registrars (registration bodies)

  1. GStough

    Informational SN EN ISO 9001:2015 and SN EN ISO 13485:2016 on Same Certificate?

    While reviewing suppliers' ISO certificates, our supplier quality clerk noticed that one of our suppliers has an ISO cert with both standards. Also, the cert does not have the ANAB or UKAS logo, but rather the Swiss Accreditation logo. When the new versions of these standards were released, we...
  2. T

    Reasons to change certification body and typical costs

    Two questions so I'll start with the last one. What's a typical fee for an auditor to certify to iso 9001: 2015? Based on size, number of sites and complexity in sure. But say 50 employees, one site and low to average level of complexity for an automotive manufacturer (2nd/3rd tier). Is there...
  3. M

    Start-Up Company looking for ISO 13485 Certification Body and Medical Device CE Mark Notified Body

    Greetings all, I am a Quality Assurance / Regulatory Affairs Manager at a Start-up in California. We are trying to get an ISO 13485 audit scheduled with BSI as well as a Technical File (or Documentation) review some time this year. Unfortunately they are refusing new customers. They don't...
  4. K

    Seeking ISO 13485 Registrar Recommendations

    We have made the decision to transition from IATF 16949 to ISO 13485. We have been with our current registrar for a long time but they are no longer supporting 13485. I'm looking for recommendations to narrow down my search. We consider audits value added and are not afraid of improvement...
  5. Leandro

    Need to register Medical Devices in Canada (FDA, HC, CMDCAS...)

    Hi! We're a company about to bring operations to Canada and we're in need to register our products - Class III prosthesis (in titanium). Also, there's the need to find a Contract Manufacturer to produce for us locally. Looking forward to hearing from you.
  6. N

    I am looking at two Registrars

    Good day, we are considering the following two registrars for certification services Intertek and SAI Global. Can anyone provide favourable reviews of either? Thank you,
  7. Q

    SAI Global Status as of July 2018

    Hello everyone what do you know about Sai global Cb? I saw an information in ANAB website, in respect that was suspended temporarily to certify companies, I'm not sure if this issue was solved. Finally what would you choose in a Cb to certificate your company in 9001? Thanks
  8. Marc

    IAF Mandatory Documents (MD Series) - Required to be used by certification bodies

    IAF Mandatory Documents (MD Series) - Required to be used by certification bodies. The IAF has updated its MD4 document which defines the rules for remote auditing by registrars. IAF Mandatory documents are not intended to establish, interpret, subtract from or add to the requirements of any...
  9. S

    Certification Body, Registrar, Notified Body - What is the difference?

    Often hear these terms - Certification Body, Registrar, Notified Body. What is the difference?
  10. 1

    ISO Registrar with waste water treatment experience

    Is anyone aware of an ISO 9001/14001:2015 registrar with waste water treatment and operations experience? We currently use NSF-ISR but it is time to re-evaluate and see what is out there. I thank you for your input!
  11. D

    How can a company transfer their AS certificate from a suspended AS91XX registrar?

    Just learned that SAI Global (Canada), Intertek and LRQA Japan are suspended in OASIS. Furthermore, SAI Global has not conducted audits for many small companies 2017 due to shortage of auditors. How does a company transfer to another registrar.
  12. P

    Delay in IATF 16949 Certification from Registrar

    Has anyone ever had to file a complaint against a Registrar?
  13. C

    Changing Registrars

    Hi there all, Changing registrars. We are looking at upgrading from ISO9001:2015 to AS9100D. Our current registrar we have no problems with, however, the quote for registration from our current registrar is $about $6000 more expensive than another. Is this a good reason to change registrars...
  14. F

    Which Medical Device Standard Registrar would you recommend?

    We were recently notified that our registrar no longer supports our device category. We have 2 options for a new registrar, neither of which do I have prior experience: LNE, and BSI, It would be helpful to our decision, if anyone can share their experiences with either registrar. (Good...
  15. WCHorn

    Transfering certificate from Registrar "A" to Registrar "B"

    Hello Cove! This is not a hypothetical; it involves a colleague. Identities have been changed for confidentiality. XYZ Company is certified ISO 9001:2008 by Certification Body (CB) A. The three-year certificate will expire in January 2018. XYZ wants to transition from CB-A to CB-B (for...
  16. D

    Breach of Contract from Registrar (Auditor Payment Issue)

    Hi; Had a nice conversation with a third party auditor that audits for a CB in USA, and the auditor was telling me that the Registrar has not paid the bills since November 2016. The amount is up to $20,000.00 and the auditor is looking for ways to collect the money. Any ideas...
  17. R

    Questioning legitimacy of CBs if not in IAQG-OASIS Database - AS9100 Certificate

    I was reviewing a sub-tier supplier's AS9100 certificate as part of a supplier evaluation. I've seen quite a few different CB certificates but this was from one I haven't seen before. Going to the IAQG-OASIS website site, I found neither my supplier nor their CB was listed there. Excuse my...
  18. C

    Registrar Charges Per CAR Written

    So I'm looking at a quote for registration services, and it says: "Auditor CAR Review will be billed at $90 per CAR written." Does anyone else's registrar charge per CAR?
  19. C

    Intertek UK

    Does somebody know what happened with INTERTEK? They are not responding any mails (sometimes just automatic answers). We need to start the process to renew certificates. Does anybody else see the same radio silence? Tnx!
  20. Q

    Supplier evaluation for registrar?

    Random question... ISO 9001 and 13485 require supplier/vendor evaluation. Does this include registrars/CBs? Other than an accreditation, are there any other requirements they must meet?
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