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supplier, approved suppliers, iso 13485 - medical device qms
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  #1  
Old 22nd October 2008, 11:16 AM
MEDQA MEDQA is offline
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Please Help! Approved Supplier List ISO 13485

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.



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?
General Suppliers are selected on their anticipated ability to meet price and delivery objectives and

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  #2  
Old 22nd October 2008, 12:08 PM
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Re: Approved Supplier List ISO 13485

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."

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Last edited by Coury Ferguson; 22nd October 2008 at 01:58 PM.
Thank You to Coury Ferguson for your informative Post and/or Attachment!
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Old 22nd October 2008, 12:57 PM
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Re: Approved Supplier List ISO 13485

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
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Old 22nd October 2008, 02:19 PM
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Re: Approved Supplier List ISO 13485

Hello - Do you include office supplies etc in your approved supplier list?
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Old 22nd October 2008, 02:23 PM
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Re: Approved Supplier List ISO 13485

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In Reply to Parent Post by HollyP View Post

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.
  #6  
Old 22nd October 2008, 02:23 PM
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Re: Approved Supplier List ISO 13485

Quote:
In Reply to Parent Post by HollyP View Post

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.

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  #7  
Old 22nd October 2008, 02:28 PM
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Re: Approved Supplier List ISO 13485

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
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Old 22nd October 2008, 03:02 PM
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Re: Approved Supplier List ISO 13485

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.
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