Product Realization in a Medical Device Component Manufacturer

[RLDEARMOND]

We are a small (Less than 20 employees) medical device component manufacturer. We do not know what most of what we machine will be used for. Do we need a full product realization system in place to meet the requirements of ISO 13485? We have no idea whether the components are critical or are just a simple component. The owner of our company insists we have a full ISO 13485 system in place with special attention to product realization requirements. I disagree and say the OEM has the ultimate responsibility for product realization as we do not know the function of most of the components we machine. Any insight would be appreciated.

 

[somashekar]

Re: Product Realization

We are a small (Less than 20 employees) medical device component manufacturer.

Why ISO13485 ?
My question stems from word component ?
What is the component ?
Is it a general engineering component that is also used in the medical device ?
Is it more a medical device component like a syring needle or a catheter tube or a blood-bag or bellow used on a patient when connected with a device ?
From what you describe, I get a feeling that you do not need an ISO13485.
You mention about machining....
Perhaps are you into some precision machined parts you make that also gets into medical device ....

 

[Wes Bucey]

Re: Product Realization

We are a small (Less than 20 employees) medical device component manufacturer. We do not know what most of what we machine will be used for. Do we need a full product realization system in place to meet the requirements of ISO 13485? We have no idea whether the components are critical or are just a simple component. The owner of our company insists we have a full IOS 13485 system in place with special attention to product realization requirements. I disagree and say the OEM has the ultimate responsibility for product realization as we do not know the function of most of the components we machine. Any insight would be appreciated.

Depending on your location (country) and the location of your customer, your organization "might" be responsible to maintain full 13485 on everything you make which goes into a medical device.

If the products are made and sold ONLY in the USA, the primary concern is FDA regulations, not ISO 13485.

on another note:
I agree with your organization owner on maintaining full adherence to the 13485 requirements, but primarily as a good business model, not just to fulfill the requirements for a potential audit.

The efficiency and efficacy of a consistent system used throughout the organization versus one only applied if there is a possibility someone is going to audit is apparent to most.

Concentrate on the value of a consistent system rather than whether an auditor will say "Tsk, tsk."

 

[somashekar]

Re: Product Realization

Depending on your location (country) and the location of your customer, your organization "might" be responsible to maintain full 13485 on everything you make which goes into a medical device.

.. ?

The OP is from US of A, and he says that he makes components that are machined and that he is not sure if they are critical or simple components in the device.

This is the Title of ISO13485 just for the recollection :

Medical devices — Quality management systems — Requirements for regulatory purposes
And this is the first general statement under the scope...
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

I agree with Robert in disagreeing with the owner about ISO13485 requirement

When the component use and criticality is unknown to the OP, I believe they are far far from being a medical device manufacturer requiring ISO13485. FDA is not here in the picture.

For me the best is ISO9001., (Unless for whatever reason the customer is demanding an ISO13485 in their QMS)
Certainly not by the fancy wish of the owner.
Product realization is equally covered and must be addressed to the required depth even in the ISO9001...... which can make an excellent business model.

on another note:
I agree with your organization owner on maintaining full adherence to the 13485 requirements, but primarily as a good business model, not just to fulfill the requirements for a potential audit.

ISO13485 has specific requirements and application as can be seen in the beginning pages of the standard. This is not a general standard for a good business model.

 

[mehtagaurav_2004]

Re: Product Realization

I agree with Somashekar..it all depends on the customer requirements....unless you are the OEM all requirements must be coming from the customer and their technical agreements

 

[sagai]

All well said, two more things I would add.

May be I am getting older but I have seen the majority of disagreements are based on the lack of knowledge of the perception of the other party.
For me in general, disagreement is a kind of dead end at the end of the one way road, and has no use at all, no way out.
I would rather prefer to have a chat and find out what has driven her/him to such conclusion and understand her/his goals and in a meanwhile catch the opportunity to influence her/his way of thinking when necessary. It is especially useful when we talking about the owner of the company.

On the other hand ... ISO13485 certification does not stipulate at all that the company is compliant with the standard. It means that the auditor proposed the certificate to be issued for the company, that's all (for me).
I have seen some of those and also have red enough warning letters revealing elementary problems for ISO13485 certified companies.
It is a long subject, but I would suggest to bear in mind the certificate itself could be a fake confidence for the owner.

