SGS Certification - Advice on their Performance

[KHR-MEDDEV]

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.

 

[ScottK]

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

 

[DannyK]

What country are you located?
In Canada and USA they usually hire ex-BSI auditors.

 

[KHR-MEDDEV]

Im am located in the UK

 

[Scanton]

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]

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?

 

[KHR-MEDDEV]

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]

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]

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.

 

[KHR-MEDDEV]

Thank you all for your help, in the end we decided to move forward with TUV for our certification services