ISO 13485 Sec 7.4 - Supplier Selection, Evaluation and Re-evaluation

Q

qualityrpb

#11
Hello all,

Although I have spent many hours on these forums, this is my first time posting. So let me start by saying that it is truly amazing to have access to such great material from brilliant minds across the world!

And speaking of brilliant, I hope someone out there has the brain power to help me out with an ISO problem. My company is ISO 13485 certified. We just completed an audit, and the auditor found several minor nonconformities. In particular, he noted that "It was observed that the procedure for supplier qualification does not clearly define the criteria for supplier selection, evaluation and re-evaluation as well as what records are maintained to demonstrate conformance." He verbally explained to me that the root of our problem was that we were not qualifying companies who supply basic office materials, including our toilet paper (yes, I specifically asked) which, no doubt, can have a dramatic effect on quality throughout an organization and should be monitored accordingly :sarcasm:.

Based on what I have seen in other posts, many experts would tell this auditor to go back to auditor school and take better notes this time. I would love tell him that, but I need to be able to back up my disagreement with substance based on the ISO 13485 standard itself. And the standard does require our company to evaluate and select suppliers (see section 7.4 of the ISO 13485:2003 text) - granted, the type and extent of control may vary, but there is no clause saying that SOME suppliers require essentially no control.

Even more problematic is the requirement to keep records of supplier evaluations (again, ALL suppliers as far as I can tell) and re-evaluations and any necessary actions. So if I buy toilet paper from Costco, then must I must maintain a record somewhere showing that I evaluated Costco and this supplier met our stringent toilet paper standards? And periodic re-evaluations of the ongoing toilet paper quality? Believe me, I really don't want to write up the product requirements in this case and evaluate them!

Any wisdom or insight experts can offer would be welcome. I would prefer to keep our quality requirements simple so that people will implement them in the places where it really matters. It seems like putting petty items like toilet paper onto the same plane as medical equipment is just begging for the employees to stop taking the quality requirements seriously.
Hi Haisoj,

I have found the same problem but even after reading all the reponses i am still not certain that I have found the answer.

Is there a method to follow when writting the evaluation procedure for approving a supplier. What are the criterias that you use for the determination whether a supplier is approved, Disapproved or conditional?

Thanks
Bob
 
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J

Jason PCSwitches

#12
You can segregate suppliers that provide you with basic supplies (toilet paper) by defining it as such in your procedure.

I don't have a copy of ISO 13485, so I'll use AS9100 (which I'm sure is not much different in this case) instead.

AS states that the organization can define the "type & extent of control applied to the supplier and the purchased product" based upon the effect of that purchased product on "subsequent product realization or the final product". That is the key, while toilet paper is vital, it hardly plays a role in the actual realization process of a given product, unless your making porta-potty's. So it's of no value & unnecessary to qualify Costco or Staples the same way you would a heat treat facility as they probably do not impact the realization process.

So don't over think it, outline something in your procedure to address such suppliers that have no effect on product realization or the final product. You can then define less stringent approval & qualification requirements for them, keeping it general.
 
T

treesei

#13
I agree with Jason. ISO does not cover everything under the roof of a facility. It specifies requirements for a quality management system which an organization needs to have to demonstrate its ability to provide a product and related services that consistently meet customer requriements and regulatory requriements. If the products I purchase from a supplier (Costco toilet paper for example) does not have anything to do with my product or processes I identified as needed for the QMS (ISO 13485 4.1 a)), it is beyond the scope of ISO 13485 and should not be part of any quality audit. It would be wise however to clearly state the scope of supplier quality management in related procedures.
 
Q

qualityrpb

#14
Thank you for your help everyone.

I am trying to write a evaluation procedure and the method to use to evaluate and re-evaluate suppliers. More so the sub-contractors and raw material suppliers. Must I audit a sub-contractor on a periodic basis. Or can I just use past performance as a qualifier for Approval.

I am trying to find a method of recording the approval process without writting down every job that we have received from the.

Can I just say that we will base Approval on the past year overall performance for ontime delivery and quality. And if I did this, do I have to Audit the sub-contractor periodically.

Thanks again
Bob
 
J

Jason PCSwitches

#15
Thank you for your help everyone.

I am trying to write a evaluation procedure and the method to use to evaluate and re-evaluate suppliers. More so the sub-contractors and raw material suppliers. Must I audit a sub-contractor on a periodic basis. Or can I just use past performance as a qualifier for Approval.

I am trying to find a method of recording the approval process without writting down every job that we have received from the.

