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Benefits from the OIML MAA for manufacturers

The OIML MAA offers manufacturers:

  • A “one-stop testing” process for type approval worldwide;
  • Better information at the beginning of the process when deciding on tests to be performed;
  • Recognized confidence in test results;
  • The use of Evaluation Reports for type approval also in countries where national regulations are not fully aligned with OIML Recommendations; and
  • An accelerated type approval process.

CECIP Comments to MAA

Posted by Martin Stoll at 2007-05-29 14:02
Preamble

European scale manufacturers are not only familiar with the OIML Certificate System but also with the requirements and the law of the European Community, in essence identical with the OIML Recommendations.

Whereas OIML Recommendations may or may-not be followed by the OIML Member States, the EC Member States are obliged to transpose Council Directives on a 1:1 scale into national law.

The European harmonized approach simplified the putting into service of weighing instruments considerably, reduced manufacturing costs and increased the efficiency of the manufacturers worldwide.

Along with the harmonized approach for obtaining EU type approval certificates, the EU introduced a series of conformity assessment modules a manufacturer can choose from. These conformity assessment modules are designed to enable a manufacturer – under certain conditions – to issue the declaration of conformity and to place the instrument on the market under his sole responsibility. The condition to do so is the existence of a quality system at the manufacturer, guaranteeing the production quality, subject to periodical audits by a European Notified Body, called ‘Issuing Authority’ by OIML.

The majority of the European Scale Manufacturers are having a quality system according ISO 9001:2000 in place and when deciding to make use of the conformity assessment module D, EC declaration of type conformity, were adding an additional section to the ISO handbook describing the conformity assessment process. The conformity assessment process not only covers the manufacturing of the instrument but also it’s putting into service at the place of use by trained and authorised personnel (second stage of initial EC verification).

As mentioned above, the harmonized approach within the EU considerably contributed to cost reduction of weighing instruments, however, a good deal of the cost savings had to be spent on entertaining the conformity to type process needed to meet the essential requirements.

CECIP is aware of the fact that the above-mentioned requirements are no guarantee for non-standard products being placed on the market, however, limits it’s placing considerably. For maximum consumer protection a harmonized approach in market surveillance is required. Market surveillance is required by the European law but not exercised by the competent bodies due to lack of funding. CECIP is of the opinion that periodical re-verification as considered in most European countries, is not an alternative to market surveillance.



Our comments

CECIP supports efforts geared to improve regulations relating to consumer- and environmental protection, safety and health matters but challenges regulations hindering free trade of goods.

To meet the requirements of customers, manufacturers of weighing instruments around the globe are facing the same challenge: top quality products at affordable prices.

Manufacturers around the globe, making their products available to the global market need to invest in a quality system guaranteeing the products meet the approved type. This statement is not only - but especially - valid for manufacturers putting their products on the EU market.

One would expect that the OIML certificate system would honour the effort by the manufacturers in producing products meeting the approved type and having a quality system in place certified by a notified body. This could be demonstrated by accepting manufacturer test results, provided the test laboratory is under the observation of the notified body or accredited under ISO 17025. Unfortunately, neither the ‘old’ nor the ‘new’ OIML certificate system foresees the acceptance of manufacturer test results: a cost driving factor not to be underestimated.

For manufacturers, another cost driving factor is the requirement for the notified bodies/issuing authorities to accredit their test laboratory or to let it be approved via peer assessment. The costs arising from such accreditation/peer assessment will – without a doubt – be loaded on the cost of the certificate. Depending of the number of certificates issued by the respective laboratory, the costs allocated can be out of proportion. Observing the cost- and human resource cutting exercises in many national laboratories throughout Europe underlines this fact.

The pace in time-to-market of new products increased considerably over the years. The European scale manufacturers are in need of notified bodies/issuing authorities close to the place of manufacture, having the expertise in testing and approving weighing equipment within the shortest possible time, issuing type approval certificates on time, having the expertise in approving quality management systems and support manufacturers in approval issues.
Notified bodies/issuing authorities not meeting the entire above are considered as another cost driving factor for the manufacturers.

OIML is urged to provide a transition period enabling notified body/issuing authority, having served the industry to its entire satisfaction over the years, in adjusting their structure to the new strategy requirements, raise the necessary funds to make the changes happen and to recruit competent personnel needed.

