SGS Certification - Advice on their Performance

#1
Hi All, just asking for opinions if anyone uses SGS for their certification services and wondering if they are any good. I know most notified bodies including BSI and TUV and extremely busy with MDR transition technical file reviews however at the moment I am just after ISO 13485 certification. Any experience working with SGS certification services would be much appreciated.
 
Elsmar Forum Sponsor

ScottK

Not out of the crisis
Leader
Super Moderator
#2
Hi All, just asking for opinions if anyone uses SGS for their certification services and wondering if they are any good. I know most notified bodies including BSI and TUV and extremely busy with MDR transition technical file reviews however at the moment I am just after ISO 13485 certification. Any experience working with SGS certification services would be much appreciated.
It's been a while, but I had a fine experience with them. Comparable to the experience I had with BSI and DNV later down the road with differed organiztions
 

Scanton

Wearer of many hats
#5
I am also based in the UK, and I use SGS for my ISO9001 & IATF16949 Certifications, and I also used SGS for 8 years in my previous company for ISO9001 & ISO14001.

My current company has been with SGS for 15+ years, and my next audit will be my final surveillance audit in a 3 year cycle.

After my experiences over the last 6 years, I will be looking to use anyone other than SGS for the next re-certification audit. Over the last 6 years their costs have continued to increase at an unjustifiable rate while the quality of their auditors has severely diminished, and communication with their account managers is poor and at best.

You may be dealing with a completely different group of people on the medical devices side, so my experience may be of no relevance at all.

I have been a loyal customer of SGS for over 2 decades, but this will end next year :-(
 

Sidney Vianna

Post Responsibly
Leader
Admin
#6
Over the last 6 years their costs have continued to increase at an unjustifiable rate
I am surprised. One of the reasons behind the continual erosion of confidence in management system certification is the commoditization phenomena, whereby, due to market conditions, pricing of CB services has been historically deflated, leading to the downward spiral in auditor calibre. Something beautifully captured in the article available @ https://elsmar.com/elsmarqualityforum/attachments/audit_clients_ims1-2006e-pdf.4691/

while the quality of their auditors has severely diminished
Is the competence of third party auditors improving?
 
#7
Thank you Vianna and Scanton. Its good to get an understanding of notified bodies since entering this agreement can be painful to change later on, I do believe the MDSAP programme has made flexibility and the "auditors nose" to diminish due to the strict subject and timelines imposed on auditors. There are certainly benefits however I think there needs to be a balanced expectations on NB auditors.
 

DannyK

Trusted Information Resource
#8
I am surprised. One of the reasons behind the continual erosion of confidence in management system certification is the commoditization phenomena, whereby, due to market conditions, pricing of CB services has been historically deflated, leading to the downward spiral in auditor calibre. Something beautifully captured in the article available @ https://elsmar.com/elsmarqualityforum/attachments/audit_clients_ims1-2006e-pdf.4691/
It may be the case with ISO 9001 but due to lack of supply and increasing demand, rates doubled for MDSAP audits (at a large auditing organization) and will be increasing again for EU MDR audits. Medical device audits are a cash cow for the big players.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#9
will be increasing again for EU MDR audits. Medical device audits are a cash cow for the big players.
Under Regulatory scrutiny, Notified Bodies have to do a much better job of managing their risks, vis a vis the PIP breast implant scandal. A lawsuit can cost a NB hundreds of millions of euros, something they can't afford.

In the unregulated "ISO certification" sector, commoditization has been bringing down the whole sector for over 2 decades now. Shameful the lack of visionary leaders in the sector.
 
