Acquisitions and Joint Ventures (Business Development Department) and ISO 13485

[sriramsl]

Dear Experts
There is a debate going on in our company whether the function that is responsible for Acquisition of companies and Joint venture (we call this as Business Development department) needs to come under ISO 13485.

I am of the opinion that on either of the case (Acquisition or JV) we acquire products to sell to our customers and hence will need to be part of the Product Realisation process (Clause 7 of 13485). But I am unable to point the specific clause to link to this activity.

Am I right? can you help me advance this argument with the interpretation of the standard
Thanks
Regards
Sriram

 

[Marcelo]

Re: Acquisition and JV

Formally, the organization applying the standard defines what is under the scope of the QMS (or not). This is why it's possible to have an organization that deals with multiple subjects (for example, medical devices and consumer devices) to exclude the part that is not related to ISO 13485 (or any other QMS standard they are applying) from the ISO 13485 QMS. But if you are certified, the certification body will also have an opinion on this, probably.

In principle, product realization is only related to the manufacturing of product (it's the old "factory floor"concept) and processes that enable the manufacturing of the product, until installation, if that's the case.

If the process you mentioned is not related to the general idea of "manufacturing of the product", I would not include it under product realization.

Again, this does not mean that tit may not be part of the ISO 13485 QMS. AS I mentioned above, if you want to include it, you simply do.

 

[Sarah Stec]

IME, the business departments that handle M&A aren't covered by ISO 13485 for those M&A activities. M&A is specifically a business function, and not one that would affect the medical device manufacturing process per se.

However, the due diligence the company does in advance of the actual merger or acquisition would (or should) cover the acquired company's quality system, their products, any issues with their products, etc. This review also wouldn't come under ISO 13485, as it's mostly a legal/regulatory function as opposed to a manufacturing function. However, the output from this due diligence review would help you assess (a) whether you would want to bring the company and their products into your QMS, (b) how you would do it, and (c) what you need to do to get the products in line with your requirements.

 

[Access2hc]

Hi there,

if your organisation is certified to ISO13485 and solely manufacture and market medical devices, then ANY department would need to have:

- documented procedures to guide them on the way to run the business (department)
- training to ensure competence

please read clause 0,1, 4, 5 in ISO13485:2016 to help you.

and just to throw an example to the mix. If the M&A department (outsourced or otherwise) FAILS to cover all aspects of the due diligence process either by exclsuion or by lack of competency, is putting the organisation at business/quality compliance risk if the acquired organisation has business/quality compliance gaps that are not adequately judged to be resolvable in a timely manner, and integrates this acquired organisation, it places the ENTIRE organisation at risk of non-compliance. Seen it happen in real life.

hope it helps

Cheers,
Ee Bin
Access2hc