Regulatory Open Forum

Applicability depends on whether the assembly of the product is "installation". Neither ISO 13485:2016 nor ISO 9000: 2015 defines the term. Your company needs to decide. (If it were me I would say that simple assembly does not mean installation.)

If assembly means installation, then the clause applies.

The second part is your relationship with the distributor. If they are also your installation supplier, then the distributor needs to create records of each installation and send them to you.

Check your QMS to see if you have defined installation someplace.

Check your distributor agreements and contracts to see if the distributor also performs installation services.

If it were me, I would ensure the QMS says, someplace, "some assembly required does not constitute installation". Then state in your quality manual that clause 7.5.3 is not applicable following clause 4.2.2.a.

Hello Anon,

Yes, it does apply to you as the Manufacturer.  Even if the device is installed by the user, a distributor, or a third-party it is the Manufacturer's responsibility to ensure the installation instructions, installation methods, and installation verification/confirmation is properly applied to the device.  As part of the User Manual (instructions for use or IFU) there are instructions included for assembly, installation, calibration, checking operation, etc., it is the Manufacturer's responsibility to make sure these are clear and a way the user can ensure installation has been performed correctly.  In fact, installation applies to all medical devices which this part of the standard has to encompass a large variety of medical devices - a less complex device like a wound care dressing may be easy to understand whereas installing an x-ray instrument is much more complex.

Applicability depends on whether the assembly of the product is "installation". Neither ISO 13485:2016 nor ISO 9000: 2015 defines the term. Your company needs to decide. (If it were me I would say that simple assembly does not mean installation.)

If assembly means installation, then the clause applies.

The second part is your relationship with the distributor. If they are also your installation supplier, then the distributor needs to create records of each installation and send them to you.

Check your QMS to see if you have defined installation someplace.

Check your distributor agreements and contracts to see if the distributor also performs installation services.

If it were me, I would ensure the QMS says, someplace, "some assembly required does not constitute installation". Then state in your quality manual that clause 7.5.3 is not applicable following clause 4.2.2.a.

Hello Richard, 

Thanks you for detailed response. This would be huge task for us to compliance with this clause as per top management. We are doing all activities except verification of installation. The only way we can do is to request all dealers, therapist to submit the verification form after assembling the product. 
Top management said that, would be very hard to keep track of every single chair.
Note: Few parts we sent our dealers assembled as well but not all.
Like wheels and frames of manual wheel chair are sent them separately in one packaging box. 

Your valuable feedback would be highly appreciated. 

Hello Anon,

Yes, it does apply to you as the Manufacturer.  Even if the device is installed by the user, a distributor, or a third-party it is the Manufacturer's responsibility to ensure the installation instructions, installation methods, and installation verification/confirmation is properly applied to the device.  As part of the User Manual (instructions for use or IFU) there are instructions included for assembly, installation, calibration, checking operation, etc., it is the Manufacturer's responsibility to make sure these are clear and a way the user can ensure installation has been performed correctly.  In fact, installation applies to all medical devices which this part of the standard has to encompass a large variety of medical devices - a less complex device like a wound care dressing may be easy to understand whereas installing an x-ray instrument is much more complex.

Applicability depends on whether the assembly of the product is "installation". Neither ISO 13485:2016 nor ISO 9000: 2015 defines the term. Your company needs to decide. (If it were me I would say that simple assembly does not mean installation.)

If assembly means installation, then the clause applies.

The second part is your relationship with the distributor. If they are also your installation supplier, then the distributor needs to create records of each installation and send them to you.

Check your QMS to see if you have defined installation someplace.

Check your distributor agreements and contracts to see if the distributor also performs installation services.

If it were me, I would ensure the QMS says, someplace, "some assembly required does not constitute installation". Then state in your quality manual that clause 7.5.3 is not applicable following clause 4.2.2.a.

Anon,

There is a bit of a mis-conception with "verification of installation" as well - there is not always a need to have a form completed and sent back to the manufacturer.  This again depends on the type of device, but a "self-install" needs to have the verification or confirmation available to the user.  Think of it as a "self-verification" as well.  In the cases of self-install or assembly by the user, Usability comes into a huge aspect here making sure the users can understand they assembled, put together, verified, calibrated, installed, etc., the device correctly.  This could simply be instructions in the IFU or pictures showing how they can confirm the assembly of the chair has been done correctly (think of an IKEA or Lego instructions).  Depending on the complexity of the device, there may be forms which needs to be completed, but usually this is getting into capital equipment devices such as IVD bench instruments or X-ray instruments.