Cheers!

 

[RLDEARMOND]

Our customers don't require that we be 13485 certified. The owner thinks it's a good marketing tool though. The problem is that we do not have the manpower to support a full 13485 compliant system. Our company is made up of mostly machinists and one inspector. I am the only regulatory person on staff and the task of entertaining both 9001 and 13485 auditors every year is a pain. We also have no engineers on staff so validations of processes are near impossible. The owner insists we inspect 100% of every part. One lot can equal 2000 parts or more meaning that human error will result in a single lot not meeting spec 100% of the time.
The owner has fired 26 employees in the last year because they could not produce 100% perfect parts all the time. Because of the large turnover there are very few employees that have been there for more than 2 years leading to even bigger problems.
Product realization and 13485 just don’t make since as we don’t have the full picture of how the products we machine will be used.

By the way, I am the VP of Quality and Requlatory for this company (for now).

 

[Stijloor]

Our customers don't require that we be 13485 certified. The owner thinks it's a good marketing tool though. The problem is that we do not have the manpower to support a full 13485 compliant system. Our company is made up of mostly machinists and one inspector. I am the only regulatory person on staff and the task of entertaining both 9001 and 13485 auditors every year is a pain. We also have no engineers on staff so validations of processes are near impossible. The owner insists we inspect 100% of every part. One lot can equal 2000 parts or more meaning that human error will result in a single lot not meeting spec 100% of the time.
The owner has fired 26 employees in the last year because they could not produce 100% perfect parts all the time. Because of the large turnover there are very few employees that have been there for more than 2 years leading to even bigger problems.
Product realization and 13485 just don’t make since as we don’t have the full picture of how the products we machine will be used.

By the way, I am the VP of Quality and Requlatory for this company (for now).

Yous boss must read all posts in this thread: "How effective is 100% inspection?"

Amazing that there are still people believing the myth of 100% inspection.

Another thread: http://elsmar.com/Forums/showthread.php?t=3835

 

[Wes Bucey]

Our customers don't require that we be 13485 certified. The owner thinks it's a good marketing tool though. The problem is that we do not have the manpower to support a full 13485 compliant system. Our company is made up of mostly machinists and one inspector. I am the only regulatory person on staff and the task of entertaining both 9001 and 13485 auditors every year is a pain. We also have no engineers on staff so validations of processes are near impossible. The owner insists we inspect 100% of every part. One lot can equal 2000 parts or more meaning that human error will result in a single lot not meeting spec 100% of the time.
The owner has fired 26 employees in the last year because they could not produce 100% perfect parts all the time. Because of the large turnover there are very few employees that have been there for more than 2 years leading to even bigger problems.
Product realization and 13485 just don?t make since as we don?t have the full picture of how the products we machine will be used.

By the way, I am the VP of Quality and Requlatory for this company (for now).

I'm sure you realize the boss needs a reeducation in the modern principles of Quality. No modern practitioner would advocate 100% inspection. In fact, what he really needs is a Dutch Uncle to gently guide him to a more efficient, efficacious business.

Simply stated - you can't inspect in quality; it has to be a part of the production (FMEA, Control Plans, etc. are just parts of a whole - they all need to be present for a smooth functioning manufacturing system.)

 

[Ronen E]

Our customers don't require that we be 13485 certified. The owner thinks it's a good marketing tool though. The problem is that we do not have the manpower to support a full 13485 compliant system. Our company is made up of mostly machinists and one inspector. I am the only regulatory person on staff and the task of entertaining both 9001 and 13485 auditors every year is a pain. We also have no engineers on staff so validations of processes are near impossible. The owner insists we inspect 100% of every part. One lot can equal 2000 parts or more meaning that human error will result in a single lot not meeting spec 100% of the time.
The owner has fired 26 employees in the last year because they could not produce 100% perfect parts all the time. Because of the large turnover there are very few employees that have been there for more than 2 years leading to even bigger problems.
Product realization and 13485 just don?t make since as we don?t have the full picture of how the products we machine will be used.

By the way, I am the VP of Quality and Requlatory for this company (for now).

Sounds baaaaad...

Time to start packing?...