Session 1:
Presentations from the governments/regulators, second part
- Market surveillance in China.
Ms. Y. Bo, Director General – CNCA/SAC - Standards in conformity assessment and market surveillance.
Mr. Z. Bilalis, European Commission - Simplifying conformity assessment : evidence of the trade effects of Supplier’s Declaration of Conformity.
Ms. B. Fliess, OECD (Trade & Agriculture Directorate) - Regulatory dialogue at the United Nations.
Ms. L. Jachia, Secretary – United Nations Economic Commission for Europe, (UNECE) Working Party on Regulatory Cooperation and Standardization Policies (W.P. 6)
N. Croft, ABNT (Brazil)
Y. Bo, CNCA (China)
China started its market surveillance system at the end of the 1970's. At that time market surveillance was done according to the compulsory standardization by some of the regulators. But now, things have changed a lot. We have very strict market surveillance procedures covering the planning of surveillance activities, the sampling of products to be checked and the selection of product characteristics to be tested etc. And also the testing laboratory now must meet the qualification requirements. Follow-up actions include a lot of things. Firstly, if any non-conformity is detected in the product, the suppliers may be subject to a fine or other sanctions, and the government agencies will also require suppliers to take action on the detected non-conformities. These are covered by our law on product quality and law on standardization. As to corrective actions, the supplier must implement their own corrective actions that will be followed up by the government agencies. Also, in recent years the government agencies have been relying more and more on the outcomes of market surveillance in formulating new and/or improving existing policies and regulations, and in supervising and coordinating the work of the standardization body, accreditation body and conformity assessment bodies etc.
O. Peyrat
Y. Bo, CNCA (China)
Yes, this exists for suppliers. Some time is given to suppliers to develop a corrective action and after that the government authorities come back and check the corrective action.
G. Beer, Germany (DIN)
Z. Bilalis, EC
It is not of the intention of the European Commission to make quality management obligatory and this is out of question. In the same way, standardization or the use of the standard is not an obligation. Whenever sectoral legislation requires manufacturers to follow certain modules we always give the choice to the manufacturer either to have a quality assurance system (which will be surveilled by a conformity assessment body), or to accept that the conformity assessment body directly checks the product produced by the manufacturer. For example, either Module B + Module D (production and quality assurance), or Module B + Module F (statistical check of the conformance of the products). If the manufacturers themselves take voluntarily proactive measures to improve the quality of their processes (product development, product conception, purchasing, production, etc.) the probability that products coming into the market pose a threat to the public is less. The European Commission recommends the manufacturers to have more quality control to reduce the numbers of non-conformity.
G. Drake, SA/SNZ (Australia and New Zealand)
Z. Bilalis, EC
The New Legal Framework actually tries to reinforce the obligation of the authorities so that the EU members States cooperate better among themselves and reach harmony. If a market surveillance authority witnesses a problem, it has to notify the Commission and the other member States immediately (and inform regarding the measures taken). The other member States have to act accordingly if this product is present on their market. As the New Legal Framework is generic and addresses all sectors, a margin of freedom is given to the regulators.
L. Jachia, UNECE (United Nations Economic Commission for Europe)
The eMARS project is not carried out by the UNECE but maintains close cooperation with the Working Party on Regulatory Cooperation and Standardization Policies (WP. 6). It held its final conference in November 2008 and delivered a strategy for the further enhancement of market surveillance in Europe. This strategy has formed the basis of the new project EMARS II which officially commenced in November 2008.
Regarding a question raised before (N. Croft's) about the product life cycle and the continual improvement process: a number of voluntary schemes exist to certify conformity and some of these schemes are very advanced in the way they work (online certificate of conformity: you can access it anytime through the Website and check. The certificate on the Website is the original one): this guarantees that the product or the facility is in line with current regulations and standards.