Hello Richard, 

Thanks you for detailed response. This would be huge task for us to compliance with this clause as per top management. We are doing all activities except verification of installation. The only way we can do is to request all dealers, therapist to submit the verification form after assembling the product. 
Top management said that, would be very hard to keep track of every single chair.
Note: Few parts we sent our dealers assembled as well but not all.
Like wheels and frames of manual wheel chair are sent them separately in one packaging box. 

Your valuable feedback would be highly appreciated. 

Hello Anon,

Yes, it does apply to you as the Manufacturer.  Even if the device is installed by the user, a distributor, or a third-party it is the Manufacturer's responsibility to ensure the installation instructions, installation methods, and installation verification/confirmation is properly applied to the device.  As part of the User Manual (instructions for use or IFU) there are instructions included for assembly, installation, calibration, checking operation, etc., it is the Manufacturer's responsibility to make sure these are clear and a way the user can ensure installation has been performed correctly.  In fact, installation applies to all medical devices which this part of the standard has to encompass a large variety of medical devices - a less complex device like a wound care dressing may be easy to understand whereas installing an x-ray instrument is much more complex.

Applicability depends on whether the assembly of the product is "installation". Neither ISO 13485:2016 nor ISO 9000: 2015 defines the term. Your company needs to decide. (If it were me I would say that simple assembly does not mean installation.)

If assembly means installation, then the clause applies.

The second part is your relationship with the distributor. If they are also your installation supplier, then the distributor needs to create records of each installation and send them to you.

Check your QMS to see if you have defined installation someplace.

Check your distributor agreements and contracts to see if the distributor also performs installation services.

If it were me, I would ensure the QMS says, someplace, "some assembly required does not constitute installation". Then state in your quality manual that clause 7.5.3 is not applicable following clause 4.2.2.a.

Hello Richard, 

Thanks for your prompt response. 

Just consider wheelchairs, and manufacturer sending wheels separately and other parts separately. However, not necessarily all parts are unassembled some parts could be assembled based on packaging box. 
Keeping the above example, 7.5.3 would be applicable to manufacturer. 

Additionally, we can mention in user manual that if device didn't assemble/install properly and not performing function as per intended use, please contact manufacturer. Do you think, by doing this, we are good to go?

The rowdy is, we are doing b2b and thus would be difficult to get verification from user and also hard when you sell almost 50 chairs per day.

Looking forward to hear your valuable feedback. 

Anon,

There is a bit of a mis-conception with "verification of installation" as well - there is not always a need to have a form completed and sent back to the manufacturer.  This again depends on the type of device, but a "self-install" needs to have the verification or confirmation available to the user.  Think of it as a "self-verification" as well.  In the cases of self-install or assembly by the user, Usability comes into a huge aspect here making sure the users can understand they assembled, put together, verified, calibrated, installed, etc., the device correctly.  This could simply be instructions in the IFU or pictures showing how they can confirm the assembly of the chair has been done correctly (think of an IKEA or Lego instructions).  Depending on the complexity of the device, there may be forms which needs to be completed, but usually this is getting into capital equipment devices such as IVD bench instruments or X-ray instruments.

Hello Richard, 

Thanks you for detailed response. This would be huge task for us to compliance with this clause as per top management. We are doing all activities except verification of installation. The only way we can do is to request all dealers, therapist to submit the verification form after assembling the product. 
Top management said that, would be very hard to keep track of every single chair.
Note: Few parts we sent our dealers assembled as well but not all.
Like wheels and frames of manual wheel chair are sent them separately in one packaging box. 

Your valuable feedback would be highly appreciated. 

Hello Anon,

Yes, it does apply to you as the Manufacturer.  Even if the device is installed by the user, a distributor, or a third-party it is the Manufacturer's responsibility to ensure the installation instructions, installation methods, and installation verification/confirmation is properly applied to the device.  As part of the User Manual (instructions for use or IFU) there are instructions included for assembly, installation, calibration, checking operation, etc., it is the Manufacturer's responsibility to make sure these are clear and a way the user can ensure installation has been performed correctly.  In fact, installation applies to all medical devices which this part of the standard has to encompass a large variety of medical devices - a less complex device like a wound care dressing may be easy to understand whereas installing an x-ray instrument is much more complex.

