Third Party On-Site Servicing - Training Records Requirements

kansascitysteve

Starting to get Involved
#1
We manufacture class II medical suction devices that are fairly large. We received our ISO 13485 certification last fall and are conflicted about required training records for servicing our equipment.

We sell our equipment all over the USA and typically call local plumbers and electricians to go to the site of our equipment to make repairs, as needed. Depending on the service or repair required, we send a service kit to the local plumbing company (complete with step-by-step installation and repair instructions and photos) to go on-site (hospital) to make the repair.

Since we are using typical local plumbers and personnel dispatched to make the repair are usually unknown to us, we are struggling with training records for service personnel.

Are training records required for each repair person (not real practical or even possible) or are we alright if we use a union plumbing company with mutliple years in plumbing experience? Nearly all repairs and services are for basic plumbing and electrical issues (leaks, pumps, etc). Looking for a way to satisfy competency for service personnel who are not our employees, but rather plumbers and electricians.

Any thoughts or advice is greatly appreciated...
 
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kgott

#2
Re: Third Party On-Site Servicing -Training Records

I'd be adding some advise to your data/info sheet about the product for your customers to use only competent persons to repairs to your product.

You have lost virtulally all control of the product now so you need to help your customers manage their competency issue responsibilites.

Its a bit like the car your brought, the manufacturer no longer has control over your car do they? They can only provide guidence, infromation and advise in their owners manual. Its similar situation.
 

kansascitysteve

Starting to get Involved
#3
Re: Third Party On-Site Servicing -Training Records

Its a bit like the car your brought, the manufacturer no longer has control over your car do they? They can only provide guidence, infromation and advise in their owners manual. Its similar situation.
Thanks for the response!


I think the main difference is that the customers who have problems with their equipment call us. We then find a local plumber or electrician in THEIR area and call them ourselves and setup a time they can go and repair the unit for our customer.


While our company may have possibly worked with a specific plumbing company in the past, there is no way of knowing exactly which plumber goes to the service call and repairs the unit.


I agree with your comparison of buying a car if the customer was looking for a local service company themselves, but I am a little concerned since our company is the one locating and calling a service comapny to do the repairs (in warranty and out of warranty).
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
#4
Re: Third Party On-Site Servicing -Training Records

I'd try to keep records on the qualifications of the suppliers that you use (i.e., trade certificates, licences, etc.). I'd also keep track of any information you send out to the suppliers to assist them in their work (i.e., information packages, name of recipient, date sent, etc.)...rather than send every time, however, perhaps an annual issue (or as information is revised) with a record of being sent.
 

harry

Super Moderator
#5
Re: Third Party On-Site Servicing -Training Records

While Automotive manufacturers had no control over you after you bought the car, they require you to send you car to their 'authorize' service centers.

In the same way, you have to exercise control over the plumbers and electricians you use (approved vendors). Limit the numbers to some good ones and conduct a training at their place - say once a year and have it recorded together with the relevant training materials, WIs and so on.
 

kansascitysteve

Starting to get Involved
#6
Re: Third Party On-Site Servicing -Training Records

I appreciate the responses and information. Since we handle service operations for all of our equipment (even 5+ yr old equipment), and use service companies located within a few miles of the hospital, we have 50-75 different service companies in use around the country. This makes it nearly impossible to perform on-site training with each company. I like the idea of documenting certifications and skills of the companies we use, I just wasnt sure if that would meet ISO or FDA trianing and competency requirements.
 
K

kgott

#7
Re: Third Party On-Site Servicing -Training Records

Perhaps you could try sending out a questionaire for sparkies and plumbers you use to complete and return and or perhaps a statement of minimum requirements they must undertake to meet. Perhaps you could request the hospitals to verify the information you might request the tradies to show them before starting the job.

Perhaps you could call for tenders to do this work and qualify them as per section 7.4.1 of 9001.

This may limit your choices of who you can use but whatever you do is a reflection of the assessment of risk to your organisation and the hospitals and criticality of the work your tradies do for the hospitals your products are used in.

If you run into an issuse of competency such as evidence of their competency as in a trade certificate from formal training, focus on the other parts of the definitions of competency in section 6.2.1 of 9001.

If what I've said here hasn't helped you much, advise and I'll see what else I can think of.
 
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