Approved Supplier List ISO 13485

M

MEDQA

#1
Hello to all,

I'm trying to revise our Evaluation of Sub Contractor procedure and the Approved Supplier List for a small ISO 13485 certified company (under 15 people). I found lots of useful info on the subject but am still concerned about my interpretation of what is needed.

The person previously responsible stated that every vendor needs to be referenced on the list.

I would like to exclude general suppliers (defined below) from the documented evaluation process used for Key suppliers affecting product quality. I also question the need to have general suppliers on the Approved list, however I can see a benefit.
The selection, evaluation & monitored performance of general suppliers seems like a reasonable purchasing responsiblity that if needed may include input from other departments but should not need evaluation documentation.

Am I missing something or does this actually make sense? - Thank you.

[FONT=&quot][/FONT]

General Suppliers: Suppliers not affecting product quality which include Office supplies, general factory supplies – tools, safety glasses, janitorial services / supplies, repair parts, etc. from OEM’s of EMS production machinery in use.
Note: We have a clean room and might need to make an exception to include clean room supplies under Key Suppliers?
[FONT=&quot][/FONT]General Suppliers are selected on their anticipated ability to meet price and delivery objectives and
 
Elsmar Forum Sponsor

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#2
This is how we evaluate and maintain the Supplier list. We are an AS9100B/ISO9001:2000 house, so they may not apply to ISO13485. This is what are procedure states:

"Qualified Suppliers are grouped in the following categories:

A. Original Equipment Manufacturers (OEM) that supply the following items:

1. Standard products referencing the manufacturer’s standard part number.

2. Standard products referencing a Specification Control Drawing (SCD).

3. Custom manufactured products referencing a SCD.

B. Distributors and Manufacturer’s Representatives that supply the following items:

1. Standard products referencing an authorized manufacturer’s part number.

2. Standard products referencing a SCD.

3. Raw materials referencing appropriate military and/or standard commercial specifications.

C. Service Providers

1. Outside Processing of manufactured items.

2. Calibration and Testing services

3. Equipment Repair and Servicing.

4. Consulting Services.

5. Building and Maintenance.

Supplier Performance Evaluations will be based upon the following criteria:

1. Consistent Quality as measured and determined by Quality Assurance.

2. Cost competitiveness as measured against purchasing history & other suppliers.

3. On Time delivery as measured against original commitment dates."
 
Last edited:
P

Phil Fields

#3
This is the statement of Scope for our Supplier approval procedure:

The requirements specified herein apply to suppliers that provide a product or service that is used in the development, manufacture, and assessment of XYZ Company products.

Yes we are an ISO 13485 registered company,
Phil
 

Stijloor

Staff member
Super Moderator
#5
Hello - Do you include office supplies etc in your approved supplier list?
You can if you want to, but office supplies do not have a direct impact on the quality of products and services you provide to your customer.

I always say: "Toilet paper and pencils are excluded."

Keep it simple.

Stijloor.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#6
Hello - Do you include office supplies etc in your approved supplier list?
Holly,

That is unnecessary at least in the AS9100/ISO9001:2000 world. If you want to include them then that would be the Company's choice. If the Company decides to add that type of classification, I would place it under Misc Suppliers, but you would need to define which type of suppliers that applies to. But, in my opinion, there is no need to include them in you Approved Vendors.
 
P

Phil Fields

#7
NO! MRO (Maintenance, Repair, Operations) type suppliers are not included in the approved supplier list.

Actually ALL suppliers are maintained on our MPR system, they are all coded to define what type of supplier they are.

A supplier that has an affect on quality (parts/service/consultant) are added to the approved supplier list per the supplier approval procedure

Phil
 
M

MEDQA

#8
Thank you!!

The goal is to keep things simple, and not induce death by paperwork.

13485 is new for all of us involved in this project, the person before me did not seem to understand simple & effective, more so "get it done and deal with it later".

I'm thinking I could really benefit from a class on simplified interpretation of requirements if that even exists.
 
