ASL requirement when the supplier is certified for ISO 13485

akp060

Involved In Discussions
#1
Hi All,

Someone told me that you don't require to list a supplier who is compliant with ISO 13485 and certified for that matter. I would like to request some opinions here, as there no such interpretation from the standard
 
Elsmar Forum Sponsor

shimonv

Trusted Information Resource
#2
You need to control the lis of your suppliers and there is really no exception. Having an ISO 13485 does not mean that you are immune from errors.
 

John Broomfield

Staff member
Super Moderator
#3
Your supplier selection and re-selection criteria have to be effective.

Blaming a certification scheme is not going to be accepted by any competent auditor, let alone your customers.
 
Thread starter Similar threads Forum Replies Date
briteme4 ASL - AS9100 / Supplier Survey Supplier Quality Assurance and other Supplier Issues 3
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N ASL Question for GitHub ISO 13485:2016 - Medical Device Quality Management Systems 7
D Licensee as a Supplier on the ASL Medical Device and FDA Regulations and Standards News 10
C ASL - Buying from unqualified manufacturers through qualified distributors Supplier Quality Assurance and other Supplier Issues 2
S Companies that maintain your machine should be in ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
F Which Business Function should Approve Suppliers and maintain the ASL Supplier Quality Assurance and other Supplier Issues 8
B Before new supplier register into ASL ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
GStough When Is It OK to Remove a Defunct Supplier From the AVL/ASL? Supplier Quality Assurance and other Supplier Issues 15
D Is a separate spreadsheet required for the ASL (Approved Supplier List)? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S AS9100 Approved Supplier List (ASL) Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
S Is it acceptable to have an ASL for Critical suppliers alone? Supplier Quality Assurance and other Supplier Issues 4
M Why do I have to rev change my ASL everytime I add or remove a supplier? Quality Manager and Management Related Issues 6
L Approving myself as a Supplier - Should we be on our own ASL AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
GStough Approved Supplier List (ASL): Document or Record? Supplier Quality Assurance and other Supplier Issues 29
S Biocompatibility requirement for electrode adapters Other Medical Device Related Standards 1
briteme4 AS9102 FAIR Requirement AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
B Put on escalation by customer? is there a requirement to notify registrar? IATF 16949 - Automotive Quality Systems Standard 6
E Translation requirement labels EU Medical Device Regulations 4
Ed Panek Does this FDA Requirement Apply to international (not USA) distributors for USA based manufacturing companies? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
A MDR requirement where unit of use packaging is too small for UDI carrier EU Medical Device Regulations 1
C Requirement for Revision of Standard in all Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K ROHs compliance requirement REACH and RoHS Conversations 1
E Language requirement DoC EU Medical Device Regulations 3
I QMS monitoring, measurement, analysis and evaluation requirement - Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
J Requirement for Signature on Document Document Control Systems, Procedures, Forms and Templates 11
C Non-sterile reusable surgical instruments - FDA sterilization requirement Other Medical Device Related Standards 2
L Water requirement for Non-sterile topical OTCs Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
B FDA requirement for CAPA Signoff ISO 13485:2016 - Medical Device Quality Management Systems 6
W Pfmea function requirement and failure mode FMEA and Control Plans 6
Y 510k requirement for bringing in gloves Medical Device and FDA Regulations and Standards News 0
S PSUR - MDR First Submission Requirement? EU Medical Device Regulations 8
J When PPAPs are not a contractual requirement APQP and PPAP 9
I Overwhelmed with attribute MSA requirement for visual inspection IATF 16949 - Automotive Quality Systems Standard 8
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P Clinical Trial Requirement - No equivalent devices in the market CE Marking (Conformité Européene) / CB Scheme 3
J Requirement for Retention of Records of Withdrawn Documents of External Origin Document Control Systems, Procedures, Forms and Templates 3
T ISO 17025: Lockout/Tagout Requirement ISO 17025 related Discussions 1
A The requirement of the PMS plan--suitable indicators and threshold values EU Medical Device Regulations 0
S Battery powered device - electrical protection requirement IEC 60601 - Medical Electrical Equipment Safety Standards Series 18
K Regulatory requirement of SaMD with machine learning component IEC 62304 - Medical Device Software Life Cycle Processes 3
P Regulatory or registration requirement for disinfectant in ASEAN Registrars and Notified Bodies 1
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
D ISO 14971:2019 vs MDR Annex 1, Requirement #4 - "Manufacturers shall inform users of any residual risks" ISO 14971 - Medical Device Risk Management 5
B IATF16949 audit requirement - Auditor request UCL and LCL must be show Xbar-R, IATF 16949 - Automotive Quality Systems Standard 7
J 21 CFR 821 Medical Device Tracking Requirement 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J Is Device Tracking Card an actual requirement under FDA regulation? Other US Medical Device Regulations 0
W Misinterpretation of requirement acceptable as root cause? Problem Solving, Root Cause Fault and Failure Analysis 19

Similar threads

Top Bottom