Regulatory Open Forum

Hello RAPS Team, 

We are class I medical devices manufacturer (self declared) and ISO 13485 certified.

As of now, our ASL, does not have MRO (Maintenance Repair Operation) or Service Provider Suppliers.
Is this correct?

Which clause in ISO Standard or regulations defined criteria, which suppliers should be on ASL.

Note: We are selling products to US, Canada, EU, UK and AUS

Will appreciate your valuable feedback

Dear Anon,

All service providers are required to be on your ASL.  This includes but is not limited to your chosen shipping company, your pest control provider, facility contractors, ISO consultant, distributors, importers etc.

Simply put, your ISO certification requires this along with the FDA QSR.

The definition of a product, 3.15 outlines what a product is.  It is not just a tangible article.  You will clearly see that services is one of the 4 categories of products.  For this reason, any entity who provides you a service must be approved and on your list.

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 16-Apr-2024 19:05
From: Anonymous Member
Subject: Approved Supplier List

This message was posted by a user wishing to remain anonymous

Hello RAPS Team, 

We are class I medical devices manufacturer (self declared) and ISO 13485 certified.

As of now, our ASL, does not have MRO (Maintenance Repair Operation) or Service Provider Suppliers.
Is this correct?

Which clause in ISO Standard or regulations defined criteria, which suppliers should be on ASL.

Note: We are selling products to US, Canada, EU, UK and AUS

Will appreciate your valuable feedback

Hello D Michelle, 

Thanks for your response but do you think, if it's make sense if I ask my SCM team to add those suppliers who provides cleaning services
How about, who provide off the shelf items such as Home depot,
How about, who provide kitchen items such as tea bags, coffee, coffee machine.

Please guide!!!

Dear Anon,

All service providers are required to be on your ASL.  This includes but is not limited to your chosen shipping company, your pest control provider, facility contractors, ISO consultant, distributors, importers etc.

Simply put, your ISO certification requires this along with the FDA QSR.

The definition of a product, 3.15 outlines what a product is.  It is not just a tangible article.  You will clearly see that services is one of the 4 categories of products.  For this reason, any entity who provides you a service must be approved and on your list.

------------------------------
D Michelle Williams
VP - Operations
United States

Original Message:
Sent: 16-Apr-2024 19:05
From: Anonymous Member
Subject: Approved Supplier List

This message was posted by a user wishing to remain anonymous

Hello RAPS Team, 

We are class I medical devices manufacturer (self declared) and ISO 13485 certified.

As of now, our ASL, does not have MRO (Maintenance Repair Operation) or Service Provider Suppliers.
Is this correct?

Which clause in ISO Standard or regulations defined criteria, which suppliers should be on ASL.

Note: We are selling products to US, Canada, EU, UK and AUS

Will appreciate your valuable feedback

Hello RAPS Team, 

We are class I medical devices manufacturer (self declared) and ISO 13485 certified.

As of now, our ASL, does not have MRO (Maintenance Repair Operation) or Service Provider Suppliers.
Is this correct?

Which clause in ISO Standard or regulations defined criteria, which suppliers should be on ASL.

Note: We are selling products to US, Canada, EU, UK and AUS

Will appreciate your valuable feedback

Hi Anon:

Even though 13485 does not require especially an approved supplier list you need to demonstrate that you purchase, components, parts, services advice etc that has an impact on the product or QMS from an approved supplier.  Regardless of the classification of the device, your organizations process determined if a service supplier needs to be approved in your QMS. 

Hello RAPS Team, 

We are class I medical devices manufacturer (self declared) and ISO 13485 certified.

As of now, our ASL, does not have MRO (Maintenance Repair Operation) or Service Provider Suppliers.
Is this correct?

Which clause in ISO Standard or regulations defined criteria, which suppliers should be on ASL.

Note: We are selling products to US, Canada, EU, UK and AUS

Will appreciate your valuable feedback