Thread starter Similar threads Forum Replies Date
U Approved Vendor (supplier) List Supplier Quality Assurance and other Supplier Issues 8
D Approved supplier list - Distributors question ISO 13485:2016 - Medical Device Quality Management Systems 6
D Approved supplier list for R&D ISO 13485:2016 - Medical Device Quality Management Systems 5
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
Q AS9120 Vendor of ESD Monitoring Equipment needs to be in the Approved Supplier List? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
gunnyshore Benchmarking: Approved Supplier List for Multiple Sites Supplier Quality Assurance and other Supplier Issues 2
L Do HR consultants need to be on Approved Supplier List? Supplier Quality Assurance and other Supplier Issues 5
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
T Do I need to approve my Registrar and include them in the Approved Supplier List? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D Corrective Action - AS9100 Approved Supplier List Audit Nonconformance Nonconformance and Corrective Action 14
S Trading Company - Evaluating Supplier Performance and Approved Supplier List ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
K Approved Vendor (Supplier) List and Supplier Evaluation Supplier Quality Assurance and other Supplier Issues 16
P Requirements for an Approved Supplier List? No new suppliers in years ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q AS9100 Clause 7.4.1 Purchasing Process and Approved Supplier List Records AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 37
T AVL (Approved Vendor List) Supplier Listing - ISO 13485 Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
N Acceptance of Supplier to AVL (Approved Vendor List) - How long? Supplier Quality Assurance and other Supplier Issues 9
L Approved Supplier List - Customer Approved Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
GStough Approved Supplier List (ASL): Document or Record? Supplier Quality Assurance and other Supplier Issues 29
R Approved Vendor (Supplier) List contain Vendor Evaluation? Supplier Quality Assurance and other Supplier Issues 6
J Approved Supplier List - Required to evaluate every supplier? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
J Required to put original manufacturers on Approved Supplier List? Supplier Quality Assurance and other Supplier Issues 6
I Approved Supplier List - R & D, Capital Equipment ISO 13485:2016 - Medical Device Quality Management Systems 4
I Which Fringe Suppliers to Include in the Approved Supplier List? ISO 13485:2016 - Medical Device Quality Management Systems 11
Z Supplier of Automatic Gaging Systems need to be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 6
B Approved Supplier List for Transportation (Trucking) and other Services IATF 16949 - Automotive Quality Systems Standard 5
ScottK ISO9001 Approved Supplier List format question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
R Approved Supplier List vs. Auctions - One-Time Equipment Buys ISO 13485:2016 - Medical Device Quality Management Systems 8
M Grandfathering suppliers to approved supplier list - Have to send out surveys? Supplier Quality Assurance and other Supplier Issues 11
Q Approved Supplier List - Control in the same way forms and procedures are? Supplier Quality Assurance and other Supplier Issues 5
D Approved Vendor (Supplier) List Issues - Class II medical device maker Supplier Quality Assurance and other Supplier Issues 2
T Our Approved Vendor / Supplier list contains EVERY supplier we currently have Supplier Quality Assurance and other Supplier Issues 15
J Approved Supplier List and Subcontractor Development Supplier Quality Assurance and other Supplier Issues 13
Jane's Should the facility landlord be an approved supplier? Supplier Quality Assurance and other Supplier Issues 12
P Approved Supplier Register and Calibration Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T Do Machine Service Contractors Need to be an Approved Supplier? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Approved Supplier Control Requirements for Outsourced Special Processes Supplier Quality Assurance and other Supplier Issues 4
P Approved Suppliers - ISO 13485 Normal Supplier Qualification Process Requirements ISO 13485:2016 - Medical Device Quality Management Systems 9
D Do Freight Carriers or Transportation Companies need to be an Approved Supplier? Supplier Quality Assurance and other Supplier Issues 14
D Approved Condom-Benzocaine Supplier name - Need Help ISO 13485:2016 - Medical Device Quality Management Systems 6
D What document do you give to your supplier after approved parts? Supplier Quality Assurance and other Supplier Issues 12
C Approved Supplier? When supplier is no longer in business. Supplier Quality Assurance and other Supplier Issues 7
B What happens if we evaluate supplier as not approved and there are no anothers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
V How to become approved supplier by Sikorsky Helicopter? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
R Approved Vendor (Supplier) if Customer Pays Sub-tier Shipping Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D How can a vendor (supplier) with no third party certification be approved? Supplier Quality Assurance and other Supplier Issues 1
Q Do I have to qualify my approved vendor (supplier) status? Supplier Quality Assurance and other Supplier Issues 2
H Approved Supplier Listing - One time purchase? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
C Approved supplier/vendor - How do I approve my Registrar? Supplier Quality Assurance and other Supplier Issues 17

Similar threads

Top Bottom