MDD 93/42/EEC Checklist during Audit


looking for answers
RONEN E said:
1. Having a requirement for <X> is not the same as a requirement for a written procedure to do <X>. An org can sometimes perfectly do something without having a written procedure for it. Anyone dealing with QMS (for instance, but not only, ISO 9001) is very aware of this difference. It’s considered fine not to have a written procedure for something where the standard (the MDD in this case) doesn’t spell out a requirement for a written procedure.
No you are right, but when your NB asks you to have one what do you do, argue the toss with them and still get a NC?

ronen e said:
2. A change in head count is not a change in the QMS nor in the product range, therefore it should not be required to be reported to the NB.
No but our NB's case was if you double your employees this will have and affect on the structure and effectiveness of your QMS (probably)

ronen e said:
3. Design changes must be reported to the NB only where a Design Examination (see Annex II . 4) was required in the initial conformity assessment, ie where the NB actually reviewed and approved the design in the first place. Hence lower class devices (that don’t require a Design Examination) are exempt from reporting design changes to the NB between audits.

Yes you are right, notifying the NB will depend on which annex you take, take a look at this from BSI (not our NB) (broken link removed)
This gives some good examples of what they look for in changes

The guidance can be found here
and here


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No you are right, but when your NB asks you to have one what do you do, argue the toss with them and still get a NC?

This is rather defeatist...It can certainly be difficult to argue with a notified body, they can be quite stubborn and prescriptive at times, but there are routes to appeal decisions. Pick and chose your battles.

In this circumstance it is relatively simple in your change control procedure to include a requirement to assess whether the NB requires notification (this is a requirement therefore it should be there); if the answer is yes indicate that you will follow the method prescribed by the NB for notification.

This addresses the immediate issue of their expectation you have proceduralised their notification. You can leave it for another time to argue whether your addition of a finance administrator to your headcount of 50 requires a notification of change...In reality I don't believe they will ever raise a NC for this and if they do you will have a very good justification for telling them to take a hike


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Number of emplyee changes audit dates of NBs. Its better to inform NB before planning audits. If your NB miss calculate audit date, its minister of healh require additional audits...
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