Thread starter Similar threads Forum Replies Date
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
M Has anyone used SGS as a CB (Certification Body)? Registrars and Notified Bodies 4
T Choosing a Notified Body for MDR - SGS/BSI/DNV/DQS-MED Registrars and Notified Bodies 0
N Reputations of ISO 9001 Certifying Bodies (Registrars) - SGS, AJA, BVQI, SAI Global Registrars and Notified Bodies 5
M What is this MORI/SGS-ICS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A List of documents to prepare for Re-certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
F Attendance possibility for a certification audit ISO 13485:2016 - Medical Device Quality Management Systems 7
V ADDING NEW MEDICAL DEVICE / Product, WHEATHER THIS AFFECTS EXISTING ISO 13485 CERTIFICATION? ISO 13485:2016 - Medical Device Quality Management Systems 4
V ISO 9001 or ISO 17065 required for an organization issuing 5 star rating certification of digital experience? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
P How to keep a ISO 9001:2015 certification when a company is sold ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Scope of ISO 13485 certification as legal manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
J CMO in Canada do they need MDSAP/13485 certification? ISO 13485:2016 - Medical Device Quality Management Systems 1
R ISO 13485 certification scope ISO 13485:2016 - Medical Device Quality Management Systems 5
A AS9100D new certification cost?? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
N ISCC Plus - The international Sustainability Carbon Certification Sustainability, Green Initiatives and Ecology 2
S Which certification to get? Professional Certifications and Degrees 3
J Implementation, establishment and certification of IATF 16949. IATF 16949 - Automotive Quality Systems Standard 6
D Regulatory Affairs Certification (RAC) Devices Exam - Autumn 2022 study Professional Certifications and Degrees 2
A MDR Article 16 Certification of Distributors by a Notified Body? EU Medical Device Regulations 8
T NDT/NDE Level 2 Technicians Certification Oil and Gas Industry Standards and Regulations 20
M PSE Certification Japan Medical Device Regulations 5
C IATF16949 certification eligibility IATF 16949 - Automotive Quality Systems Standard 6
D IATF 16949 Certification and Letter of Conformance expiry (Help!!!) IATF 16949 - Automotive Quality Systems Standard 8
H API monogram 4F - Certification process Oil and Gas Industry Standards and Regulations 2
J Recommendations for certification bodies ISO 13485:2016 - Medical Device Quality Management Systems 4
S Certification of equipment after move General Measurement Device and Calibration Topics 14
J Help to understand and response to API AAR during the re-certification audit Oil and Gas Industry Standards and Regulations 17
G Medical Device Auditor (CMDA) certification exam by ASQ - looking for input Career and Occupation Discussions 3
D Automotive Customer asking for ISO 14001 Certification from suppliers ISO 14001:2015 Specific Discussions 3
I Foreign manufacturer registered place of business in EU for CE certification EU Medical Device Regulations 1
eldercare Multi-Site ISO/AS Certification Requirement for some sites ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 22
Casana ISO 17025 - Contractor certification? IATF 16949 - Automotive Quality Systems Standard 5
blackholequasar ISO 13485 certification prior to Medical Device Manufacturing... worth it? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Commonizing use of Certification Body providers within a Global Organization Registrars and Notified Bodies 2
P Does FDA require certification for quality system internal audit for auditor? Qualification and Validation (including 21 CFR Part 11) 1
M Can we combine AS9100 and DO-254 certification? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
H R&D Lab ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
L Significant subcontractor update, still under MDD Certification, possible? CE Marking (Conformité Européene) / CB Scheme 3
B ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 2
S How to calculate Effective Number of People for ISO 13485 Certification? General Auditing Discussions 2
S Inventory prior to AS9120 certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P Certification process for registered device China Medical Device Regulations 12
F Medical cart self certification EU Medical Device Regulations 1
B Managed Certification Projects FAA vs EASA EASA and JAA Aviation Standards and Requirements 0
B Regulatory Affairs Certification (RAC) Book - Fundamentals of Medical Device Regulations Medical Device and FDA Regulations and Standards News 0
B IATF Certification Body Recommendations Registrars and Notified Bodies 3
C Certification vs Accreditation Training (General) Training - Internal, External, Online and Distance Learning 1
I Class VI certification on seals, o-ring and plastic for a WFI system Qualification and Validation (including 21 CFR Part 11) 0
G Trying to get a financially reasonable ISO Certification Body Registrars and Notified Bodies 8
A Selling products with OEM certification expired EU Medical Device Regulations 0

Similar threads

Top Bottom