Applicability depends on whether the assembly of the product is "installation". Neither ISO 13485:2016 nor ISO 9000: 2015 defines the term. Your company needs to decide. (If it were me I would say that simple assembly does not mean installation.)

If assembly means installation, then the clause applies.

The second part is your relationship with the distributor. If they are also your installation supplier, then the distributor needs to create records of each installation and send them to you.

Check your QMS to see if you have defined installation someplace.

Check your distributor agreements and contracts to see if the distributor also performs installation services.

If it were me, I would ensure the QMS says, someplace, "some assembly required does not constitute installation". Then state in your quality manual that clause 7.5.3 is not applicable following clause 4.2.2.a.

'Additionally, we can mention in user manual that if device didn't assemble/install properly and not performing function as per intended use, please contact manufacturer. Do you think, by doing this, we are good to go?'

Yes, essentially that is what would be done if there are any difficulties or "verification" could not be confirmed, the user can always reach out to the manufacturer.  Of course as mentioned, there are many things to consider so incorporating usability into the process is a good way to confirm approach.

Hello Richard, 

Thanks for your prompt response. 

Just consider wheelchairs, and manufacturer sending wheels separately and other parts separately. However, not necessarily all parts are unassembled some parts could be assembled based on packaging box. 
Keeping the above example, 7.5.3 would be applicable to manufacturer. 

Additionally, we can mention in user manual that if device didn't assemble/install properly and not performing function as per intended use, please contact manufacturer. Do you think, by doing this, we are good to go?

The rowdy is, we are doing b2b and thus would be difficult to get verification from user and also hard when you sell almost 50 chairs per day.

Looking forward to hear your valuable feedback. 

Anon,

There is a bit of a mis-conception with "verification of installation" as well - there is not always a need to have a form completed and sent back to the manufacturer.  This again depends on the type of device, but a "self-install" needs to have the verification or confirmation available to the user.  Think of it as a "self-verification" as well.  In the cases of self-install or assembly by the user, Usability comes into a huge aspect here making sure the users can understand they assembled, put together, verified, calibrated, installed, etc., the device correctly.  This could simply be instructions in the IFU or pictures showing how they can confirm the assembly of the chair has been done correctly (think of an IKEA or Lego instructions).  Depending on the complexity of the device, there may be forms which needs to be completed, but usually this is getting into capital equipment devices such as IVD bench instruments or X-ray instruments.

Hello Richard, 

Thanks you for detailed response. This would be huge task for us to compliance with this clause as per top management. We are doing all activities except verification of installation. The only way we can do is to request all dealers, therapist to submit the verification form after assembling the product. 
Top management said that, would be very hard to keep track of every single chair.
Note: Few parts we sent our dealers assembled as well but not all.
Like wheels and frames of manual wheel chair are sent them separately in one packaging box. 

Your valuable feedback would be highly appreciated. 

Hello Anon,

Yes, it does apply to you as the Manufacturer.  Even if the device is installed by the user, a distributor, or a third-party it is the Manufacturer's responsibility to ensure the installation instructions, installation methods, and installation verification/confirmation is properly applied to the device.  As part of the User Manual (instructions for use or IFU) there are instructions included for assembly, installation, calibration, checking operation, etc., it is the Manufacturer's responsibility to make sure these are clear and a way the user can ensure installation has been performed correctly.  In fact, installation applies to all medical devices which this part of the standard has to encompass a large variety of medical devices - a less complex device like a wound care dressing may be easy to understand whereas installing an x-ray instrument is much more complex.

Applicability depends on whether the assembly of the product is "installation". Neither ISO 13485:2016 nor ISO 9000: 2015 defines the term. Your company needs to decide. (If it were me I would say that simple assembly does not mean installation.)

If assembly means installation, then the clause applies.

The second part is your relationship with the distributor. If they are also your installation supplier, then the distributor needs to create records of each installation and send them to you.

Check your QMS to see if you have defined installation someplace.

Check your distributor agreements and contracts to see if the distributor also performs installation services.

If it were me, I would ensure the QMS says, someplace, "some assembly required does not constitute installation". Then state in your quality manual that clause 7.5.3 is not applicable following clause 4.2.2.a.