Template for Vendor (Supplier) Qualification

Hello All,

We have a poor vendor qualification program in place currently. I was wondering if anyone is willing to share their vendor qualification procedure & related questionnaires/ forms that clearly identifies following:

1) Defines type of vendors: Critical/ non-critical, contract manufacturer, contract labs, consultants
2) Have separate qualification procedure for each of them
3) A vendor response assessment form

Any help shall be greatly appreciated.

Thanks,

Re: Template for Vendor (Supplier) Qualification needed

Have you looked here: Supplier Related File Attachments

Examples:
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Re: Template for Vendor (Supplier) Qualification needed

dolly_milly said:

Hello All,

We have a poor vendor qualification program in place currently. I was wondering if anyone is willing to share their vendor qualification procedure & related questionnaires/ forms that clearly identifies following:

1) Defines type of vendors: Critical/ non-critical, contract manufacturer, contract labs, consultants
2) Have separate qualification procedure for each of them
3) A vendor response assessment form

Any help shall be greatly appreciated.

Thanks,

Click to expand...

Hello dolly_milly, Welcome to the cove

There is plenty of material on the subject as Marc has indicated. Since you are new, you may go to the 'post attachment list' at the top or use 'search' button, type your querry and off you go.

You may find two for ready reference here at post #2: Methods for determining Supplier Capacity in various industries

Umang

Re: Template for Vendor (Supplier) Qualification needed

Hello Marc & Umang,

Thank you for the help. However it has many good documents, none of them is very relavant to what I am looking for. I need a questionnaire that pertains to Medical device industry & is in accordance to ISO 13485:2003. Do you have anything specific to share?

Re: Template for Vendor (Supplier) Qualification needed

dolly_milly said:

Hello Marc & Umang,

Thank you for the help. However it has many good documents, none of them is very relavant to what I am looking for. I need a questionnaire that pertains to Medical device industry & is in accordance to ISO 13485:2003. Do you have anything specific to share?

Click to expand...

Dolly, did you ever find anything relative to the ISO 13485 New Supplier Qualification form. I to am looking for that right now. I also need the form to clarify a supplier class, a checkpoint for quality contract and purchase specification criteria.

Thanks,
Tammy

Re: Template for Vendor (Supplier) Qualification needed

Dear Tammy,

No I am still hunting for it !! Let me know if you come across anything.

Thanks,

Re: Template for Vendor (Supplier) Qualification needed

If I may, I would like to challenge your line of thought regarding the need for procedure(s). In accordance with ISO 13485:2003 clause 7.4.1 'the organization shall establish documented procedures to ensure that purchased product conforms to specified purchase requirements". Nowhere in the standard is there a requirement for a documented procedure for suppllier selection, so I am challenging the need for one within your organization.

The standard goes on to say "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." The standard does not require that the criteria is documented, only established. It also further implies that it is up to the organization to establish the criteria in accordance with its particular requirements. Therefore, using a supplier selection or evaluation template from another organization does not necesarily mean that it will meet your organization's needs; it does provide a reference to consider and build on, however.

My suggestion is to establish a cross-functional team and establish your own criteria and methods on how you select and monitor your suppliers, as well as what evidence you (will) retain that you are following your practice. An auditor WILL ask to see such evidence (it is required by the standard) but should not expect to see a documented procedure or instruction.

Re: Template for Vendor (Supplier) Qualification needed

If the company fails to develop a supplier re-evaluation program then what is a true root cause that you can think of.

Re: Template for Vendor (Supplier) Qualification needed

Hello,

I am new to this site and have found it very helpful so far. Thank you.

I too need to figure out and write a procedure on how to qualify our vendors. Does anyone have a procedure they can share related to the pharma/biotech/med device industry?

Thanks!

Re: Template for Vendor (Supplier) Qualification needed

chimie said:

Hello,

I am new to this site and have found it very helpful so far. Thank you.

I too need to figure out and write a procedure on how to qualify our vendors. Does anyone have a procedure they can share related to the pharma/biotech/med device industry?

Thanks!

Click to expand...

Welcome to the Cove

Vendor Qualification Procedure

Supplier Qualification Procedure