SBS - The best value in QMS software

How is the NB ISO 13485 audit for CE Marking different from regular ISO audit ?

S

SGquality

Quite Involved in Discussions
#1
#1
Pls help me - one of our US site is getting ready for Notified Body EN/ISO 13485 audit.

Can you pls tell me how is this different from a regular ISO 13485 audit not meant for CE marking ?

Thanks !
 
12 questions to ask before buying a QMS
Elsmar Forum Sponsor
M

Marcelo

Inactive Registered Visitor
#2
#2
Notified Bodies in principle do not audit per ISO 13485, they audit the the Directives requirements. On the other hand, they usually sell a service (as an CB) to audit per Iso 13485 to fulfill the QMS requirements of the Directives.

So, it?s important to understand what you are being audited for.

If it?s an ISO 13485 audit by an CB, it will be the same as always.

If really an NB audit, it will focus on the Directives requirements.
 
S

SGquality

Quite Involved in Discussions
#3
#3
Marcelo Antunes said:
Notified Bodies in principle do not audit per ISO 13485, they audit the the Directives requirements. On the other hand, they usually sell a service (as an CB) to audit per Iso 13485 to fulfill the QMS requirements of the Directives.

So, it?s important to understand what you are being audited for.

If it?s an ISO 13485 audit by an CB, it will be the same as always.

If really an NB audit, it will focus on the Directives requirements.
Click to expand...
Thanks Marcelo. Where can I find details on how NB would audit for Directives ?
 
M

Marcelo

Inactive Registered Visitor
#4
#4
On the Directives themselves. They will audit the "route" used for CE Marking. For example, if the route used is a full quality assurance system (might be the case as you mentioned ISO 13485), they will audit per Annex II of the MDD (for example, not sure if that is the directive used)
 
M

Marcelo

Inactive Registered Visitor
#5
#5
Just an addendum - for Europe, you will probably want to use EN harmonized standards (because they give presumption of conformity). Some EN standards have different texts or interpretations in Europe - in the case of EN Iso 13485:2012, it has additional annexes related to the Directives (they don?t change requirements, but link the requirements with the essential requirements from the Directives).
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
F ISO 13485 - EU countries that could request another audit ISO 13485:2016 - Medical Device Quality Management Systems 2
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
B Using external FDA and ISO 13485 audit as internal audit Internal Auditing 6
L ISO 13485:2016 Clause 8.4 - Analysis of Audit Observations ISO 13485:2016 - Medical Device Quality Management Systems 8
M Internal audit consultant ISO 13485 (English speaker) Consultants and Consulting 3
P Dropping ISO 9001 limits the scope of the ISO 13485 audit? ISO 13485:2016 - Medical Device Quality Management Systems 6
E MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP Canada Medical Device Regulations 9
J ISO 13485 Audit Nonconformance written against 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 25
J Training documentation - ISO 13485 audit and the auditor had questions General Auditing Discussions 7
J EU ISO 13485:2016 Recertification Audit - Effect of 10 Minor Nonconformances EU Medical Device Regulations 2
J ISO 13485 Recertification audit extension ISO 13485:2016 - Medical Device Quality Management Systems 1
M Internal Audit Assessment Criteria - ISO 13485:2016 Internal Auditing 21
A ISO-13485 7.1 - Preparing for our MDSAP audit ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485: 2016 Internal Audit - Is sampling on projects allowed? ISO 13485:2016 - Medical Device Quality Management Systems 6
D Where I can find an ISO 13485:2016 Audit Schedule example? ISO 13485:2016 - Medical Device Quality Management Systems 4
L Need HELP with Internal Audit Program ISO 13485.2003 Quality Management System (QMS) Manuals 3
J Internal Audits - Closing Audit Deficiency Reports (ISO 13485) Internal Auditing 4
S EN ISO 13485:2016 vs. ISO 13485:2016 - Unannounced MDD Audit yesterday ISO 13485:2016 - Medical Device Quality Management Systems 4
V Under what circumstances will a Registrar Audit a Company? (ISO 13485 - Canada) Canada Medical Device Regulations 5
A Audit Checklist for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 19
S Audit checklist for "Design Controls" per ISO 13485 wanted Internal Auditing 3
somashekar ISO 13485 plus ISO 9001:2015 will now attract a minimum 2 day upgrade audit ISO 13485:2016 - Medical Device Quality Management Systems 9
M ISO 13485 Audit Questions - Internal Auditor Training and other Requirements ISO 13485:2016 - Medical Device Quality Management Systems 10
J Can I conduct Internal Audit for combined ISO 9001, ISO 13485 and ISO 14001? Internal Auditing 37
Q Writing appropriate ISO 13485 Audit Report Findings Internal Auditing 15
K Including ISO 13485 Audit JPAL Registration Japan Medical Device Regulations 3
M ISO 13485 Certification - Internal Audit Program Required ISO 13485:2016 - Medical Device Quality Management Systems 12
J Pre-Revenue Medical Device Company ISO 13485 Audit ISO 13485:2016 - Medical Device Quality Management Systems 1
F Response to ISO 13485 Audit Minor Nonconformances ISO 13485:2016 - Medical Device Quality Management Systems 6
L Mock Audit by External Consultant (ISO 13485) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
Q Class I Technical File reviewed during ISO 13485 Certification Audit by NB CE Marking (Conformité Européene) / CB Scheme 10
A Quality Objectives 5.4.1 - KPI SOP - ISO 13485 Audit Observations EU Medical Device Regulations 6
M IAF-MD9 Audit Man-Days Requirements for ISO 13485 Quality Manager and Management Related Issues 30
R How much "harder" is an ISO 13485 Registration Audit compared to ISO 9001 ISO 13485:2016 - Medical Device Quality Management Systems 6
Q Post Market Surveillance SOP - ISO 13485 Audit Nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 3
L ISO 13485 Internal Audit Schedule example needed Internal Auditing 9
T One Supplier Audit Checklist to cover ISO 9001:2008 and 13485:2003 Supplier Quality Assurance and other Supplier Issues 1
T I'm seeking ISO 13485:2003 Supplier Audit Checklist Supplier Quality Assurance and other Supplier Issues 1
C Lapse between ISO 13485 certificate expiring and new audit ISO 13485:2016 - Medical Device Quality Management Systems 9
J General ISO 13485 Certification Assessment Audit Question ISO 13485:2016 - Medical Device Quality Management Systems 1
C Contract Manufacturer and Stage 2 Audit for ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 5
M QSIT-Based ISO 13485 Internal Audit Schedule Internal Auditing 8
G Need help in an upcoming ISO 13485 Audit ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 Audit Finding on Regulatory Issues - Internal Audits ISO 13485:2016 - Medical Device Quality Management Systems 8
S Freshman needs help with ISO 13485 Audit Process ISO 13485:2016 - Medical Device Quality Management Systems 46
R ISO 13485 Surveillance Audit Nonconformances and Report Help Needed ISO 13485:2016 - Medical Device Quality Management Systems 9
C System Root Cause and CA (Corrective Action) for ISO 13485 Audit Nonconformances ISO 13485:2016 - Medical Device Quality Management Systems 3
K ISO 13485 Audit help needed General Auditing Discussions 20
Le Chiffre ISO 13485:2003 Voluntary Audit Report Submission Program ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom