MDR requires the NB to perform "tests in order to check that the quality management system"

#1
Hi Everyone,
I have a small question regarding the following requirement from NB during site audit:
[MDR 2017/745 - Annex IX; Chapter I (3.3) pg.148; under QUALITY MANAGEMENT SYSTEM]
"Notified bodies shall periodically, at least once every 12 months, carry out appropriate audits and assessments to make sure that the manufacturer in question applies the approved quality management system and the post- market surveillance plan. Those audits and assessments shall include audits on the premises of the manufacturer and, if appropriate, of the manufacturer's suppliers and/or subcontractors. At the time of such on-site audits, the notified body shall, where necessary, carry out or ask for tests in order to check that the quality management system is working properly. It shall provide the manufacturer with a surveillance audit report and, if a test has been carried out, with a test report."

What can be A TEST of the QMS? (beside of the usual performed review and assessment of the QMS during audit)

Thank you in advance for your answers and help.
Maya
 
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shimonv

Trusted Information Resource
#2
Hi Maya,
The text of MDR like MDD is often ambiguous. I believe that the reference for "tests" here may refer to a physical or laboratory test. In other words, where the notified body is in doubt about the effectiveness of the QMS processes, they can carry out or ask the manufacture to run some tests.

Shimon
 

SKM.Sunil

Involved In Discussions
#4
In my opinion, the term "test" in audits used in addition to than doing some test in labs or so...

In MDR the NB will challenge any procedure maintained under QMS, to show realtime test to that adopted method. It can be anything like
Product quality or
suppliers audit (real time checking how a PO performed as specified)
NB can create a dummy market feedback to check its deployed handling methods
on-line manufacturing verification
or challenging any study/test protocols to demonstrate its correctness.
etc...etc...

for. e.g. - In recent time one of our client was facing a safety audit (ISO 45001 Occupational health and safety)....The Auditors put real fire to check (only knowledge of top management)
1. If all employees are aware of it
2. How quickly the response team working on the event
 
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