M
Hello,
We are finally ready to go for our ISO 13485 audit. We found a company in Sweden that is certified by Swedac, but only for ISO/IEC 17021, NOT 13485.
The company claims that ISO/IEC 17021 is an umbrella certification and they are qualified to issue a 13485 certificate.
Is this common place? Will regulatory agencies accept this certification (17021) as being sufficient for a 13485 certificate?
Is this confusing?
We are finally ready to go for our ISO 13485 audit. We found a company in Sweden that is certified by Swedac, but only for ISO/IEC 17021, NOT 13485.
The company claims that ISO/IEC 17021 is an umbrella certification and they are qualified to issue a 13485 certificate.
Is this common place? Will regulatory agencies accept this certification (17021) as being sufficient for a 13485 certificate?
Is this confusing?
