I work for a pharmaceutical company that is new to devices & ISO. All of our procedures were designed to comply with 21 CFR 211. – I recently initiated some requests to begin evaluating the suppliers for our new medical device product. We have an existing procedure for approving suppliers which begins with sending the suppliers a 13 page “supplier quality system questionnaire”. I looked at the regulations and it seems to me that both ISO and 820 only require that you establish a procedure evaluating and approving suppliers. They don’t require a particular format or any specific questions, so the current questionnaire seems sufficient to me. - However, our internal auditor objected to our use of the existing questionnaire because hasn’t been tailored to medical devices. Does anyone have any thoughts on this? Do I need a device specific questionnaire?

I work for a pharmaceutical company that is new to devices & ISO. All of our procedures were designed to comply with 21 CFR 211. – I recently initiated some requests to begin evaluating the suppliers for our new medical device product. We have an existing procedure for approving suppliers which begins with sending the suppliers a 13 page “supplier quality system questionnaire”. I looked at the regulations and it seems to me that both ISO and 820 only require that you establish a procedure evaluating and approving suppliers. They don’t require a particular format or any specific questions, so the current questionnaire seems sufficient to me. - However, our internal auditor objected to our use of the existing questionnaire because hasn’t been tailored to medical devices. Does anyone have any thoughts on this? Do I need a device specific questionnaire?

In my opinion, definitely No. The IA is incorrect in their assessment. Now I am answering this based upon my knowledge of ISO9001:200x and AS9100x and not an expert in ISO13485, which may require something else.

I work for a pharmaceutical company that is new to devices & ISO. All of our procedures were designed to comply with 21 CFR 211. – I recently initiated some requests to begin evaluating the suppliers for our new medical device product. We have an existing procedure for approving suppliers which begins with sending the suppliers a 13 page “supplier quality system questionnaire”. I looked at the regulations and it seems to me that both ISO and 820 only require that you establish a procedure evaluating and approving suppliers. They don’t require a particular format or any specific questions, so the current questionnaire seems sufficient to me. - However, our internal auditor objected to our use of the existing questionnaire because hasn’t been tailored to medical devices. Does anyone have any thoughts on this? Do I need a device specific questionnaire?
We have a need to go to a supplier because we cannot or do not want to do that process ourself. Hence your approval of the supplier has to be centered towards what part or process you outsourse from the supplier. What you may assess of that supplier perhaps is how he can meet and supply you what you desire to the required quality and quanity and timely delivery. How he can sustain and continually improve and be able to grow with your future demand plans. His ability to give engineering solutions and be able to handle complaints and corrective actions systamatically....
So what “supplier quality system questionnaire” you mention, does it address all these ? I am sure it cannot be same start to end for all suppliers. Think of it. Your internal auditor seems to be asking you these or similar questions >>>>>>> Is he correct ???
Good luck Jim.
Somashekar
INDIA

I'm not very familiar with the medical devices standard so there may be something unique there that I don't know about.

Generally speaking, whatever questionnair you use, it should be tailored to your use. Are there any questions that are not on the current one that you would like to see asked? You can pass the current one around the purchasing and engineering staff and ask them to red line it with suggestions. Does the current one have questions that you don't need? Then tailor it yourself.

Don't forget that you need to evaluate your suppliers. Filling out a survey is not an evaluation on your part. Someone needs to review the returned survey, and sometimes ask additional questions to make an effective evaluation. Sometimes a D&B report is a good idea to confirm their stability. The survey is just a tool to aid in the evaluation.

Does anyone have any thoughts on this? Do I need a device specific questionnaire?We have had a number of discussions around supplier surveys (questionnaires). My professional experience is that such surveys are, for the most part, meaningless and useless, simply because most suppliers will lie through their teeth, before answering the surveys in a truthful manner, if that casts a shadow about their capability.

In your case, you mentioned that such surveys are just the beginning of the supplier approval process. So, it might not be as critical as for other organizations which solely rely on these questionnaires.

Concerning your question if the surveys should be customized to the type of product your suppliers support you with, yes, it does make sense. However it is not a requirement of the 13485 Standard.

We have had a number of discussions around supplier surveys (questionnaires). My professional experience is that such surveys are, for the most part, meaningless and useless, simply because most suppliers will lie through their teeth, before answering the surveys in a truthful manner, if that casts a shadow about their capability.

In your case, you mentioned that such surveys are just the beginning of the supplier approval process. So, it might not be as critical as for other organizations which solely rely on these questionnaires.

Concerning your question if the surveys should be customized to the type of product your suppliers support you with, yes, it does make sense. However it is not a requirement of the 13485 Standard.
Absolutely... The questionner is only an information gathering method. Going further, Audits at supplier, sample and pilot runs, Third party or external laboratory verifications, and many more such steps need to be done in order to qualify or approve the supplier, the extent of checks and controls being in line with the complexity of the supplied part or process.........

