Supplier Qualification Audit on site or off site?

[zhang126]

Hi,

Is there any regulation say supplier qualification audit must be done on site? For a supplier who has many good certificates, e.g. ISO 13485, is it good enough to have a paper audit in distance to qualify it as our supplier?

[Sidney Vianna]

In Reply to Parent Post by zhang126

For a supplier who has many good certificates, e.g. ISO 13485, is it good enough to have a paper audit in distance to qualify it as our supplier?

A certificate that a quality system is in compliance with a standard, e.g., ISO 13485, should NEVER be the only criteria to qualify a supplier. Provided that the certificate is trustworthy and you can have confidence in it, it can (and should be) used as a COMPONENT of a supplier oversight process. How critical is the supplier? What risks do they represent to you? Have you had any history with them? What is their historical performance? There are many other issues that should be evaluated when selecting and maintaining suppliers.

[Kales Veggie]

In Reply to Parent Post by Sidney Vianna

A certificate that a quality system is in compliance with a standard, e.g., ISO 13485, should NEVER be the only criteria to qualify a supplier. Provided that the certificate is trustworthy and you can have confidence in it, it can (and should be) used as a COMPONENT of a supplier oversight process. How critical is the supplier? What risks do they represent to you? Have you had any history with them? What is their historical performance? There are many other issues that should be evaluated when selecting and maintaining suppliers.

Exactly.

[Ajit Basrur]

In Reply to Parent Post by zhang126

Hi,

Is there any regulation say supplier qualification audit must be done on site? For a supplier who has many good certificates, e.g. ISO 13485, is it good enough to have a paper audit in distance to qualify it as our supplier?

If a supplier has a ISO 13485 cert, he fulfils your basic requirements but auditing that supplier is required to check for other aspects mainly on his technical capabilities. The ISO 13485 is a quality management system and may not reveal his technical competence which is very vital for your product / part, isnt it ?

[rclanzillotto]

To your question Zhang..no there is no such regulation requirirng you to do an on-site evalutation. I agree with the others in that supplier qualification should not be based on ISO 13485 certification alone. However it is an excellent starting point. I personally do not go in and conduct a redundant quality audit but instead zero in in the procedures and processses directly relating to the component i am receiving. Best regards

[brahmaiah - 2010]

In Reply to Parent Post by zhang126

Hi,

Is there any regulation say supplier qualification audit must be done on site? For a supplier who has many good certificates, e.g. ISO 13485, is it good enough to have a paper audit in distance to qualify it as our supplier?

There is no requirement in the standard(ISO 9001) that you should audit your supplier at site.All that is required is you should evaluate your supplier before purchasing as per a documented critaria for approval and records of supplier evaluation shall be available.Read the standard:

"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)".
V.J.Brahmaiah

[Sidney Vianna]

In Reply to Parent Post by brahmaiah

There is no requirement in the standard(ISO 9001)

Please note that this thread was placed in the ISO 13485 Forum. The OP asked about regulatory requirements that would force an organization to physically assess their suppliers "in loco". Regulation examples: USA FDA QSR, EU Medical Device Directive, etc.

[Ajit Basrur]

In Reply to Parent Post by brahmaiah

There is no requirement in the standard(ISO 9001) that you should audit your supplier at site.All that is required is you should evaluate your supplier before purchasing as per a documented critaria for approval and records of supplier evaluation shall be available.Read the standard:

"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)".
V.J.Brahmaiah

The question refers to the suppliers catering to the medical device industry. This is a heavily regulated industry and the requirements of ISO 9001 may not hold valid.