for our categories I, II and III.
From the single first time buy we overbought. We changed our firmware and used this company to reflash the boards. I no longer use this supplier for the original use of board manufacturing and now we use them mostly for reflashing firmware. The reflashing of boards we do not consider the same risk as manufacturing the boards from scratch.

Question:
Can a single supplier fit two or more categories for risk? I want to argue we dont require an onsite audit of them since we are not using them to make boards and only reflash already made boards.OTOH I want to keep them as class I in case we do eventually order more boards. Should I break the company in half? 1) makes new boards 2) reflashes boards?

What should I do?
 
Elsmar Forum Sponsor

somashekar

Leader
Admin
#2
What ever fits you best.
You are more concerned about your risk and hence your supplier can fit into two or more category, based on your assessment of each type of risk. You therefore apply the controls accordingly.
Make your QMS work for you. Don't be a slave to QMS
 
#3
I would keep them a category I supplier but write a deviation or memo explaining why you will not be auditing them at this time. The supplier should be audited prior to receiving the higher risk parts through.
 
Thread starter Similar threads Forum Replies Date
R Supplier Controls we can place on Single-Source Suppliers ISO 13485:2016 - Medical Device Quality Management Systems 2
Ed Panek Sensitive Supplier Issue - Single source supplier ISO 13485:2016 - Medical Device Quality Management Systems 6
L Single-cell lithium ion battery regulations IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
R Labeling requirements for single use devices Manufacturing and Related Processes 4
renenatasha Single Registration Number (SRN) EU Medical Device Regulations 2
E Sources of every single paragraph of the ISO 9001 standards? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
K Lithium Ion - Single Fault Safe - Deep Discharge IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S DHF/DMR/MDF for a software-only, cloud-based, single-instance device Medical Information Technology, Medical Software and Health Informatics 2
N Is this a single integral drug device combination product EU MDR CE Marking (Conformité Européene) / CB Scheme 1
R CND nomenclature for single use instruments CE Marking (Conformité Européene) / CB Scheme 1
P Violation of CE mark - Re-use of single-use Products CE Marking (Conformité Européene) / CB Scheme 2
M What are the basics of Medical Device Single Audit Program (MDSAP)? ISO 13485:2016 - Medical Device Quality Management Systems 7
D SINGLE FAULT CONDITION, short circuit and open circuit of any component (IEC 60601-1 3.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
shimonv Single lot release for sterile packaging 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
N Where to find Regulations for Reprocessing and Reuse of Single-Use Devices Other Medical Device Related Standards 2
T Single Fault Condition IEC 60601 Clause 8.7.1 shorting Cr/Cl in Patient Applied Part IEC 60601 - Medical Electrical Equipment Safety Standards Series 8
D Partial FAI - AS9102 - One single drawing has 10 part numbers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Sidney Vianna Informational IAF and ILAC Seek Contractor for Establishment of a Single International Organization for Accreditation ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 2
F UDI - Unit of Use and Class I, single-use devices EU Medical Device Regulations 5
A Single use non-sterile syringe used in the oral cavity - Laboratory test advice US Food and Drug Administration (FDA) 7
D How to get EUDAMED Single Registration Number (SRN) EU Medical Device Regulations 19
CycleMike GD&T - Hole pattern - Print (attached) has a single Datum Reference Frame Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
K Does company who manufacture but does not design or carry out clinical trials is responsible for CE marking for single use medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 3
F 2017/745 Article 31 Single Registration Number Medical Device and FDA Regulations and Standards News 5
M Informational EU draft act – Single-use medical devices – safety and performance requirements for reprocessing Medical Device and FDA Regulations and Standards News 0
Q IATF rule for single site - Ingots from scrap metal recycling company IATF 16949 - Automotive Quality Systems Standard 0
R Critical suppliers (Definition of) and MDSAP (Medical Device Single Audit Program) ISO 13485:2016 - Medical Device Quality Management Systems 22
A Touch current in single fault conditions test and earth leakage current in normal conditions test, are they really different tests? IEC 60601 - Medical Electrical Equipment Safety Standards Series 9
T No Defined Shelf Life/Expiration Date - Disposable single-use, non-invasive, non-sterile Other Medical Device Regulations World-Wide 2
F Reprocessing or refurbishing? Single Use Medical Device CE Marking (Conformité Européene) / CB Scheme 0
S How to make Single Sign On (SSO) Comply e-sig requirements? ISO 13485:2016 - Medical Device Quality Management Systems 4
E Sample size for design verification of variable in single use device Design and Development of Products and Processes 20
G Single DFU for multiple medical devices in one box Other Medical Device Regulations World-Wide 0
M Medical Device News Health Canada - Medical Device Single Audit Program (MDSAP) Transition Plan Canada Medical Device Regulations 2
A ISO 2859 Single Sampling - Clarification regarding the sampling table Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
bio_subbu Indian government issues guidance on Grouping Medical Devices in a Single Submission Other Medical Device Regulations World-Wide 1
F Marketing a single medical device with multiple indications Other US Medical Device Regulations 4
G IEC 61010 - Single Fault Condition - Protective Impedance Implementation IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
T Definition Sole source VS. Single Source - Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
Edward Reesor MDSAP (Medical Device Single Audit Program) Costs Canada Medical Device Regulations 7
Mikey324 GR&R - Little to no part to part variation in single part number Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 14
R How many Corrective Action Request can be Issued by DCMA for a single issue? Nonconformance and Corrective Action 2
I Label Expiration Date - Single Use Combination Medical Device EU Medical Device Regulations 2
M What are Single Fault Conditions and how to test - IEC 80601-2-13 Other Medical Device Related Standards 0
M Merge Technical File, DMR, and Device File into a single document? Other Medical Device and Orthopedic Related Topics 3
P Single Use Disposable Dental Syringe - CE Marking Advice EU Medical Device Regulations 4
S IEC 60601-1 - Label Physical Requirements for Disposable (Single Use) Medical Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
E Single Fault Condition Simulation IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N Reliability Testing of a Single-Use (Disposable) Medical Device Reliability Analysis - Predictions, Testing and Standards 4
R Standards Specific to Single Channel ECG Medical Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 1

Similar threads

Top Bottom