SBS - The Best Value in QMS software

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!
 
Last edited by a moderator:
Elsmar Forum Sponsor

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.
 
Last edited:

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?
 
Thread starter Similar threads Forum Replies Date
L Calibration of Dial Thickness Gauge - What reference standard need I follow? General Measurement Device and Calibration Topics 5
D Renewable Energy - Is there is a standard that we must follow? Other ISO and International Standards and European Regulations 25
L OHSAS 18001 requirement that PPE follow a national or international standard? Various Other Specifications, Standards, and related Requirements 6
B ISO13485 Standard Documentation Packages ISO 13485:2016 - Medical Device Quality Management Systems 2
S ISO/IEC 15408 - Is this is Certifiable Standard? Other ISO and International Standards and European Regulations 2
C Requirement for Revision of Standard in all Documentation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Lighting Standard for Metal Processing Inspection Manufacturing and Related Processes 4
F USB-IF standard EU Medical Device Regulations 0
F Is USB-IF standard compliant with ISO13485? Medical Device and FDA Regulations and Standards News 3
A Is there a standard on tolerances of substances ? Medical Device and FDA Regulations and Standards News 1
P Pooled Standard Error - Minitab Statistical Analysis Tools, Techniques and SPC 0
SABRINA DJILALI SAIAH Implementation of the ISAS-MEDIA 9001 standard in a TV channel ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
B European Harmonized vs IEC standard IEC 62366 - Medical Device Usability Engineering 2
Moumen H Variations between ASTM A29 Standard for steel bars and Mill test certificates specs Manufacturing and Related Processes 1
D Which ISO Standard to purchase? ISO 13485:2016 - Medical Device Quality Management Systems 7
K IEC 60601-1:2005/AMD2:2020, Why this standard version is 3.0? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
C Standard -Machinist Handbook Customer Complaints 4
N EN 813, EN 12277, EN 1497 - Testing some harness prototypes to an EN standard Various Other Specifications, Standards, and related Requirements 0
R Remote Audits for ISO 9001 (or any other standard) General Auditing Discussions 31
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
Y Auditory alarm standard IEC 60601-1-8 Reliability Analysis - Predictions, Testing and Standards 0
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
S Shore A hardness Tester Acceptance Criteria Standard Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 2
Sidney Vianna What ISO Standard (under the TC 176) supports the UN Sustainable Development Goal #10? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q EN ISO 13485:2016/AC:2018 - AC:2018 being stated in the applicable harmonized standard listing Other ISO and International Standards and European Regulations 1
J SAE J1739 standard IATF 16949 - Automotive Quality Systems Standard 2
Marcel DS LV 123 - BMW, AUDI, Mercedes Standard VDA Standards - Germany's Automotive Standards 1
F Standard Calibration Procedures: Recommended Practice ISO 17025 related Discussions 0
M FDA News FDA Releases Draft Guidance Clarifying Application of ISO 10993-1 Biocompatibility Standard Medical Device and FDA Regulations and Standards News 0
Y UL 1998 Standard: software classes Software Quality Assurance 0
G What to do with correction factors overlooked by an accredited standard (6.4.11)? ISO 17025 related Discussions 5
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Anonymous16-2 SOP (Standard Operating Procedure) Numbering Document Control Systems, Procedures, Forms and Templates 7
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
Skooma Deburring and Tolerances - Is there a Standard for deburring or removing material? Manufacturing and Related Processes 3
B Purchasing AS9100D Standard in Japanese AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
O In addition to the standard, what other ISO 13485 sources do people recommend? ISO 13485:2016 - Medical Device Quality Management Systems 5
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
M Informational RoHS Standard - EN 63000:2018 to replace EN 50581:2012 Medical Device and FDA Regulations and Standards News 11
M IEC 60601-1 1988 - Device developed in 2012 with standard of 1988 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
P Cenelec updated standard information CE Marking (Conformité Européene) / CB Scheme 1
S Is there a standard for sample size during R&D phase Other ISO and International Standards and European Regulations 18
J Standard used to determine if check fixture gauge is acceptable Reliability Analysis - Predictions, Testing and Standards 2
N Program or application for standard time measurement in industry from video surveillance? Human Factors and Ergonomics in Engineering 1
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Question on whether IEC 60601-2-62 standard is applied IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
B Clause 5.1.12 of Technical Standard IEC 62304/A1 IEC 62304 - Medical Device Software Life Cycle Processes 5

Similar threads

Top Bottom