The OIML MAA is concentrating in issuing certificates of conformity without taking other important issues, relevant for consumer protection, into account. Some OIML Member States don’t miss an opportunity to stress the issue of ‘golden samples’ being presented by manufacturers to obtain OIML certificates of conformity. However, neither the ‘old’ nor the ‘new’ OIML certificate system prevents non-standard products from being put on the market.

CECIP is of the opinion that unless OIML considers all of the above, the OIML MAA only generates additional costs without adding value to the certificate system.


Martin Stoll
President of CECIP Legal Metrology Group

Reply from the BIML

Posted by gaucherr at 2007-08-28 11:53
We understand that European scale manufacturers are not necessarily familiar with the OIML Certificate System, since the European Standard EN 45501 is the harmonized standard which gives a presumption of conformity to the essential requirements of the European Directive.

But the requirements of EN 45001 are aligned on those of OIML R 76 (edition 1992). This means that if a manufacturer obtained an EC type approval, it could also request an OIML Certificate of Conformity based on the same test results as those used to issue the EC type approval. Such an OIML Certificate might facilitate the application for national type approval outside of Europe. Such a procedure could reduce the cost for manufacturers and improve the worldwide recognition of test results.

The OIML Mutual Acceptance Arrangement (MAA) is an additional tool to the OIML Certificate System (now called the “OIML basic Certificate System”) since it includes an evaluation of the testing laboratories responsible for type approval testing. These laboratories are evaluated on the basis of ISO/IEC 17025 requirements, the evaluation being based on:
• their accreditation, if any and if consistent with the scope of the Declaration of Mutual Confidence (DoMC), or
• peer assessments organized by the OIML.

Consequently, an OIML MAA Certificate of Conformity has an added value to an OIML basic Certificate regarding confidence in test results. In addition, participants in a DoMC agree to use OIML MAA Certificates in conjunction with test data obtained from other participant's testing laboratories when issuing their own national Certificates

Moreover, in a DoMC there is a possibility to take into account additional national requirements from participating countries whose regulations are not totally aligned with OIML requirements. Consequently, in certain countries in which a manufacturer wants to apply for a type approval, it has the possibility to perform all the relevant tests in one single country.

The BIML agrees on the fact that the OIML MAA shall only be considered as a "step", since it does not cover all the conformity assessment modules as defined in the European Directive (e.g. conformity of the instruments manufactured to the type approved, initial verification, Declaration of conformity by the manufacturer based on a certification of his quality management system).

The OIML MAA is related to type approval testing only and does not cover the issues related to conformity to type. Nevertheless, the OIML is considering this issue and that of market surveillance. An ad-hoc working group was set up two years ago, the aim being to set up a complete set of modules, in line with those defined in the European Directives. Nevertheless, in the meantime the OIML MAA should contribute to reducing type approval testing costs and to increasing acceptance of test results worldwide.

One critical issue mentioned in your comments is the fact that the OIML MAA does not take into account test results from manufacturers; this issue is under discussion in the context of the revision of OIML B 10. As indicated above, the third-party testing laboratories operating under a DoMC are evaluated on the basis of ISO/IEC 17025. This means that at least consistent requirements should be applicable to manufacturers' testing laboratories. Different options could be envisaged to define the criteria to be applicable.

However, even if according to the European Directive test results from manufacturers may be taken into account for issuing a European type approval, the various European countries have not yet defined harmonized criteria on this issue.

Criteria for evaluating the manufacturer should be agreed upon at any time data from manufacturers are accepted.

The first OIML MAA Certificates have recently been issued. The BIML will follow their use by manufacturers to obtain the relevant national type approvals in the various countries concerned.

Experience gained in the first DoMCs will provide valuable inputs for the revision of OIML B 10. We look forward to your contribution in this revision process.

OIML MAA

Posted by Robin Long at 2010-08-04 10:53
Is there a list of OIML approved MAA testing laboratories, for example I have an OIML MAA certificate from a particular company who claim to have tested load cells to the R60 standard and have the MAA, but I am unsure as to whether this company or certifIcate is recognised and true,

If it is then am I to believe that these products have full type approval certification for Eurpoe or do they then need to go through more series of testing to obtaion full recognition as an OIML or EC type approved cell,


Thanks

 

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