Can Exclusions be Made in QMS Manual - We make NO implantable devices

[qualitygoddess]

If our company only does a little medical device business, and none of it includes implantable devices, can I exclude this in the quality systems manual? We want to register to ISO 13485 and ISO 9001. Would I write an exclusionary statement, similar to what I would do for ISO 9001?

--Jodi

[Al Rosen]

Originally Posted by qualitygoddess

If our company only does a little medical device business, and none of it includes implantable devices, can I exclude this in the quality systems manual? We want to register to ISO 13485 and ISO 9001. Would I write an exclusionary statement, similar to what I would do for ISO 9001?

--Jodi

Yes, in your QM Scope. Refer to ISO 13485:2003 1.2 & 4.2.2(a)

From 1.2 Application

If any requirement(s) in Clause 7 of this International Standard is (are) not applicable due to the nature of the
medical device(s) for which the quality management system is applied, the organization does not need to include
such a requirement(s) in its quality management system [see 4.2.2 a)]

4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusion and/or nonapplication (see 1.2),