Regarding the voluntary field and regulatory field, there should be no replication of the task that have been done by the manufacturer. There are numerous ways for the authorities and businesses to collaborate (sharing test results for instance). UNECE expects to continue to work closely with ISO/CASCO, to ensure that they deliver a common message and perhaps organize events in conjunction or back to back... UNECE's strengths are the fact that it is an Intergovernmental Organization, that it started working on Market Surveillance issues several years ago, and also its partnership with Eastern European countries
Regarding the voluntary field and regulatory field, there should be no replication of the task that have been done by the manufacturer. There are numerous ways for the authorities and businesses to collaborate (sharing test results for instance). UNECE expects to continue to work closely with ISO/CASCO, to ensure that they deliver a common message and perhaps organize events in conjunction or back to back... UNECE's strengths are the fact that it is an Intergovernmental Organization, that it started working on Market Surveillance issues several years ago, and also its partnership with Eastern European countries
M. Malekpour, ISIRI (Iran)
B. Fliess, OECD
The producer is 100% responsible for the product that is put on the market. If the product is imported, the Supplier's Declaration of Conformity (SDoC) regime requires that the producer has a legal entity that represents him in the importing country.
Y. Bo, CNCA (China)
In China’s law on product quality, China has very specific provisions for the conformity assessment bodies: if the certified products do not conform with the compulsory requirements, the authorities will make further investigations. If the conformity assessment body also violates the law, then the conformity assessment body will also assume related liabilities.
Z. Bilalis, EC
The supplier is always responsible for what he produces and the conformity assessment body is always liable for the good performance of his duties. The authorities are also responsible for the good performance of their duties. All stakeholders involved in producing and getting the product to market are liable.
Questions sent by email
Indonesia (BSN)
Z. Bilalis, EC
The supplier is always responsible for what he produces and that conformity assessment body is always liable for the good performance of his duties. The authorities are also responsible for the good performance of their duties. All stakeholders involved in producing and getting the product to market are liable.
Indonesia (BSN)
B. Fliess, OECD
SDoC maybe requires more established post market surveillance than other conformity assessment regimes. But assuming that we have a sector (electrical or telecommunications) where many countries would adopt a SDoC regime, it would be important that these countries collaborate in their market surveillance activities in this particular sector (exchange of information) and nationally between suppliers and authorities to make SDoC successful. You need to educate the suppliers about what is expected in terms of responsibility (even more under a SDoC regime). Regulators need also to be educated and trained to the post market responsibilities. The switch from a pre-market surveillance regime to a post-market surveillance regime is quite difficult to put in place.
COMMENT - G. Beer, DIN (Germany)
3 elements are needed in any market access regime:
- Liability legislation (the producer is responsible for what he places on the market;
- The conformity assessment aspect (pre-market measures: from SDoC to testing to a 3rd party certification) and this should be adapted with regard to the risks that the product represents;
- Market surveillance. This is needed in any case!
Indonesia (BSN)
Y. Bo, CNCA (China)
The measurement would be the consumers' complaints based on selected types of incidents.
Z. Bilalis, EC
One tool is the consumers'/users' survey. Second is a comparison between the products checked in a given sector and how many dangerous products have been found.
L. Jachia, UNECE
It has to do with the assessment of risks and we really need to work more on the assessment of risks in the market in order to be able to measure the reliability of the products on the market. Regarding the non-conformance and counterfeiting: there is an attempt to shift the responsibility to no one because a counterfeited product has no name on it.
B. Fliess, OECD
One should not use as an indicator the number of recalls or warning (because they may be indicative of the surveillance regime health).
Indonesia (BSN)
CASCO Secretariat (not answered during the workshop)
ISO has established a Project Committee on product recall. The Project Committee will meet for the first time in May 2009. The NWIP quotes a US and a European document:
- RECALL HANDBOOK, A Guide for Manufacturers, Importers, Distributors and Retailers, CPSC (Consumer Product Safety Commission).
- PRODUCT SAFETY IN EUROPE: A Guide to corrective action including recalls.
Gabon (ANTT)
CASCO Secretariat (not answered during the workshop)
Developing countries without a functional market surveillance may be subject to the dumping of products on their market from developed countries where the product fails to meet requirements. ISO can assist by ensuring there is adequate guidance and best practice document available to developing countries. Also important would be the rapid sharing of such information among authorities. The process of information sharing was an area for further discussion identified by the workshop. Any progress made in this will be communicated to interested parties via the ISO Website.
S. Name, ORG (County)
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Botswana (BOBS)
CASCO Secretariat (not answered during the workshop)
One of the output of the workshop may be the development of a "best practice guide". This would then be available to developing countries to assist with the implementation of any system.