What portions of 13485 and the quality system in general must be followed by a company that is utilizing a contract manufacturer for manufacturing and distribution and has a contract engineering firm that has conducted all design and development for the products. Is Section 7 applicable if the engineering and contract manufacturing contractors are doing the work?

Essentially, the company is a sales group that wants to hold the CE mark as well. Management Review is conducted and the company is involved in the design review as well.

Thanks,

Here I Am

As a consultant, I have dealt with several "virtual manufacturers." The easiest way to deal with this situation is to outsource it to a certified ISO 13485 company. The registrar will probably want to visit the contract maniufacturer and enjgineering firm to ensure that the controls meet the ISO 13485 requirements.


Also, as part of the internal audit process, you should be auditing these key suppliers.

Your QMS cannot exclude the manufacturing or engineering clauses.

Danny

Danny has clarified it very well.

Clauses 7.1 & 7.2 can not be excluded. Though you outsourced your design, you can not exlude it, since design input and design review might involve your organization necessarily. All your outsourced processes/vendors are to be evaluated and approved in accordance with clause 7.4. Clauses 7.5 and 7.6 - though your organization doesn't involve in manufacturing, but the device master record will be provided by you, you need to play monitoring & control role of 7.5 and 7.6. In my opinion, you shall not exclude anything from clause 7.0

AG Kumar

I understand that you can not omit Section 7. But how much can you write into your quality system and your SOPs besides that we are involved with the review and approval of design and that all vendors including contract enginnerring and manufacturing vendors are audited and monitored in accordance with the vendor management SOP?

I am having difficulty writing some of the SOPs considering the company is essentially approving design and doing distribution activies. How much information needs to be present for things such as purchasing controls since the company is only purchasing services, handling and storage since contractors are doing those activies?

Thanks for the responses.

What portions of 13485 and the quality system in general must be followed by a company that is utilizing a contract manufacturer for manufacturing and distribution and has a contract engineering firm that has conducted all design and development for the products. Is Section 7 applicable if the engineering and contract manufacturing contractors are doing the work?

Essentially, the company is a sales group that wants to hold the CE mark as well. Management Review is conducted and the company is involved in the design review as well.



In addition to previous responses, your contract(s) with your engineering and manufacturing contractors must reflect your responsibilities and the responsibilitites of your subs under section 7. Look here for possible solutions: