On site Technical File Review by our NB

S

SteveK

#1
With our previous NB I sent Technical Files on a disc to their offices for review (too big for email). However, our very new NB is planning to review four technical files by three auditors on our site over two days next year. Now I know TFs were reviewed first hand during an normal audit in the past (when stuff was less complicated), but I thought nowadays all NBs did reviews remotely. It is just there would be added costs for accommodation, meals, travel etc. which all seems unnecessary.

What are other peoples thoughts and current experience in this respect?

Is it just a money making plan?

Steve
 
Elsmar Forum Sponsor

Remus

Involved In Discussions
#2
Re: On site Technical File Review?

Notified Bodies have to perform technical file audits on site. European Commission is writtign nonconformity if they wont. Thats why they are sending auditors.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#3
Re: On site Technical File Review by our NB?

The pressure being exerted onto NB's to stop the assembly line approach to assessments should be paid attention to, by accreditation bodies.

The commoditization of system certification has to stop, or else.
 
R

rcjpedro

#4
If I only knew then what I know now!

I've had both on-site and off-site TF reviews.

Unfortunately my experience is that different auditors will have different opinions regarding the same subject!

I'm now in the process of responding to a open TF CAPA resulting from an off-site review.

On site reviews can have auditors doubts settled on the spot, off site reviews will almost always have doubts settled with a TF CAPA.

If your NB charges for CAPA review, review costs will absolutely surpass auditor travel and accommodation expenses.

In the future we are only considering on site reviews.

Unless your TF review raises no questions from the new auditor.
 
Thread starter Similar threads Forum Replies Date
M Office and manufacturing site relocation effect on Device Technical File CE Marking (Conformité Européene) / CB Scheme 2
O Medical Device Technical File Confidentiality - On site reviews EU Medical Device Regulations 14
somashekar About Technical File being available at Manufacturing Site ISO 13485:2016 - Medical Device Quality Management Systems 3
ScottK Opening for Manager, Supplier Quality Engineering on my team- Orangeburg, NY - On-site Job Openings, Consulting and Employment Opportunities 0
A ISO 9001- any advise please with transitioning from a paper based system to eQMS and multi site scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R CQI 9 site specific IATF 16949 - Automotive Quality Systems Standard 3
F Site level CMRT reporting: how? Miscellaneous Environmental Standards and EMS Related Discussions 0
T Ford Q1 MSA - Virtual Site Visit Hardware Manufacturing and Related Processes 14
R Transport of components off site for final assembly. Medical Device Related Regulations 2
Vader22 IATF 16949 extended manufacturing site help IATF 16949 - Automotive Quality Systems Standard 4
chris1price Irradiation site for dose audit Other Medical Device Related Standards 2
A Alternative to on site audit in China EU Medical Device Regulations 2
eldercare Multi-Site ISO/AS Certification Requirement for some sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
P Manufacturing site vs manufacturing date symbol Medical Device and FDA Regulations and Standards News 1
D Secondary Manufacturing Site on DoC EU Medical Device Regulations 1
B Site removal from MDSAP multi-site Certificate ISO 13485:2016 - Medical Device Quality Management Systems 4
R IATF 16949 Certification for new site with transferred product--what is the impact with CSR and scorecards? IATF 16949 - Automotive Quality Systems Standard 4
M IATF 16949 - Audit of Remote Location/Support Site and IT IATF 16949 - Automotive Quality Systems Standard 4
S Would this be a second site for the purposes of internal and third party audits? General Auditing Discussions 4
A OEM On-Site Calibration issues during Covid19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
SANTHSH API Spec. Q1 clause 5.6.1.2 On site evaluation Oil and Gas Industry Standards and Regulations 12
D Limited Scope for second site Question? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Sites to List on Multi-Site Certifications Registrars and Notified Bodies 1
D Certifcate of Free Sale Listing Physical Site from Belgium Competant Authority EU Medical Device Regulations 3
N Address of Legal Manufacturing Site in ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 13485 extended Site (Two companies) ISO 13485:2016 - Medical Device Quality Management Systems 2
C New to Site - Request Help with API Q2 Implementation Oil and Gas Industry Standards and Regulations 9
Z US Manufacturing Site Closing, device manufactured elsewhere Medical Device and FDA Regulations and Standards News 1
L Manufacturing site expansion - When to notify your NB EU Medical Device Regulations 3
N Can a (class I) medical device be manufactured in a GMP certified site with no ISO13485? EU Medical Device Regulations 18
M IATF 16949 (6.1.1 - Planning and Risk Analysis for a remote site) Process Maps, Process Mapping and Turtle Diagrams 5
J Remote location vs. site extension IATF 16949 - Automotive Quality Systems Standard 3
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
Casana IATF 16949 7.1.5.3.2 External Laboratory - On Site Calibration IATF 16949 - Automotive Quality Systems Standard 8
Q IATF rule for single site - Ingots from scrap metal recycling company IATF 16949 - Automotive Quality Systems Standard 0
M Inputs on definition of very similar processes for multi site audit sample - IAF MD1 2018 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Quality Manual for 2nd site Quality Management System (QMS) Manuals 3
S Sterilization Site Move - Dec 2018 FDA Guidance Document 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
B Multi-site certification (IAF MD1) - for 9001, 14001, OHSAS/45001 ISO 14001:2015 Specific Discussions 19
G Timing allowed by IATF to close a Remote Site Minor Nonconformance IATF 16949 - Automotive Quality Systems Standard 2
S Legal Manufacturer FDA Reporting Obligations for Using New Contract Sterilization Site Other Medical Device Regulations World-Wide 0
A A purpose of a Stage 1 audit - Off site document review Registrars and Notified Bodies 3
M FDA News USFDA Final Guidance – Manufacturing Site Change Supplements: Content and Submission Medical Device and FDA Regulations and Standards News 1
Ajit Basrur FDA News FDA Guidance Document: Manufacturing Site Change Supplement US Food and Drug Administration (FDA) 0
S ISO 17025 Requirements for Mobile On-site Calibration ISO 17025 related Discussions 2
A Adding Remote Site to Current IATF 16949 Certification IATF 16949 - Automotive Quality Systems Standard 2
B Manufacturing site relocation of pre amendment Class II medical device Manufacturing and Related Processes 4
B Site Move - Question about Updating Product Labels 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
A Supporting Site Quality Manual and References Requirements IATF 16949 - Automotive Quality Systems Standard 14
D Adding a new site to 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4

Similar threads

Top Bottom