Can I just say that we will base Approval on the past year overall performance for ontime delivery and quality. And if I did this, do I have to Audit the sub-contractor periodically.

Thanks again
Bob

You define your approval criteria. As long as it is effective you can do it however you want. Just outline the criteria, follow it & keep records of the verification/approval - no worries.

Keep in mind that delivery & quality may not be the only aspects you need to examine. During contract review you need to determine if your customers are flowing down any requirements related to your sub-tiers; for example, they may require certain special processing be carried out by a Nadcap certified facility.
 
T

treesei

#16
Can I just say that we will base Approval on the past year overall performance for ontime delivery and quality. And if I did this, do I have to Audit the sub-contractor periodically.
First am I right to define a sub-contractor as a contractor your supplier/contractor uses? If so, your supplier/contractor is fully responsible for managing it. Your involvement depends on the importance and risk of this sub-contractor to you, from relying on your contractor (for example, the process/product is simple and you are completely comfortable with the sub's capability) to deep invlovement including periodical audits (for example, your contractor manufacturer sub-contracts to another manufacturer which has the potential but you are yet fully comfortable with but will use for significant cost reduction).

If the sub-contractor actually is your supplier by definition, then you are fully responsble for it in the eyes of your customer. Do you need to periodically audit it? Again it is a risk-based decision. Set your criteria reasonably and stick to them. You will be fine.
 
H

HaleKimo

#17
Hello. I have followed this thread closely & have a related situation that I would like to present to the group. I ask for and welcome your advice/comments:

My company is ISO 13485 certified (SGS). Our particular site is a Shared Services Center where orders for finished medical devices are processed. We have no manufacturing... no physical distribution (no warehouse, trucks, forklifts, anything), in fact, I have not seen any product that we sell. This is a call center and I work in a Quality/Regulatory support capacity for our sister manufacturers & Distribution Centers in other cities (who follow thier own respective QMSs).

My point--

ISO 13485 has been interpreted here as requiring us to manage our "suppliers" (finished device manufacturers, both affiliated and 3rd party-- who are also 13485 certified, following their own QMSs)

Some basic questions I have are (1) In this situation, does a Shared Services Center need ISO 13485 certification? (I will assume it would be desired even though the scope of our last audit was so narrow), and (2) May I have some advice on an SSC managing (13485 certified) "Suppliers" of finished Medical Devices as part of Product Realization?

Thank you.

Best regards,

HaleKimo
 
M

MIREGMGR

#18
(1) In this situation, does a Shared Services Center need ISO 13485 certification? (I will assume it would be desired even though the scope of our last audit was so narrow)


When a multi-site medical device company is certified by site, my view is that it's good corporate practice to certify all sites, even those that don't design or manufacture products. The alternative in my view would be to combine multiple sites under one management, one QMS and one certification.

In my view, this should be done even when a site such as yours has a narrow scope of activity, if that activity is related to design, production, production-related purchasing, distribution, or customer interactions.

May I have some advice on an SSC managing (13485 certified) "Suppliers" of finished Medical Devices as part of Product Realization?
My view would be that your site, not being involved in production, production-related purchasing or distribution, doesn't have Suppliers of devices. You only have Suppliers of that which you purchase or that otherwise is transferred to your control. As you describe your company, those functions are within the scope of other company sites' QMSs, not yours.

I'd guess that your only regulated activities are related to customer communication including determination of customer requirements, customer feedback, and other aspects of post market surveillance and complaint handling; possibly aspects of traceability; and possibly aspects of installation and service, i.e. planning and coordination.
 
H

HaleKimo

#19
MIREGMGR,

you are right on with your guess of my regulated activities. Especially regarding customer communication and product traceability. I completely agree with your reply to both of my questions as my reason for asking is to learn more in an effort to dissuade my team from interpreting too much into 13485, thereby duplicating activities already being performed by our manufacturers.

I have one other question regarding 13485 7.4.1 through 7.4.3… Are these passages intended for Manufacturers?

I know—it’s a very broad question… replies from anyone in the forum would be helpful.

Thank you.

Best regards,

HaleKimo
 
M

MIREGMGR

#20
All purchasing must be procedurized and documented, but the degree of control required is per the second sentence of 7.4.1. Thus if your site has no discernable effect on product realization, your purchasing activities require the least amount of control.

That might mean, for instance, that your specification for copy paper might be "Staples #1234", and your purchasing procedure might include a blanket statement that all office material specifications allow substitution as determined equivalent by the Office Manager, operational-disposables specs by the Facilities Manager, and so forth.
 
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