Template for Vendor (Supplier) Qualification

E

ENatvig

#21
Re: Template for Vendor (Supplier) Qualification needed

Hello
I am having some issues with Vendor Qualifications as well. Our system for vendor qualifications is rather weak; however, we are a contract medical device manufacturer, so some things apply and many things don't. I'm asking for any advice regarding qualifying our vendors (how do I know if one is critical? what is the best way to rate them? is there a way around a physical audit, or do all critical vendors need a physical audit every two years?)
Any help would be greatly appreciated
Thanks!
 
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J

jtenrec

#22
While most of the posts are concerned with ISO 13485, as a medical device manufacturer, my primary concern is with the FDA.
[FONT=&quot]Sec. 820.50 Purchasing controls. [/FONT]
[FONT=&quot] [/FONT]
[FONT=&quot]Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.[/FONT]
[FONT=&quot](a)Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall:[/FONT]
[FONT=&quot](1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.[/FONT]
[FONT=&quot](2) Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.[/FONT]
[FONT=&quot](3) Establish and maintain records of acceptable suppliers, contractors, and consultants.[/FONT]
[FONT=&quot](b)Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device. Purchasing data shall be approved in accordance with 820.40.[/FONT]
We are ISO 13485 certified, but our legal obligation is to the FDA first. You will find that it generally harmonizes with 13485. Better to get dinged by your ISO auditor than your FDA auditor!
 
M

MBTEX

#23
How do you handle Vendors like Best Buy etc... where you purchase consumer products.
 
Last edited by a moderator:

Ronen E

Problem Solver
Staff member
Moderator
#24
How do you handle Vendors like Best Buy etc... where you purchase consumer products.
What is the context? ISO 13485? Part 820? Other?

The answer usually also depends on what it is you purchase and whether / to what extent it may have an effect on finished device quality.

Cheers,
Ronen.
 

v9991

Trusted Information Resource
#25
How do you handle Vendors like Best Buy etc... where you purchase consumer products.
in addition to what Ronen has said....
procedurally.... we would label them separately as "suppliers" and "manufacturers"; i.e. this distinction should give you specific(s)/clarity of expectations from each one of them.
suppliers:- would require to have terms and conditions with manufacturers viz., Q.Agreement, warranties, + their own QS etc.,
manufacturers :- would need to comply with corresponding requirements as required by category...
hope this is relevant and helps...
 
M

MBTEX

#26
What is the context? ISO 13485? Part 820? Other?

The answer usually also depends on what it is you purchase and whether / to what extent it may have an effect on finished device quality.

Cheers,
Ronen.
Both 820 and ISO 13485.

During one of our previous audit we were told we need to approve all vendors.

Most of the things we purchase from these type vendors do not apply to products we manufacture that fall under 820 regulations, But we try to treat everything the same.
 

Ronen E

Problem Solver
Staff member
Moderator
#27
Thanks for the clarifications.

During one of our previous audit we were told we need to approve all vendors.
All vendors? Even those who supply coffee ingredients for the office? If that was the case, and I was in your shoes, I'd ask the auditor: "Show me the Shall, please."

we try to treat everything the same.
I understand the logic of treating all products the same, whether they are medical devices or not, given that some of them are. Double standard within a facility usually erodes the higher standard rather quickly, ending up with a single standard which is nearer the lower one. However, taking it further to also treat all vendors (for all supplied goods, for all products) the same is IMO a waste of resources and maybe even goes against the regulation intent.

Having said all the above, if your current released SOP says you have to approve ALL vendors, you should follow it until you orderly change it (no matter what the rationale of this requirement was in the first place).

? 820.50
Purchasing controls.
Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements.
(a) Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Each manufacturer shall:
(1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented.
(2) Define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results.
(3) Establish and maintain records of acceptable suppliers, contractors, and consultants.
(b) Purchasing data. Each manufacturer shall establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device. Purchasing data shall be approved in accordance with ? 820.40.
ISO 13485:2003:
7.4 Purchasing
7.4.1 Purchasing process
The organization shall establish documented procedures to ensure that purchased product conforms to specified purchase requirements.
The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.
The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).
(Emphses added)

You have the discretion. All you have to do is formalize the criteria and follow them.

Cheers,
Ronen.
 
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