SBS - The best value in QMS software

Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI)

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#11
M E M O R A N D U M

To:

From:

cc: N/A

Date:

RE: Justification for Supplier Approval Outside standard SOPs (or something like this)

Purpose:

The purpose of this memo is to document the benefits of using this supplier despite not adhering to established predicate standards defined for other suppliers....

Background:

<A background on how you got here and what the history is>

References:

· Risk Management SOP-RISK-001

FDA QSR Reference

· Traceability Matrix, list your documents here

· Design and Development Plan for devices # # #

· ISO 14971:2019 Medical devices – Application of risk management to medical devices.

Methods:

· Test Reports, literature review, etc.

The official opinion of an expert in this subject matter.

That persons resume cv

Justification:

During the design process of your product name, one of the product requirements was that <Explain why this supplier is unique to provide the parts/service to meet customer requirements.>

Explain the risk of not using your normal SOP

Explain how you will mitigate that risk

Explain the duration of time this memo will serve


Conclusion:

Why this is acceptable.
 
Elsmar Forum Sponsor

MDRexpert

Involved In Discussions
#13
Can someone tell me what they are doing specific to GS1?
I am wondering if this is just our company or other people have had similar issue?
 
Thread starter Similar threads Forum Replies Date
was named killer AS9100 Supplier Approval Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
Ajit Basrur Quality Agreement with supplier covering medical devices and consumer requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
R Supplier related drawings and verification of process requirements - Source Inspection AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
E FDA Supplier Labeling Requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
K ISO 9001 Requirements for Raw Material Supplier Assessment and Approval ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
P ISO 9001:2015 Supplier Certification Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
B IATF 16949 Supplier QMS Requirements IATF 16949 - Automotive Quality Systems Standard 3
H Sorting Supplier Requirements - IATF 16949 Cl. 8.4.2.3 IATF 16949 - Automotive Quality Systems Standard 8
A VW Supplier Product Safety Representative (PSB) Responsibilities and Requirements VDA Standards - Germany's Automotive Standards 4
S IATF 16949 Supplier Management - Supplier Tooling Requirements Supplier Quality Assurance and other Supplier Issues 1
B IATF 16949 Cl. 7.1.5.3.2 - External Laboratory Sub-Supplier Requirements IATF 16949 - Automotive Quality Systems Standard 2
P Automotive Supplier PPAP Level Requirements Supplier Quality Assurance and other Supplier Issues 12
I Difference between ASQR (Aerospace Supplier Quality Requirements) and AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 20
A How to Verify Supplier I-9 Forms for ITAR Requirements Other ISO and International Standards and European Regulations 2
S AS9100 Approved Supplier List (ASL) Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
C "Sister Plant" Supplier Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
M ISO 13485 Calibration Supplier Evaluation Requirements question Other ISO and International Standards and European Regulations 2
M Input regarding A9100 Supplier Qualification Requirements Supplier Quality Assurance and other Supplier Issues 8
S Supplier Retained Records Requirements - AS9100 4.2.4 Control of Records AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
A ISO 13485 Supplier Monitoring Minimum Requirements Supplier Quality Assurance and other Supplier Issues 3
C International Supplier Audit (ISO9001:2008 + Manufacturing Requirements) Supplier Quality Assurance and other Supplier Issues 4
D Approved Supplier Control Requirements for Outsourced Special Processes Supplier Quality Assurance and other Supplier Issues 4
E What are Validation Requirements for Vendor (Supplier) Processes Supplier Quality Assurance and other Supplier Issues 5
P Supplier's Agreement to Flowdown Requirements - Unsigned Purchase Orders AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Moncia Supplier Audit Requirements for ISO 22000 - Is a schedule required? Food Safety - ISO 22000, HACCP (21 CFR 120) 5
D Aftermarket Supplier Quality Requirements IATF 16949 - Automotive Quality Systems Standard 6
E Changing Critical Supplier: What are the requirements Other US Medical Device Regulations 8
V Plating Supplier PPAP Revalidation Requirements - A-Coat GM 9984132 Plating Process APQP and PPAP 1
T AS9100 and related AS9102 Supplier First Article Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
C Supplier Management Requirements - AS9100 vs. ISO13485 Supplier Quality Assurance and other Supplier Issues 5
B EN 13980-2002 and EN 80079-34-2011 - 7.4.1.c) Supplier Evaluation Requirements Manufacturing and Related Processes 2
K Gamma Ray Sterilization Quarterly Dose Auditing Supplier Requirements ISO 13485:2016 - Medical Device Quality Management Systems 5
G Auditor Requirements - AS9100 Vendor (Supplier) Audits Quality Manager and Management Related Issues 2
C AS-9100 rev C Clause 4.2.4 - Supplier Records Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
S AS9100 Requirements for Supplier & Subtier Supplier Control Federal Aviation Administration (FAA) Standards and Requirements 4
C Does anyone have the Ford Supplier Requirements Manual (including Q1)? Customer and Company Specific Requirements 2
F AS9100 8.5.2 g - Flowing Down Corrective Action Requirements to a Supplier AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Medical Device/IVD Manufacturer Supplier Requirements - Compliant to ISO 13485?? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
P Requirements for an Approved Supplier List? No new suppliers in years ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D NADCAP Requirements - Supplier Pushdown of Requirement to be Certified AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
K Supplier Performance and Supplier Rating Process - AS9100 Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
P Approved Suppliers - ISO 13485 Normal Supplier Qualification Process Requirements ISO 13485:2016 - Medical Device Quality Management Systems 9
Q Level of PPAP - Bulk Chemicals Supplier Requirements APQP and PPAP 2
Q Supplier Special Process System Assessments - CSR Requirements Customer and Company Specific Requirements 2
F PPAP Material Test Results Requirements - Material Supplier Identification QS-9000 - American Automotive Manufacturers Standard 1
S PPAP Requirements for Submission to our Customers for a New Supplier APQP and PPAP 1
Q Supplier PPAP Requirements - TS 16949 Clause 7.3.6.3 IATF 16949 - Automotive Quality Systems Standard 12
T AVL (Approved Vendor List) Supplier Listing - ISO 13485 Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
T Diversity Vendor (Supplier) Requirements for Tier 1 and 2 Companies Customer and Company Specific Requirements 3
A Product Serialization Supplier Requirements Procedure to Fight Counterfeiting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom