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

Maya Yurista

Registered
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
 

shimonv

Trusted Information Resource
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
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
 

ParisTommy

Starting to get Involved
Hello,

I read the "test" as a traceability test - the QMS ensures the traceability of devices and an obvious test of the QMS would be to ask for a demonstration of the traceability system.

Kind regards
Tom
 

Enghabashy

Quite Involved in Discussions
*The surveillances /un expected visits of the accredit notified body should performed according the regulations , he shall refer to the regulation to perform the tasks according the accredit scope , the regulation could be obligatory European directives & the relevant harmonized STDs. as stated in the regulation
*The notified body is issuing schedule audit plan which may 2 principle tasks " as the regulation requirements also " : 1-verification activities ; products /material tests according Q Management system implemented in the organization; it could be followed by notified body test reports , 2- issuing visit / audit report which summarizing the results & findings " if something found "
*The notified body can review the historical company records as part of management system surveillance audit; the records could be : -the company routine tests & samples results , -the action taken if there's findings , -the process of customers complaints,- the ISO 9001 final report & checking if there's any finding related the products in management system audit reports , ---etc.
*the notified body tests could be made in company premises if there's competent Lab. otherwise he can withdraw samples to perform the test in external competent / accredit Lab. ; the samples could be taken from any location as regulation statements also
 

Tidge

Trusted Information Resource
Consider this a possible admission of a personal defect, but I'm going to need some context to understand why this response is relevant to the OP.

*The surveillances /un expected visits of the accredit notified body should performed according the regulations , he shall refer to the regulation to perform the tasks according the accredit scope , the regulation could be obligatory European directives & the relevant harmonized STDs. as stated in the regulation
*The notified body is issuing schedule audit plan which may 2 principle tasks " as the regulation requirements also " : 1-verification activities ; products /material tests according Q Management system implemented in the organization; it could be followed by notified body test reports , 2- issuing visit / audit report which summarizing the results & findings " if something found "
*The notified body can review the historical company records as part of management system surveillance audit; the records could be : -the company routine tests & samples results , -the action taken if there's findings , -the process of customers complaints,- the ISO 9001 final report & checking if there's any finding related the products in management system audit reports , ---etc.
*the notified body tests could be made in company premises if there's competent Lab. otherwise he can withdraw samples to perform the test in external competent / accredit Lab. ; the samples could be taken from any location as regulation statements also
 

Enghabashy

Quite Involved in Discussions
Quality management system in the company shall cover the routine tests ' as example withdraw samples from each production batch, the above statement is indicating that the notified body can verify the effectiveness of implementation by , where necessary, carry out or ask for tests as the QMS statement also
 

Tidge

Trusted Information Resource
So is the suggestion that, as part of an NB audit of the QMS, that the auditors seize product and send it to a NRTL for testing to demonstrate the QMS is in compliance?
 

Sidney Vianna

Post Responsibly
Leader
Admin
:topic:
.The Auditors put real fire to check

Are you serious? External auditors started a FIRE at the registrant's premises during an ISO 45001 audit? In most countries, that would lead to serious trouble. If the CB auditors were interested in witnessing a drill, something that should be a part of the OHSMS, they should ask for one.

Crazy stuff.
 
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