Question About Exemptions Allowed in ISO 13485-Registered Service Industry

[GStough]

Hi folks!

I was asked to pose this question and see what the experts here have to say about it, so here goes....

In an ISO 13485:2003-registered company which is a service provider, what elements (if any) of the standard are normally exempted?

If anyone can help, it would most definitely be appreciated!

Thanks...

[Doug Tropf]

7.3 Design and Development possibly.

[GStough]

In Reply to Parent Post by Doug Tropf

7.3 Design and Development possibly.

Thanks, Doug. I guess I should have said "in addition to 7.3 Design and Development..."

Are there any others that you know of?

[Doug Tropf]

In Reply to Parent Post by GStough

Thanks, Doug. I guess I should have said "in addition to 7.3 Design and Development..."

Are there any others that you know of?

1.2.1 of ISO 14969 indicates that "Certain product realization requirements of ISO 13485 can legitimately be omitted in one of two ways: they can be "excluded", or they might be "not applicable". It is important to note, however, that any exclusion or non-applicability should be detailed and justified in the organization's quality manual".

[GStough]

In Reply to Parent Post by Doug Tropf

1.2.1 of ISO 14969 indicates that "Certain product realization requirements of ISO 13485 can legitimately be omitted in one of two ways: they can be "excluded", or they might be "not applicable". It is important to note, however, that any exclusion or non-applicability should be detailed and justified in the organization's quality manual".

Thanks Doug!! This is what was needed. I appreciate your help very much!

[Marc]

In Reply to Parent Post by GStough

are normally exempted?

As an FYI, I think these are typically referred to as exclusions rather than exemptions (in case you do a search).

[Roland Cooke]

See section 1.2 of 13485.

You can only exclude Design & Development, and then only if you are not required to have Design Control for regulatory purposes. For example, a manufacturer whose sole product is an implantable bone screw whose design hasn't changed in 30 years must still cater for design control (i.e. at the very least, the process for how design changes would be made if the need arose).

A service provider may or may not be able to exclude design, depending on what the service to their customers involves.


You can deem other sections of Clause 7 (only) as non-applicable, as long as appropriate justification is documented.

Examples include - active products, implanted products, sterile products, handling of customer-supplied product, etc etc.