Understanding accreditation, MoUs, certifications

Mark Meer

Trusted Information Resource
#1
Hi all.

I'm in dire need of some guidance as to understanding accreditation, memorandums of understanding, certifications and test-report recognition.
(please correct me if I'm erroneously mixing-up/misusing any of these terms :eek:)

There are so many agencies, I'm quickly getting confused.

For example:

  • The IECEE has a Memorandum of Understanding (MoU) with the IAF (International Accreditation Forum)
  • The IAF has the CNAS (China National Accreditation Service) as a member and signatory.
  • The CNAS then accredits a test-lab to ISO/IEC 17025 with a scope of a particular IEC testing standard.
  • That accredited test lab then certifies a device to the testing standard, and issues a test-report.

The clarifications needed are:
  1. Do I have the associations between these organizations correct?
  2. What are the roles of the "middle men" in this chain (i.e. the IAF and CNAS), when the IECEE has it's own list of member testing labs?
  3. Given this chain association, does this mean that the test-report issued by the accredited test lab would be recognized by members of the IECEE?

Many thanks in advance to anyone who can shed light...
 
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Marcelo

Inactive Registered Visitor
#2
It?s difficult.

Your comments have some problems, mainly because the IAF is usually related to system accreditation, not lab testing (the ILAC is related to lab testing). You also don?t need the IECEE in this (the IECEE is another "scheme", as is the IAF).

Usually it works like this:

- The ILAC has the CNAS (China National Accreditation Service) as a member and signatory.
- The CNAS then accredits a test-lab to ISO/IEC 17025 with a scope of a particular IEC testing standard.
- That accredited test lab then tests a device to the testing standard, and issues a test-report.

If there?s a related certification:

- The IAF has the CNAS (China National Accreditation Service) as a member and signatory.
- The CNAS then accredits a certification body to ISO/IEC 17021 with a scope of a particular IEC testing standard.
- That accredited certification body then certifies a device based on the testing report from the test lab as above, and issues a certificate of compliance.



The IECEE scheme do more or less both together, and there are schemes that do both together also.

Also, I?m not 100% sure that China works like this, because they have their certification process intertwined with the regulatory process (which sucks).
 
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Mark Meer

Trusted Information Resource
#3
Thanks Marcelo. It's difficult indeed. :yes:

Thanks for clarifying the difference between the IAF and ILAC. They seem to be often mentioned together in the same sentence, and their memberships appear quite similar.

You also don?t need the IECEE in this (the IECEE is another "scheme", as is the IAF).
So what is the purpose of a Memorandum of Understanding, if not to align the schemes for some basis of mutual recognition?

And on that note, why is the IECEE CB Scheme touted as such an effective key to global recognition of certification, when it appears there are other bodies (e.g. IAF) that also have international schemes?

Also, I?m not 100% sure that China works like this, because they have their certification process intertwined with the regulatory process (which sucks).
Wouldn't the CNAS, as a member/signatory to the IAF and ILAC, be required to work according to this system? The purpose, after all, is to align testing, accreditation and certification practices, no?

Also, you may easily substitute ANSI, IAS, A2LA for CNAS. I'm just trying to get my head around who does what and what the purpose/responsibilities of all these agencies is...

That accredited certification body then certifies a device based on the testing report from the test lab as above, and issues a certificate of compliance
Forgive me, but I might have to clarify: what is the difference between a test-report and test-report+certification? Is it surveillance? With certification, do the test-labs take on added responsibility?
 

Marcelo

Inactive Registered Visitor
#4
So what is the purpose of a Memorandum of Understanding, if not to align the schemes for some basis of mutual recognition?
Yes it is, but I just said that the IECEE having a memorandum with the IAF (it?s in fact with the IAF and ILAC) is another layer in the process.

And on that note, why is the IECEE CB Scheme touted as such an effective key to global recognition of certification, when it appears there are other bodies (e.g. IAF) that also have international schemes?
Because they want to market it that way? :p The IECEE scheme is really focused on electrical equipment, and in fact more to the business side. And yes, there?s other schemes.

Wouldn't the CNAS, as a member/signatory to the IAF and ILAC, be required to work according to this system? The purpose, after all, is to align testing, accreditation and certification practices, no?
Yes, they would, but please note, certification was created as a business solution, not a regulatory one. China (and Brazil, for example) have certification processes tied to regulations, and this might change the way the process is conducted (for example, the INMETRO certification process for medical equipment follows ILAC-IAF rules, but it has some changes because the regulator is ANVISA and the certification is made for them).


Forgive me, but I might have to clarify: what is the difference between a test-report and test-report+certification? Is it surveillance? With certification, do the test-labs take on added responsibility?
Certification follows models/schemes as defined, for example, in ISO/IEC 17067:2013.

For example, the Type 5 product certification scheme historically includes type testing of product design, evaluation of manufacturer?s quality system and market surveillance, including periodic auditing.

Test reports from test houses are usually only used as part of the type testing as required by the certification scheme. They by themselves only mean that the tested product complies with the standard.

As I mentioned, certification bodies produces certificates, not test labs.
 
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Mark Meer

Trusted Information Resource
#5
Marcelo: once again thanks. You're really helping to clear up this murky business.

