Approved Supplier List ISO 13485

[MEDQA]

If it existed at that time, you could question it......

Sadly, the consultants service in not the only contributor to this living nightmare.

Bit by bit I'm trying to sort out what we needs to happen to satisfy requirements.

My current challenge is management of capa, internal / external. Do we need to verify the effectiveness of supplier c/a the same way we verify internal c/a.

We have no capa software to simplify and various forms and databases. I want to take my ball and go home.

If I had a good working system to view, I would be much better off.

 

[mjmendez1]

I am writing the same procedure. Our company is about 30 people and we now require this procedure because we are hiring a service to translate software and manuals. What have you learned? I found a form on this forum that a company uses to evaluate vendors, but I feel like it is far more complex that we need.

 

[DrM2u]

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.

Someone please enlighten me ... where in ISO 13485:2003 clause 7.4 is stated that an organization shall establish and maintain an Approved Supplier List?!?

MEDQA, maybe you should challenge your organization and anyone else on this ASL requirement. Keep in mind that whatever procedures you might have (documented or not) they are your procedures to control, change and implement as they best fit the organization as long as they meet the requirements of the applicable standards and regulations. You might just eliminate the need for an answer to your original post by eliminating the ALS. Food for thought ... worth today.

 

[mjmendez1]

I think maybe you mean FDA QSR (21 CFR 820) which requires an APL.

 

[DrM2u]

I think maybe you mean FDA QSR (21 CFR 820) which requires an APL.

Could you please quote the exact paragraph of FDA CFR 820 that requires an APL or the equivalent of an Approved Supplier list?

 

[mjmendez1]

Subpart E--Purchasing Controls
Sec. 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.

Subpart E--Purchasing Controls
Sec. 820.50 Purchasing controls.
Here is the link to the text:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

 

[DrM2u]

As I asked before, can you point out where FDA requires that an Approved Supplier List (or its equivalent)? Just highlight it in your quote of the CFR 820.50 above. No unsanctioned interpretations, please.

 

[12stones]

As I asked before, can you point out where FDA requires that an Approved Supplier List (or its equivalent)? Just highlight it in your quote of the CFR 820.50 above. No unsanctioned interpretations, please.

DrM2u is correct in his statement that an ASL is not required per the FDA in 820.50. Nor is it required by ISO 13485. It is a common practice, however, in meeting part of the requirement where companies "define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants" in their ASL as an easy way to point how they're meeting these requirements to an auditor or investigator during an audit or inspection.

Like anything in establishing a QMS, there's many ways to skin this cat. You need to evaluate what's most effective for your organization based on your processes as well as based on the requirements.

 

[mjmendez1]

How do you interpret part 3?

 

[mjmendez1]

Ok, I guess you are correct. When I went looking for the reason for what is common practice, I interpreted part 3 as a requirement for the records of approved vendors that many keep.