Who approves work by the quality engineer?

Hello,
This might be an obvious question to ask but I genuinely would like an answer to this query. I am the quality engineer in a small medical device company comprising three people.
I have produced the ISO 13485:2012 QMS. I am using the system I have produced but is it okay for me for example to generate a change request, implement the change and approve it, signing off and closing out the change request myself.
Thank you.

Sorry to 'answer' your question with questions, but who originally reviewed and approved the QMS? What do your document control procedures say?

I've usually taken the tack that Quality and some Management representative review and approve both the QMS and changes to the QMS.

And you don't see this as a conflict of interest? The standard does not dictate whom within the organization performs these actions, but there should be some sense of checks and balance. A change to the system should be reviewed by those areas that are impacted by the change and approved by a level higher than you (or even higher depending on the nature of the change). If the change is within only your department perhaps it would be wise to have one of your peers review the change and your manager, supervisor, or whomever your "boss" is to approve it. Then it would be alright for you to implement the change. It just seems like you have your hands into too many pockets. Just MHO...

The short answer is more senior management approves their work.

The management system belongs to management. They approve of documents that guide the work of the quality engineer.If these don't have sufficient controls its managements problem.

Thank you all so much for your replies. My gut told me that someone ought to be reviewing my work, however, we are a small start up company and as a result my boss is often off site. I have made changes to my change request procedure indicating that I have authority to make minor changes to documents such as typos however, anything of any significance must be approved and reviewed by top management. I really appreciate all the replies thank you.

Hi,

I have consulted to several companies in similar settings, and my experience shows that "being off site" is not the real problem with getting senior management's attention, to whatever it is they need to attend to. After all, today's technology has essentially removed all barriers off tele-communication / electronic information transfer. Rather, it is a matter of attitude and priorities, on top management's part; which no amount or level of technology can fix (moreover, they often use technology as an escape path!...).

I think it's a bad idea to defer all significant changes sign-off to that time in the future when your boss finally comes home and is relaxed and happy enough to actually scribble a signature on your paper (with or without proper prior review); just as it would be a bad idea to get yourself allocated with overarching approval powers. My recommendation would be to talk this issue out with your boss and come up with a middle way (perhaps make use of peer review?) that would be sensible and sustainable.

Cheers,
Ronen.

Eileen,
Quality management representative (required by ISO13485) may sign all the QMS documents. IF possible, anyone from upper level. I'm wondering how your QMS is working if you sign all the documents? Let me know if you need more help.

regards, Javier

Ronen E said:

Hi,
My recommendation would be to talk this issue out with your boss and come up with a middle way (perhaps make use of peer review?) that would be sensible and sustainable.

Cheers,
Ronen.

Click to expand...

Just to expand on what Rohen has said about peer review. Ideally whoever is accountable for outcomes of the process should be the person who does this review but in very small business like yours this might not be possible.

A good alternative is to get a peer to do if you can because someone else with similar competences will know what to pay attention to and whats important.

If you need to do it yourself used a documented checklist and comment, not tick, each item you review. That way evidence is generated that the review has been done and it has followed a structured process.