...and this might change the way the process is conducted (for example, the INMETRO certification process for medical equipment follows ILAC-IAF rules, but it has some changes because the regulator is ANVISA and the certification is made for them).
But presumably the changes are minor, and would not affect mutual recognition from other ILAC/IAF members?

Certification follows models/schemes as defined, for example, in ISO/IEC 17067:2013.
So, technically, correct use of the term "certified" would have to indicate the scheme?
(e.g. "certified to [standard] according to [scheme]"). If there is no scheme there is no certification?

What about NRTL certification? Is that an entirely separate scheme?
 

Marcelo

Inactive Registered Visitor
#6
Quote:
...and this might change the way the process is conducted (for example, the INMETRO certification process for medical equipment follows ILAC-IAF rules, but it has some changes because the regulator is ANVISA and the certification is made for them).
But presumably the changes are minor, and would not affect mutual recognition from other ILAC/IAF members?
Yes, in principle they would not.

Quote:
Certification follows models/schemes as defined, for example, in ISO/IEC 17067:2013.
So, technically, correct use of the term "certified" would have to indicate the scheme?
(e.g. "certified to [standard] according to [scheme]"). If there is no scheme there is no certification?
Certification is generally defined as the provision by an independent body of written assurance (a certificate) that the product, service or system in question meets specific requirements. So it could mean anything.

For example, to a product standard, I could give a certificate saying that the product under test is in accordance with the standard. But this would only mean that that product was in accordance.

If you want to show that a product is continuously (or continually, I never know which word to use in english) is in accordance (for example every product manufactured by a manufacturer), you would need to verify other things. That?s what the IAF certification schemes do, for example.

Although in my opinion the correct way would be to say "certified to [standard] according to [scheme]", the "scheme" is not usually used in the description directly. It?s generally used indirectly because the certification itself is based on a scheme. It might not even call a particular standard, in fact.

For example, in the case of Brazil, the certification processes by INMETRO have their own rules (a document called "Conformity assessment rules") that defines the process, including the certification model. On the case of medical equipment, the certification process document mentions that the certification scheme or model is a product certification ISO type 5. Also, there?s lot?s of standards used (mostly IEC 60601 series). So, when a manufacturer gets a certificate, the certificate says that it?s conformity assessment certificate, and mentions, between other things, the certification rule and the standards used (and they include the INMETRO logo and IAF logo, meaning they are granted following their rules).
 
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Marcelo

Inactive Registered Visitor
#7
Sorry, forgot about the NTRL question...

What about NRTL certification? Is that an entirely separate scheme?
Yes, in fact it?s a US certification scheme, and as the other ones, they follow their own rules.

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=DIRECTIVES&p_id=2004

CERTIFICATION -- The procedure by which written assurance is given that a supplier provides a product, process, or service which conforms to a standard or specification. Within the context of the NRTL Program, the NRTL provides such assurance showing that it has determined a product conforms to one or more specific consensus-based U.S. safety standard(s). The certification must be evidenced by the NRTL's certification mark on the product.

CERTIFICATION BODY -- Within the context of the NRTL Program, the part of the NRTL's organization that conducts the product certification, as opposed to testing laboratory, activities, i.e., listing and labeling and inspection of manufacturer's facilities.

CERTIFICATION MARK -- Protected mark, applied or issued under the rules of a certification, indicating that adequate confidence is provided that the relevant product, process, or service is in compliance with a specific standard or other normative document.
 

Ronen E

Problem Solver
Staff member
Moderator
#8
To summarize, there's a lot of money to be made in this business, and lots of guards are required to guard the guards, and some national pride is involved while everyone is preaching that international harmonization is beneficial to all, and so we end up where we are.
 

Marcelo

Inactive Registered Visitor
#9
To summarize, there's a lot of money to be made in this business, and lots of guards are required to guard the guards, and some national pride is involved while everyone is preaching that international harmonization is beneficial to all, and so we end up where we are.
Agreed. On the other hand, we should not forget that certification was created in principle by the industry for the industry to make more money, and although we do have a certification industry today, it seems to still be good, otherwise it would not exist anymore.

As I mentioned above, it?s was created and it?s primary goal is business. Although today we have a lot of certification schemes related to regulatory control, they are in fact separate things, and that?s why in part people get confused about it.
 

Mark Meer

Trusted Information Resource
#10
To summarize, there's a lot of money to be made in this business, and lots of guards are required to guard the guards, and some national pride is involved while everyone is preaching that international harmonization is beneficial to all, and so we end up where we are.
So true. Unfortunate...but true.

As I mentioned above, it?s was created and it?s primary goal is business. Although today we have a lot of certification schemes related to regulatory control, they are in fact separate things, and that?s why in part people get confused about it.
I'm still confused about it.

What do you mean by "it's primary goal is business"? By that do you mean these agencies' intent is:
- Serving manufacturers' business interests, by somehow facilitating testing and marketing?
OR
- Their own business interests, and it's all just creative new ways to make money, with questionable value?

The bottom-line concern for manufacturers is regulatory, so I don't see how these schemes, unless somehow tied to regulatory control, would have any reason to exist.

Why would a manufacturer need to seek out an accredited test-lab or certification body, unless the services they deliver are required for or facilitate regulatory needs?
 
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