Medical Device Component Suppliers - Require ISO 13485 system?

[Cathy]

I know supplier quality and qualification can be talked about through the main body of the Cove, but I would like to talk about suppliers of Medical Device components. I am in the process of improving our supplier quality end of the business and I would like input from other covers on how they handle their suppliers.

Because the majority of suppliers do not supply a finish MD we do not always ask for a quality system and to date this has worked well. Majority of our suppliers are v. quality focused.
Does anyone ask for the supplier to have an ISO13485 system and if so do you see this as a signifcant benefit to your business?

[Aaron Lupo]

Cathy-

Good question. The company I work for is not a supplier of components of medical devices but services (laboratory testing, sterilization and assembly and packaging). We do not require any of our suppliers to have ISO certification we recommend it but do not require it. What we will do is assess their current system by asking them to complete a questionnaire and based on the response we receive back we will determine if we need to perform an on-site audit or not. We already perform 100% inspection of the materials we do order and if we see a problem developing the supplier will be notified and we will request a formal response. Do I think we would see any benefits by requiring our suppliers to be ISO 13485 certified not likely most of our suppliers already have to follow FDA requirements and those that don’t have a clear understanding of what we will be using the materials for. JMHO

[Kevin Mader]

Cathy,

I'm in agreement with ISO GUY.

My advice, always keep it simple. Unless there is a prescriptive requirement to include something (i.e. mandated Quality Management System), only make it a requirement if you think that there is general benefit in doing so. Also, when making this consideration, think holistically about the benefit (does it suit you, the supplier, the customer, the rest...).

Making a QMS mandate for your supplier may actually work against you (resources are now thinned down to take on the ISO requirements while attention to quality is replaced thus allowing quality levels to slip). Give it good thought.

Regards,

Kevin

[ISO MAN]

Cathy
the company I work for is a manufacturere of MD and we are certified ISO 9001, 13485 and MDD. We never asked our suppliers to have an ISO1385, however we ask them to forward test certificate with the details of the sampling plans and the AQL they use. hence we keep an eye on the items we recive. Also we conduct an interview with the supplier to determine the acceptance of the supplier.

ISOGUY,
can you share the questionare you use it since I think it is a good idea I can try to use it.

[wrodnigg]

Hello Cathy,

I do not see a requirement for a certification of a supplier, but "it helps".

I implemented a system which is based on the criticality of materials. Incoming goods are defined as major/minor/non critical.

For non critical goods we set the qualification to "supplier in good standings".

For minor critical goods the supplier should have some kind of QMS, and for critical goods the supplier should have a certified QMS.

I write "should", because if the quality of the goods is o.k. and the supplier-audits were too, this is also acceptable.

A supplier wtih a certified QMS can reduce your efforts to incoming inspections, if you have established quality agreements with your suppliers (e.g. AQL contracts)

regards~ghw

[Wicker]

Cathy,
We do not require our suppliers to have ISO certification, however each new supplier (contractor or material) are required to complete a survey regarding their quality system. Each quarter a supplier evaluation form is completed by us so we understand if our suppliers are meeting our expectations. We also do on-site audits for our more critical suppliers.

I'm fairly new in the quality aspect of the business but have been asked to evaluate all our parts and suppliers to simplify our inspection process and to form more of a partnership with our suppliers. This is really difficult when working with medical devices. I've been trying to get parts dock-to-stock but when it comes to the critical components it's difficult to turn off inspection regardless of the supplier's track record. So I've started working with one of our suppliers to get their inspection process in line with ours so we feel more confident that they can consistently provide us with good parts.

[liuyy]

Cathy,
The result is what you really want.Don't worry about the certification of ISO 9001 or ISO 13485 of suppliers,unless it is required by regulations.

[wrodnigg]

Within "CE-regulations" it is not required.