The questionner is only an information gathering method. You would be surprised to find out how many organizations rely solely on a single-page survey to "qualify" a new vendor. Risk management is a foreign concept for them.

All the other value-added steps you listed are non-existent in many, many organizations' supply monitoring processes, because it cost money to perform most of them.

Thanks for all of the feedback! I think the reason that I'm getting frustrated by this situation is that this questionnaire is only our starting point. Our auditor is also going to audit the each site. The questionnaire is only a starting point. Yes, the questionnaire needs to be updated for devices, but the changes seem rather minor to me. - To be honest, I'm running into this type of situation with the entire project. One person says 'Go!' and then the next person says "Stop!".

We have had a number of discussions around supplier surveys (questionnaires). My professional experience is that such surveys are, for the most part, meaningless and useless, simply because most suppliers will lie through their teeth, before answering the surveys in a truthful manner, if that casts a shadow about their capability.

In your case, you mentioned that such surveys are just the beginning of the supplier approval process. So, it might not be as critical as for other organizations which solely rely on these questionnaires.

Concerning your question if the surveys should be customized to the type of product your suppliers support you with, yes, it does make sense. However it is not a requirement of the 13485 Standard.

Absolutely... The questionner is only an information gathering method. Going further, Audits at supplier, sample and pilot runs, Third party or external laboratory verifications, and many more such steps need to be done in order to qualify or approve the supplier, the extent of checks and controls being in line with the complexity of the supplied part or process.........

You would be surprised to find out how many organizations rely solely on a single-page survey to "qualify" a new vendor. Risk management is a foreign concept for them.

All the other value-added steps you listed are non-existent in many, many organizations' supply monitoring processes, because it cost money to perform most of them.
Wow! I am surprised you believe so many suppliers lie and cheat on the surveys.

My suspicion (anecdotal - no hard documentation) is customers send out these surveys like junk mail to dozens of prospective suppliers BEFORE establishing a more discriminating selection process than sending a questionnaire to every supplier for the product or service who happens to have a listing in the Thomas Register.

I also suspect suppliers who fib on the questionnaire are aware the customer does absolutely zero followup to confirm the answers.

It is probably beyond the scope of this thread (:topic:) to point out a 13 page questionnaire is way too long for most suppliers and not nearly long enough for a select few suppliers. (As a supplier, I NEVER filled out such a questionnaire until I had a long talk with an official at such customer which satisfied me the questionnaire was a real step to getting actual business, rather than the dubious honor of being an "approved" supplier, but getting no business. Most times, after such talk, the questionnaire found its way into the round file where we stored paper for recycling.)

Regardless of my opinion or anyone else's on the worth and efficacy of a 13 page questionnaire, I agree ISO 13485 does not specifically address the issue of "how" an organization should go about the approval process of suppliers. That said, however, I also suspect the auditor had severe misgivings about the followup to such a questionnaire and did not see documented evidence the questionnaire and any answers on it (whether true facts or outright lies by the supplier) had any probative value in establishing the relative worth of a supplier to the customer's supply chain.

Thanks for all of the feedback! I think the reason that I'm getting frustrated by this situation is that this questionnaire is only our starting point. Our auditor is also going to audit the each site. The questionnaire is only a starting point. Yes, the questionnaire needs to be updated for devices, but the changes seem rather minor to me. - To be honest, I'm running into this type of situation with the entire project. One person says 'Go!' and then the next person says "Stop!".
Jim, You actually need to GO >> STOP >> CHECK >> CORRECT >> GO >> and so on.... That is the great PDCA cycle on the basis of which the quality management system is made.
Good luck ...

Thanks for all of the feedback! I think the reason that I'm getting frustrated by this situation is that this questionnaire is only our starting point. Our auditor is also going to audit the each site. The questionnaire is only a starting point. Yes, the questionnaire needs to be updated for devices, but the changes seem rather minor to me. - To be honest, I'm running into this type of situation with the entire project. One person says 'Go!' and then the next person says "Stop!".

Perhaps something to consider adding if it isn't already on the questionnaire is "Is your company registered to an ISO standard? If so, which one?" (ask for a copy), and also "Is your company registered with the FDA?". These are a couple of the questions I have seen on supplier evaluation surveys.

Good luck, Jim! :bigwave:

I agree completely with Sidney.

You won't learn anything of value on the questionnaires you get back. Don't waste your time with them.

Perhaps something to consider adding if it isn't already on the questionnaire is "Is your company registered to an ISO standard? If so, which one?" (ask for a copy), and also "Is your company registered with the FDA?". These are a couple of the questions I have seen on supplier evaluation surveys.

Good luck, Jim! :bigwave:
I think FDA registration is meaningful. ISO 17025 registration is meaningful.

You should never base a purchasing decision on ISO 9001 registration. If I were in a quality management position today, I wouldn't even ask about it.