Does anyone use SGS for ISO 13485 / CE certification

N

nozzle

Involved In Discussions
#1
#1
Hi all,
Is anyone who uses SGS experiencing any issues with them? Two companies who I act as a distributor for still have not received their CE certificates from Belgium, CE 1639, despite work on transferring from SGS UK CE0120 starting in early September.
I've also heard a rumour that SGS UK are taking over 8 weeks to issue new ISO 13485 certificates following successful recertification audits.

Just wondered if anyone here had heard anything or is being affected by this?
 
Highly Rated Gage Tracking - Learn More
Elsmar Forum Sponsor
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
G Does anyone know about tobacco-free nicotine pouches? US Food and Drug Administration (FDA) 0
R Does anyone use iQMS for their ISO based document control? Manufacturing and Related Processes 1
Q Does anyone know what this call out means? Manufacturing and Related Processes 3
H Does anyone has feedback on a notified body for small companies? EU Medical Device Regulations 3
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 3
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
N Does anyone have experience of GB/T 34986-2017? China Medical Device Regulations 1
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
GreatNate Metrotom - Does anyone have any exposure to the Zeiss Metrotom 800 or 1500? Manufacturing and Related Processes 0
M Honda Audits - Does anyone have any experience with the QAV audit? General Auditing Discussions 4
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
J Does anyone here use ISOXpress/IMSXpress QMS software? Software Quality Assurance 11
K Does anyone have a copy of a GM 5 Phase Problem solving form Problem Solving, Root Cause Fault and Failure Analysis 1
M Does anyone have a good verification and validation plan template? ISO 13485:2016 - Medical Device Quality Management Systems 8
B Does anyone charge for annual layouts? APQP and PPAP 8
N Does anyone know a registrar that offers both ISO 9001 and ISO 17020? Registrars and Notified Bodies 6
W Does anyone have any experience with the Easy Metric System? General Measurement Device and Calibration Topics 2
J Does anyone have a good APQP template that meets IATF requirements? APQP and PPAP 3
D IATF 16949 - 8.5.2.1 Traceability Plan - Does anyone have an example? IATF 16949 - Automotive Quality Systems Standard 4
C Does anyone have an AS9100:2015 audit schedule template? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
R Does anyone have example test report of defibrillator IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
G Definition Parallel Loop - Does anyone know what the term Parallel loop means? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
B Does Anyone utilize MS Outlook Read Receipts ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
L Does anyone know what is going on in DQS? Registrars and Notified Bodies 1
P Scope Document - Does anyone happen to have an Example Scope Document (4.3)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Does anyone have a comparison between ISO 9001:2015 and ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
D Does anyone have a list of the IATF "Shalls" they would be willing to share? IATF 16949 - Automotive Quality Systems Standard 4
S Plant within a Plant - Does anyone currently manage their facility this way? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
E Does anyone have experience implementing a Tiered QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J Does anyone have an example Authority Listing SOP example? Misc. Quality Assurance and Business Systems Related Topics 3
S Does anyone know what a healthcare GDSN data pool actually looks like? Hospitals, Clinics & other Health Care Providers 2
R Does anyone have any experience on change control? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
ScottK Does anyone have experience with how MDD unanounced audits of suppliers are going? EU Medical Device Regulations 21
A Does anyone have experience providing a summary of Pre-IDE discussions in the 510k US Food and Drug Administration (FDA) 1
S Does anyone use the Boeing STP0565 and STP0637 specs? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Does anyone have a breakup of Establishments based on Device Classes ? Other US Medical Device Regulations 1
R Legal Register - Does anyone have an example of a legal register? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A MDS software - Does anyone have experience with iPoint? RoHS, REACH, ELV, IMDS and Restricted Substances 8
P Does anyone have a DFMEA process Interface Matrix .xls template FMEA and Control Plans 7
S Does anyone know about FIAT Normation N.9.91320/02 ? Customer and Company Specific Requirements 2
M Does anyone here have experience implementing PCI DSS (Data Security Standard) IEC 27001 - Information Security Management Systems (ISMS) 10
R Does anyone know why the TC 176 website has been hijacked by CSA? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
S Does anyone have procedure on "Regulatory Compliance"? US Food and Drug Administration (FDA) 18

Similar threads

Top Bottom