Which standard to follow, local or international?

qualprod

Trusted Information Resource
#1
Hello colleagues

When complying to ISO 9001: 2015, I bought on-line the original version.
I live in Mexico. So my reference is ISO 9001 2015, however an equivalent standard is also issued by a mexican organization of standards, named PROY-NMX-CC -IMNC-2017.

What standard should I follow and be referred in my system?
Should it be a NC if I follow the standard bought online? is not the mexican equivalent.

Many Thanks - I appreciate it!
 
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Eredhel

Quality Manager
#4
I'm speaking a little out of my knowledge. But I did a quick Google translation of the front page of the standard and came up with this:

"medical devices quality management systems requirements for regulatory purposes"

If that's true then it might be that you are required to do this one, but is a customer asking you to also be ISO?
 

qualprod

Trusted Information Resource
#5
Sorry is this, NMX-CC-9001-IMNC-2015
ISO 9001:2015, is the same standard we all know, but it has some inserted text related to the mexican regulatory office.
I have been using this version, since our clients just ask compliance with 9001 2015, dont specify any equivalent local standards nor our CB .
 
B

BoardGuy

#6
Sorry is this, NMX-CC-9001-IMNC-2015
ISO 9001:2015, is the same standard we all know, but it has some inserted text related to the mexican regulatory office.
I have been using this version, since our clients just ask compliance with 9001 2015, dont specify any equivalent local standards nor our CB .
According to the Catálogo de Normas, Instituto Mexicano de Normalización y Certificación, A.C. NMX-CC-9001-IMNC-2015 is the Mexican national standard version of ISO 9001. In the US, we call it ASQ/ANSI/ISO 9001:2015. The only real deference would be that it is written using Mexico’s Spanish of the Americas translation of ISO 9001:2015, which would be deferment from Spain’s use of Castilian Spanish found in UNE-EN ISO 9001:2015.

For certification purpose, you should ask your Certification Body in Mexico to issue the certification with both references as they contain the same requirements. No NC should be issued if you used ether for certification purposes.
 
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qualprod

Trusted Information Resource
#7
Thanks Eredhel and Boardguy

Ok, but really what is the added value if the CB issues the certification adding the mexican version?

What negative issues I may expect if is not included?

Thanks
 

Eredhel

Quality Manager
#8
Do you have any customers driving a requirement for ISO certification, or do you have any concerns about your organization driving a need for ISO certification?
 
B

BoardGuy

#9
Thanks Eredhel and Boardguy

Ok, but really what is the added value if the CB issues the certification adding the mexican version?

What negative issues I may expect if is not included?

Thanks
Value of Listing MX Standard: National pride. If it is the expectation of the businesses you will be dealing to support the country, then you should list it. What are the expectations of your interested parties on this?

Value of Not Listing MX Standard: Most organization will not understand that it is Mexico’s version of ISO 9001:2015. Again, what are the expectations of your interested parties?
 
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